Regeneron suspended testing its antibody cocktail in patients on high-flow oxygen or ventilation after an independent data monitoring committee flagged safety concerns. Two other cohorts in the trial—which focuses on hospitalized patients—are continuing as planned, and a separate trial in outpatients will also continue.
The CDC asked states to come up with vaccine distribution plans by Tuesday as WHO announced it's not convinced the front-runner shots actually work in the elderly.
Plus, smartwatches and Fitbits could help spot COVID-19 cases and support public health efforts to slow the disease's spread, a new study found.
And meanwhile, Novo Nordisk's oral diabetes med Rybelsus is on the upswing after COVID-delayed doctor visits siphoned off new prescriptions earlier this year.
The worldwide case count passed 45.3 million Friday afternoon, with more than 1.18 million reported deaths, according to Johns Hopkins University's COVID-19 dashboard.
Please read below for the latest updates. Daily COVID-19 tracker entries from April 21 through Aug. 11 can be found here. Entries from Jan. 30 through April 20 are here.
UPDATED: Friday, OCt. 30 at 3:11 p.m. ET
In a phase 3 antibody trial, Regeneron stopped testing the therapy on patients needing high-flow oxygen or mechanical ventilation after an independent data monitoring committee flagged safety concerns. The committee did clear Regeneron to continue enrolling hospitalized patients who need either no or low-flow oxygen and said its outpatient trial could continue "without modification." Story
Novo Nordisk's diabetes med Rybelsus took a hit from reduced prescribing during the pandemic, but executives said the launch is turning around. About 33,000 U.S. doctors are now writing prescriptions for the drug—back to pre-COVID levels—said Camilla Sylvest, EVP of of commercial strategy and corporate affairs at Novo. The company also launched a DTC ad campaign for Rybelsus in September and saw an "immediate increase" in website visits, she added. Story
Wearable devices like smart watches and Fitbits could spot COVID cases and help slow the disease's spread, according to early study data from Scripps Research Translational Institute. The DETECT study and its smartphone app logs participants' daily activity and matches that data with self-reported symptoms and potential testing results. The first six weeks of the study, which covered 30,000 participants, suggest significant changes in a person's heart rate, sleep quality and daily movement could help identify new infections. Story
The CDC has asked states to "preposition" vaccine doses at key sites around the U.S. and demanded critical distribution info by Tuesday, including a list of each jurisdiction's top five sites where a shot could be received and administered. Problem is, many states lack the funds to mount such a plan, and the federal government isn't providing.
The World Health Organization isn't yet convinced that frontrunners in the COVID-19 vaccine race will work in older patients. “While the information coming from the vaccine developers is encouraging, WHO has not yet seen published data on the efficacy of a vaccine candidate in the elderly,” an agency spokesperson told CNBC. The comments follow AstraZeneca's announcement Monday that its shot triggered a similar immune response in adults young and old.
Israel on Sunday aims to dose the first patient in a phase 1 trial of its vaccine candidate, Brilife, developed by the country's Institute for Biological Research. The trial aims to recruit 80 healthy volunteers between the ages of 18 and 55. The study will assess the shot's safety, as well as whether participants develop antibodies to the virus.
UPDATED: Friday, Oct. 30 at 9:04 a.m. ET
The U.K. kicked off rolling reviews of AstraZeneca and Pfizer's vaccines, Bloomberg Quint reported, citing a person close to the matter. The U.K. is still subject to the European Medicines Agency's approval process until the end of the Brexit transition this year, but the government has said it could jump ahead to offer a temporary vaccine authorization. The EMA previously said it had begun rolling reviews of the shots.
Speaking of AstraZeneca, the British drugmaker tapped Lonza to help manufacture drug substance for its combo antibody hopeful, AZD7442. The antibody pairing is currently in phase 1, though AZ plans to push the drug into phase 3 in the next few weeks, Lonza said. Lonza will produce the drug substance in the U.S. and aims to start work in the first half of 2021.
The UK BIA Antibody Taskforce—a British consortium dedicated to developing antibodies against COVID-19—pinpointed different antibody combinations to further develop as a cocktail therapy. Early indications suggest the antibody cocktail could be competitively potent and differentiated from other products in the clinic. Regeneron and Eli Lilly are among those working on antibody therapies against the virus. As for next steps, the UK BIA team will seek funding to support further development and manufacturing of the candidates, BIA chief, Steve Bates, said.
In-patient hospital beds are more than 80% full in Atlanta, Minneapolis and Baltimore, while specific ICU units in Tampa, New York City and Birmingham, Alabama are at over 95% capacity, NPR reported, citing HHS documents. While that information circulates internally, it isn't made available to the public, which could hamper collective efforts to curb the virus' spread and save lives, health experts told NPR.
And on Thursday, the United States recorded at least 90,000 new COVID cases—the equivalent of more than one per second, The New York Times reports. The country over the past week has reported more than 500,000 new cases and surpassed 9 million total since the pandemic began. Over a seven-day period ended Thursday, 24 states added record numbers of cases. Colorado, for instance, reported more than 2,000 new cases Thursday, Illinois more than 6,400 and New Mexico more than 1,000—all records for those states.
UPDATED: Thursday, Oct. 29 at 3:15 p.m. ET
In 2020's third quarter, Gilead Sciences sold $873 million of Veklury, also known as remdesivir, but a recent WHO study challenging the antiviral's efficacy in hospitalized patients could drag down Q4 sales, analysts figure. Plus, new therapies, such as antibodies from Regeneron and Eli Lilly are on their way, the analysts said. Meanwhile, Gilead CMO Merdad Parsey pointed out Wednesday that the WHO trial didn’t distinguish between patients requiring low- or high-flow oxygen, had no data monitoring, no data verification and 20% of the data are missing in the preliminary analysis. Story
Speaking of Veklury, U.S. care coordinator CarePort Health in August reported that about 6% of patients were receiving treatment with the drug across its client hospitals and care centers—a low number that CarePort attributes to supply constraints. By mid-October, Veklury usage rates were up to 19%, CarePort told FiercePharma, suggesting supplies had rebounded. Meanwhile, the steroid dexamethasone peaked at a 40% usage rate in that same period.
COVID-19 Infection rates in Moderna's phase 3 vaccine trial are in line with expectations, positioning the company to deliver two-month follow-up safety data by the second half of November. “Since we are following the ZIP codes and the counties from which these participants come, we have pretty sophisticated models of what to expect, and I think we’re on track for those expectations,” Moderna CMO Tal Zaks said.
Pfizer's mRNA partner BioNTech aims to deploy its shot in Germany within hours of an approval or authorization there, The Wall Street Journal reports. It's working with regional German health authorities to set up vaccination centers across the country's 16 states, as well as mobile vaccination teams to administer the shot in nursing homes and rural areas. BioNTech has also started storing doses at an undisclosed transport hub and will start shipping shots immediately after approval, a company spokesperson told WSJ.
Scientists at the Regeneron Genetics Center linked four gene locations and three specific genes to COVID-19 risk and severity, findings presented at the American Society of Human Genetics showed. Regeneron's team scoured data from 868,021 people across six studies and four ancestries, studying genetic differences in three categories: susceptibility to infection, need for hospitalization and severe outcomes like death. Story
Italy's National Institute for Infectious Diseases, L. Spallanzani, was approved to run a trial of the generic osteoporosis drug raloxifene in mild COVID-19 patients. The trial will test the drug's safety and ability to inhibit viral replication in 450 participants. Dompé Pharmaceuticals, Fraunhofer Institute and the University of Leuven in May filed a patent for raloxifene in COVID-19 after Exscalate4CoV, a public-private consortium backed by the EU, pegged the drug for potential use against the disease.
UPDATED: Thursday, Oct. 29 at 9:23 a.m. ET
Among non-hospitalized patients, Regeneron's antibody hopeful, REGN-COV2, cut COVID-related medical visits by 57% in the 29 days after treatment, phase 2/3 data showed. Regeneron found that 2.8% of patients on the antibody had a medical visit related to COVID-19, compared with 6.5% of people in the placebo group. Regeneron tested both a low and high dose, and found dosing had no significant effect on virologic or clinical efficacy. That fact could prompt the drugmaker to move forward with its lower dose, which could boost the number of treatment courses available. Story
Moderna is gearing up to launch its mRNA-based vaccine candidate and has already received $1.1 billion in deposits for supply, the drugmaker said Thursday alongside its Q3 earnings announcement. Aside from confirmed deals with the U.S. and several other countries, Moderna said it was in talks with the World Health Organization's global vaccine distribution effort, COVAX, to work out a tiered pricing model for its shot.
Meanwhile, Takeda will import and distribute 50 million doses of Moderna's shot in Japan starting in the first half of 2021, pending approval—part of a three-way agreement between the companies and Japan's Ministry of Health Labour and Welfare. Takeda recently agreed to help manufacture Novavax's shot at its Japanese facilities to shore up long-term supply for the country.
GlaxoSmithKline's threefold COVID-19 vaccine effort is progressing and, if clinical results are strong, could lead to three GSK-partnered shots in late-stage development by year-end, CEO Emma Walmsley said. The drugmaker is working with Sanofi, Medicago and Clover Pharmaceuticals on those three separate candidates. Plus, "pivotal" data on GSK's Vir-partnered antibody is expected by end of year, she added.
And after Sanofi and GSK on Wednesday pledged to supply 200 million vaccine doses to COVAX, Medicins Sans Frontieres (MSF) called on the companies to release details on price, supply and distribution of any shot that wins authorization or approval. Drugmakers developing pandemic vaccines should sell their products at cost, and must open the books to show the public exactly where that price lands, Kate Elder, senior vaccines policy adviser at MSF’s Access Campaign, said.
NIAID director Anthony Fauci for the first time supported a nationwide mask mandate to combat the surge of COVID-19 cases in the U.S. In an interview with CNBC and the Journal of the American Medical Association, Fauci suggested that protective measures like mask wearing had "not been done uniformly and consistently throughout the country," adding that such efforts were needed to prevent a second round of lockdowns.
And state and local officials are rolling out new restrictions as cases mount. El Paso, Texas, for instance, implemented a nightly curfew, while Coeur d’Alene, Idaho, recently passed a mask mandate. Meanwhile, the lack of clear direction has left states and cities to fend for themselves. “If you don’t have a national standard, what you have is a piecemeal approach, and you have absolutely no way of really containing the spread of this virus because people are not going to remain static," Denver's mayor, Michael B. Hancock, said.
UPDATED: Wednesday, Oct. 28 at 3:19 p.m. ET
GlaxoSmithKline's vaccine business is suffering "short term pressures" from the pandemic, CEO Emma Walmsley said. With American doctor visits delayed through July and August, GSK's shingles vaccine Shingrix posted third quarter sales of £374 million, down 25%, though vaccination rates reached pre-COVID levels by the quarter's end, CFO Iain Mackay said. Elsewhere, a "disrupted" back to school season siphoned sales from GSK's meningitis B shot Bexsero, while flu vaccines posted a 21% sales increase. Story
The FDA granted 510(k) clearance to Abiomed's compact, all-in-one life support system, Breethe OXY-1. The system exchanges oxygen for carbon dioxide in the blood and then pumps it back into the bodies of patients hit with respiratory failure or cardiogenic shock caused by COVID-19 and other viruses and conditions. Its portability aims to support patients' movements as they transition to walking on their own. The device is cleared for up to six hours of use, though it can be used for longer in emergency situations. Story
Covaxx teamed up with integrated logistics company Maersk, laying out a framework to deploy the drugmaker's shot, UB-612, globally. Covaxx's multitope synthetic peptide-based vaccine is currently in a phase 1 trial in Taiwan. The company plans to manufacture 100 million doses during early 2021, with the goal to crank one billion doses by next year's end.
Current vaccine trials will be too short and too small in scope to show whether a shot curbs hospitalizations and deaths, William Haseltine, chair and president of Access Health International, told Kaiser Health News. Still, there's a case for the approach: Original studies of the measles vaccine only showed that it prevented disease, but later trials confirmed it drastically reduced mortality, too, Kathleen Neuzil, director of the University of Maryland’s Center for Vaccine Development and Global Health, said.
Global enrollment in clinical trials has rebounded to pre-COVID levels, according to a new report by study management firm Greenphire. The second quarter seems to have hit CROs and trial service companies the hardest, but enrollment is now up 85% from April, and has even surpassed pre-pandemic enrollment trends, climbing 3% since January, the Greenphire data showed. Story
UPDATED: Wednesday, Oct. 28 at 9:18 a.m. ET
Sanofi and GlaxoSmithKline will provide 200 million doses of their vaccine to COVAX, a global effort co-led by the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations to develop, produce and equitably distribute COVID shots. Elsewhere, Sanofi and GSK have pledged 300 million doses to the EU and up to 600 million doses to the U.S. Story
The U.S. government agreed to pay Eli Lilly $375 million for 300,000 vials of the drugmaker's experimental antibody, LY-CoV555, despite mixed data so far. The deal is contingent on an emergency authorization from the FDA. Under the deal, Lilly would ship the initial doses within two months after winning an emergency nod. The U.S. also has an option to buy 650,000 more vials through June 30. The NIH this week stopped a trial of Lilly's antibody, citing minimal benefit in hospitalized patients. In a separate study, data in patients with milder disease was positive for just one of three doses.
Delays in manufacturing scale-up prompted Novavax to push the start of its late-stage U.S. vaccine trial to the end of November. Meanwhile, interim data from a separate phase 3 trial in the U.K. could roll in by early 2021, and Novavax plans to share data from its ongoing phase 1/2 study on Friday at a CDC meeting, the drugmaker said.
Novartis is set to pay Molecular Partners $69 million upfront to develop, manufacture and market two COVID-fighting DARPin antivirals. Molecular Partners will run phase 1 trials on one of the candidates, MP0420, set to begin in November, and complete preclinical work on the other, MP0423, before Novartis takes the reins on phase 2 and phase 3 studies. Novartis will pay Molecular Partners an additional CHF 150 million, plus royalties, if it takes up an option on both drugs. Story
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) kicked off a rolling review of Moderna's mRNA-based vaccine candidate. The MHRA can now start an independent assessment of the shot using information provided by Moderna and will accept new evidence as it rolls in until the application is complete.
The U.K. could make a COVID-19 vaccine available for some people before Christmas—if those shots prove safe and effective in clinical trials—though an early 2021 launch is "more realistic," said Kate Bingham, head of the country's Vaccines Taskforce.
Governments should work to boost their local drug supply chains, not just in response to the current COVID-19 pandemic, but also to prepare for future public health crises, Martin Meeson, CEO of Fujifilm Diosynth Biotechnologies, said. The industry has "worked really well" to maintain access to critical drugs, but more collaboration among groups like universities doing drug discovery work and manufacturers is needed, he added.
UPDATED: Tuesday, Oct. 27 at 3:35 p.m. ET
A lower-than-expected number of COVID-19 infections in Pfizer's phase 3 vaccine trial means data aren't yet ready for an interim analysis—which in turn likely means the company won't hit its original goal of producing interim results this month. It still hopes to launch the shot by year-end, though, CEO Albert Bourla said. When the data are available, the interim analysis would take "between five and seven days," Bourla said, pushing a readout into the first week of November at the earliest. Story
Merck expects the pandemic to take a $2.5 billion chunk out of its 2020 revenue, but it's still managing revenue growth, and it's optimistic that 2021 will bring a resurgence, particularly for suffering HPV vaccine Gardasil. The company's also looking out for results from its COVID-19-fighting work—both the Ridgeback Bio-partnered antiviral drug, molnupiravir, and Merck's homegrown vaccine hopeful. Its $12.6 billion in third quarter revenue, a 1% increase year over year, was buoyed by its cancer blockbuster Keytruda and its pneumococcal shot Pneumovax. Story
Novartis' best-selling drug Cosentyx breached blockbuster territory in the third quarter, pulling in $1.01 billion, though it still came in below industry watchers' expectations. The cause? Pandemic-related dermatology slowdowns, Novartis’ pharma chief Marie-France Tschudin said. Only an estimated 70% to 90% of the drugmaker's pre-COVID-19 target patients have gone back to see their doctors, she added. Story
Eli Lilly's diabetes med Trulicity grabbed $1.11 billion in third-quarter sales, up 9% over the same period last year but below analyst estimates. Part of that can be chalked up to pricing declines. Concerned that pandemic-related job losses would make it hard for patients to access Trulicity on commercial plans, Lilly prioritized access in Medicaid. More patients are on government insurance plans than before, which led to a 6% price decline in the third quarter, boosting top-line sales but hurting net prices, the company said. Story
San Francisco's Nektar Therapeutics got the go-ahead to run a phase 1b study of its investigational cancer med, bempegaldesleukin, or Bempeg, in mild COVID-19 patients. The hope is that Bempeg's ability to stimulate lymphocyte production will boost the effects of existing treatment regimens. Nektar will kick off recruitment in early November and aims to enroll up to three cohorts of 10 patients each.
Covance hit $1.24 billion in third-quarter revenue, a 5.7% increase over the same period last year. Much of that growth came down to the company's COVID-19 testing efforts. Elsewhere, its drug development business "continues to recover" from ongoing trial delays, site restrictions and pandemic-fueled supply chain gaps, Covance said in its financial report. Story
UPDATED: Tuesday, Oct. 27 at 9:30 a.m. ET
The National Institutes of Health axed its trial of a combination of Eli Lilly's experimental antibody and Gilead Sciences' Veklury, or remdesivir, in hospitalized COVID-19 patients, citing a "lack of benefit." Enrollment in the trial was paused earlier this month over a potential safety concern, though an independent review board said Monday that it confirmed similar safety outcomes for patients on the antibody and placebo. Meanwhile, Lilly's own studies of the drug, LY-CoV555, will proceed normally, the company said. Story
Former FDA Commissioner Scott Gottlieb, M.D., stood by the agency's approval of Gilead's Veklury, or remdesivir, last week, despite lackluster data on the drug from a WHO-run trial. “The balance of the data shows that it is providing a benefit,” Gottlieb told CNBC's "Squawk Box." “We rushed a lot of medicines into clinical development, not necessarily optimizing them. This is sort of the first generation of medicines. Nothing, probably, is going to be a home run.”
South Korea kicked off a preliminary review of AstraZeneca and the University of Oxford's shot, the country's Ministry of Food and Drug Safety said. The agency has formed a screening team to review nonclinical test data on the vaccine and expects a formal approval application to roll in within 90 days under the country's rapid review program for COVID-19 drugs and vaccines.
India's Cadila Healthcare is looking for contract manufacturers to help crank out an additional 50 million to 70 million doses of its plasmid DNA vaccine, on top of the 100 million doses it can produce itself, managing director Sharvil Patel said. The aim is to eventually license the vaccine to other countries, which would require ex-Indian manufacturing, he added. Cadila's vaccine is currently in a phase 2 trial, and the company expects to start recruiting for phase 3 in December.
Conservative opposition parties in Canada passed a motion to launch a probe into the government's handling of the pandemic, which may force disclosure of details surrounding the purchase of vaccines, personal protective equipment, medical devices and drugs. Those disclosures could put the country's pandemic contracts in jeopardy, Procurement Minister Anita Anand said. Meanwhile, Pfizer Canada President Cole Pinnow allegedly raised concerns about the motion and its effect on closely guarded company information, The Canadian Press reported.
The pharma industry needs to work with airports directly to hammer out vaccine distribution plans, Cold Chain Association (CCA) Secretary General Nicola Caristo said. Some hubs, like Emirates Airlines' SkyCentral DWC cargo facility in Dubai South, are already vying to offer space, while others are teaming up. The CCA is partnering with the International Air Transport Association to pool feedback and best practices, and the International Air Cargo Association joined forces with pharma.aero to support vaccine distribution readiness.
UPDATED: Monday, Oct. 26 at 3:00 p.m. ET
An emergency vaccine nod could create an ethical dilemma for blinded vaccine studies, Christine Grady, head of the bioethics department at the NIH Clinical Center, told Science. Patients in the trial would have a right to know whether they received the authorized shot, she argued. An emergency OK could also prompt studies to provide the cleared vaccine rather than placebo; without a placebo control, trials would take longer and cost more, too, Grady said.
The FDA won’t require preapproval manufacturing inspections for companies seeking vaccine authorization, Bloomberg reported, citing agency official Jerry Weir. Instead, drugmakers will need to submit details on their manufacturing processes and set up internal quality control units. Moderna, among the front-runners in the vaccine race, has yet to gain FDA approval for one of its products and has never had a facility inspected by the FDA, an agency database shows. Story
Israel aims to kick off human trials of its vaccine candidate, Brilife, next week, the country's Institute for Biological Research (IIBR) said. IIBR's shot uses a vesicular stomatitis virus loaded up with proteins that form coronavirus "crowns," which the body then recognizes as COVID-19, triggering an immune response. The phase 1 study will begin Nov. 1, with a phase 2 start expected in December.
Genomics company Helix can now offer its virus test for on-site and unsupervised self-collection, plus asymptomatic screening, thanks to an expanded emergency nod from the FDA. The new emergency use authorization cuts out the need for medical staff to oversee sample collection and makes California’s Helix one of the few labs cleared to test people without symptoms. Story
South Korea’s Celltrion scored an emergency thumbs up from the U.S. FDA for its rapid COVID-19 test, Sampinute. The test is designed to deliver results within 10 minutes and has a 94% sensitivity rate, according to the company, which is also working on a COVID-19 antibody. Story
Boots, a consumer pharmacy in the U.K., will sell LumiraDx’s rapid COVID-19 test at an initial 50 locations, aiming to boost screening of patients without symptoms. LumiraDx’s test should take around 12 minutes to work and uses a nose swab that can be inserted into a portable machine inside the shop. The test costs £120 ($156) and aims to help control so-called asymptomatic spread. Story
ContraFect kicked off an expanded access program to provide its lysin therapy exebacase to help clear bacteria in the bloodstreams of COVID-19 patients suffering from secondary methicillin-resistant staphylococcus aureus (MRSA) infections. The new protocol is available to clinical sites taking part in the company’s phase 3 staph aureus study and allows doctors to use the drug in hospitalized COVID-19 patients who can't enroll in the trial.
The Fraternal Order of Real Bearded Santas will no longer appear in the HHS' $250 million pandemic ad campaign, nor will they receive early access to approved vaccines, as promised by former HHS communications lead Michael Caputo, The Wall Street Journal reported. The ad campaign has hit other snags, and appears to be on hold after HHS Secretary Alex Azar ordered a review of the effort to determine whether it serves a valid public health purpose. Story
UPDATED: Monday, Oct. 26 at 10:00 a.m. ET
Johnson & Johnson's vaccine could become available for emergency use by January, said Ruxandra Draghia-Akli, head of public health research and development at the company. J&J on Friday announced plans to restart its late-stage vaccine trial, recently paused over safety concerns. Results from that study are expected by year-end.
AstraZeneca's pandemic vaccine appears to trigger an immune response in both younger and older patients and triggered milder side effects in the elderly, the drugmaker said. "It is encouraging to see immunogenicity responses were similar between older and younger adults," a spokesperson said via email. In July, the drugmaker unveiled blood test data that showed its vaccine produced a "robust" immune response in a group of healthy adults ages 18 to 55.
And under its vaccine pact with the University of Oxford, in accounting for its cost of production, AstraZeneca can add up to 20% to its manufacturing costs to represent the other expenses it's incurred. The company has repeatedly said it would offer its vaccine "at no profit," so calculating its costs is key to determining the price. The company is shouldering costs "in excess of $1 billion globally" on top of manufacturing itself, a company spokesperson said.
The European Medicines Agency (EMA) is willing to accept a vaccine that works in less than 50% of patients, if the safety risks don't outweigh the benefits. The EMA guidance differs from that of the U.S. Food and Drug Administration, which is calling for at least 50% efficacy for a shot to snare an emergency nod.
At least five aides or advisers to Vice President Mike Pence tested positive for the virus over the weekend—information that Pence admitted Sunday he'd tried to withhold. Meanwhile, the White House appears to have thrown in the towel on curbing the virus' spread. “We’re not going to control the pandemic,” White House Chief of Staff Mark Meadows said. “We are going to control the fact that we get vaccines, therapeutics and other mitigations.”
And after testing negative Sunday, Pence plans to continue campaigning "in accordance with the CDC guidelines for essential personnel," the vice president's press secretary said. As for whether that puts others at risk, "the short answer is yes," ex-FDA commissioner Scott Gottlieb said. The White House needs to be explicit about the risks, and Pence should wear a high-quality mask, engage in social distancing and undergo "serial testing," Gottlieb said.
UPDATED: Friday, Oct. 23 at 3:10 p.m. ET
The FDA wrapped its investigation and gave AstraZeneca the OK to resume its U.S. vaccine trial, a source close to the matter told The Wall Street Journal. The FDA didn't find the vaccine responsible for the two cases of a potential neurological side effect that prompted the clinical hold, but couldn't rule out a link to the shot, either. The agency will now ask researchers to inform trial participants about those cases and monitor patients for any related neurological events.
Merck's slow-and-steady approach to COVID-19 vaccine development runs at odds with others in the race, and it sparked debates within the company, too, The Wall Street Journal reports. Before the virus was a full-blown pandemic, some staffers wanted to jump on a shot, but were rebuffed by CEO Ken Frazier and chief scientist Roger Perlmutter, who argued that the process could take years and might detract from other research, sources told WSJ.
In the weeks since the FDA flouted the White House to publish stricter safety guidelines for a COVID-19 shot, HHS Secretary Alex Azar has openly discussed firing its commissioner, Stephen Hahn, Politico reports. The guidance, which calls for two months additional safety data before a shot is eligible for review, was released within materials for yesterday's hearing on vaccine developments, irking Azar. Still, it's unlikely the White House will remove Hahn at this time, sources told Politico. Story
Those extra two months of safety monitoring, which start after a volunteer has received the last dose of a vaccine, may not be enough, experts at Thursday's meeting said. Longer-term data is needed to show how long immunity lasts, or whether side effects occur, they said. Meanwhile, the FDA could grant "expanded access" to a shot, more limited than an emergency nod, and typically used to give experimental meds to severely ill patients, director of the agency's Office of Vaccines Research and Review, Marion Gruber, said.
Convalescent plasma failed to curb disease progression or death rates in hospitalized patients with moderate COVID-19, a phase 2 trial from the Indian Council of Medical Research showed. Researchers enrolled 464 patients, with half receiving plasma plus standard of care, and the other half standard care alone. Nineteen percent of patients in the plasma arm progressed to severe disease or died, compared to 18% of people in the control group. Meanwhile, 68% of patients in the plasma arm tested negative for the virus on day 7 of the trial, versus 55% in the control group. Story
A COVID-19 shot will likely be available in Germany early next year, the country's health minister, Jens Spahn, told Der Spiegel. The country is buying a surplus of vaccines and could eventually sell unneeded doses to other countries or donate them to poorer nations, Spahn said. Elsewhere, Daily Bild reported that the country plans to set up 60 cold-chain storage-equipped special vaccination centers to kick off inoculations as early as this year.
UPDATED: Friday, Oct. 23 at 9:27 a.m. ET
Gilead Sciences' Veklury, also known as remdesivir, snared a green light in hospitalized COVID-19 patients over the age of 12, making it the first pandemic treatment to win a full FDA approval. The antiviral first grabbed an emergency nod in May after it was shown to lower recovery time in hospitalized patients. Meanwhile, the drug failed to curb mortality or decrease the length of hospitals stays in a recent WHO-run trial. Story
And Gilead will likely see a revenue bump from Veklury, though coronavirus-related sales are expected to taper off in the second half of 2021, Citigroup analyst Mohit Bansal predicts. Based on hospitalization rates, Bansal estimated demand for $780 million worth of Veklury in the year's third quarter.
AstraZeneca could offer an initial readout from its late-stage vaccine trial in mid-November, if the shot is around 60% effective, Jefferies analysts predicted. If efficacy lands closer to 50%—the FDA's minimum requirement for an emergency nod—that data readout would likely emerge in December instead. AZ's vaccine may also prove more successful at moderating symptoms than preventing them outright, which could hinder a swift readout, the analysts said.
Meanwhile, Peru rebuffed a vaccine purchase deal with AstraZeneca, Prime Minister Walter Martos said. The government took issue with the number of doses AZ was offering. Plus, Peru requested data from the British drugmaker's vaccine trials, which AstraZeneca has not supplied.
Pfizer and Johnson & Johnson are seeking FDA guidance on how to recruit and retain vaccine trial volunteers once a shot is made publicly available. Ahead of the agency's first COVID-19 vaccine hearing Thursday, J&J urged FDA to discuss plans to keep trials on track, warning that an approval or authorization could cause volunteers to withdraw from studies.
IAVI and Serum Institute of India (SII) struck a pact with Merck KGaA to develop monoclonal antibodies to treat COVID-19. The group will run accelerated studies on antibodies co-created by IAVI and Scripps Research; if either one or a combination passes muster in the clinic, Merck KGaA will handle commercialization in developed countries, while SII leads global manufacturing and marketing in low- and middle-income nations.
At Thursday's final presidential debate, President Donald Trump suggested that the recent surge in COVID-19 infections would "soon be gone." Democratic nominee Joe Biden's take? "We're about to go into a dark winter." Trump also has "no clear plan" to tackle the pandemic, Biden said. "I'm going to shut down the virus, not the country. It's [Trump's] ineptitude that caused the country to shut down in large part," he added.
And as the world races toward a COVID-19 vaccine, doctors are doling out more pneumonia shots as a preventive measure, fueling record-high demand for Merck's pneumococcal lung infection vaccine, Pneumovax 23, Reuters reports. Merck is now hustling to keep up with demand, but supplies are low in certain European markets, a company spokesperson said. Germany, Italy, Belgium, Austria and Ireland are among those affected. Story
The University of Birmingham teamed up with the University of Cambridge, Dupont Teijin Film, Innospec and FiberLean to develop a surface treatment designed to capture aerosol droplets and inactivate the virus. The team envisions the protectant being delivered through additives in existing commercial products like detergent, or integrated into packaging, where it would form a long-lasting film. Research will take place over 18 months, with the goal to rapidly push the product to market.
UPDATED: Thursday, Oct. 22 at 3:40 p.m. ET
At Thursday’s much-anticipated FDA hearing over COVID-19 vaccine developments, officials talked distribution plans, safety and efficacy requirements, and much more. The CDC is already working on a multiphase strategy to make vaccines available to Americans, with plans to tap partnerships with local jurisdictions and pharmacies. Story
But vaccine skepticism remains. Experts with the Reagan-Udall Foundation are seeking to learn what people think about COVID-19 vaccines, and they said on Thursday they’ve heard serious doubts about the process. The group’s CEO Susan Winckler called what she heard “powerful, illuminating and sobering.” Story
Moderna has completed enrollment for its large phase 3 trial on its COVID-19 vaccine. Investigators have enrolled thousands of high-risk participants, plus 11,000 people from communities of color. Story
Industry officials including Ovid Therapeutics CEO Jeremy Levin and BIO CEO Michelle McMurry-Heath wrote an open letter in the Nature Research Bioengineering Community in support of NIAID director Anthony Fauci and the “the institutions and organizations that are working tirelessly to combat the COVID-19 pandemic.” Letter
Indian company Bharat Biotech has been approved for phase 3 trials of its COVID-19 vaccine, Covaxin, in India. The company developed the immunization in collaboration with the Indian Council of Medical Research. Story
UPDATED: Thursday, Oct. 22 at 9:30 a.m. ET
Roche will shell out $350 million to Atea Pharmaceuticals to help develop, produce and deploy its oral antiviral, AT-527, currently in a phase 2 trial in hospitalized patients with moderate COVID-19. If the drug wins approval, Atea will distribute it in the U.S., with potential support from Roche's Genentech unit, while Roche covers distribution outside the states. The drug is expected to enter a phase 3 trial in non-hospitalized patients sometime next year. Story
AstraZeneca's vaccine correctly follows the genetic instructions programmed into it by developers, an independent study from researchers at Bristol University found. Those genetic instructions detail how to make the coronavirus' spike protein, which triggers the immune reaction and trains the body to respond to a real infection. The study has not been peer-reviewed and was published as a preprint.
Meanwhile, the paerticipant who died in AstraZeneca's global vaccine trial did not receive the drugmaker's shot, Bloomberg reported, citing a source close to the matter. Brazil's health authority Anvisa received word of the volunteer's death Monday, along with a partial report from an international committee overseeing the trial's safety, which recommended the study proceed normally. The University of Oxford said it had no concerns after running its own review.
Most Americans could receive a vaccine by June of next year, Operation Warp Speed chief Moncef Slaoui said on ABC news. If a vaccine snares approval before year-end, the country will have roughly 20 million to 40 million doses ready for deployment to high-risk groups, he added. Also, AstraZeneca's U.S. trial is due to resume "imminently," he added, and while Slaoui said he hasn't faced political pressure personally, he fears the looming election has added to the politically fraught environment surrounding COVID vaccine development.
Americans may initially receive Regeneron's COVID-19 antibody cocktail for free, because the U.S. government subsidized development and production, and has promised to snap up early doses. But that only covers part of the cost, one expert pointed out. For one thing, the drug must be infused, which raises costs. Even after copays, patients could owe between $2,000 to $10,000 per treatment. Meanwhile, limited supplies mean many won't have access to the treatment even if they can afford it.
The FDA has added an hour-and-a-half window to Thursday's meeting of its vaccine advisers to allow for public input. The agency will also stream the meeting live on YouTube in a bid to increase public confidence in an eventual shot. During the initial meeting, the Vaccines and Related Biological Products Advisory Committee will lay out expectations for looming vaccine reviews, discuss what's known about the virus so far and detail safety monitoring plans for shots that snare a green light.
Fujifilm tapped Shanghai's Carelink Pharmaceutical to exclusively market its flu med favipiravir, sold as Avigan, to treat COVID-19 in China. The drugmakers also plan to co-develop a parenteral injection formulation of the drug. Fujifilm last Friday filed for approval of Avigan to treat COVID-19 in Japan.
Indian drugmaker Dr. Reddy's Laboratories was hit by a cyber attack that forced plant closures in the U.S., U.K., Brazil, India and Russia. Dr. Reddy's expects its services to be up and running again within 24 hours, the company's chief information officer said. Dr. Reddy's and the Russian Direct Investment Fund recently scored renewed approval to run late-stage trials on Russia's Sputnik V shot in India.
Scientists in Canada, Australia and Chile joined forces to run a trial on the drug interferon as a preventive treatment in households where one or more people has recently tested positive for COVID-19. Set to kick off next week in Santiago, Chile, the trial could yield results in as little as four weeks. Eligible participants will receive the drug 72 hours after someone in the house tests positive, plus two more doses six and 11 days after that. The aim is to see whether early administration clears the virus faster and curbs its spread to others.
UPDATED: Wednesday, Oct. 21 at 3:10 p.m. ET
A patient in AstraZeneca's phase 3 vaccine trial has died, though the study will continue, Reuters reports, citing the Brazilian health authority Anvisa. The patient who died was Brazilian, the Federal University of Sao Paulo said, and received a placebo rather than the vaccine, Brazilian newspaper O Globo reported. "There have been no concerns about safety of the clinical trial," the University of Oxford said, confirming plans to keep testing.
California will set up its own panel of experts to vet incoming coronavirus vaccines, Gov. Gavin Newsom said Monday. The 11-person panel of epidemiologists, biostatisticians and infectious disease experts will review any shot that passes the FDA's bar before it goes out to Californians, Newsom said. The move comes amid a firestorm of criticism over potential political interference at the FDA. New York also plans to run independent reviews on FDA-approved shots.
Pfizer's vaccine could pull in peak sales of $3.5 billion next year before leveling out at about $1.4 billion a year after that, SVB Leerink analysts wrote to clients Wednesday. And while Pfizer is developing the shot with BioNTech, it still stands to profit after splitting the proceeds, due to the exceptionally high demand for a COVID-19 shot. Pfizer's vaccine could initially grab 50% of the market, but will drop to around 25% once vaccines from Johnson & Johnson, Moderna, AstraZeneca, Sanofi and others enter the fray, the analysts predict. Story
Aridis Pharmaceuticals' inhaled monoclonal antibody treatment for COVID-19 successfully cleared signs of the novel coronavirus in infected hamsters at a far lower dose than other experimental antibodies, administered via infusion. Armed with those results, Aridis aims to test its nebulizer-delivered treatment in non-hospitalized mild-to-moderate COVID-19 patients in the first half of 2021. Story
Stanford Medicine kicked off plans to survey the population of greater San Francisco for COVID-19 to help build an early warning system for future pandemics. The Community Alliance to Test Coronavirus at Home, or CATCH Study, will rely on mix of self-collection testing kits—developed with the Chan Zuckerberg Biohub, also helping fund the study—and daily patient reporting of symptoms and exposures through an online portal. Story
Testing juggernaut Thermo Fisher's third-quarter revenue topped $8.52 billion, up 36% from the same period in 2019, and a whopping $2 billion of that came from coronavirus-related income. Its life sciences solutions and speciality diagnostics segments brought in an extra $1.72 billion and $550 million, respectively, and revenue from lab products and services grew as well, adding $490 million—although total analytical instruments sales came in at $1.34, slightly below 2019's $1.36 billion. Story
IQVIA upped its full-year guidance as business recovers from COVID-19. The CRO posted $8.06 billion in revenue for the first nine months of the year, down 1.2% at constant currency rates. Its Technology and Analytics unit posted growth of 5.6%, hauling in $3.43 billion, while R&D dragged, largely due to pandemic disruptions at research sites, with revenue at $4.07 billion, down 5.4% versus that same period last year. The company now expects full-year sales of $11.1 billion to $11.25 billion, a notch up from the $11 billion to $11.1 it predicted last quarter. Story
UPDATED: Wednesday, Oct. 21 at 9:30 a.m. ET
Eli Lilly hired an outside consultant to review its Branchburg, New Jersey, plant—one of five producing the drugmaker's COVID-19 antibody—after receiving an Official Action Indicated notice from the FDA tied to quality control issues. Lilly reiterated that it has not received a warning letter.
Meanwhile, inspectors again flagged Lilly's Branchburg plant during an inspection in July and August, citing "a major failure of quality assurance." Employees at the plant failed to investigate potential quality control problems and regularly overrode testing systems, an FDA memo said, as reported by Bloomberg. Story
Pfizer is gearing up for its "biggest-ever vaccination campaign," with the goal to begin shipping vaccines "very shortly after" winning an FDA authorization. In addition to revving up two refrigerated storage sites in Europe and the U.S., the drugmaker designed a reusable container that can store up to 5,000 doses at ultracold temperatures for up to ten days. Pfizer expects to move about 7.6 million doses to airports daily. Story
If a shot snares approval by early 2021, vaccinations could make a dent in the pandemic by next year's second quarter, BioNTech CEO Ugur Sahin told South China Morning Post. That said, vaccine makers, scientists and the media will need to push to dispel vaccine skepticism ahead of a product launch, he added. Efficacy data on the first subjects infected with COVID-19 in Pfizer and BioNTech's phase 3 is expected in the next few weeks.
Roche's arthritis med tocilizumab, sold as Actemra, did little to curb deaths in patients hospitalized with COVID-19 pneumonia, two randomized studies published in JAMA found. In a 123-subject trial, 17 out of 60 patients given Actemra worsened after 14 days, and two died, compared with 17 of 60 patients whose condition deteriorated on standard care. A separate trial found Actemra may lower the risk of death and ventilation by day 14, though 28-day mortality remained the same. Story
Meanwhile, an observational study on nearly 4,000 U.S. patients, also published in JAMA, found that 28.9% of subjects who received Actemra died compared with 37% of those who didn't receive the Roche med. Those data warrant further investigation of the drug as a potential pandemic therapeutic, researchers said in editorial accompanying the study.
Once several vaccines have hit the market, a "very large portion" of those shots could eventually be manufactured in India, said Mark Suzman, CEO of the Bill & Melinda Gates Foundation, adding that India will be a key area of focus in the next wave of the pandemic. The Gates Foundation so far has committed $300 million to Serum Institute of India as the drugmaker looks to crank out 200 million doses of Novavax and AstraZeneca's shots in 2021.
UPDATED: Tuesday, Oct. 20 at 3:19 p.m. ET
The FDA completed its review of a patient illness from AstraZeneca's phase 3 trial and could allow the British drugmaker to resume its U.S. vaccine study as early as this week, Reuters reports, citing sources close to the matter. It's unclear how the agency will characterize the illness, but researchers will need to detail the incident on future consent forms, one source said. U.K. regulators previously claimed there was "insufficient evidence" to link the illness to AZ's shot—and the FDA seems to agree, based on a draft of a letter to U.K. trial participants, obtained by Reuters, that details the outcome of the U.S. review. Story
Sinovac's shot proved safe after two doses, preliminary data from a Brazilian phase 3 of the Chinese biotech's vaccine showed. Brazil's Butantan Institute tested the shot in 9,000 volunteers and plans to release efficacy data once all 15,000 subjects in expanded trials have received the vaccine, the institute's director said. Meanwhile, the shot appeared to trigger an antibody response, too, Sao Paulo 's state health secretary said.
China National Pharmaceutical Group, also known as Sinopharm, may have capacity to crank out more than 1 billion vaccine doses in 2021, the company's chairman said at a media briefing. Roughly 60,000 people so far have received the shot in phase 3 trials, an official at China's Ministry of Science and Technology added. Since July, hundreds of thousands of Chinese citizens have been dosed with experimental vaccines under an emergency program.
Only 43% of Black Americans say they'll get a vaccine once one is available, down 22% from August, The Harris Poll found. White Americans' shot willingness stands at 58%, down 11 points from that same month. Overall, trust in different sources for COVID-19 info was lower among people of color, too. Seventy-two percent of Black Americans counted doctors and nurses as reliable sources, compared to 87% of white respondents. Meanwhile, drugmakers like Johnson & Johnson are working to improve outreach to minority communities as they gear up for potential vaccine rollouts. Story
When the FDA's vaccines advisory panel sits down to meet for the first time this Thursday, members will lay the groundwork for specific shot reviews to come, attempting to provide a "level playing field" for all developers, an agency briefing document says. The FDA will seek its expert panel's advice on topics like vaccine confidence, distribution, safety monitoring and more. As for individual vaccines, the FDA will require a separate meeting of the committee for each application that comes through. Story
Spanish drugmaker Rovi, on the hook to carry out fill-finish duties on Moderna's mRNA vaccine hopeful, expects to start producing the shot "very soon" should it win a thumbs up from U.S. regulators, the company said.
Vaccitech, the biotech behind AstraZeneca and the University of Oxford's late-stage pandemic shot, tapped Kite Pharma and Pfizer vet Margaret Marshall, M.D., as its new chief medical officer. Marshall's move comes two months after the Oxford spinout won U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation shots, including the AstraZeneca vaccine it helped develop. Story
Roche, enlisted to aid Regeneron produce and commercialize its antibody cocktail, is investing $500 million over five years to build a global technical operations center at its Canadian pharma headquarters in Mississauga, Ontario. Roche will use the Mississauga addition to organize production globally across its 13 plants and 11 sites, a company spokeswoman said. The logistics hub will also add 500 new jobs by 2023. Story
UPDATED: Tuesday, Oct. 20 at 9:13 a.m. ET
The first interim analysis of Moderna's shot will occur after 53 people in the drugmaker's phase 3 develop COVID-19. That review will likely happen in late November, teeing up a potential emergency nod in December, Moderna CEO Stéphane Bancel said. An approval decision could get pushed into 2021, though, if it takes longer for trial patients to develop confirmed, symptomatic infections. Meanwhile, Moderna is also ramping up production ahead of a possible approval.
The Government Accountability Office plans to investigate alleged political pressure from the Trump Administration on the Centers for Disease Control and Prevention and the Food and Drug Administration. The investigation will start in January and is set to run for three months in a bid to "determine whether this interference has violated the agencies' scientific integrity and communication policies," according to a Senate request for the audit.
Specialist contract research organization hVIVO, Imperial College London and the Royal Free Hospital plan to kick off the world's first COVID-19 challenge trial in January, armed with £33.6 million ($43.6 million) in U.K. government support. To start, researchers will try to identify the smallest amount of virus needed to cause COVID-19 in up to 90 volunteers, with data expected in May. If that data passes review, the challenge study model could then be used to assess how vaccines work in humans. Story
Pfizer and BioNTech kicked off a phase 1/2 trial of their mRNA vaccine hopeful in Japan, with plans to recruit 160 people ages 20 to 85 years old. Pfizer and its German mRNA partner previously agreed to supply Japan with 120 million doses of their vaccine hopeful in the first half of 2021, provided it's approved for use.
Spain is set to receive 31.6 million doses of AstraZeneca's vaccine between December and June, if the shot passes muster in the clinic, Spanish Health Minister Salvador Illa said. The shots fall under a broader supply deal for up to 400 million AstraZeneca doses to the European Union, which member states are able to buy according to their country's population.
UPDATED: Monday, Oct. 19 at 3:27 p.m. ET
Anthony Fauci, in his role as “designated senior representative” of the U.S. government, will be among the first to look at vaccine trial results from Moderna, Johnson & Johnson, AstraZeneca and others, documents obtained by ProPublica show. One catch? Fauci’s oversight doesn’t extend to Pfizer’s shot, since the drugmaker is conducting its phase 3 study without Operation Warp Speed or NIH support.
Johnson & Johnson has yet to shed light on the "unexplained illness" that put its phase 3 vaccine trial on pause last week, eschewing a level of transparency that's crucial for the public to trust—and take—and approved shot, Paul Offit, M.D., part of an FDA advisory committee that will review the vaccine, told CNN. Director of the Center for Vaccine Development at Texas Children's Hospital, Peter Hotez, M.D., Ph.D., agreed: "By shrouding this in secrecy... it somehow conveys the message that something untoward is happening."
The National Governors Association is looking to the Trump Administration for answers on how a national vaccine rollout will work. Some key questions? Will states receive additional funding to support shot distribution and inoculation; how will administration costs be covered for those without insurance; and just how does the government plan to divvy up supplies between states? The Association is also seeking clear guidance on how to deploy vaccines to Federal entities like prisons and Veterans Affairs, and has asked about management of basic supplies like needles, dry ice and more.
The Chinese city of Jiaxing will offer Sinovac's experimental vaccine, CoronaVac, at a price of 200 yuan ($29.75) per dose, or about $60 for the full, two-dose course, the city's Centers for Disease Control and Prevention said on social media, adding that vaccinations had already kicked off for certain groups like medical workers. China has OK'd profits for shot makers, but stated that COVID-19 vaccines should be priced close to cost.
LabCorp launched a new antibody test to gauge whether COVD-19 vaccines work. The company’s Cov2Quant test, for use in clinical trials of potential vaccines and therapies, aims to assess the strength of a person’s immune response to the virus by providing a quantitative measurement of the concentration of IgC antibodies in a person’s blood. The test is currently available for research and hasn't received a nod for widespread use, though the CDC tapped the new test for use in its epidemiological studies, LabCorp said. Story
Around 75% of U.S. laboratories still lack adequate testing supplies to meet pandemic demand, and many others report shortages of materials needed to test for more common illnesses, too, a new survey found. According to the data, labs are currently running at an average of 41% of their total testing capacity. Thirty-two percent said they lack necessary in vitro diagnostic hardware, and nearly 30% said they face shortages of viral transport media, used to keep testing samples stable during shipping. Story
Evotec’s U.S. subsidiary snared an undisclosed sum from the Bill & Melinda Gates Foundation to find and work on new monoclonal antibody drugs against COVID-19. Evotec’s U.S. unit, Just, will use the grant to develop its candidates to work against severe disease in “vulnerable populations in low and middle income countries,” the company said. Just will leverage its software toolset, Abacus, to perform in silico analysis of several lead candidate sequences of anti-coronavirus antibodies and is also on the hook for cell line development of two lead molecules, the company said. Story
As the pandemic wears on people’s mental health, Otsuka Pharmaceutical has stepped up to bat. Otsuka’s American division in May signed on as a sponsor for the Well Beings Youth Mental Health Project, working on a Ken Burns-produced documentary series, Hiding in Plain Sight: Our Mental Health Crisis. Meanwhile, as lockdowns, fear of infection and limited access to mental healthcare set in in April, Otsuka America created a YouTube series, Building Mental Resiliency, to offer patients advice and resources. Story
UPDATED: Monday, Oct. 19 at 9:28 a.m. ET
Pfizer's factory in Puurs, Belgium, kicked off production on hundreds of thousands of vaccines ahead of a potential U.S. approval in November, the drugmaker's U.K. head, Ben Osborn, told the Mail on Sunday. The doses in production now are being stockpiled and are ready to ship globally once the company snares the OK.
Meanwhile, AstraZeneca and the University of Oxford's vaccine hopeful could win approval for high-risk patients in the U.K. by year-end, England's deputy chief medical officer told The Times of London. "It isn't a totally unrealistic suggestion that we could deploy a vaccine soon after Christmas," said the official, reportedly "bullish" during the press briefing about the prospect of a phase 3 data reveal from AstraZeneca between the end of this month and next.
UNICEF, in partnership with Gavi, the Vaccine Alliance, will purchase and deploy more than half a billion single-dose syringes and other critical equipment in preparation for a looming shot rollout, the U.N. agency said Monday. UNICEF aims to obtain the half-billion syringes by year-end, and will also lock down 5 million safety boxes for disposal, plus solar-powered refrigerators to help store vaccines in countries with limited infrastructure.
The U.S. may soon enter the "hardest phase" of the pandemic, former FDA Commissioner Scott Gottlieb, M.D., said Sunday. While treatment practices have improved since March, "a lot more people" are likely to become infected through the end of the year, Gottlieb said. “There’s not going to be an intervention that really thwarts this, short of the ability to get a vaccine,” he added, pinning the availability of a shot to sometime next year.
Neuroradiologist Scott Atlas, M.D., who joined the U.S.'s coronavirus task force late this summer, has sown discord within the group, publicly dismissing the use of masks, shooting down testing expansions and advocating for the natural spread of infection until the country reaches herd immunity, The Washington Post reports, citing 41 administration officials. Meanwhile, White House coronavirus response coordinator Deborah Birx, whose profile and influence have reportedly eroded since Atlas' arrival, has pushed for his removal from the task force, the Post writes.
Serum Institute of India (SII) is gearing up to run late-stage trials of Codagenix's intranasal vaccine candidate, pending regulatory approval, the country's Health Minister said. The live attenuated candidate is slated to enter a U.K. phase 1 by year-end, while SII will is on the hook to tackle later studies in India. Meanwhile, India's Bharat Biotech is prepping for its own nasal spray vaccine study on a separate candidate from the Washington University School of Medicine.
UPDATED: Friday, Oct. 16 at 2:59 p.m. ET
Johnson & Johnson's TNF blocker Remicade, Bristol Myers Squibb's arthritis med Orencia and AbbVie's experimental drug ceniciviroc were pegged to take part in an NIH-run phase 3 that will test the drugs, plus Gilead Sciences' Veklury, in hospitalized COVID-19 patients. The hope is that adding the immune modulator drugs to Gileads' antiviral may curb the overactive—and sometimes fatal—immune response known as "cytokine storm." Story
Russia approved an imported and domestic version of Gilead Sciences' antiviral to treat COVID-19, the country's Health Ministry said. Remdesivir, sold by Gilead as Veklury, boasts a full approval in Japan and emergency nods in the U.S., India and South Korea. Meanwhile, the drug failed to curb death rates in a multinational trial run by the World Health Organization, data posted Thursday showed.
The pandemic switch from in-person to virtual meetings offers companies a chance to change how they forge deals, Sanofi's head of partnering, Alban de La Sablière, figures. Conferences like J.P. Morgan and ASCO are helpful relationship builders, but they shouldn't drive how drugmakers run their pipelines, he said. The big question once the pandemic passes is how to mix digital with in-person events. "[We] should be able to have the best of both worlds. We can make events more efficient... but still have a personal feel to it," La Sablière said. Story
Beckman Coulter snared a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid diagnostic to help identify Multisystem Inflammatory Syndrome in Children, or MIS-C—a life-threatening COVID-19 complication that can attack several organs at once. Beckman will work to create a blood-based biomarker to detect signs of the pediatric disease, which manifests symptoms similar to many childhood illnesses in its early stages. The BARDA funding will also support a Beckman-run trial across three sites. Story
Cue Health won $481 million from the U.S. Department of Defense to scale up production of its handheld COVID-19 diagnostic and deliver 6 million tests to the federal government over the next six months. Cue Health aims to deliver 30,000 tests by March 2021 and will boost production of testing kits to 100,000 per day. The company's rapid molecular test, which uses a nasal swab and delivers results via smartphone, won an FDA green light in June. Story
Synthego teamed up with the Quantitative Biosciences Institute at the University of California, San Francisco (UCSF), to use CRISPR-engineered cell lines to speed up discovery of potential COVID-19 drugs. Inspired by a USCF study that laid out drug-repurposing targets, Synthego pivoted its CRISPR platform to validate those targets by editing genes individually and as a series, revealing the genes and cell pathways the virus needs to infect or grow inside human cells, a study published in Science showed.
UPDATED: Friday, Oct. 16 at 9:30 a.m. ET
Gilead Sciences' Veklury, also known as remdesivir, failed to curb death rates in a multinational trial run by the World Health Organization, data posted Thursday showed. The study is still unpublished and awaiting peer review. More than 11,300 adults with confirmed infections were treated with either one or a combination of Veklury, hydroxychloroquine, lopinavir, interferon or interferon plus lopinavir. No drug or combination lowered death rates, the odds of moving onto mechanical ventilation, or length of hospital stays, the study showed. Story
For its part, Gilead contested the findings, citing discrepancies in trial procedures among various sites, as well as differences among patients who received the drug. The drugmaker also pointed Reuters toward "more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir."
Pfizer won't file its shot for an emergency nod until at least the third week of November, CEO Albert Bourla said—diverging from earlier comments that the company might pursue an authorization in late October. The drugmaker could have preliminary data on the vaccine's effectiveness by this month's end, but Pfizer will need to collect additional manufacturing and safety data well into next month, Bourla said, quashing any remaining hope that a shot could win U.S. approval before the Nov. 3 election. Story
Meanwhile, Pfizer and BioNTech are hustling to scale capacity ahead of a potential vaccine approval, BioNTech chief Ugur Sahin said. The companies previously set a target to deliver 100 million doses—enough for 50 million people—by year-end. Once those shots are doled out, "then we will enter a struggle to provide it," Sahin said. BioNTech last month snapped up a former Novartis plant in Germany, expected to have capacity for 750 million doses a year by late 2021. Meanwhile, both companies are on the hunt for potential manufacturing partners.
Former New Jersey governor Chris Christie was treated with a combination of blood thinners, Gilead's remdesivir and Eli Lilly's experimental antibody cocktail when he spent several days in an intensive care unit with COVID-19. Christie told the New York Times he was "wrong" not to wear a mask at the White House. “I hope that my experience shows my fellow citizens that you should follow CDC guidelines in public no matter where you are and wear a mask to protect yourself and others,” he said.
Fujifilm is seeking Japanese approval for Avigan to treat COVID-19 after the flu med beat placebo at shortening the time to patient improvement in a late-stage trial. The Japanese government has also tapped Fujifilm to triple national stockpiles of the drug. Meanwhile, Fujifilm earlier this year sold Dr. Reddy's Laboratories the exclusive rights to Avigan in India, which, along with Russia, has OK'd the drug in COVID-19.
AstraZeneca inked a deal with Switzerland to supply the country with 5.3 million doses of its COVID-19 jab. Earlier this year, the Swiss government secured early access to 4.5 million doses of Moderna's mRNA-based shot. The country has also joined the World Health Organization's equitable vaccine distribution scheme, COVAX.
Just 28% of air cargo companies set to transport eventual COVID-19 jabs say they're prepared for the task, a survey by the International Air Cargo Association and Pharma.Aero found. Nineteen percent said they felt "very unprepared." One of the biggest hurdles will be keeping vaccines cold; only 54% of air cargo carriers currently have cold-chain ground equipment and loading devices in place, and just 45% of those companies are able to handle sub-zero shipping at all their locations.
UPDATED: Thursday, Oct. 15 at 2:00 p.m. ET
Sanofi and Translate Bio's mRNA vaccine candidate protected mice and monkeys in a preclinical study, the partners said Thursday. The data provide backing for a phase 1/2 trial set to start this quarter, the partners said. Meanwhile, Sanofi is already in human testing with its GlaxoSmithKline-partnered vaccine. As it stands, Pfizer/BioNTech and Moderna are the leading mRNA vaccine players. Story
The COVID-19 pandemic and biosimilar competition hurt Roche's top line during the third quarter. The Swiss pharma giant's big-selling cancer drugs Avastin, Rituxan and Herceptin came in below analyst estimates, with Herceptin hit the hardest. On the flip side, multiple sclerosis drug Ocrevus and hemophilia med Hemlibra showed signs of recovery. Story
In a new lawsuit, Public Citizen is seeking to force the Department of Health and Human Services to release documentation on billion-dollar contracts with pharmaceutical companies developing COVID-19 vaccines. The nonprofit says the U.S. government's Operation Warp Speed has handed out more than $10 billion in secret deals to the pharmaceutical industry.
After reports that Black people have contracted COVID-19 at higher rates than other demographic groups, Ala Stanford, M.D., and other Black doctors sprang into action to help more people get access to tests. So far, the Black Doctors COVID-19 Consortium has tested more than 10,000 people. Story
UPDATED: Thursday, Oct. 15 at 9:28 a.m. ET
Pfizer and BioNTech's late-stage vaccine trial is still on track to deliver early data for a possible emergency nod next month, provided a certain infection threshold is met, BioNTech chief Ugur Sahin told Bloomberg. So far, side effects from the phase 3 have fallen in line with those observed in earlier studies. Meanwhile, Eli Lilly and Johnson & Johnson both halted trials this week due to safety concerns.
Meanwhile, Pfizer and BioNTech could post preliminary vaccine data this week, SVB Leerink analyst Daina Graybosch wrote to clients, citing company comments. The trial's independent data monitoring board could push that data reveal into November, but that wouldn't imply the shot fell short, Graybosch added. Moderna also appears on track to present early phase 3 data in November, and on Wednesday snared eligibility to apply for fast-track approval in Europe.
AstraZeneca, whose U.S. vaccine trial has been paused for more than a month, last week delivered safety data to the FDA, CNN reported, citing a source close to the matter. AZ needed to reformat data from its U.K. trial, where a patient illness triggered the original clinical hold because the European Medicines Agency and FDA store data differently, the source said. But ex-FDA chief Robert Califf, M.D., figures the lag time is linked to agency requests for specialized tests or additional follow-up, rather than a formatting issue.
Clinical holds are a natural part of the regulatory process that not only protect trial participants, but also play a key role in determining the safety and efficacy of a vaccine or drug, FDA Commissioner Stephen Hahn told Bloomberg. In terms of AstraZeneca's trial, the agency wants to be "very thorough" in its investigation, which depends on a give-and-take between the drugmaker and the FDA that can draw out the process, Hahn said.
The private sector has a responsibility to help "[stabilize] our society" in the wake of COVID-19 and the "economic freefall, racial and other social inequities that it has unmasked," Merck CEO Ken Frazier said at a Forbes virtual summit. Corporate America ought to push for more diversity in hiring, help protect political processes and lobby for better education, healthcare and social justice, Frazier said. “What makes me worry, ultimately, is when people don't believe in our institutions... then I think our society begins to come apart.” Story
The Trump Administration is running more than 40 Facebook ads in battleground states touting Regeneron's antibody cocktail, which President Donald Trump received, among other drugs, after his COVID-19 diagnosis. "You're going to get the same medicine. You're going to get it free—no charge," Trump states in the ads. Meanwhile, Regeneron reportedly has enough doses of the as-yet-unapproved medicine for just 50,000 patients.
British spies are defending COVID-19 vaccine research against powers seeking to steal or sabotage it, MI5 Director Ken McCallum told reporters. Vaccine research faces two major threats: First, someone could attempt to steal intellectual property or "fiddle with the data," Gen. McCallum said; elsewhere, MI5 will look to combat misinformation designed to sow doubt about a shot's integrity.
India's Bharat Biotech slashed the number of participants in a phase 2 trial of its experimental shot, Covaxin, CNBC-TV18 reported. The trial initially enrolled 750 volunteers before rolling that number back to 380 and reducing the number of trial sites. Researchers maintain that no major safety setbacks have occurred. Meanwhile, India's drug regulator asked Bharat to submit full safety and immunogenicity data from its phase 2 before it advances to the final stage of testing.
UPDATED: Wednesday, Oct. 14 at 3:00 p.m. ET
Vaxart is facing government investigations and class action lawsuits for playing up its role in Operation Warp Speed, allegedly to inflate company stock and benefit insiders. Vaxart in late June said it had been selected for the government project; in reality, the company was running preliminary studies for potential Warp Speed support. The similarly-timed purchase and sale of Vaxart shares by hedge fund Armistice Capital, which has two execs on Vaxart's board, added fuel to the legal imbroglio. Story
Roche aims to launch a lab-based version of its Elecsys antigen test in Europe by year-end, with plans to pursue an emergency nod in the U.S. The automated test uses swabs and is designed to process up to 300 samples per hour on a single machine. The test will complete Roche's arsenal of PCR, antibody and antigen tests for use both in the lab and in settings like clinics and testing sites. Story
Emergent BioSolutions' shares plunged last month on word that its customer AstraZeneca put its vaccine trial on hold, and again this week after similar news from Johnson & Johnson—but investors may be overreacting, analysts at Cantor Fitzgerald and Wells Fargo wrote in notes to clients. Contract protections for Emergent's deals with J&J, AstraZeneca and HHS should net the company around $1.5 billion regardless of trial outcomes, Cantor wrote. Story
Switzerland's Relief Therapeutics and NeuroRx's drug RLF-100, or aviptadil, boosted survival and recovery rates in patients admitted to an intensive care unit with severe COVID-19 and respiratory failure, compared with standard treatment, topline data from an open-label prospective study showed. Eighty-one percent of the 21 patients given RLF-100 survived beyond 60 days, compared with 17% of the 24 subjects in the control group, the company said.
Only 17% of Black Americans say they'd definitely get a vaccine, even if the shot were free and deemed safe by scientists, a new Kaiser Family Foundation survey found. A slim 9% voiced confidence that a shot would be properly tested and fairly distributed. The poll of 777 Black adults underscores vaccine hesitancy rooted in discrimination and systemic racism in healthcare, Axios said, and highlights the need for credible outreach in communities of color.
YouTube is cracking down on vaccine misinformation. In an update to its COVID-19 policies published in May, the tech giant will now bar videos and other content that spreads false information about COVID-19 shots, including allegations that they may lead to death or infertility, or be used to implant microchips in patients. Earlier this year, YouTube started barring pandemic content that runs afoul of facts published by the World Health Organization.
UPDATED: Wednesday, Oct. 14 at 9:15 a.m. ET
The National Institutes of Health will run a mid-stage trial of AbbVie and Boehringer Ingelheim's monoclonal antibody Skyrizi—approved last year to treat some forms of plaque psoriasis—in combination with Gilead Sciences' Veklury, also known as remdesivir, as a potential COVID-19 treatment. The NIH also plans to test Humanigen's experimental antibody lenzilumab in combination with Gilead's antiviral.
Eli Lilly's Branchburg, New Jersey, plant—gearing up to crank out the drugmaker's antibody hopeful, LY-CoV555—was flagged last November for quality control concerns. Last year, FDA inspectors found that data had been deleted improperly and cited Lilly for inconsistent laboratory controls. Investigators flagged additional concerns in August, which could result in a warning letter if the problems aren't resolved. Story
Vaccine or no, we will be living with the coronavirus for years to come, Eli Lilly CEO David Ricks told Bloomberg. The reason? Vaccine protection may well deteriorate over time, and it's uncertain how effective they'll be in the first place. Meanwhile, many people may choose not to get vaccinated, a "tragedy," Ricks said, arguing the U.S. should push for nearly 100% vaccine compliance.
Forty-seven percent of American voters said they'd likely seek a vaccine if NIAID director Anthony Fauci recommended it, a new poll from Politico and Morning Consult found. Among the 1,986 registered voters polled, 45% said they'd seek a CDC-recommended vaccine, while 41% said they'd take NIH advice and 36% said they'd listen to the FDA. Meanwhile, only 19% said they'd pursue a jab on President Donald Trump's recommendation, compared with 26% who'd take the cue from Democratic nominee Joe Biden.
Kindred Biosciences' CDMO unit Centaur Biopharmaceutical Services expanded its manufacturing pact with Vaxart to help churn out doses of the biotech's oral vaccine hopeful, plus other COVID-19 shot candidates, Centaur said in a release. Centaur will scale up its California and Kansas plants to handle the work.
China National Biotec Group, or Sinopharm, will provide its two inactivated vaccine candidates free of charge to students going abroad to study. Both shots are in the final stages of human testing and won an emergency nod from the country's drug regulator in July. As of September, more than 350,000 people had received the experimental Sinopharm shots outside of clinical trials, the state-run Science and Technology Daily reported last month.
AstraZeneca agreed to provide 100 million doses of its vaccine candidate to Indonesia by the first half of 2021, the country's foreign minister said Wednesday.
Russia approved a second COVID-19 vaccine, President Vladimir Putin said Wednesday. The shot, developed by Siberia's Vector Institute, wrapped early-stage human trials last month, Reuters reports. Putin pushed for increased manufacturing of the Vector shot, as well as the Gamaleya Institute's Sputnik V jab, which scored a world-first approval in August before completing late-stage trials.
Cytiva Life Sciences scored $31 million from the HHS' Biomedical Advanced Research and Development Authority and the Department of Defense to boost manufacturing capacity for products needed to make COVID-19 vaccines, such as liquid and dry powder cell culture media, bioreactors and more. Under the deal with Operation Warp Speed, Cytiva will expand manufacturing capacity at its Massachusetts facilities and create dual capabilities at its Utah sites. Story
UPDATED: Tuesday, Oct. 13 at 3:19 p.m. ET
Eli Lilly's phase 3 trial of its antibody monotherapy dubbed LY-CoV555 is on pause after its independent data monitoring board flagged a potential safety concern, the company told CNBC Tuesday. The ACTIV-3 trial is testing Lilly's antibody in combination with Gilead Sciences' Veklury, or remdesivir, in ambulatory and hospitalized patients. The particular safety concern that triggered the hold wasn't identified. Story
Meanwhile, Lilly tapped Japan's Fujifilm Diosynth Biotechnologies to boost manufacturing of CoV555 for eventual delivery to low- and middle-income countries, the Japanese manufacturer said. Fujifilm will set aside production capacity at its Hillerød, Denmark, biologics site, where commercial manufacturing is pegged to kick off in April. Lilly last week said it would pursue an emergency nod for the antibody despite some mixed interim results from a pivotal phase 2. Story
Bristol Myers Squibb's hematology unit had to contend with three drug launches amid the pandemic, but the products may have actually benefited from the unusual circumstances, EVP and president of hematology Nadim Ahmed said. BMS is touting its beta-thalassemia and anemia med Reblozyl's ability to curb blood transfusions as patients limit in-office visits. Plus, BMS recently won a nod for its oral acute myeloid leukemia med Onureg. Story
Seven of Johnson & Johnson's branded drugs, including Erleada, Darzalex, Imbruvica and more, braved pandemic headwinds to post double-digit percentage growth in Q3. That said, patients remain "cautious" about in-person doctor visits, CFO Joe Wolk said, which puts a damper on new patient starts. Story
Kernal Biologics, a self-professed "mRNA 2.0" company, thinks the tech may be better suited to treatments for cancer and COVID-19 than vaccines, co-founder and CEO, Yusuf Erkul, M.D., said. It's OK if an mRNA shot developed by Moderna or BioNTech targets antigens expressed by both diseased and healthy cells, because it would still trigger an immune response, Erkul figures. Meanwhile, one of Kernal's next-gen mRNA products might be used in lieu of antivirals or antibodies to fight COVID-19 by turning patients' cells into drug factories. Story
Indian drugmakers Dr. Reddy's, Zydus Cadila, Glenmark, Torrent and Hetero inked a letter of intent with the state of Hidalgo, Mexico, to build a pharma hub for manufacturing and logistics. It's part of Mexico's bid to establish a homegrown drug industry as countries worldwide struggle against COVID-19 to maintain access to generic and branded drugs produced abroad. Story
UPDATED: Tuesday, Oct. 13 at 9:23 a.m. ET
Johnson & Johnson put its vaccine trials on hold after a study participant was hit with an "unexplained illness," the drugmaker said Monday. The exact nature of the safety scare remains unclear, though J&J plans to release more information as it investigates. AstraZeneca last month paused its COVID vaccine trials after a patient in the U.K. fell ill. While AZ's studies have resumed in a number of countries, including the U.K., its U.S. trial remains paused. Story
Pfizer got a thumbs up from the FDA to include younger participants—aged 12 through 15—in its coronavirus vaccine study. In September, the company expanded its 30,000-person phase 3 trial to enroll 14,000 additional subjects, aiming to improve diversity across age groups and minority populations, and to include those with stable chronic infections like hepatitis B, hepatitis C and HIV.
The Takeda-led CoVIg Plasma Alliance, which includes CSL Behring, Biotest AG and other companies, kicked off manufacturing work on its hyperimmune globulin therapy while a phase 3 trial of the treatment plows ahead, Takeda chief executive Christophe Weber said Monday. The alliance on Friday enrolled the first patients for its late-stage trial after months of delays and expects to deliver results from the 500-subject study by year-end. Story
Osaka University and drug development venture AnGes launched a clinical trial of their DNA-based vaccine candidate at Osaka University Hospital, Japan's first clinical trial for a potential COVID-19 shot. Small-scale results, expected within about a month, will determine whether the partners can kick off a larger, 500-person trial plotted for November. AnGes so far has received ¥9.4 billion ($89 million) through an emergency grant from the Japanese government for shot production, plus another ¥2 billion ($19 million) for development.
China's Sinopharm unveiled an online reservation system for patients seeking the state-owned firm's COVID-19 vaccine in Beijing or Wuhan. More than 70,000 people have already joined the vaccine queue, the Global Times reported, and students planning to travel abroad are among those eligible to receive the shot. Sinopharm has two shot candidates in late-stage trials and won an emergency nod for one of its vaccines in July.
Ranitidine bismuth citrate, or RBC—used for decades to treat ulcers—cleared viral loads in the nasal cavities and lungs of hamsters after the fourth day of COVID-19 infection, a new animal trial out of the University of Hong Kong found. The drug appeared to stop the coronavirus' double-stranded DNA from unwinding into single strands, a crucial step for virus replication. The team is now looking to develop an injectable formulation of the drug, typically administered in an oral dose form.
UPDATED: Monday, Oct. 12 at 2:36 p.m. ET
Thailand has signed a licensing deal with British drugmaker AstraZeneca to finish and distribute doses of the University of Oxford's recombinant COVID-19 shot, dubbed AZD1222. The licensing pact will cover distribution in Thailand as well as other East Asian nations in the region.
The FDA has given its emergency use authorization for Abbott's newest lab-based COVID-19 antibody test, making it the company's eighth diagnostic tentatively approved in the U.S. Dubbed AdviseDx, the test can be used to identify a type of antibody called immunoglobulin M in blood samples, Reuters reported.
UPDATED: Monday, Oct. 12 at 9:58 a.m. ET
With Regeneron on the path to an emergency use authorization for its COVID-19 antibody cocktail, former FDA Commissioner Dr. Scott Gottlieb warned the U.S. is "too late" to produce enough antibody therapy courses to meet potential demand. On CBS' Face the Nation on Sunday, Gottlieb said demand would likely reach 300,000 to 400,000 treatment courses per month for high-risk individuals. In an earlier segment, Regeneron CEO Len Schleifer said the drugmaker only had about 50,000 courses of its therapy, REGN-COV2, on hand. Story
Speaking of Schleifer, the Big Pharma chief told Face the Nation that President Donald J. Trump's treatment results with REGN-COV2 would be considered as a "case of one" in terms of efficacy data and reiterated the company's focus on large-scale clinical trials.
Meanwhile, the U.S. government has shelled out $486 million to support late-stage clinical trials and possible supply of AstraZeneca's own antibody cocktail, dubbed AZD7442. The cocktail is being studied as a preventative for COVID-19 in a 6,000-patient phase 3 trial with the goal of providing protection for up to 12 months on a single dose. Story
Turning to vaccines, Pfizer and BioNTech signed a pair of supply deals for their mRNA-based COVID-19 shot, BNT162, with Taiwan and New Zealand this weekend. The Taiwan deal is the much larger of the two, with the Far East nation set to receive up to 30 million doses. Around 10 million of those doses are set to be delivered by first quarter 2021.
Celltrion's antibody candidate is now being tested as a preventative treatment for frontline healthcare workers after phase 1 data in South Korea backed the therapy's safety. The candidate, CT-P59, will be tried on 1,000 asymptomatic patients who have been exposed to COVID-19 infection as part of the trial, Celltrion said.
Daewoong's COVID-19 drug candidate has received regulators' go-ahead to pursue phase 1 clinical trials in Korea. The therapy, dubbed DWRX2003, is currently in phase 1 trials in India and the Philippines with confirmatory safety testing ongoing. Daewoong's drug is being studied to prevent the spread of the novel coronavirus in lung tissue and nasal discharge, the drugmaker said.
UPDATED: Friday, Oct. 9 at 3:51 p.m. ET
Eli Lilly touted new findings from the NIAID-sponsored trial of Olumiant in combination with Gilead’s remdesivir, with coronavirus patients who needed supplemental oxygen benefiting the most. Last month, Lilly said it would discuss a potential emergency authorization from the FDA for the rheumatoid arthritis drug after the trial met its endpoints. Story
The FDA updated its dashboard for tracking the number of treatments in development for the COVID-19 pandemic, including more than 550 individual drug programs in planning stages, outside of vaccines, and more than 350 trial protocols reviewed by the agency.
BARDA tapped contract research organization Pharm-Olam to join its clinical studies network for medical countermeasures—the second CRO this week, after PRA Health. With a two-to-five-year contract worth up to $250 million, the company will cover trials from phase 1 to 4, as the agency looks to bolster its pandemic response. Story
Beckman Coulter has received an emergency authorization for its high-throughput IgM antibody test, joining its assays for IgG antibodies and the IL-6 biomarker for identifying patients with a potentially severe immune system response.
Oxford Nanopore secured an in vitro diagnostic CE Mark for its rapid LamPORE diagnostic test, which runs on the company’s GridION desktop analyzer with a rate of false-negative and false-positive results under 1%.
UPDATED: Friday, Oct. 9 at 10:40 a.m. ET
The NIH has launched a phase 3, placebo-controlled study to explore whether a plasma-based treatment can boost the effectiveness of Gilead antiviral remdesivir, tapping therapies from Emergent BioSolutions, Grifols and a collaboration led by Takeda and CSL Behring dubbed the CoVIg-19 Plasma Alliance. Story
New data from a placebo trial of Gilead’s remdesivir showed the antiviral improved recovery times, reduced the chance of a patient progressing to more severe stages and significantly cut the risk of death among those who received low-flow supplemental oxygen. Story
Anthony Fauci praised Regeneron’s experimental antibody cocktail, saying there is “a reasonably good chance” that it helped President Trump following his COVID-19 diagnosis. In early studies, REGN-COV2 showed it can reduce viral load; now, the president is calling for emergency clearance of the treatment following a glowing review in a video posted to Twitter earlier this week. Story
But despite the free publicity, biotech’s political donations have largely flowed to Democratic campaigns ahead of the 2020 election, reversing a long trend, according to a KHN analysis. Story
Researchers at the Johns Hopkins University have illustrated a way to potentially stop the novel coronavirus by targeting out-of-control immune cells. SARS-CoV-2 can bring on dangerous cascades of inflammation, but the researchers found that targeting a specific blood protein could break the chain reaction, and they pointed to drugs already in development. Story
NIH and the National Cancer Institute have launched a new research group to study coronavirus immunity and boost nationwide antibody testing. The Serological Sciences Network for COVID-19, or SeroNet, will tap over 25 U.S. academic, government and private sector institutions, while delivering over $150 million in grant funding.
Meanwhile, researchers at Massachusetts General Hospital found that people who survive serious COVID-19 infections can have long-lasting immune responses against the virus, with high IgG levels observed after four months. Their paper was published in Science Immunology.
UPDATED: Thursday, Oct. 8 at 3:08 p.m. ET
Eli Lilly touted new findings from the NIAID-sponsored trial of Olumiant in combination with Gilead Sciences's remdesivir. Coronavirus patients who needed supplemental oxygen benefited the most from Lilly's treatment, the company said. Olumiant is already approved for rheumatoid arthritis, and the company last month said it would discuss a potential emergency nod in COVID after the trial met its endpoints.
While a COVID-19 vaccine by the end of the year is "possible," it remains "unlikely," Guido Rasi, the head of the European Medicines Agency told Bloomberg in an interview. Even if drugmakers are able to submit data in a few weeks and the regulator takes a "minimum time of evaluation," that'd put potential rollouts at or near the end of the year, he said.
The U.S. could have 100 million COVID-19 vaccines available by the end of the year, HHS secretary Alex Azar said at a Goldman Sachs virtual event Thursday, as reported by CNBC. Earlier this week, Operation Warp Speed head Moncef Slaoui said he expects enough vaccine doses to vaccinate 30 million people in 2020.
The National Institutes of Health has started a new trial of Gilead Sciences' remdesivir plus a highly concentrated solution of antibodies in the U.S. and 17 other countries. The solution being tested is anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG.
In a MSNBC interview Thursday, NIAID director Anthony Fauci said there's a "reasonably good chance" Regeneron's antibody "made a significant difference in a positive way" in the treatment of President Donald Trump.
UPDATED: Thursday, Oct. 8 at 8:46 a.m. ET
Regeneron's moment in the spotlight continued as President Donald Trump again praised the drugmaker's antibody therapy in a new Twitter video. The company is now seeking an emergency use authorization for its COVID-19 therapy, and the president vowed to provide it to Americans for "free." Story
AstraZeneca has pledged to not profit from its COVID-19 vaccine program during the pandemic, but a memo cited by the Financial Times shows the "pandemic period" could end as soon as July 2021. The company could extend the not-for-profit period if the company "acting in good faith considers that the SARS-CoV-2 pandemic is not over.” Story
Questioned about its patents, Moderna has pledged to not enforce its intellectual property during the pandemic, The Wall Street Journal reports. In an interview, company president Stephen Hoge said Moderna is "quite studiously not asserting infringement." The drugmaker believes other COVID-19 vaccines might infringe its patents, but it didn't specify which programs. Moderna is also open to licensing the patents after the pandemic. Fierce Pharma story
Johnson & Johnson has entered another vaccine supply pact. In a deal unveiled Thursday, the company agreed to supply 200 million doses of its vaccine if it's approved by regulators. The deal allows an option for an additional 200 million doses. Story
After reports of remdesivir shortages in Europe, Gilead Sciences teamed up with the European Commission for a joint procurement agreement. The deal allows member countries to buy the drug for both real-time demand and stockpiling needs, with those purchases coordinated by the European Commission. Story
Vaxart, which is working on an oral vaccine against COVID-19, signed a manufacturing deal with Kindred Bio. While the company hasn't yet started human testing, the deal will provide "commercial scale" manufacturing capabilities. Story
CDMO Rentschler Biopharma has signed on to help BioNTech with several aspects of the mRNA vaccine manufacturing process. BioNTech is partnered with Pfizer on one of the leading COVID-19 vaccine candidates. Story
UPDATED: Wednesday, Oct. 7 at 3:00 p.m. ET
Snags in Roche’s switch from an older warehouse to a new distribution center hamstrung its U.K. division’s shipments of COVID-19 tests and diagnostic supplies across the country, Reuters reported. Labs may need to fall back on shortage contingency plans, and the issue has led to “a very significant drop in [Roche’s] processing capacity,” the drugmaker said in a letter to customers obtained by the news outlet. Roche aims to prioritize shipments of molecular and antibody tests to the NHS as it works to resolve the problem. Story
Gilead Sciences shipped 20,300 doses of its antiviral Veklury, also known as remdesivir, to the EU after countries reported shortages of the drug, a company spokeswoman said. The $8.2 million order provides enough doses for 3,400 patients and amounts to roughly one to two weeks of treatment supply, Reuters reported. Meanwhile, Gilead is on track to meet real-time global demand this month, even if COVID-19 cases spike, the spokeswoman added. Story
Regeneron's star is rising on news that President Donald Trump received its experimental antibody cocktail. CEO Leonard Schleifer made marathon TV appearances this week and last to discuss the move, while Regeneron Chief Scientific Officer George Yancopoulos on Monday touted the cocktail on MSNBC and refuted speculation that the president received special treatment. Over the weekend, the company’s stock price climbed from $565 at Friday’s market close to $598 at Monday’s open, trading as high as $609 on Tuesday before closing at $583. Story
Israel's Mapi Pharma pledged capacity at its finished-dose vaccine plant in Jerusalem and said it plans to open its cold-chain storage capacity for the country to help boost Israel's supply of COVID-19 shots, the drugmaker said Wednesday. Mapi is also working to install a new fill-finish line at its Jerusalem plant for sterile liquids and inhalable powders, and it said it was in talks with several "major" vaccine developers and other nations to boost its efforts. Story
Nephron Pharmaceuticals got slapped with a warning letter from the FDA's Office of Prescription Drug Promotions for emails trumpeting its generic asthma med budesonide as a treatment for COVID-19 symptoms. Nephron CEO Lou Kennedy in July sent an email claiming the drug relieved respiratory symptoms of the virus, adding that one doctor had called the treatment a "silver bullet." Nephron said it's working with the FDA on the matter. Story
Surgeries are making a COVID-19 comeback as the industry adopts new protocols and meets patient concerns, CEOs from a slate of devicemakers said at an event Tuesday. Surgical procedures are inching closer to pre-COVID levels despite an early plunge, L.E.K. Consulting’s managing director, Monish Rajpal, said. Firms like Stryker, meanwhile, have moved procedures out of hospitals, setting up free standing, ambulatory surgery centers. Plus, telemedicine, virtual consults and in-home patient care will likely become standard for surgery follow-ups, the CEO of Olympus’ U.S. division said. Story
Fluvoxamine, a long-approved antidepressant with anti-inflammatory properties, may help curb the risk of hospitalization or death in patients with early-stage disease, a recent trial backed by the COVID-19 Early Treatment Fund showed. The fully remote trial, run by Washington University in St. Louis, enrolled 152 patients over the age of 18 with confirmed, mild cases of COVID-19. None of the 80 participants given the drug experienced clinical deterioration, compared to six out of 72 subjects in the placebo arm, the team said in a release.
The Indian Council of Medical Research got a thumbs up from India’s drug regulator to kick off clinical trials of its Biological E-partnered antibody treatment, made using antibody-laden blood plasma taken from horses that have recovered after being injected with the virus. Meanwhile, Johnson & Johnson in August tapped Biological E to help produce its recombinant DNA-based shot.
UPDATED: Wednesday, Oct. 7 at 8:35 a.m. ET
Eli Lilly submitted an initial request for emergency authorization of its antibody therapy, LY-CoV555, in higher-risk patients recently diagnosed with mild or moderate COVID-19. The drugmaker plans to wait until November to pursue a nod for its combination therapy, which combines LY-CoV555 and another antibody, LY-CoV016. That cocktail recently curbed viral load, symptoms and hospitalizations in mild to moderate patients, interim phase 2 data showed. Meanwhile, Lilly thinks it could churn out up to 1 million 700-mg doses of its monotherapy in the year's fourth quarter. Story
Pfizer and Moderna's vaccine data readouts are expected sometime between next month and December, Warp Speed chief Moncef Slaoui said. Data will likely emerge in three waves, starting with Pfizer and Moderna, followed by efficacy data on one or two other hopefuls, potentially teeing up about 30 million immunizations by year-end, Slaoui said. Meanwhile, Slaoui expects AstraZeneca to deliver data outside the U.S. sometime in October or November. Story
The FDA could invoke a commissioner's finding—a rarely-used power that lets the agency disclose serious safety concerns, often ahead of a product ban—if shot makers aren't transparent with their vaccine data, Peter Marks, director of the Center for Biologics Evaluation and Research, said. Marks floated the option when asked about the FDA's investigation into AstraZeneca's shot and its U.S. trial; that study remains paused in the U.S. after a patient in the U.K. fell ill.
Meanwhile, the FDA on Tuesday launched a new webpage for COVID-19 vaccines along with its tougher emergency authorization guidance. The page covers updates from the agency, comments from FDA leaders on the approval process, information for developers and more.
With hospitalizations climbing in Europe, the continent faces shortages of Gilead Sciences' Veklury, also known as remdesivir, officials report. Twenty-seven EU states and the U.K. in July penned a deal to secure enough Veklury doses for about 30,000 patients, while the U.S. itself secured 500,000 courses, effectively running Gilead dry through September. Now, Holland, Poland and Spain have reported shortages, and the U.K. is rationing its supplies.
An experimental shot developed by the Institute of Medical Biology under the Chinese Academy of Medical Sciences proved safe in a study of 191 healthy subjects, phase 1 data show. The shot also triggered an immune response and the most commonly reported side effects were mild pain, fatigue and irritation at the injection site, a preprint of the team's study published on medRxiv said. Story
UPDATED: Tuesday, Oct. 6 at 3:00 p.m. ET
Career experts at the Center for Biologics Evaluation and Research at the FDA will have the final say in the safety, efficacy and manufacturing reviews that precede emergency authorization of a vaccine, Commissioner Stephen Hahn, M.D., said Monday. The agency has safeguarded the centers against outside pressure to focus on "science and data," he added. Hahn's pledge follows repeated claims by President Donald Trump that a shot will be ready before the Nov. 3 election. Story
Meanwhile, the FDA on Tuesday released tougher vaccine guidelines despite alleged White House efforts to keep those recommendations under wraps. For an emergency nod, the FDA suggests at least two months of data monitoring after patients receive their final doses; Moderna has agreed to that standard, and if Pfizer were to do the same, it likely wouldn't be able to submit data until after the Nov. 3 election. Story
The White House endorsed the FDA's tougher vaccine guidelines, the Wall Street Journal reported, citing people close to the matter. The White House for two weeks has objected to the recommendations, which would make a vaccine green light ahead of the presidential election nigh impossible.
Saliva tests for COVID-19 are taking off in the U.S., Kaiser Health News reports. More comfortable than swab-based diagnostics, saliva tests also help save on crucial testing supplies and may limit the virus' spread between doctors and patients. Yale University, whose SalivaDirect test won an emergency nod in August, is offering its protocol on an open-source basis, approving labs in Minnesota, Florida and New York to run the test. The FDA has also OK'd spit tests from schools like Rutgers and the University of South Carolina, and Columbia University is developing a saliva test for use at home.
China is in early talks with the World Health Organization to review its locally-made vaccines for possible use outside the country, a WHO official said. Under WHO's emergency use program, China's four vaccine hopefuls—developed by Sinopharm, Sinovac and CanSino—would be swiftly evaluated for potential use by WHO member states and UN procurement agencies. On its own, China has inoculated hundreds of thousands of local workers and other high-risk people with shots still in late-stage testing.
Clinical trial tech firm eResearchTechnology (ERT), recently hit by a ransomware attack that stalled COVID-19 work with IQVIA and Bristol Myers Squibb, has shaken up its leadership. Several days after news of the attack broke, ERT said current CEO and President Jim Corrigan was stepping down to make way for Joe Eazer, who most recently steered the ship at Conifer Health Solutions. It's not clear whether the two events are linked, and ERT has yet to pinpoint the source of the attack. Story
UPDATED: Tuesday, Oct. 6 at 9:00 a.m. ET
Pfizer and BioNTech's mRNA-based shot is now part of a "rolling review" process by the European Medicines Agency (EMA) to assess data as it's submitted, following a similar move with AstraZeneca's jab, the EMA said. The EMA will start by reviewing lab and animal testing data, as well as early trial data on humans, Pfizer and BioNTech said. Story
Meanwhile, Pfizer and BioNTech are also facing a patent suit from Allele Biotechnology, which accuses the drugmakers of using an Allele-made fluorescent protein to develop its COVID vaccine, without paying royalties. Pfizer and BioNTech have not yet reacted to the lawsuit. Allele separately leveled similar allegations against Regneron; the antibody-maker said it would "vigorously defend" its position in court. Story
GlaxoSmithKline and Vir Biotechnology are launching a global phase 3 study of their monoclonal antibody, VIR-7831, for early treatment of COVID-19 patients at high risk of hospitalization. The move to phase 3 follows a positive assessment of phase 2 data by an Independent Data Review Board. The study will target 1,300 non-hospitalized patients, aiming to measure their progression to hospitalization or death. Initial results could be ready by year-end, with a full readout slated for January 2021, the companies said.
Oxford Biomedica snagged a thumbs up from the U.K. Medicines & Healthcare Products Regulatory Agency to use a fourth manufacturing suite at its Oxbox facility to pump out AstraZeneca's COVID-19 jab. The green light follows another manufacturing suite approval in September. The facility is set up to churn out viral vectors, and the approval is expected to more than double Oxford's manufacturing capacity, the company said. Story
India's Dr. Reddy's Laboratories on Friday applied to the country's drug regulator to run a phase 3 trial of Russia's Gamaleya Institute-developed Sputnik V vaccine, but a government committee asked for a revised protocol, citing issues with the phase 2 data provided. The company will now be on the hook to run phase 2 and phase 3 trials of the shot in the country, the committee said, rather than relying on the existing phase 2.
President Donald Trump's positive COVID-19 diagnosis was followed by a slew of confirmed cases among White House staffers, but the administration hasn't stepped up contact tracing efforts to track cases that may have originated at a "super-spreader" event at the Rose Garden ten days ago, the New York Times reports. Meanwhile, an internal email confirmed the CDC was ready to deploy scientists for contact tracing efforts, but the White House neglected to take them up on the offer.
The novel coronavirus can spread beyond six feet indoors, the CDC said Monday, two weeks after it removed a previously posted statement about airborne transmission. The virus can "sometimes spread" through tiny particles—produced by coughing, sneezing, talking and singing—that linger in the air, though that isn't its primary route of transmission, the agency said. The move is the latest example of slow and puzzling pandemic responses from the CDC, the New York Times points out.
UPDATED: Monday, Oct. 5 at 3:05 p.m. ET
President Donald Trump is at Walter Reed National Military Medical Center taking Regeneron's antibody cocktail, Gilead Sciences' remdesivir and most recently, the steroid dexamethasone after testing positive for COVID-19. The use of dexamethasone, used to treat severe cases of the disease, has sparked concern about the President's health, though Trump's doctor yesterday said he was "doing well." Meanwhile, Regeneron reached out to Democratic nominee Joe Biden's campaign to offer its treatment as a preventative. Story
Regeneron's decision to give the President its antibody therapy put the drugmaker in "a very tough situation," CEO Leonard Schleifer told CNBC. Trump's doctors requested the drug on compassionate use grounds, which permits access to experimental drugs for "immediately life-threatening" illnesses. The FDA was in charge of the the final decision and the White House won't play a role in the company's plans to file for an emergency nod, Schleifer added.
And in some less than stellar news for Regeneron, the company's antibody cocktail is facing a patent suit for allegedly unauthorized use of Allele Biotechnology's fluorescent protein, mNeonGreen, during its development. Allele's fluorescent protein is added to cells so that scientists can watch, for example, how a drug interacts with a virus. It's this tech that allowed Pfizer and BioNTech to advance their vaccine "at lightspeed," Allele said in its complaint.
Pfizer and Moderna's jabs caused some unpleasant side effects like fever, headache and chills, five patients enrolled in phase 3 trials told CNBC—but symptoms often went away after a day, and those involved in the studies said the discomfort was worth it—if it means immunity from COVID-19. Still, communicating those side effects is important, one patient said; transparency about patient experience could be crucial in getting the public to take an approved jab, especially after a patient illness triggered a clinical hold on AstraZeneca's vaccine trial last month.
The National Institutes of Health will deploy $234 million through its COVID-19 diagnostic development initiative to improve testing access among underserved populations, focusing on minority groups, older patients, pregnant women and people who are incarcerated or homeless. Partnering with an initial 32 institutions, the project will first connect existing, large-scale testing programs to build a collaborative research network. Researchers will also assess how historical, social and economic factors affect testing uptake. Story
Quidel won an emergency nod for a new antigen assay built on its cartridge-based Sofia 2 system—a so-called "ABC" point-of-care test that screens for influenza A, influenza B and COVID-19. The new diagnostic, which aims to turn out results in 15 minutes, uses a single swab and helps doctors distinguish among respiratory diseases—much needed as flu season looks set to collide with the ongoing pandemic. Story
Nvidia is teaming up with AstraZeneca, GlaxoSmithKline and the U.K.'s National Health Service in an artificial intelligence project to boost drug development and healthcare research. Nvidia plans to build Britain's most powerful supercomputer, using GPU chip technology best known for high-end graphics performance, and give AZ and GSK first dibs on access. Story
UPDATED: Monday, Oct. 5 at 9:54 a.m. ET
A global health system, national security and economic stability are the keys to tackling future public health crises, Johnson & Johnson CEO Alex Gorsky said. The U.S. ought to curb its "maniacal focus" on speed to prioritize resilience and sustainability, Gorsky said. Meanwhile, President Donald Trump's recent diagnosis shows how vulnerable we are and how important it is to continue working to curb the virus' spread, he added.
India's Bharat Biotech tapped the U.S.-based ViroVax to crank out adjuvant for its inactivated vaccine hopeful, Covaxin, currently advancing through phase 2 trials. Bharat has used ViroVax's Alhydroxiquim-II adjuvant under license from the start of development, chairman and managing director of the Indian biotech, Krishna Ella, Ph.D., said.
Philadelphia's eResearchTechnology (ERT), makers of clinical trial software used in the rapid push to develop drugs, tests and vaccines against COVID-19, was hit with a ransomware attack that stalled several studies, ERT's vice president of marketing said Friday. Employees were locked out of their data and had to track subjects with pen and paper, but no patients were affected, ERT said. IQVIA, helping AstraZeneca run its vaccine trial, and Bristol Myers Squibb were among those affected, though the impact was "limited," IQVIA said.
Air cargo carriers like Fedex, DHL and Lufthansa are gearing up for large-scale vaccine transport by installing temperature-monitoring systems and "freezer farms" to store shots in transit as the industry prepares to deliver as many as 20 billion COVID-19 jabs. The bulk of vaccine products are expected to be shipped by air, but the cargo industry currently lacks capacity for such a massive rollout, the head of the International Air Transport Association said.
A shot approval will not provide a pandemic panacea, Kaiser Health News reports. The first shots to snare approval are unlikely to boast the same level of efficacy as established jabs; they'll also be subject to rigorous real-world testing once they win a green light. Plus, patients may have to wait months to receive a shot as distribution efforts prioritize high-risk groups. The best recourse? Keep wearing a mask and stick to social distancing well into 2021, health experts say.
President Donald Trump failed to disclose a positive test result Thursday before a more thorough diagnostic confirmed his COVID-19 diagnosis, the Wall Street Journal reported, citing sources close to the matter. Trump received a positive result Thursday evening before making an appearance on Fox News, where he said he was still awaiting a readout. He also allegedly told advisers not to reveal their positive results, creating an air of secrecy that has sparked concern within the West Wing.
Abbott's ID NOW rapid test has long been used to screen for the virus at the White House, but the test is only designed to screen patients within the first seven days of showing symptoms and is much less accurate when used on those who are asymptomatic or presymptomatic. The Trump Administration has routinely used Abbott's diagnostic to clear people to go into meetings without masks, the New York Times reports, an approach not endorsed by the test's emergency authorization from the FDA.
Meanwhile, only 34% of Americans believe the President is being honest in his comments about the novel coronavirus, a new poll from Reuters and Ipsos found. Fifty-five percent of the 1,005 U.S. adults polled said they don't trust Trump's pandemic rhetoric, while another 11% were unsure.
UPDATED: Friday, Oct. 2 at 4:31 p.m. ET
Top White House officials appear unlikely to sign off on the FDA's proposed guidelines for deciding the fate of a COVID-19 vaccine, the Wall Street Journal reports. The officials have objected to various points, including a requirement that researchers monitor trial participants for side effects for two months after they receive a shot, the WSJ's sources said. The conflict doesn't bode well for the coming weeks, when late-stage trial data are expected to start rolling in.
Now that the news has sunk in about President Donald Trump's positive COVID-19 test, doctors are making suggestions about potential treatments—and drugmakers aren't talking. Regeneron and Eli Lilly wouldn't tell the New York Times whether Trump might receive their experimental antibodies. Steroids, convalescent plasma, Gilead Sciences' antiviral remdesivir and anti-inflammatories such as Lilly's Olumiant are also possibilities, of course.
But late Friday afternoon, President Trump's doctor did disclose his treatment—and he was indeed treated with Regeneron's experimental antibody cocktail. He's also taking aspirin and famotidine, aka Pepcid, which is in clinical testing against COVID, but hasn't been proven effective. Then again, Trump may just be using it for heartburn.
Potus doctor note on his treatment > pic.twitter.com/V74wON51aU
— Maggie Haberman (@maggieNYT) October 2, 2020
LabCorp won an FDA emergency authorization for a COVID-19 test that doesn't require chemical reagents to free the coronavirus’s RNA from a sample. Instead, the test uses a heat-based process that traps and concentrates viral particles to coax out their genetic material for sequencing. And that means the company can avoid relying on the extraction reagents that have fallen into short supply over the course of the pandemic. Story
UPDATED: Friday, Oct. 2 at 9:10 a.m. ET
AstraZeneca's phase 1/2 vaccine trial resumed in Japan—the fifth country to restart studies on the shot after a patient illness prompted a clinical hold last month. While trials have also kicked back off in the U.K., Brazil, India and South Africa, the British drugmaker's U.S. test is stuck on pause pending an FDA investigation, now expanded to include data on other shots using the same viral vector platform.
Moderna won't have enough safety data on its shot to seek an emergency nod before at least Nov. 25, CEO Stéphane Bancel told the Financial Times—contradicting rumblings from President Donald Trump that a shot could be ready ahead of the Nov. 3 election. Meanwhile, the company expects to file for a full approval by late January at the earliest, teeing up a potential green light in 2021's first or second quarter, Bancel said.
The FDA expanded its emergency authorization of Access Genetic's molecular diagnostic test OraRisk, enabling it to screen samples gathered by rinsing a person's mouth with saline. OraRisk in July snared a green light for use with nasopharyngeal, nasal and oral swabs. The expanded nod cuts out the need for swabs and aims to assist people who have trouble providing enough saliva for a direct test. Story
A $300 million HHS ad campaign to ease Americans' pandemic despair may be unraveling, Politico reports: Within the agency itself, one official called the effort a "boondoggle" and said the funds would be better put toward medical supplies like personal protective equipment. Meanwhile, more than 30 celebrities approached for the effort, from Lady Gaga to Billy Joel, declined to join, the news outlet said. Story
President Donald Trump and first lady Melania Trump have tested positive for COVID-19, the President said Friday morning. Trump will remain quarantined in the White House for an unspecified amount of time, costing him much of his remaining time on the campaign trail.
Meanwhile, a negative test result put Secretary of the Department of Health and Human Services, Alex Azar, in the clear, Azar tweeted this morning.
UPDATED: Thursday, Oct. 1 at 3:10 p.m. ET
After months of letting the U.S. government handle distribution for remdesivir, Gilead Sciences took over the process on Thursday. AmerisourceBergen will keep serving as the distribution partner, and the setup will allow hospitals to order as much drug as they need. The company said it is now meeting "real-time demand" in the U.S. after reports of shortages in recent months.
Following the U.S. presidential debate on Tuesday, Pfizer CEO Albert Bourla wrote to employees that the event was "disappointing." He said the company's vaccine program is moving "at the speed of science," and that politics won't play into the company's decision-making, CNBC reports.
The European Medicines Agency said it started a "rolling review" of AstraZeneca's COVID-19 vaccine and is taking its first look at early data from lab studies. Most of the evidence for the review has yet to be submitted.
People participating in trials for Moderna and Pfizer vaccines have reported chills, fevers, aches and exhaustion. CNBC interviewed 5 participants, and they all said the side effects are worth protection against COVID-19.
Amid worries that politics will play into vaccine reviews, Moderna CEO Stéphane Bancel told the Financial Times his company's shot won't be available until after the U.S. election. For distribution to the general public, late first quarter or early second quarter 2021 is a "reasonable timeline," he said.
Even after a vaccine is available, life won't immediately return to normal. That's the finding in a report from researchers assembled by the Royal Society, who predict a gradual relaxation of measures to curb the spread of the disease, BBC says.
UPDATED: Thursday, Oct. 1 at 9:30 a.m. ET
The FDA is expanding its investigation into AstraZeneca's vaccine candidate to include clinical data on other shots that use the same viral vector platform, such as the University of Oxford's Chikungunya virus, flu and malaria jabs, all based on the same ChAdOx1 engineered chimpanzee adenovirus, Reuters reported. AZ's U.S. vaccine trial remains on pause after a case of transverse myelitis triggered a clinical hold, though studies have resumed in the U.K., South Africa, India and Brazil. Story
Meanwhile, the European Medicines Agency is expected to announce an accelerated, "rolling review" of AstraZeneca's shot as early as this week, Bloomberg reported, citing a source close to the plan. The move would allow regulators to see AZ's late-stage trial data early in a bid to speed up the review process, suggesting the Oxford-partnered shot could be the first to see approval in Europe.
Fujifilm will carry out manufacturing work on clinical supplies of VLP Therapeutics' RNA-based vaccine hopeful, the companies said in a release. VLP, which has a Japanese unit that takes part in drug research with government bodies and universities, won funding for its shot from the Japan Agency for Medical Research and Development. Meanwhile, Fujifilm in July agreed to churn out shots for Novavax's late-stage vaccine trial.
Hydroxychloroquine is back in the news, though it hasn't fared any better at treating COVID-19. Among 125 healthcare workers, the antimalarial drug failed to beat placebo at staving off infection, a University of Pennsylvania study published in JAMA found. Four patients tested positive for COVID-19 in both the 64-subject hydroxychloroquine arm and the placebo cohort, prompting the team to advise against the drug's use as a pandemic treatment.
COVID-19 vaccines were a hot button issue in Tuesday's debate between President Donald Trump and Democratic nominee Joe Biden. Trump claimed the U.S. was "weeks away" from an effective shot and, when questioned about claims from his administration that a vaccine wouldn't be widely available until next summer, said he's "spoken to the companies, and we can have it a lot sooner." Biden, meanwhile, said he didn't trust Trump on the issue. Story
UPDATED: Wednesday, Sept. 30 at 3:19 p.m. ET
Baylor College of Medicine's “second generation” recombinant protein vaccine could launch in late summer or early fall of next year, according to Peter Hotez, M.D., Ph.D., dean of the college's National School of Tropical Medicine. The team's work on other coronavirus shots and its reliance on proven tech have sped development and limited costs, Hotez said. India's Biological E will produce the vaccine, which is slated to start human testing next month.
Pfizer is moving “precisely at the speed of science” to develop its COVID-19 shot, chief communication officer Sally Susman said at a virtual event—but when politics creep in, trust falters. Susman’s solution? “[T]o raise our own voices and try our best to silence those who are hurting the cause of science and truth.” Johnson & Johnson comms chief Michael Sneed agreed, with both execs stressing the need for transparency, collaboration and diversity to cement reputation gains and bolster trust in the industry. Story
Hologic’s centralized lab test for COVID-19 can now be used to screen asymptomatic people, thanks to an expanded FDA emergency authorization. The agency also OK’d the diagnostic for pooled testing, where multiple samples are screened together and only tested individually after a positive result. The test is one of four approved for wider screening, joining kits from LabCorp, Kaiser Permanente and DxTerity Diagnostics. Story
Even after a shot is approved, sick patients will still need COVID-19 therapeutics, Novartis chief Vas Narasimhan said. To that end, the drugmaker expects results in late October or early November from a phase 3 trial pitting its anti-inflammatory drug Ilaris, also known as canakinumab, against severe COVID-19. Meanwhile, Novartis and Incyte are testing their cancer med ruxolitinib, sold in the U.S. as Jakafi, in COVID-19 patients battling overactive immune responses.
Monoclonal antibodies from the likes of Vir Biotechnology, Regeneron and Eli Lilly have drummed up interest as potential COVID-19 therapies, but if the pandemic persists, there won't be enough, the Washington Post reports. Antibodies must be synthesized by living organisms in special reactors—a biological process that can't be rushed. Plus, many of those reactors are already occupied making drugs for other diseases like cancer.
UPDATED: Wednesday, Sept. 30 at 9:20 a.m. ET
Moderna's vaccine hopeful triggered an immune response in older adults at both dose levels, expanded phase 1 data showed. After receiving a second shot, 40 older adults displayed binding antibodies on par with those found in plasma from recovered COVID-19 patients. T cell response in the 100-mcg dose group had increased by day 43, while the response was lower in the 25-mcg arm. Story
Regeneron's antibody cocktail curbed virus levels and relieved symptoms faster than placebo in non-hospitalized COVID-19 patients, early data from its adaptive phase 1/2/3 trial showed. The cocktail appeared to work best in patients who'd yet to mount a strong antibody response against the virus, and the higher dose had a statistically significant effect on virus levels seven days after treatment. Patients on the high dose recovered in eight days at the median, compared with the low-dose group's six and the placebo arm's 13. Story
The University of Oxford aims to test AbbVie's anti-TNF drug Humira as a potential COVID-19 treatment. Studies have shown that COVID-19 patients taking anti-TNF drugs for inflammatory bowel disease and inflammatory arthritis are less likely to require hospitalization, Oxford said in a release. The university plans to target older patients and will recruit up to 750 from care homes across the U.K.
Chinese drugmaker Shenzen Kangtai will begin testing its inactivated vaccine in humans immediately, a securities filing showed, and the company has already built a new production facility for the shot. Separately, AstraZeneca in August tapped Shenzen Kangtai to crank out at least 200 million doses of its Oxford-partnered vaccine for China by the end of 2021.
The Trump Administration is eroding public faith in the FDA, which could prompt fewer people to take a vaccine once one is approved, seven former FDA commissioners wrote in a Washington Post op-ed. The former agency chiefs, who included Robert Califf, Scott Gottlieb and Margaret Hamburg, voiced confidence in FDA's scientific rigor, but warned that political intrusion would only prolong the pandemic.
The push to develop drugs and vaccines against COVID-19 could help the pharma industry revamp its public image—and justify its focus on profits, GlaxoSmithKline CEO Emma Walmsley said. “The world has never seen our industry as more important,” she said. “We have a chance to improve our reputation if we deliver on our purpose to find solutions responsibly. But we also need to explain better why it’s in everyone’s interests that we continue to do it profitably." Story
Meanwhile, Walmsley said she's confident a vaccine will be widely available next year. The challenge lies in scaling up production to meet demand, she said. GlaxoSmithKline has teamed up with French drugmaker Sanofi on its vaccine hopeful, on track for potential approval in 2021.
UPDATED: Tuesday, Sept. 29 at 3:17 p.m. ET
Serum Institute of India (SII) will help produce an additional 100 million vaccine doses for eventual distribution through the World Health Organization's COVAX scheme. Under a deal with the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance—now providing a total of $300 million in funding to SII—the Indian vaccine giant will produce up to 200 million vaccine doses from AstraZeneca and Novavax for deployment to poorer countries, including India. Story
Orgenesis will pay $15 million in stock to acquire Koligo Therapeutics, snaring its anti-COVID-19 cell therapy hopeful in the process. Koligo's autologous treatment, made using fat harvested from infected patients, contains mesenchymal stem cells, vascular endothelial cells and immune cells. Koligo expects those cells to migrate back to the lung and other inflammation sites after readministration, which could improve oxygenation, support antibody production and curb inflammation, the company thinks. Story
Windtree Therapeutics got the nod to launch a phase 2 trial of its synthetic surfactant, lyo lucinactant, in COVID-19 patients with lung injury and acute respiratory distress syndrome (ARDS). Windtree will start by testing the safety and efficacy of its treatment in up to 20 COVID-19 patients with ARDS who are on mechanical ventilation. The trial is pegged to begin in the next several weeks, with recruitment expected to take between three to six months, the company said.
Russia plans to share the first six weeks of data from its late-stage vaccine trial, head of the country's Gamaleya Institute, Alexander Gintsburg, told Reuters. The plan to publish interim data from the first 42 days of the trial, which dosed its first 5,000 volunteers on Sept. 9, would see results issued sometime after Oct. 21. That could make Russia's late-stage data reveal the first worldwide, ahead of other drugmakers with shots in phase 3.
The American Healthcare Association (AHCA) and the National Center for Assisted Living (NCAL) called on states to make those living and working in long term care facilities "the highest priority" for vaccine distribution. In a letter (PDF) to the National Governor's Association, AHCA and NCAL execs pointed out the high risks faced by nursing home and assisted living facility residents, who are often older and suffer from a range of underlying health conditions.
UPDATED: Tuesday, Sept. 29 at 9:36 a.m. ET
Johnson & Johnson tapped Michigan's Grand River Aseptic Manufacturing (GRAM) to carry out fill-finish work on up to 100 million vaccine doses for the U.S. strategic reserve, GRAM said. The CDMO in June wrapped up a $60 million expansion to install a "large scale" fill-finish facility in Grand Rapids, Michigan, where it will perform work on the J&J shot. Story
Pfizer plans to supply nearly $22.2 million in drugs to the U.S. national stockpile to combat COVID-19, plus future public health emergencies. The move comes as part of the Strategic National Stockpile's restructuring and resupply plan to combat future resurgences of the virus. Pfizer is on the hook to provide the combination antibiotic Zosyn, plus dopamine, hydromorphone, cisatracurium, dobutamine, ondansetron and the popular blood thinner heparin, an award notice stated.
FSD Pharma got a thumbs up to launch a phase 2 study of its drug, ultramicronized palmitoylethanolamide (PEA), in hospitalized COVID-19 patients. The company thinks its oral drug could curb the overactive immune response known as cytokine storm. Subjects will be dosed beginning next month at 600-mg or 1,200-mg twice daily, together with standard care, and outcomes compared with standard care alone.
The U.K. will donate £571 million ($735 million) to the World Health Organization's equitable vaccine distribution scheme, COVAX, with around £500 million of that sum "for developing countries to protect themselves," Prime Minister Boris Johnson told the UN General Assembly. Johnson stressed the need for broad access to vaccines for a global inoculation drive to succeed.
The federal government will supply states with around 150 million rapid, Abbott-made COVID-19 tests, encouraging them to use roughly 100 million tests to screen teachers and students and conduct baseline surveillance, President Donald Trump said at a White House press conference. The government will send out shipments from a previous order of Abbott's portable BinaxNOW tests.
UPDATED: Monday, Sept. 28 at 3:05 p.m. ET
The FDA slapped a partial clinical hold on Inovio’s phase 2/3 vaccine trial, citing “additional questions” about the study, the drugmaker said Monday. Details were slim, but the company did say the pause wasn't related to any side effects in phase 1 testing, which will proceed normally. Story
The HHS' $300 million pandemic-related ad campaign touched off an outcry—again—after Politico reported leaked details. Among the concerns were its funding sources: FDA contributed $15 million for pre-campaign work, while most of the program's $300 million budget was requisitioned from CDC funds appropriated by Congress, Politico revealed. Story
CapsoVision got the OK to offer its ingestible camera pill—designed to scan the inside of a person’s gastrointestinal tract—for fully remote, at-home use during the pandemic. The FDA will allow patients to swallow the capsules without doctor supervision to limit spread of COVID-19. Story
United Biomedical’s Covaxx division dosed the first healthy volunteers in a phase 1 study of its multitope peptide-based vaccine candidate. The trial in Taiwan will test two ascending-dose injections spaced 28 days apart, the company said. Covaxx will stagger patient groups to assess safety on the fly, and Taiwan’s Academia Sinica will assess the shot’s ability to trigger antibody and T cell responses.
South San Francisco-based biotech Aligos Therapeutics aims to go public with a $100 million IPO to boost its early work on a functional cure for chronic hepatitis B, as well as an oligonucleotide treatment for COVID-19. Aligos in July partnered with KU Leuven's Centre for Drug Design and Discovery in Belgium to develop a protease inhibitor as a potential pandemic therapeutic. Story
Military personnel outnumber civilian scientists in the U.S. government's Warp Speed vaccine program, an organizational chart obtained by Stat shows, raising concerns about whether military officials are qualified to lead the massive public health campaign.
UPDATED: Monday, Sept. 28 at 9:20 a.m. ET
Johnson & Johnson's vaccine hopeful triggered an immune response in healthy patients at just one dose, early phase 1/2 data showed. The drugmaker tested single and double doses across two adult cohorts and another group of subjects over the age of 65, with the low vaccine dose producing an immune response on par with the higher dose, preprint data show. Side effects were less frequent in the elderly cohort, which could suggest their immune response was not as robust. Story
Pfizer said Friday it expects conclusive data from its late-stage vaccine trial in October, but a group of more than 60 researchers and bioethicists have urged the drugmaker to monitor study participants for at least two months after they receive a second dose—pushing a potential emergency nod or approval into late November. The researchers penned a letter to Pfizer Friday, and the company is drafting a response, a Pfizer spokeswoman said.
The efficacy of the four vaccines currently in late-stage U.S. testing may vary across different patient groups, NIAID director Anthony Fauci told JAMA. "There may be different vaccines for different situations," Fauci said. “It could be that you would recommend, that if you are an older person you get this vaccine versus that." Fauci added that it was necessary for the U.S. to have a range of vaccines to allocate to specific populations.
Members of the data safety and monitoring board set to review data on potential COVID-19 shots from Moderna, Johnson & Johnson and AstraZeneca remain unnamed, save for review board chief Richard Whitley, M.D., a Gilead Sciences board member and professor at the University of Alabama-Birmingham. While the board's anonymity has raised concerns about political influence on a vaccine decision, many experts have vouched for Whitley and touted the board's power to standardize the review process across multiple vaccine programs.
'New' FDA guidance on a vaccine emergency use authorization—which has sparked a row between the White House and the U.S. regulatory agency—isn't new at all, former FDA Commissioner Scott Gottlieb told CBS Sunday. Rather, the guidelines are "an articulation of the principles and standards the FDA has been using for a long time," Gottlieb said. He added that the same standards were communicated to drugmakers at the start of the vaccine development process.
Australian biotech Ena Respiratory's experimental nasal spray, designed to boost the immune system to fight cold and flu, lowered levels of the virus that causes COVID-19 by up to 96% in ferrets, the drugmaker said Monday. The nasal spray, which could be used alongside a vaccine, is poised to enter human trials in less than four months, pending regulatory approval and successful toxicity studies, Ena Respiratory said.
UPDATED: Friday, Sept. 25 at 3:13 p.m. ET
United Airlines partnered with GoHealth Urgent Care and Dignity Health to provide COVID-19 tests to passengers on certain routes. Starting next month, people flying from San Francisco International Airport (SFO) to Hawaii must either complete a self-collected, mail-in test before their trip or take Abbott’s rapid ID NOW swab test at SFO, with a negative result allowing passengers to skip quarantine requirements after landing. Story
Among Americans familiar with a recent vaccine safety pledge by nine drugmakers, 55% reported a more positive view of those companies, The Harris Poll recently found. Fifty-one percent of respondents said they felt positive about the development of COVID-19 vaccines in general. The survey follows an agreement in early September from CEOs at AstraZeneca, Johnson & Johnson, Moderna, Pfizer and five other companies not to pursue approval or authorization for a shot without conclusive positive data. Story
China won the World Health Organization's blessing before starting an emergency use program in July that has seen hundreds of thousands of people receive experimental COVID-19 vaccines before those shots complete phase 3 trials, an official with China's National Health Commission said Friday. The Chinese government in June drafted a trial for the program, which covers shots made by Sinopharm and Sinovac, and after informing agency representatives in China, "gained the understanding and support of the WHO," the official said.
Russia will sell its Avigan generic Avifavir in 17 more countries beyond the six where it's already available as a COVID-19 treatment, Russia's sovereign wealth fund said Thursday. Russia will supply the drug to EU members such as Bulgaria and Slovakia, as well as countries in Africa, the Middle East and Latin America. Meanwhile, Avigan maker Fujifilm said Wednesday it would pursue approval for the flu med to treat COVID-19 in Japan next month.
As pandemic closures lift, the U.S. aesthetics business is booming, and drugmakers have responded with a suite of marketing campaigns. AbbVie’s Allergan Aesthetics recently restarted its “Own Your Look” campaign for its flagship Botox treatment. Meanwhile, Galderma in June kickstarted a grassroots campaign for its Restylane Kysse lip filler after its mid-pandemic approval in May. And Merz Aesthetics recently tapped Gwyneth Paltrow as the celebrity spokesperson in a new campaign for Xeomin, its anti-wrinkle botulinum toxin. Story
UPDATED: Friday, Sept. 25 at 9:15 a.m. ET
Novavax kicked off late-stage vaccine testing Thursday with a trial launch in the U.K. The drugmaker aims to recruit 10,000 volunteers there in hopes that the country's high case count will help the trial enroll quickly and provide a near-term look at efficacy. The U.K. trial aims to fill at least 25% of its slots with seniors 65 years and older and recruit groups hard-hit by the virus, including racial and ethnic minorities. The U.K. recently agreed to buy up to 60 million doses of Novavax's jab. Story
Meanwhile, during a tour of its labs with BIO CEO Michelle McMurry-Heath, M.D., Ph.D., and Maryland Governor Larry Hogan, Novavax CEO Stanley Erck said the company plans to start a 30,000-subject trial in the U.S. "in a few weeks" and will launch a phase 3 in India after that.
Plus, Novavax tapped Endo International's Par Sterile Products unit for fill-finish work on its jab. Par Sterile has already started production at its Rochester, New York, plant, and aims to supply initial batches to Novavax for its U.S. phase 3. Par Sterile will also carry out fill-finish duties on doses pegged for commercial distribution. Financial terms and dose volumes were not disclosed.
European governments will help cover liability costs if AstraZeneca's vaccine candidate triggers unexpected side effects post-authorization, Reuters reported, citing an EU official. Under the deal, struck in August and only achieved thanks to AZ's lower price for its shot, European governments will help pay claims over a certain threshold, though the official declined to say what that cap was or how the cost would be split among EU states. Sanofi, reportedly charging a higher price for its shot, did not win the same liability shield.
The White House may reject the FDA's tougher guidelines for a vaccine emergency nod, President Donald Trump said Wednesday, painting the proposed guidance as a political hit. The new FDA standards cleared a Department of Health and Human Services review Tuesday, Politico reported. Trump's resistance to the tougher guidance is the latest in a string of events that experts fear may undermine public confidence in a vaccine.
UPDATED: Thursday, Sept. 24 at 3:05 p.m. ET
The U.S.' Operation Warp Speed plans to incorporate one more COVID-19 vaccine into its development and manufacturing efforts, and hints about the candidate seem to suggest Merck's program will be included, Bloomberg reports. Warp Speed head Moncef Slaoui said the "TBD" vaccine will be a live attenuated program that could potentially be administered orally, details that match Merck's work, according to the news service.
While Merck and fellow vaccine giant Sanofi aren't among the early COVID frontrunners, they could end up winning in the long run, Stat reports. The companies have vaccine R&D and manufacturing know-how, and could capture significant market share in the end, even if they aren't first to market.
After news broke that the FDA would implement tougher vaccine standards, President Donald Trump said Wednesday that the White House would have to approve the plan. The FDA declined to comment on the president's assertion, according to CNN reporter Kaitlan Collins. Two former FDA commissioners, Scott Gottlieb and Robert Califf, publicly supported the agency's move on Twitter.
As you might expect, i agree with Scott on this as do other former FDA commissioners. The swirl around this emphasizes the critical importance of the biomedical community getting very familiar with the vaccine trials and possible outcomes. https://t.co/khk0gjSBME
— Robert M Califf (@califf001) September 24, 2020
Meanwhile, concerns over politicization of the review process have prompted New York to conduct its own reviews, Gov. Andrew Cuomo said Thursday. While the state won't have a say in approving vaccines, it could hold off on distribution until it feels the shots are safe and effective, the New York Times reports.
UPDATED: Thursday, Sept. 24 at 9:20 a.m. ET
Novavax is homing in on a deal to provide more than 100 million vaccine doses to the EU, Reuters reported, citing a senior EU official. Novavax has already pledged 100 million doses to the U.S. and 60 million to the U.K. Meanwhile, the EU has inked supply deals with AstraZeneca for 400 million doses and secured 300 million more from Sanofi and GlaxoSmithKline. Officials there are also in talks with J&J, Moderna, CureVac and Pfizer. Story
BioNTech, partnered with Pfizer on its leading mRNA vaccine candidate, won't take part in U.K. challenge trials, wherein patients are deliberately infected with the virus to gauge the efficacy of vaccines, the Financial Times reported. AstraZeneca and Sanofi also said their shots will not be involved.
Scientists are calling on AstraZeneca to release more information about the patient illness that triggered a clinical hold of its phase 3 vaccine trial this month. AZ's trials kicked back off in countries such as the U.K. and India, while its U.S. test remains paused pending an FDA investigation. The University of Oxford said the illness was likely unrelated to the vaccine; Peter Hotez, a virologist and vaccine specialist at the Baylor College of Medicine in Houston, shares that view, but warned that lack of transparency could damage public trust in the vaccine program.
The Royal London and Whipps Cross hospitals in London, England, will launch a trial of the AstraZeneca-made drug, AZD1656—originally designed to treat hyperglycemia—to test whether it can lower blood sugar in COVID-19 patients with diabetes and potentially curb the immune response known as cytokine storm. The 150-patient Arcadia trial is set to run over the next four months across 15 sites in the U.K.
The FDA granted an emergency use authorization (EUA) for the Assure COVID-19 IgG/IgM Rapid Test Device, the first antibody test approved to screen for the virus in point-of-care settings using finger prick blood samples. The test won authorization for lab use back in July, before the FDA reissued its EUA this month. The move aims to speed up and simplify the process for finger stick serology tests.
Switzerland's Relief Therapeutics and its U.S. partner NeuroRx are pursuing an FDA emergency nod for their drug, RLF-100. Coronavirus patients who received the drug—previously used to treat conditions like erectile dysfunction—demonstrated a "threefold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement," the companies said in a release, citing a 51-person study.
Lumen Bioscience snared nearly $4 million from the U.S. Army Medical Research and Development Command to develop a cocktail of nanobodies—derived from the antibodies of camelids like llamas—to treat gastrointestinal infection in COVID-19 patients and potentially curb transmission. The grant will also support engineering work on a new manufacturing plant that could churn out 1 billion doses per year. Lumen expects to push its cocktail into phase 2 by spring 2021 and start manufacturing by summer.
By March or April, the U.S. should have around 700 million vaccine doses available, enough to inoculate roughly 350 million people, CDC head Robert Redfield said at a Senate Health, Education, Labor and Pensions Committee hearing. He added that it could take until July of 2021 to vaccinate the entire American public. At the same hearing, NIAID director Anthony Fauci said he also expects the U.S. to have around 700 million total doses by April.
UPDATED: Wednesday, Sept. 23 at 3:10 p.m. ET
AstraZeneca's phase 3 vaccine trial is still on hold in the U.S., pending the completion of an FDA investigation into the patient illness that triggered the original pause, Department of Health and Human Services Secretary Alex Azar said Wednesday. AZ's trial has since resumed in the UK, Brazil, South Africa and India.
The FDA is drafting new guidance on the requirements for a vaccine to win an emergency use authorization (EUA), the Washington Post reported. The agency will consider an EUA for companies that have a median of two months follow-up, starting at the second dose, on their phase 3 trial subjects, leaks published by the Post suggest. Plus, the FDA will reportedly require that the placebo arms of those trials have at least five cases of severe COVID-19, as well as confirmed cases in older subjects. Story
Researchers at the University of California, San Diego, may have found a new target for COVID-19 vaccines. The team found that glycans—interlocking sugar molecules that shield the virus' infamous spike protein—help stabilize the virus' receptor binding domain, which allows it to infect human cells. Introducing mutations that delete these glycans greatly reduced the virus' ability to bind to healthy cells, the team found. Meanwhile, the spike protein's head is less shielded by gylcans than the stalk, which could make it easier to target with large molecule therapies like antibodies. Story
A scant 42% of likely U.S. voters plan to get a COVID-19 shot once it becomes available, down from late July when 58% said they'd get the jab, a recent survey by Change Research found. Of the 4,448 likely voters polled—3,018 from six battleground states and another 1,430 from around the country—61% in the national group said they feared President Donald Trump may rush the release of a vaccine to boost his re-election chances, while 57% from the swing state group shared that view.
UPDATED: Wednesday, Sept. 23 at 9:20 a.m. ET
Johnson & Johnson kicked off its 60,000-person phase 3 vaccine trial Monday. The drugmaker's adenovirus-based shot has entered the final stage of testing behind several other rivals, but it could have an edge over those from Pfizer, Moderna and AstraZeneca: The J&J jab must be refrigerated, but not frozen, which could make distribution easier if the shot snares approval. Plus, the company is hoping its vaccine will work after a single dose. Story
Sanofi and GlaxoSmithKline inked a deal with Canada to provide up to 72 million doses of their recombinant protein-based vaccine hopeful, starting in 2021. The partners launched a phase 1/2 trial of their vaccine earlier this month and expect first results by December, with the goal being to push the shot into phase 3 before year-end.
Separately, Canada dialed up its Moderna Therapeutics order to cover 20 million doses of the drugmaker's RNA-based vaccine hopeful. The country also has an option to purchase 36 million additional Moderna jabs.
Plus, Gilead Sciences and pharma distributor McKesson Canada have agreed to supply up to 150,000 vials of the antiviral Veklury, also known as remdesivir, to Canada, the country's Minister of Public Services and Procurement said Tuesday.
Fujifilm's influenza med Avigan, sold generically as favipiravir, helped COVID-19 patients with non-severe pneumonia recover faster than those on placebo, phase 3 data showed. The data released were thin, but Fujifilm said it will conduct an analysis of the readout to seek a COVID-19 nod for Avigan in Japan as early as October. Story
Humanigen tapped Thermo Fisher to boost manufacturing on its monoclonal antibody lenzilumab, currently in a phase 3 registrational study to test whether the drug can curb the immune response known as cytokine storm in COVID-19 patients. Thermo Fisher could kick off commercial-scale production this year, the companies said in a release. Humanigen recently forged separate manufacturing pacts with Lonza and Catalent and hopes to secure an emergency nod for the drug in 2020. Story
UPDATED: Tuesday, Sept. 22 at 3:11 p.m. ET
New York’s Codagenix tapped Serum Institute of India (SII) to manufacture its nasal spray vaccine for COVID-19. SII agreed to crank out doses for large-scale safety and efficacy studies and shore up supplies ahead of a potential green light, Codagenix said in a release. Codagenix has so far tested its live-attenuated candidate in animals and plans to launch a phase 1 trial in the U.K. by year-end.
Johnson & Johnson’s new web campaign, “My Health Can’t Wait,” aims to equip patients and doctors with resources needed to keep medical care on track during the pandemic. Alongside patient tools, the campaign website also includes doctor tips for better patient communication, surgery discussion checklists and more. The move could boost J&J’s medical devices unit, which reported a 32.5% sales drop in 2020’s second quarter when many patients were bypassing elective surgeries and procedures. Story
Arizona Research Center scientists got the go-ahead to run a phase 1 trial pitting the decades-old pancreatitis drug nafamostat against COVID-19. The team's pill formulation of the drug, typically given via infusion, will undergo an initial study in healthy subjects before moving on to patients with COVID-19. If phase 1 results are strong, the drug could be fast-tracked to reach patients in as little as nine months, the center's Chief Medical Director said.
Russia will bear the brunt of legal liability should its Sputnik V vaccine prove unsafe, Reuters reported, citing Kirill Dmitriev, head of the Russian state fund that’s marketing the shot abroad. “We are putting our money where our mouth is by not asking for full indemnity in partnerships we create in different countries,” Dmitriev told Reuters. He did not say whether buyers would shoulder partial liability.
UPDATED: Tuesday, Sept. 22 at 9:30 a.m. ET
Top pediatricians are calling on vaccine makers to kickstart trials in children. As it is, a COVID-19 vaccine that's safe and effective for children may not be available until fall of 2021, because pediatric trials would require new protocols, and it could take a year to yield results. AstraZeneca, Johnson & Johnson, Moderna and Pfizer have all said they'll pursue approvals in children.
Speed and cooperation between rivals are the hallmarks of the pharmaceutical industry's response to COVID-19, Eli Lilly CEO Dave Ricks told CNBC. Ricks pointed to Lilly's recent data reveal on its anti-COVID-19 antibody cocktail as evidence of that efficiency. "We developed this antibody and got to proof of concept in six months,” Ricks said. “Usually, that’s more than six years.” He also trumpeted Lilly's recent team-up with Amgen to boost capacity for its antibody hopeful.
Pfizer and BioNTech's mRNA-based vaccine candidate could be the first shot to win U.S. approval, President Donald Trump suggested. "Pfizer's doing really well," Trump told Fox News, responding to a question about which shot might snare a green light. "Johnson & Johnson... they'll probably be a little later," he added, also acknowledging efforts by Moderna and AstraZeneca.
A vaccine price tag between €5 and €15 ($6 to $18) per dose would be "reasonable," President of the Executive Board of Vaccines Europe, Sue Middleton, said during a hearing in the EU Parliament. Vaccines Europe is a specialized vaccines group within the the European Federation of Pharmaceutical Industries and Associations that represents major pharma companies.
India and Pakistan have ramped up production of their licensed versions of Veklury, also known as remdesivir, but the majority of the 127 countries covered under Gilead Sciences' deal have yet to sign up for supplies. India's Hetero says it's shipped about 800,000 doses domestically since June and exported it to 25 countries, while Cipla has only shipped to South Africa. Some health experts have called on Gilead to make remdesivir copies available worldwide.
Speaking of Indian drugmakers, Dr. Reddy's Laboratories could kick off late-stage trials of Russia's Sputnik V vaccine in the next few weeks, a company executive told Reuters. Russia's sovereign wealth fund will deploy 100 million doses to Dr. Reddy's for the phase 3 test. Meanwhile, Russia has struck a separate deal with Indian manufacturers to churn out 300 million shot doses.
UPDATED: Monday, Sept. 21 at 3:06 p.m. ET
The National Institutes of Health will provide funding worth a total of $22.8 million to seven companies and schools working on digital health projects for COVID-19. Each one-year contract covers an award for feasibility testing followed by an option for development funding. The selected projects come from IBM and the University of California, San Francisco, working on separate contact tracing tools; Evidation Health, which plans to create an AI-driven early warning system; plus iCrypto; Vibrent Health; physIQ; and Shee Atiká Enterprises. Story
Esperion Therapuetics was set to launch its cholesterol drug Nexletol on March 30—then the pandemic touched down, upending the drugmaker’s plans. By March 12, Esperion began pivoting to digital sales tools. "It’s pretty amazing how fast we had to shift and pivot to this new environment,” Esperion Executive Director of Marketing Renee Marotta said. “We had to throw out the playbook and really embed into people’s heads that playbook is no longer meaningful." Story
The World Health Organization's COVID-19 Vaccines Global Access Facility, or Covax, which aims to develop and deploy $2 billion worth of vaccine doses by the end of 2021, on Monday released a two-phase distribution scheme. Enrolled countries would first receive doses for 3% of their populations, and then enough to cover 20%. In the second phase, Covax would apportion shots to countries at the highest risk. So far, 64 higher-income nations have signed on, with China and the U.S. notable exceptions.
The National Medical Association (NMA)—formed in 1895 when Black doctors faced exclusion from other medical societies—is setting up a task force to screen federal decisions on COVID-19 vaccines. The move comes as experts' faith in the FDA, CDC and Trump Administration has faltered, the New York Times pointed out. “It’s necessary to provide a trusted messenger of vetted information to the African-American community,” NMA President Leon McDougle, M.D., told Stat.
At-home dialysis has taken off during the pandemic thanks to social-distancing requirements, telehealth rollouts and patients’ own concerns about the virus, Kaiser Health News reported. Fresenius Medical Care North America, one of the U.S.’ biggest dialysis providers, said it performed 25% more home dialysis training sessions in the year’s first quarter compared to the same period in 2019. Meanwhile, doctors are asking more diabetes patients to consider the at-home option, and the Trump Administration in July considered boosting Medicare reimbursements for home dialysis machines. Story
UPDATED: Monday, Sept. 21 at 9:13 a.m. ET
AstraZeneca is aiming for 50% efficacy with its University of Oxford-partnered shot and expects an independent safety review board to perform early analysis of its data once a total of 75 trial participants become infected with the virus, a trial blueprint published Saturday said. AZ is the third major shot maker to release its protocol after Pfizer and Moderna. The British drugmaker has faced scrutiny over a potential patient side effect that prompted a clinical hold of its phase 3 vaccine trial earlier this month.
The European Commission urged EU governments to back talks with a seventh vaccine maker—a move that will require a cash infusion for the EU emergency fund that has so far made €2 billion ($2.4 billion) available for shot supply deals, Reuters reported, citing two EU sources. The EU has reached deals with AstraZeneca and Sanofi and is in talks with Johnson & Johnson, Moderna, Pfizer and CureVac for potential vaccine supplies.
Meanwhile, that seventh shot maker looks to be Italian biotech ReiThera, in early talks with the EU to provide doses of its vaccine candidate co-developed by Germany's Leukocare and Belgium's Univercells, Reuters reported, citing a source close to the company. ReiThera's single-dose jab is based on a non-replicating adenovirus vector, the same tech used in AZ and J&J's shots. It's currently in a phase 1 trial, which should yield data by year-end, the company said.
The state drug firm China National Biotec Group (CNBG) filed two inactivated vaccine candidates for conditional approval in the country, company vice president Zhang Yuntao said. If approved, the shot will go toward a large-scale, voluntary public inoculation effort, and the price for two doses won't exceed ¥600 ($88), Zhang said. CNBG's shots already boast emergency nods in the country, alongside another inactivated candidate made by Sinovac.
Russia has inked preliminary deals to provide its Sputnik V vaccine to countries such as Brazil, Mexico, Saudi Arabia and India, plus it has announced supply talks with roughly 10 other nations. All told, the country has received interest in about 1.2 billion doses. To shore up ex-Russian supplies, the country has tapped manufacturing hubs in India, Brazil and South Korea, while it hopes to produce 30 million doses for its own population by year-end. The shot won approval in Russia ahead of phase 3 data , though the country has since launched a 40,000-subject, late-stage trial.
UPDATED: Friday, Sept. 18 at 3:05 p.m. ET
Two generic forms of the flu med favipiravir, sold as Avigan by FujiFilm, were cleared for pharmacy sale to treat COVID-19 in Russia, the country’s Health Ministry said Thursday. The Russian-made generics, Areplivir and Koronavir, are expected to hit shelves at the same time, joining a third Avigan generic, Avifavir, which already boasts a COVID-19 green light in the country. Avigan has not been approved for COVID-19 in Japan, despite high hopes for the drug earlier this year from then-Prime Minister Shinzo Abe.
HHS Secretary Alex Azar personally pushed to strip the FDA's oversight on lab-developed tests last month despite objections from FDA Commissioner Stephen Hahn, Politico reported. The disagreement has created a rift between the FDA and HHS and led to screaming matches between Azar and Hahn, Politco said, citing a number of current and former Trump Administration officials. For its part, the HHS maintains that it did not overrule the FDA, and Hahn late last month told lawmakers that the HHS's legal division made the testing call.
Patchy data on COVID-19 antigen testing around the country has left the public and healthcare officials blind to the true scope of COVID-19 infections in the U.S., Kaiser Health News reported. Many states, including California, Texas and New Jersey, either don’t report antigen test results or don’t count antigen positives as confirmed COVID-19 cases. As the government pushes out a suite of rapid tests over slower, but more accurate, PCR tests, schools and businesses that rely on them for reopening could trigger even greater outbreaks of disease, the KHN team wrote. Story
Clinical trial suspensions triggered by COVID-19 peaked in early June and have risen again after an initial drop, with over 28,000 sites currently on pause, clinical trial firm Phesi reported. Two-hundred clinical trials wrapped enrollment in June, likely playing catch up after widespread suspensions over the previous three months, but just 70 trials completed recruitment last month, Phesi found. Phase 2 and 3 studies were the hardest hit. Story
UPDATED: Friday, Sept. 18 at 9:21 a.m. ET
Patients with COVID-19 pneumonia who received Roche's rheumatoid arthritis med tocilizumab, or Actemra, plus standard of care were 44% less likely to move onto mechanical ventilation or die compared to those on standard care alone, phase 3 data showed. But that top-line win was driven by patients staying off ventilators, Roche said; there was no statistically significant difference in death rates between the two arms of the trial. Story
Speaking of Roche, the Swiss drugmaker launched its Elecsys COVID-19 antibody test in markets accepting the CE mark Friday and filed for an emergency nod from the U.S. FDA. The test, which targets and measures antibodies directed against a certain region of the virus' infamous spike protein, could track vaccine-induced immune response in clinical trials and help screen blood plasma donations, Roche said in a release.
The European Union locked in a deal for up to 300 million doses of Sanofi and GlaxoSmithKline's recombinant protein-based vaccine candidate, European Health Commissioner Stella Kyriakides tweeted. The agreement comes on the heels of an earlier EU deal to purchase up to 400 million AstraZeneca doses and coincides with the deadline for World Health Organization members to join the agency's equitable shot distribution scheme, COVAX. Story
Moderna and Pfizer may tap the mRNA platforms they've used to develop COVID-19 vaccines to create better flu shots, the drugmakers said at separate investor events this week. Moderna thinks it could build a vaccine to surpass the typical 40% to 60% efficacy bar by swapping out genetic sequences according to sampling done at the height of flu season, CEO Stephane Bancel said. Meanwhile, Pfizer said it hoped to expand its mRNA work to develop a shot against multiple strains of the flu by 2022.
Chinese vaccine maker Sinovac tapped Alibaba's Health Information Technology unit to set up a platform for COVID-19 inoculations, including online appointment booking and post-vaccination health tracking, Alibaba said Thursday. Sinovac's shot, CoronaVac, is in phase 3 testing in China, Brazil, Indonesia and Turkey.
Diagnostics firm Cellex plans to develop a rapid COVID-19 test that patients can perform at home. The test is designed to deliver results in 15 minutes and double-check readouts through a companion smartphone app developed by Gauss. The app will also guide patients through the nasal swab collection process and send results straight to health authorities. Cellex and Gauss hope to win FDA approval for the test this fall. Story
The pharma industry's reputation is gaining as drugmakers hustle COVID-19 drugs and vaccines through the clinic, but companies need to make real changes if they want public goodwill to last, Interbrand Health Executive Director Barry Silverstein said. “This is a moment in time for a reset and for a new dialogue—one that emphasizes people, one that is mission-based, and one that’s inspiring to their employees, the public and investors,” Silverstein said. Story
UPDATED: Thursday, Sept. 17 at 3:29 p.m. ET
After Moderna on Thursday unveiled its vaccine phase 3 trial protocol, Pfizer followed suit later in the day. The New York drugmaker released a 137-page document outlining all of the details of the trial, which has already enrolled about 29,000 people.
A group of 11 state treasurers from both political parties asked Gilead Sciences to reconsider its pricing on antiviral remdesivir. The treasurers say taxpayers "have already paid the price" and "deserve an affordable treatment when loved ones" face severe COVID-19 cases. Gilead's treatment carries a list price of $3,120 per course.
CDC director Robert Redfield on Wednesday said that COVID-19 vaccines won't be available to most Americans until the middle of 2021, prompting the president to say otherwise. As Stat News points out, the episode was just the latest instance of the CDC mishandling public health messaging amid the pandemic.
UPDATED: Thursday, Sept. 17 at 9:20 a.m. ET
The safety scare that triggered AstraZeneca's clinical hold "is considered unlikely to be related to the vaccine," according to an Oxford University document on the shot trial. AZ's studies were put on pause last week after a patient in the U.K. was hit with a serious potential reaction—inflammatory spinal cord condition transverse myelitis, according to a New York Times source. Trials have resumed in the U.K., Brazil, South Africa and India, while the U.S. study remains on pause.
Moderna will consider an emergency use authorization for its shot in high risk groups if interim phase 3 data show the vaccine is at least 70% effective, CEO Stéphane Bancel told Reuters. An independent safety board is set to look over Moderna's data as soon as a total of 53 subjects in the trial are infected with COVID-19; Moderna expects that review to take place in November, but it could happen as early as October, the company has said.
BioNTech is buying a German manufacturing facility from Novartis with capacity to produce 750 million vaccine doses per year. BioNTech kept mum on the financial details, but it expects the deal to close in 2020's fourth quarter. The site is pegged to supply 250 million doses in the first half of next year, scaling up to the 750-million dose count once it's fully operational. It will help BioNTech boost production of its Pfizer-partnered shot, "[p]articularly in the first half of 2021," CEO Ugur Sahin said.
Meanwhile, Pfizer hit its 30,000-patient recruitment goal for the phase 3 trial of its BioNTech-partnered vaccine, the drugmaker said Wednesday. Pfizer submitted an "amended protocol" to the FDA over the weekend to add another 14,000 subjects to its trial. If Pfizer wins approval for the expansion, it will look to recruit younger patients, plus those with chronic conditions such as stable HIV, Hepatitis B and Hepatitis C.
Eli Lilly tapped Amgen to boost supply capacity for its potential COVID-19 therapies, including the antibody treatment LY-CoV-555. The drugmakers did not provide details on how the work would break down, but with their forces combined, they hope to crank out millions of antibody doses as early as next year, Lilly said in a release. Eli Lilly published data this week linking its antibody treatment to reduced hospitalizations in mild to moderate COVID-19 patients.
Takeda and its partners will kick off a late-stage trial of a COVID-19 blood plasma therapy this month after initial delays. The Takeda-led group, known as the CoVIg-19 Plasma Alliance, will run the trial in partnership with the NIAID in the U.S., with plans to recruit 500 subjects from the United States, Britain, Argentina and Denmark, an NIH posting said. The partners aim to compare outcomes from the plasma-based product against Gilead's Veklury (remdesivir) and a placebo.
Germany's Merck KGaA, which supplies lab equipment and has a part in more than 50 global COVID-19 vaccine projects, has overcome production shortages as it looks to meet a surge in demand from companies tackling the pandemic, Reuters reports. Merck has rushed to clear order backlogs on filtration products, while the team has shifted working hours to contend with a shortage of single-use, plastic bioreactors, CEO Stefan Oschmann said. Plus, the company has reportedly overcome low supplies of speciality chemicals used in COVID-19 diagnostics.
UPDATED: Wednesday, Sept. 16 at 3:17 p.m. ET
Pfizer and BioNTech's vaccine hopeful boasted a mild to moderate safety profile, with rare instances of severe reactions, phase 3 data through Aug. 27 showed. In 5,664 people ages 18 to 64 who received one dose, 38% reported fatigue, while 35% experienced headache and 16% had chills; the side effect rate was lower among another group of 1,816 older patients. Most side effects after the second dose were also mild to moderate, though more severe reactions did crop up after a second injection, Pfizer reported. Story
Meanwhile, BioNTech and fellow mRNA-based shot maker CureVac snared a combined $745 million in vaccine development funding from the German government. BioNTech scored $445 million in milestone-based funding, the drugmaker said Tuesday, while CureVac bagged $299 million in German funding earlier this month. Based on the government-set milestones, CureVac expects to grab $122 million of that total by the end of the year. Story
French drugmaker Valneva tapped Berkeley's Dynavax to help churn out enough adjuvant for 190 million COVID-19 vaccine doses by 2025, the partners said this week. Dynavax aims to deliver an initial adjuvant order—enough for 100 million doses—by 2021, with an option for the equivalent of 90 million doses by 2025. Earlier this week, Valneva inked a supply pact worth up to $1.63 billion with the UK to deliver upward of 190 million vaccine doses by 2025. Story
Only 27% of Americans said they would get a COVID-19 vaccine as soon as it's ready, down 6 percentage points from a month ago, weekly tracking surveys by the media and marketing services company Engine showed. Seventy-seven percent of respondents plan to get the jab eventually—but half of those people said they aim to wait for more research and safety data first. Meanwhile, 32% of those polled had "significantly reduced" confidence in a vaccine after news of AstraZeneca's clinical hold broke. Story
The FDA published data outlining the sensitivity of 58 molecular coronavirus tests, measured according to each diagnostic's limit of detection—a metric that describes the lowest amount of viral particles needed in a sample for a test to yield a correct result. That stat is different from analytical sensitivity, used to measure a test's rate of false negatives. PerkinElmer’s detection kit topped the list, followed closely by tests from ScienCell, BioCore, DiaCarta and others. Meanwhile, Qiagen’s respiratory disease panel ranked last. Story
Plus, Siemens Healthineers will team up with the CDC and the EU’s Joint Research Centre to help standardize international antibody tests for COVID-19. The triple effort aims to peg each viral protein of SARS-CoV-2, along with those proteins' associated antibody levels needed to thwart infection. Current antibody tests cover a wide range of viral proteins, and under the FDA's validation guidelines, companies often test assays against their own internal standards, rather than compare them with a common scientific benchmark. Story
Eli Lilly's anti-COVID-19 antibody curbed hospitalizations in patients with mild to moderate disease, but the lowest and highest doses out of three tested failed to beat placebo, interim phase 2 data showed. The BLAZE-1 study tested three doses against placebo in 452 patients by comparing subjects' viral load from baseline to day 11; only the middle, 2,800-mg dose met its primary endpoint, and Lilly has yet to release full data. Meanwhile, the company said its antibody led to a 72% risk reduction in hospitalizations, but that stat was based on a small group: five members from the 302-subject antibody arm went to the hospital, compared with nine from the 150-person placebo group. Story
A drug based on an antibody fragment 10 times smaller than a full-sized antibody was highly effective in treating and preventing COVID-19 in mice and hamsters, a team at the University of Pittsburgh School of Medicine found. Several of the researchers have since launched the startup Abound Bio to push the candidate into clinical trials, potentially as an inhaled COVID-19 drug. The fragment's small size could better penetrate infection sites and provide an alternative to infusion-based antibody treatments, the researchers said. Story
UPDATED: Wednesday, Sept. 16 at 10:33 a.m. ET
The U.S. FDA plans to work closely with AstraZeneca to parse through the safety scare that triggered last week's clinical hold, Commissioner Stephen Hahn said. He added that the FDA still doesn't know the cause of the side effect, reportedly the inflammatory spinal cord condition transverse myelitis. AZ's U.S. trial remains on hold pending FDA and safety panel investigations, Reuters reported Monday.
Meanwhile, the Serum Institute of India (SII) got the go-ahead from India's drug regulator to resume local trials of AstraZeneca's shot, a source close to the matter said Wednesday. The Drugs Controller General of India (DCGI) issued the green light after talks with U.K. authorities and AstraZeneca itself, the source said. SII will also boost safety monitoring of its trials and inform participants of any new findings, a DCGI source added.
AstraZeneca also restarted its vaccine trial in South Africa, Reuters reported, citing the South African health department's director of affordable medicines. Trials have also kicked back off in the U.K. and Brazil.
It's "unlikely, but certainly not impossible" that Pfizer will have enough phase 3 vaccine data to bring its shot before an FDA advisory committee on Oct. 22, CEO Albert Bourla told CNBC. Despite his cautious language, Bourla went on to say the drugmaker has a "very good sense" it will be able to offer an efficacy readout before the end of October. Meanwhile, Pfizer also thinks its shot could surpass the 50% efficacy bar required by the FDA, Bourla said.
Plus, the U.S. government plans to kick off vaccine distribution as early as one day after a shot wins authorization, an official from the Department of Health and Human Services said Wednesday. The Centers for Disease Control and Prevention will be on the hook to decide how to allocate and distribute the limited number of initial doses.
Russia will supply 100 million doses of its Sputnik V vaccine to Dr. Reddy's Laboratories in India, where the drugmaker plans to run a phase 3 trial on the Gamaleya Institute-made shot, the Russian Direct Investment Fund (RDIF) said Wednesday. The RDIF previously struck a deal with Indian manufacturers to churn out 300 million doses of the vaccine in-country; those shot deliveries could start later this year, subject to completion of trials and Indian approval.
An undisclosed number of volunteers dropped out of Johnson & Johnson's phase 2 vaccine trial in Spain, lead investigator Alberto Borobia told Reuters, though he added that there were enough reserve volunteers to keep the trial moving. The patients hit the exit over side effect concerns following AstraZeneca's clinical hold last week, Borobia said. J&J kicked off its Spanish phase 2 Monday, with tests expected to wrap on Sept. 22.
UPDATED: Tuesday, Sept. 15 at 3:30 p.m. ET
While the U.S. weighs whether to restart its AstraZeneca vaccine trial, Brazil's health regulator Anvisa on Tuesday gave the British drugmaker the OK to test its vaccine on an additional 5,000 patients, the Sao Paulo university running the phase 3 trial said. Last month, the Brazilian government set aside $360 million to secure an initial 100 million AZ doses, plus licensing rights to produce the Oxford University-partnered shot at the Oswaldo Cruz Foundation.
Some health officials are praising AZ for initiating the trial hold last week. “This is what we want to see with trials, it is a well-run trial. Safety is always critical, it is crucial and they have looked at that in an appropriate manner,” World Health Organization official Margaret Harris told Swiss journalists Tuesday.
Don't look for a global vaccine rollout anytime soon, even with the combined might of Big Pharma and major government investments, the CEO of the Serum Institute of India, Adar Poonawalla, told the Financial Times. Poonawalla predicts it will take four to five years for manufacturers to crank out the roughly 15 billion doses he thinks will be needed for a global inoculation push—and those manufacturers currently lack the capacity to meet that demand. "I have not heard of anyone coming even close to that [level] right now,” Poonawalla said.
South Korea plans to shell out $146 million to secure COVID-19 vaccines for around 60% of its population, or about 30 million people. $70 million from that fund will go toward 20 million doses from the WHO's COVAXX facility, while the rest will be put toward an initial 40 million doses from private drugmakers, South Korean health authorities said. Meanwhile, South Korea's SK Bioscience in July signed on to help manufacture AstraZeneca's shot, and it's also penned a deal to produce part of Novavax's jab last month.
The nose could make up prime real estate for COVID-19 therapeutics, scientists from Johns Hopkins University found. In a recent study, researchers ID'd large amounts of the protein ACE2—one of the pathways the novel coronavirus may use to infect healthy cells—in the back of the nasal cavity, providing a potential foothold for the virus. But a simple iodine solution could help rinse the virus out of the nose and throat, early evidence published in Ear, Nose & Throat Journal showed.
UPDATED: Tuesday, Sept. 15 at 9:02 a.m. ET
Novavax inked a manufacturing agreement with the Serum Institute of India, the world's largest vaccine producer by doses, that takes the company's peak global capacity to more than 2 billion doses annually. Serum Institute will start producing doses in 2021. For Novavax, the deal follows others with Fujifilm and AGC Biologics to boost manufacturing.
BioNTech, partnered with Pfizer and Fosun Pharma, picked up a €375 million ($445 million) funding commitment from the German government for its COVID-19 vaccine work. Under the deal, BioNTech aims to bolster its German manufacturing presence. The German government plans to spend €750 million in total funding vaccine candidates.
Aside from its current emergency nod in hospitalized patients, Gilead Sciences is testing remdesivir in an outpatient setting by IV and through inhaled administration, CEO Dan O'Day told CNBC.
AstraZeneca has scored $1.2 billion in federal funding for its COVID-19 vaccine work, but the company also raised drug prices this year more than its peers, an analysis by 46brooklyn Research shows. Many companies only raised prices once this year, but AstraZeneca raised prices for some medicines twice. LA Times story
Meanwhile, AstraZeneca's phase 3 COVID-19 vaccine trial has resumed in Brazil. The restart follows a similar development in the U.K., but U.S. officials have not cleared the trial to start again in the States. As the FDA considers allowing the trial to resume, officials at the "highest levels" of the National Institutes of Health are "very concerned" about a safety scare that caused the trial to be paused, Avindra Nath, a viral research expert at NIH, told Kaiser Health News.
With trials "proceeding smoothly" in China, citizens there may be able to get vaccines as early as November, a government official said.
Lonza has entered a manufacturing pact with Humanigen to help bolster capacity for lenzilumab, which is in phase 3 testing. Reuters story
Aside from COVID-19's devastating death toll, the pandemic has reversed two decades of progress in immunizing children globally. Tens of millions have slipped into extreme poverty, the Gates Foundation found. Wall Street Journal story
UPDATED: Monday, Sept. 14 at 2:40 p.m. ET
The U.K.'s Recovery Trial will run a phase 3 study of Regeneron's antibody cocktail, REGN-COV2, in hospitalized COVID-19 patients, the New York-based drugmaker said Monday. The trial, which aims to dose at least 2,000 subjects with Regeneron's cocktail, will assess its effect on mortality, length of hospital stay and need for ventilation. The company itself is testing the duo in two phase 2/3 COVID-19 treatment trials and a phase 3 prevention trial.
The FDA will likely issue an emergency use authorization (EUA) for a COVID-19 shot in targeted groups before granting a full approval—and that's a good thing, ex-FDA commissioners Scott Gottlieb and Mark McClellan wrote in a Wall Street Journal op-ed. Gottlieb and McClellan stressed that an EUA would still require a shot to prove its safety in clinical trials, adding that the process gives the FDA power to request additional data as a condition of approval. The biggest downside, according to the former chiefs? A staged vaccine rollout wouldn't quickly provide herd immunity.
South San Francisco's Vaxart got the go-ahead to test the safety of its oral vaccine candidate in a phase 1 trial. Vaxart will start recruiting this month and expects to launch its trial within a few weeks, a company spokesperson said in an email; results are expected early next year. The company aims to share vaccine data next month from a challenge trial in hamsters and is awaiting results from a challenge trial in monkeys.
AbbVie ordered workers in R&D, sales and marketing to return to work on-site Monday in a bid to re-establish its "face-to-face" work environment, CNBC reported, citing an Aug. 27 email to AbbVie staffers. The drugmaker has put precautions in place to prevent on-site spread of COVID-19, but many employees told CNBC they remain nervous about returning to work while the pandemic rolls on. Story
Thirty-four percent of Americans hold a positive view of the pharma industry, Gallup's 2020 image survey showed—a seven-point increase over last year's 27%. Still, 49% of respondents said they view the industry negatively, earning it the second-to-last spot in the annual poll, just behind the federal government. That's better than the 58% who reported a negative view in 2019; opinions may have shifted thanks to greater appreciation for the industry amid the pandemic, Gallup senior editor Lydia Saad said. Story
UPDATED: Monday, Sept. 14 at 9:30 a.m. ET
AstraZeneca got the go-ahead to resume its phase 3 vaccine trial in the U.K. after last week's clinical hold, thanks to a green light from the country's Medicines Health Regulatory Authority. AZ said it “cannot disclose further medical information” related to the hold, but the New York Times last week reported that a patient in the U.K. was found to have transverse myelitis, an inflammatory spinal cord condition that can be caused by viral infection. Tests elsewhere, including in the U.S., remain on hold. Story
Pfizer and BioNTech aim to scale up enrollment in their phase 3 vaccine trial to include around 44,000 participants, the partners said Saturday, adding that they expect to hit their current 30,000-subject recruitment goal this week. The expansion would also boost trial diversity, including patients as young as 16 years old, plus those with chronic, stable HIV and hepatitis B and C, the partners said. Story
Pfizer and BioNTech also think they have a 60% chance at knowing whether their lead mRNA vaccine candidate works by October, Pfizer CEO Albert Bourla told CBS on Sunday. Bourla trumpeted the diversity of Pfizer's phase 3 trial: Globally, 60% of participants are caucasian, while minorities make up the other 40%; plus, 44% of the enrollment population consists of older patients, the CEO said. He added that the company would aim to recruit more LatinX and African American subjects in its proposed recruitment scale-up.
Merck & Co. started dosing patients in a phase 1/2 trial of its vaccine candidate in Belgium. The 260-subject trial will test the viral vector-based shot's safety and ability to trigger an immune response against COVID-19 in healthy volunteers, the company said. Merck snapped up the vaccine candidate in May through its buyout of Themis Bioscience. The pharma giant aims to provide coronavirus protection using a proven vaccine platform that works with a single dose, the drugmaker has said.
The U.K. shelled out €470 million ($558 million) for 60 million doses of Valneva's inactivated vaccine candidate, slated for delivery in the second half of 2021, the French biotech said in a release. The country has the option to purchase another 40 million doses for 2022, plus an additional 30 million to 90 million doses across 2023 to 2025. Altogether, those purchases could amount to €900 million (about $1 billion) in revenue. The government will also invest upfront in Valneva's Livingston, Scotland, manufacturing plant, with those funds recouped against the U.K.'s supply pact. Story
Eli Lilly plans to file its Incyte-licensed rheumatoid arthritis med, Olumiant, known generically as baricitinib, for an emergency use authorization in COVID-19, the company said Monday. Paired with Gilead's Veklury, also known as remdesivir, Olumiant reduced recovery time by a median of one day for hospitalized COVID-19 patients, compared with those on Veklury alone, data published Monday from the NIAID-sponsored Adaptive COVID-19 Treatment Trial showed. Story
Meanwhile, scientists and health experts are calling for greater transparency around vaccine trials, arguing that Americans deserve to know more about the programs funded with billions of dollars in taxpayer money. Last week, nine pharmas, including AstraZeneca and Pfizer, pledged to "stand with science" in the hunt for a vaccine, but critics pointed out the joint statement lacked a promise to share vital details with scientists and the public.
The Trump administration put up $16 million toward a new data system to help public health officials schedule COVID-19 vaccinations and manage shot supplies. The Vaccine Administration Management System was developed by Deloitte using technology from Salesforce and tested in a series of pilot projects over the summer. Health experts blasted the move for bypassing U.S. states' established vaccine trackers, which have been honed over decades. Meanwhile, healthcare providers who may use the the new federal system have not been given a chance to preview it, a group of lobbyists and trade groups said.
UPDATED: Friday, Sept. 11 at 3:22 p.m. ET
Verily snared FDA approval to begin pooled testing for COVID-19 on up to 12 samples at once at its coronavirus-dedicated testing lab in San Francisco, which runs an adapted version of Thermo Fisher's TaqPath RT-PCR testing kit and boasts a stated capacity of several thousand tests per day. The company also published guidance for others looking to tap its sample collection methods and laboratory processes. Story
Celltrion's COVID-fighting monoclonal antibody, CT-P59, was well-tolerated in healthy patients and did not trigger any side effects at the highest dose, interim phase 1 data showed. Celltrion has also launched a phase 1 trial of the drug in mild COVID-19 patients, with plans to conduct further phase 2 and 3 trials in 500 subjects from 12 countries. The South Korean drugmaker also aims to recruit around 3,000 total subjects, including some from its earlier prevention trial, to test the treatment as a preventive for those in close contact with COVID-19 patients. Story
Sinopharm subsidiary China National Biotec Group has injected hundreds of thousands of people with two of its COVID-19 vaccine candidates under an emergency OK from Beijing issued in July, the company said this week. Meanwhile, Sinovac has given its shot to around 3,000 of its employees and their family members, including the company's CEO. All three candidates are still in phase 3 testing.
Country-specific efforts to lock down vaccine supplies could prolong the pandemic and hamstring efforts to provide broad access to an eventual jab, United Nations Secretary General Antonio Guterres warned at a meeting about the WHO's Access to COVID-19 Tools (ACT) Accelerator program. The WHO on Tuesday said that 78 countries had pledged to join the vaccine pillar of the ACT Accelerator, COVAX. Meanwhile, the U.S. said it would not join the program, while China, with four vaccine candidates in phase 3 testing, has yet to sign on.
President Donald Trump acknowledged the dangers of the COVID-19 pandemic back in February and admitted to downplaying the threat during a March interview with journalist Bob Woodward, according to an audio clip posted Wednesday by the Washington Post. Trump said Wednesday that he'd done so in order to prevent panic; meanwhile, Democratic nominee Joe Biden called the move a "life-and-death betrayal of the American people."
Meanwhile, as flu season approaches and the pandemic rages on, NIAID director Anthony Fauci cautioned against underestimating the virus. "We've been through this before," Fauci said, likening the pandemic to the early days of the AIDS epidemic, which over the past few decades has resulted in millions of deaths and more than 70 million infections. "Don't ever, ever underestimate the potential of the pandemic. And don't try and look at the rosy side of things."
Britain plans to launch a new COVID-19 contact tracing app across England and Wales later this month that will allow people to check into venues by scanning a QR code displayed at the entrances of bars, restaurants, movie theaters and other places where people gather. The National Health Service will then use that info for its Test and Trace program in a bid to boost contact tracing efforts. Currently, people in the U.K. must manually fill in their contact information when they enter a venue.
UPDATED: Friday, Sept. 11 at 9:30 a.m. ET
Eight FDA career executives, including the director of the agency's Center for Biologics Evaluation and Research, Peter Marks, pledged to make decisions on the basis of sound science in a USA Today opinion piece. The FDA execs conceded that the agency exists within a political environment, stressing the importance of regulatory independence amid potential pressures.
The National Institutes of Health (NIH) launched two late-stage clinical trials of blood thinners in COVID-19 patients. In a trial of hospitalized COVID-19 patients, subjects will receive varying doses of the generic blood thinner heparin to test its safety and efficacy in preventing clotting events, the NIH said, while non-hospitalized patients will receive either aspirin or a low dose of Bristol Myers Squibb and Pfizer's Eliquis. Plus, the NIH is plotting a third trial to test blood thinners in moderate to severe COVID-19 patients who've been discharged from the hospital.
United Biomedical's Covaxx penned an agreement with the University of Nebraska Medical Center (UNMC) to run clinical trials on Covaxx-made therapeutics and vaccines, with the initial focus on a phase 1/2 trial of the drugmaker's COVID-19 vaccine, UB-612. In May, Covaxx entered a separate partnership with UNMC to to run large-scale COVID-19 antibody diagnostic testing and processing.
Meanwhile, Covaxx tapped Dasa—Brazil and Latin America's largest diagnostics maker—to run phase 2/3 trials of its synthetic multitope vaccine candidate in Brazil, the companies announced Wednesday. Covaxx will supply doses of UB-612 to Dasa, which will head up clinical testing once it wins approval from Brazil's drug regulator, ANVISA. Trials will take place at public and private laboratories and hospitals, and will also be carried out by contract research organizations, Covaxx said.
China, which has four vaccine candidates in the final stage of testing, is leveraging its inoculation efforts to repair damaged ties and bolster alliances with countries in Latin America, Africa and more. The country has already promised the Philippines priority access to a vaccine, while China's Sinovac will provide over 110,000 free shot doses to Bangladesh. Meanwhile, India has sought to counter China's move on South Asia by pledging its own doses to countries like Nepal and Bangladesh.
Speaking of China, the country on Wednesday approved a phase 1 trial of Beijing Wantai Biological's nasal spray vaccine for COVID-19, co-developed by researchers at Xiamen University and Hong Kong University. The spray contains contains a weakened form of the flu that carries segments of the coronavirus' spike protein. A vaccine delivered through the nose may have a better shot at thwarting the virus in the respiratory tracts, some researchers think.
UPDATED: Thursday, Sept. 10 at 3:14 p.m. ET
British companies iAbra and TT Electronics are set to debut their 20-second COVID test at London's Heathrow Airport. The device uses a digital microscope and artificial intelligence to search a mouth swab sample for signs of the novel coronavirus. Validation studies have shown it's highly accurate. FierceMedTech story
More than half of Americans—62%—are worried the FDA will approve a vaccine prematurely under political pressure from the Trump administration, a new Kaiser Family Foundation survey shows. The survey also shows lower levels of trust in the CDC and NIAID director Anthony Fauci from April.
As COVID vaccines move forward, FDA's Center for Biologics Evaluation and Research director Peter Marks confirmed that any emergency use authorization would require an advisory committee meeting to review data.
While experts have raised warnings about the possibility of flu and COVID-19 circulating simultaneously this fall and winter, good news is emerging from the Southern Hemisphere. COVID-19 mitigation measures have "all but eliminated" the flu season, The Economist reports.
In convincing people to get COVID vaccines when they're available, analytics firm Civis found personal stories resonate the most. People were 5% more likely to say yes to a vaccine if they were shown a story about a young healthy person who contracted COVID-19 and died, the firm found. Story
UPDATED: Thursday, Sept. 10 at 9:23 a.m. ET
AstraZeneca still expects to learn by year-end whether its vaccine candidate works, so long as it's able to resume its trial soon, CEO Pascal Soriot said Thursday. AZ put its phase 3 vaccine study on hold this week after a U.K. trial participant reported a potentially serious side effect. While an official diagnosis has not been made, the patient showed symptoms of transverse myelitis, a spinal cord inflammatory condition; a positive diagnosis would ultimately be submitted to an independent safety committee, who would then make the call on whether to resume the trial, Soriot said. Story
Plus, the Serum Institute of India paused testing on AstraZeneca's shot following the British drugmaker's clinical hold, the company said Thursday. The news comes after the Serum Institute announced Wednesday it had not faced any safety issues and would continue trials on the AZ vaccine. Meanwhile, India's drug regulator issued a show-cause notice to the Serum Institute for failing to inform it of AstraZeneca's clinical hold in other countries.
Meanwhile, Emergent BioSolutions, on the hook to help produce bulk drug substance for AstraZeneca's vaccine, won't suffer financially if the University of Oxford-partnered shot fails to cross the finish line, Cantor analysts figure. Emergent's contract with AZ includes protections that will see the company reap most of the $174 million it's owed under the first year of the deal; plus, $87 million has already come Emergent's way for tech transfer and preparation, the analysts noted. Story
Gilead Sciences' Veklury, also known as remdesivir, is in short supply in the U.S., according to a slate of doctors around the country, despite the fact that other nations like India and the Philippines report ample stores of the COVID-fighting antiviral. One reason for that supply imbalance? Many of those countries are able to purchase generic remdesivir, while Gilead has exclusive license to sell Veklury in the U.S.
National Institutes of Health director Francis Collins on Wednesday diverged from the Trump Administration's suggestion that a vaccine might be ready by Election Day. “Certainly, to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you," Collins said, adding that the recent AstraZeneca hold reinforced the need to maintain safety over speed.
UPDATED: Wednesday, Sept. 9 at 3:00 p.m. ET
AstraZeneca's clinical hold could play out a number of ways: If the spinal cord condition transverse myelitis is confirmed as a reaction to the shot, AZ may have to "terminate" its program, SVB Leerink analyst Andrew Berens figures. Meanwhile, the AZ hold could position Moderna's mRNA shot to beat AstraZeneca's to market, fellow SVB analyst Mani Foroohar said. Plus, other drugmakers testing adenovirus-based vaccines will likely face delays as they rework consent forms and patient brochures. Story
Pfizer and BioNTech's leading mRNA vaccine hopeful triggered a neutralizing antibody response in macaques, as well as antigen-specific T cell responses in both monkeys and mice, data published Wednesday on the preprint site BioRxiv showed. After receiving two doses of the vaccine, macaques who were challenged with COVID-19 had no viral RNA in their lower respiratory tracts, whereas most non-immunized animals did, Pfizer reported. Story
Sinovac's COVID-19 shot CoronaVac yielded a safe immune response in patients over the age of 60, phase 1/2 data published Wednesday showed. Sinovac gave two doses to 421 healthy adults between 60 and 89 years of age and found that the shot was well-tolerated at low, medium and high-doses. The immune response in the older volunteers was comparable with results previously published on patients between 18 and 59 years old, Sinovac said in a release.
New Jersey CDMO Catalent will pump $130 million into its gene and cell therapy manufacturing facility in Harmans, Maryland, adding five late-stage clinical and commercial manufacturing suites to the site. Along with a cell and gene therapy foothold, the expansion could support Catalent's COVID-19 vaccine production efforts. AstraZeneca last month tapped Catalent to help churn out bulk drug substance and viral vectors for its shot at the Harmans site. Story
Qiagen plans to roll out a rapid antigen test in the fourth quarter that leverages the diagnostics firms' portable testing hub. Co-developed with Australia's Ellume, the digital hub can process up to eight test sticks at once, or more than 30 swab samples per hour, and aims to turn out results in less than 15 minutes, Qiagen said. The hub can also run antibody and antigen tests at the same time. Qiagen hopes to make two versions of the test available later this year. Story
OncoImmune raised $56 million in its second round of funding as it looks to push its experimental drug CD24Fc through late-stage trials for leukemia and COVID-19. Designed to regulate inflammatory responses to tissue injures and mainly tested in graft-versus-host disease, the drug is in phase 3 tests to see whether it can prevent immune destruction in severe and critical COVID-19 patients. The trial is close to its 270-subject enrollment goal and top-line readouts are "expected soon," the biotech said. Story
UPDATED: Wednesday, Sept. 9 at 9:45 a.m. ET
AstraZeneca placed its phase 3 vaccine trial on hold after a U.K. participant suffered a severe reaction—potentially transverse myelitis, or inflammation of the spinal cord, a New York Times source reported. AstraZeneca has not revealed the timeline to complete its investigation and resume dosing but said it would move fast to limit trial disruptions. Story
Pfizer and BioNTech wrapped talks with the European Commission to provide an initial 200 million vaccine doses to the EU, with the option to supply another 100 million doses at a later date, the partners said in a release. Slated for delivery by year's end, doses will be made at BioNTech's German manufacturing sites and Pfizer's Belgian plant. The deal marks the partners' largest initial vaccine order to date. Story
Russia will supply 32 million doses of its Sputnik V vaccine to Mexico's Landsteiner Scientific, the Russian Direct Investment Fund (RDIF) said. Vaccine deliveries are pegged to start in November, pending Mexican approval, and Landsteiner will be on the hook for distribution duties. The RDIF thinks the vaccine delivery could cover around 25% of Mexico's population.
On the topic of Sputnik V, Venezuelan President Nicolas Maduro proposed that nearly 15,000 political candidates receive the Gamaleya Institute-made jab in a bid to campaign safely during the country's upcoming legislative elections. An undisclosed amount of Russian vaccines are pegged for delivery in September for clinical trials, Maduro said, adding that "other vaccines" would arrive in October.
Australia's Starpharma pivoted its dendrimer-based drug delivery platform to develop a long-acting, water-soluble version of Gilead Sciences' Veklury, also known as remdesivir, that can be administered via subcutaneous injection. The under-the-skin approach could take Veklury beyond the hospital—where it's approved for COVID-19 patients as an infusion—and expand access to the antiviral in countries with less-developed healthcare systems, CEO Jackie Fairley said. Story
UPDATED: Tuesday, Sept. 8 at 3:45 p.m. ET
Moderna may not hit the $4 billion to $5 billion annual vaccine sales highs that consensus estimates have predicted, SVB Leerink analyst Mani Faroohar figures. A strong phase 3 update and emergency nod for the shot in the fourth quarter are "broadly expected," but Big Pharma competition and dampened vaccine demand could prove major stumbling blocks. For its part, SVB Leerink has pegged Moderna's annual COVID-19 shot sales at around $2 billion or less. Story
Meanwhile, Moderna and Pfizer's phase 3 trials are expected to complete enrollment by September's end, NIAID director Anthony Fauci told PBS NewsHour's Judy Woodruff. It will then take another month or more for the drugmakers to test a second dose in patients, putting prospective vaccine readouts well past election day in the U.S. Sufficient data for a vaccine approval likely wouldn't arrive until year-end, Fauci added.
Six of Sanofi's clinical trials across 31 countries have hit COVID-19 snags, analytics firm GlobalData found. Those six trials have faced disruption due to trial delay or slower enrollment issues brought on by the pandemic and could hamper the French drugmaker's ability to file and win approvals for various drugs, GlobalData said. Plus, two phase 3 pivotal trials testing sarilumab, marketed as Kevzara, in non-COVID-19 indications have been suspended.
LabCorp aims to launch an at-home version of its Pixel self-collection kit, which can test a single sample for COVID-19, respiratory syncytial virus (RSV) and influenza. The test, offered through hospitals and other healthcare providers under a COVID-19 green light issued in May, uses a short nasal swab designed for the lower portion of the nostril. Pending FDA review, LabCorp thinks the at-home version could help people distinguish between COVID-19, RSV and the flu, which often present with similar symptoms. Story
AstraZeneca tapped fitness guru and heart attack survivor Bob Harper to star in its "Survive Today" TV spot, encouraging viewers to call 911 at the first sign of heart attack symptoms—even if those patients are concerned about catching COVID-19 at the hospital. The PSA fits into AZ's "Our Hearts Are Open" campaign, which aims to support people with cardiovascular, chronic kidney disease and diabetes during the pandemic. Story
UPDATED: Tuesday, Sept. 8 at 9:23 a.m. ET
A suite a drugmakers—including Pfizer, Moderna, GlaxoSmithKline, Sanofi and Johnson & Johnson—released a joint statement pledging to follow a scientifically rigorous approval process for their vaccines. The statement aims to reassure the public that the companies won't seek accelerated approval amid political pressure to OK a shot before the U.S. presidential election. Story
Pfizer and BioNTech plan to push a fifth vaccine candidate into a phase 1/2 study this month, an SVB Leerink analyst Daina Graybosch said Friday. The shot, which falls under the partners' BNT162 program and uses nucleoside-modified RNA, or modRNA, showed preclinical promise and could work as a follow-on candidate to the partners' leading shots, Graybosch said, quoting company management. Story
CSL inked a deal with the Australian government to crank out 51 million doses of the University of Queensland's "molecular clamp"-based coronavirus vaccine, with the first doses slated for release in mid-2021, the company said in a release. Meanwhile, CSL also signed on to manufacture around 30 million doses of AstraZeneca's jab in Australia, with delivery expected early next year if the vaccine wins out in the clinic. Story
The U.K. health service thinks AstraZeneca and the University of Oxford's COVID-19 vaccine hopeful will likely be available in the first few months of 2021, health secretary Matt Hancock said Monday. AZ has already pledged 30 million vaccine doses to the U.K. and started production on those shots ahead of approval; plus, the British pharma major kicked off its phase 3 vaccine trial in the U.S. last week.
Sanofi's GlaxoSmithKline-partnered vaccine candidate will likely cost less than €10 ($11.80) in Europe if it passes muster in the clinic, the drugmaker's French president Olivier Bogillot told France Inter radio. Meanwhile, a Sanofi spokesperson told Reuters that a final price would only emerge once the shot moves into the final stage of testing. AstraZeneca, on the other hand, is expected to price its shot at about €2.50 in Europe.
The Japanese government on Tuesday OK'd an expenditure of ¥671.4 billion ($6.32 billion) from its emergency budget reserves to lock down coronavirus vaccine supplies, the country's Ministry of Finance said. Japan's government hopes to secure enough vaccine doses to provide shots to all its citizens free of charge by mid-2021.
Around 90% of Sinovac employees and their families have taken the Chinese drugmaker's experimental COVID-19 vaccine, Reuters reported, citing the company's CEO, Yin Weidong. The shot launched in July under a Chinese emergency use program that targets medical workers, food market employees, and those who work in the transportation and service sectors. Sinovac's CoronoVac shot, currently in phase 3, has been pegged for the emergency scheme and offered to around 2,000 to 3,000 employees and their families on a voluntary basis, Yin said.
Speaking of Sinovac, the drugmaker's shot proved safe in older patients, but also triggered a slightly weaker immune response in that group than it did younger subjects, according to preliminary data from a phase 1/2 trial shared with Reuters. Full data from that trial, launched in May, have not been released. Ninety percent of patients from three groups who took two shots of a low-, mid- and high-dose of Sinovac's vaccine experienced a significant antibody response, with the lower levels in older patients in line with expectations, a company spokesperson said.
South Korea's Celltrion will kickstart commercial production of its COVID-fighting antibody drug this month, with the aim to churn out roughly 1 million doses ahead of approval. Celltrion completed a 32-subject phase 1 study of the treatment in South Korea and is recruiting another nine patients for an additional phase 1. Meanwhile, the company has also launched a human study in the U.K.
UPDATED: Friday, Sept. 4 at 9:15 a.m. ET
With AstraZeneca's vaccine now in phase 3 testing in the U.S., the Department of Defense pledged five of its military sites to help the British drugmaker run trials on the University of Oxford-partnered jab. The study will take place at Naval Medical Center and Wilford Hall Ambulatory Surgical Center in San Diego, Joint Base San Antonio, Walter Reed National Military Medical Center in Bethesda, Maryland, and Fort Belvoir Community Hospital in Fort Belvoir, Virginia, the Pentagon said.
Johnson & Johnson's vaccine hopeful triggered an antibody immune response and curbed disease progression in a group of hamsters, the drugmaker said Thursday. The rodents received a single dose of the vaccine and were then exposed to the coronavirus four weeks later. In addition to an antibody response, vaccinated hamsters appeared to lose less weight than their unvaccinated peers and avoided serious clinical outcomes like pneumonia or death.
Merck & Co., slow to start in the COVID-19 vaccine race, may push its Themis-bought measles vector-based candidate into human testing "fairly soon," CEO Ken Frazier said Thursday, adding that the drugmaker's second shot hopeful from IAVI could enter trials later this year.
Germany's CureVac thinks it could produce its mRNA-based vaccine at scale by year-end, investor Dietmar Hopp told German business paper Handelsblatt. The biotech aims to turn out 100 million doses before 2020's close and hopes to win regulatory approval in spring or summer of 2021, Hopp added. CureVac may also look to boost its deal with Grohmann, part of Elon Musk's Tesla, to create RNA printers for decentralized vaccine distribution, Hopp said.
In the meantime, CureVac may receive up to €252 million ($297 million) from the German Federal Ministry of Education and Research to boost development and rapidly expand production of its mRNA-based COVID-19 hopeful, the biotech said in a release. Payments are contingent on predefined milestones, and CureVac expects to snag up to €103 ($121 million) million in 2020, followed by another €149 million ($176 million) next year.
Russia's recently approved Sputnik V vaccine spurred an antibody response in 100% of patients with minimal side effects, data from two trials—each enrolling 38 healthy adults—showed. The data were published Friday in the Lancet. Faced with criticism for its approval of the Gamaleya Institute-developed shot ahead of phase 3 trial data, Russia last week teed off a late-stage vaccine study that aims to recruit around 40,000 subjects.
Speaking of Russia's vaccine, the Philippines health ministry is set to hold talks with the Russian embassy and representatives from Pfizer to potentially lock down vaccine doses for the Southeast Asian country. President Rodrigo Duterte has been angling for affordable shots from Russia and China in a bid to restore the country to normalcy by December. The Philippines aims to buy 40 million doses worth $400 million from multiple drugmakers, and it's also plotting an October trial of Russia's shot, a spokesman for Duterte said in August.
Meanwhile, the World Health Organization doesn't expect widespread vaccination against COVID-19 to start until next year, citing a lack of strong, late-stage data from front-runners like Pfizer and Moderna, plus Russia, with its recently approved shot, that meet the agency's 50% efficacy standard, spokeswoman Margaret Harris said Friday.
Even if a shot wins approval in the U.S. this year, two-thirds of Americans said they won't get the jab immediately, and a quarter said they wouldn't ever get the vaccine, a new poll by USA Today and Suffolk University found. Of the 1,000 people polled, the remaining third were split between 27% who wanted to get the shot as soon as it was made available and 6% who were undecided. Respondents 75 years of age or older were most likely to say they would get the vaccine straightaway.
UPDATED: Thursday, Sept. 3 at 2:55 p.m. ET
AstraZeneca tapped New York-based CDMO Albany Molecular Research to perform fill-finish work on “millions of doses” of the drugmaker’s University of Oxford-partnered shot at its Albuquerque, New Mexico, site. Financial terms were not disclosed, but Albany Molecular said it would shore up production of the adenovirus-based vaccine through 2021 on “unprecedented manufacturing timelines.” Story
The NIH pegged nine more test makers to advance through its “Shark Tank”-style COVID-19 diagnostics competition and put up $129.3 million in new funding. Lab-based test makers Illumina and the Broad Institute of MIT and Harvard won the NIH's blessing, among others. Meanwhile, the NIH backed three point-of-care test makers, including MatMaCorp and MicroGEM International, working on a cartridge-based spit test that can also detect respiratory diseases like the flu. Story
The U.S. won’t join the WHO’s COVID-19 Vaccine Global Access Facility, or COVAX, White House spokesman Judd Deere said. WHO Secretary-General Tedros Adhanom Ghebreyesus has made repeated calls for developed countries to join the initiative to combat “vaccine nationalism." Meanwhile, the White House in July sent a letter to the U.N. saying Washington would begin the formal process of withdrawing from the WHO.
California’s legislature approved a measure Monday that would allow the state’s top health agency to partner with drugmakers by January to produce generic or biosimilar drugs, including insulin. The measure seeks to make state-developed generics “widely” available at a time when COVID-19 has exposed “glaring gaps” in the ability of hospitals, government drug purchasers and other entities to maintain stable supplies of drugs and medical equipment, the bill’s author, Sen. Richard Pan, D-Sacramento, said.
Up to 45 U.S. hospitals may look to join a clinical trial on blood plasma in COVID-19 run by Vanderbilt University Medical Center, the study’s lead investigator, Todd Rice, M.D., told Kaiser Health News. Several hospitals, like the Ohio State University Wexner Medical Center, aim to prioritize patient enrollment in the trial and limit plasma’s use outside of studies, citing concerns over the observational data that won the treatment its emergency nod last month.
The Serum Institute of India and Biological E have penned major shot manufacturing deals with pharma giants AstraZeneca and Johnson & Johnson, respectively, but experts fear those companies may struggle to make and distribute enough vaccines to curb India's COVID-19 outbreak. Given the country's massive size and the cold storage needs of many front-runner shots, India's vaccination campaign could take years, Gagandeep Kang, a vaccine expert at the Christian Medical College in Vellore, India, told Nature.
UPDATED: Thursday, Sept. 3 at 9:12 a.m. ET
Sanofi and GlaxoSmithKline pushed their vaccine candidate into phase 1/2 testing, with plans to enroll 440 people across 11 U.S. clinical trial sites. The partners hope to deliver safety and efficacy results by December and move into phase 3 that same month, teeing up a potential approval for the shot in the first half of 2021. Sanofi and GSK have already pledged supplies to the U.S. and are in talks to supply doses to the U.K. and EU. Story
Novavax's recombinant vaccine safely triggered an immune response on day 35 of testing, phase 1 data published Wednesday in the New England Journal of Medicine showed. The drugmaker tested 5-microgram and 25-microgram doses in 131 healthy adults; 83 subjects received the shot with an adjuvant, while 25 received an non-adjuvanted shot and 23 got placebo. Novavax has now kicked off its phase 2 and aims to advance the shot into phase 3 in October.
The World Health Organization issued new guidance urging doctors to use low-cost, widely available steroids like dexamethasone, hydrocortisone and methylprednisolone to treat severely ill COVID-19 patients, after a slew of trials confirmed their benefit in that group. JAMA on Wednesday posted a pooled analysis of seven studies evaluating the three steroids in more than 1,700 patients, concluding that each drug curbed the risk of death. Story
CDC Director Robert Redfield, M.D., called on states to expedite applications for COVID-19 vaccine distribution facilities and "consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020," McClatchy reported, characterizing Redfield's letter as part of an ongoing push to jump-start U.S. vaccinations. Others, like Larry Corey, M.D., an expert who is co-leading vaccine studies in the U.S., doubt the shots currently in phase 3 trials can definitively prove safety and efficacy within that time frame. Story
Speaking of the CDC, the agency sent planning documents to public health agencies around the U.S. last week detailing plans to roll out two shots, dubbed Vaccine A and Vaccine B, possibly by October or November. According to the document, Vaccine A—most likely Pfizer's jab, The New York Times estimated—may be available in October, with 10 million to 20 million potential doses ready the next month, while 10 million doses of Vaccine B, most likely Moderna's, could be available by November.
A slate of biotech CEOs urged their peers running clinical trials on COVID-19 drugs and vaccines to release data through peer-reviewed journals and well-respected scientific meetings rather than press releases alone. In an open letter organized by the Biotechnology Innovation Organization, the CEOs, who come from companies such as Alnylam and Alkermes, also stressed the need for an independent FDA and a depoliticized national pandemic response. Story
Boynton Beach, Florida, resident Jacob Serrano—who has lost seven family members to the coronavirus—became the first American dosed with AstraZeneca and the University of Oxford's COVID-19 vaccine candidate last Friday.
UPDATED: Wednesday, Sept. 2 at 3:20 p.m. ET
New Jersey-based CDMO Catalent will invest $50 million into a third high-speed filling line at its Bloomington, Indiana, plant, expected to boost capacity by an additional 80 million vials per year. Catalent in April teamed up with Johnson & Johnson to handle fill-finish duties on the drugmaker's COVID vaccine at its Bloomington site. The CDMO will also shore up work on J&J's shot at its Anagni, Italy, plant, and has agreed to help with drug substance production and fill-finish work on AstraZeneca's vaccine at its Anagni and Harmans, Maryland, sites, respectively. Story
If interim phase 3 data are strong enough, the independent data and safety monitoring board overseeing COVID-19 vaccines would have a "moral obligation" to end the trial early and speed up the review process, NIAID director Anthony Fauci told Kaiser Health News. Fauci's comments come amid a firestorm of criticism over potential political interference at the FDA, although Fauci added that he trusts the members of the board, who are not government employees. Story
The U.S. Department of Health and Human Services tapped the Washington D.C. consulting firm Fors Marsh Group to head up its $250 million public messaging campaign to help the Trump administration “defeat despair, inspire hope and achieve national recovery" in the face of COVID-19. Reactions to the plan on social media late Tuesday were largely negative, painting the campaign as a political maneuver by the White House and a misuse of funds. Story
A seven-day treatment of the low-cost, widely-available steroid hydrocortisone gave severely ill COVID-19 patients a 93% better chance at recovery than those who didn't receive the steroid, a study from Imperial College London and the U.K.'s Intensive Care National Audit & Research Centre found, prompting the U.K.'s National Health Service (NHS) to recommend the drug in COVID-19 patients. The NHS previously green lit dexamethasone in COVID-19 after the U.K.-run Recovery Trial showed the steroid slashed death rates in hospitalized patients.
When it comes to COVID-19 news, both Democrats and Republicans hold doctors, nurses and nationally-recognized hospitals in high regard, a new Harris Poll found. Meanwhile, 71% of Republicans trust pandemic news from the White House, but only 28% of Democrats do, while 61% of Democrats trust the national news media compared to 36% of Republicans. As for the pharma industry, 71% of all people polled said they trust drugmakers working on COVID-19 vaccines. Story
Sixty-seven percent of healthcare experts surveyed over the summer plan to use decentralized clinical trials to combat COVID-19 disruptions, analytics firm GlobalData found. Out of 150 respondents, only 34% were already using decentralized trials, many of which were contract research organizations. Meanwhile, virtual trial companies like Science 37 and Medable have racked up funding and partnerships, respectively, for their decentralized trial work. Story
Nocion Therapeutics snared Sage Therapeutics' Christopher Silber, M.D., to serve as chief medical officer at the company. Nocion last month grabbed a speedy approval from the U.K.'s drug regulator to launch a phase 1 trial of its first program, an inhaled treatment for chronic and acute cough, which the company believes could benefit COVID-19 patients and potentially limit the virus' spread by curbing transmission between patients, family members and hospital staff. Story
UPDATED: Wednesday, Sept. 2 at 9:30 a.m. ET
Roche will launch a rapid antigen test in late September for countries accepting Europe's CE mark, with plans to pursue an emergency use authorization from the U.S. FDA, the drugmaker said in a release. The nasal swab-based test can turn out results in 15 minutes and will be used in point-of-care settings for symptomatic and asymptomatic patients. Roche has pegged its supply at 40 million tests per month at launch and hopes to double that by year-end.
Convalescent plasma, granted a controversial emergency use authorization in COVID-19 based on an observational study, not a placebo-controlled trial, should not be considered standard of care for patients with the disease, the National Institutes of Health said, citing a lack of data to recommend either for or against the treatment. The NIH called for more clinical trials on plasma and encouraged the public and healthcare providers to take part in those studies. Story
A fast-tracked vaccine authorization ahead of the U.S. Presidential election is unlikely, former FDA Commissioner Scott Gottlieb, M.D., told CNBC. By Gottlieb's estimation, a shot would need to boast around "70% to 80%" efficacy to yield a readout in October strong enough to warrant a green light before November 3. It's more likely that the ongoing phase 3 trials could deliver enough data for analysis in November, Gottlieb added. Earlier this week, current FDA Commissioner Stephen Hahn, M.D., said the agency would consider fast-tracking a shot before phase 3 trials are complete, if the benefits outweigh the risks.
EU member states could purchase vaccines through the World Health Organization's distribution scheme COVAX, separate from the current EU procurement plan, which so far has locked down an initial 300 million doses from AstraZeneca, the European Commission said. The policy shift would potentially allow EU members to tap doses from companies such as Merck & Co., Inovio and Novavax. Meanwhile, those countries would not be allowed to angle for doses from drugmakers already in talks with the EU, including Johnson & Johnson and Sanofi.
Chinese customs officials failed to approve shipments of CanSino Biologics' vaccine candidate to Canada for a prospective phase 3 trial—potentially due to political tensions between the two countries, Guy Saint-Jacques, a former Canadian ambassador to China said. CanSino, which early this year was at the forefront of the vaccine race, has yet to begin phase 3 trials on its shot. Meanwhile, some health experts worry the shot's immune response may fall short of rival vaccines.
California-based biopharma MediciNova is working on a number of vaccine candidates, including an intranasal vaccine that uses a viral vector platform from Japan's Mie University and MediciNova's development partner BioComo. MediciNova narrowed down its candidates by inoculating mice with a single intranasal dose, and it's now gearing up production for safety tests and clinical trials.
UPDATED: Tuesday, Sept. 1 at 3:17 p.m. ET
Sanofi and Regeneron are pulling the plug on Kevzara in COVID-19 after the rheumatoid arthritis med failed to significantly shorten patients' hospital stays or speed up their improvement in a phase 3 trial, Sanofi said Tuesday. Kevzara is one of two high-profile IL-6 inhibitors to stumble in COVID studies: In late July, Roche said its IL-6 inhibitor Actemra had also failed to meet its endpoints in a coronavirus phase 3, though the Swiss drugmaker remains committed to researching the drug in COVID-19, potentially in combination with Gilead's Veklury (remdesivir). Story
Meanwhile, Actemra, known generically as tocilizumab, blunted the activity of proteins called cytokines that can lead to deadly immune reactions in COVID-19 patients, data from Osaka University researchers show. The drug also put a damper on the protein PAI-1, which causes small blood clots throughout the body, including the lungs, the study found. All seven COVID-19 patients dosed with Actemra in the study recovered "promptly" from fever and malaise, and their PA-1 levels rapidly declined, the team said.
CanSino Biologics' COVID-19 vaccine, approved for military use in China, and Russia's green-lit shot from the Gamaleya Institute may share a common weakness: both vaccines are based on a common cold virus—adenovirus type 5, or Ad5—that many people already have some immunity to. Those people's immune systems could attack the viral vector itself, rather than the coronavirus, hampering the vaccines' efficacy.
United Biomedical's COVAXX division is developing the first multitope peptide-based vaccine against COVID-19, slated to enter human trials in Taiwan by summer's end and expected to start phase 1/2 studies at the University of Nebraska Medical Center this fall. COVAXX believes its B- and T-cell vaccine candidate will be easily scalable and won't require cold storage, and the company expects to be able to produce up to 100 million doses by next year's first quarter.
The Department of Health and Human Services (HHS) will spend $250 million on a media-spanning ad campaign with the goal to "defeat despair and inspire hope" around COVID-19, Politico reported. More than 10 communications companies are allegedly interested in spearheading the big money effort, whose budget for a five-month push towers over spending on other public health awareness initiatives. The CDC, for instance, has spent $93 million on public health TV ads since mid-March, data from the real-time TV ad tracker iSpot.tv shows. Story
In the hunt for a COVID-19 shot, several scientists have skipped drug regulators altogether and whipped up their own D.I.Y. vaccines. One such effort, the Rapid Deployment Vaccine Collaborative, or RadVac, backed by Harvard geneticist George Church, has developed a nasal spray vaccine using viral proteins called peptides. Many of RadVac's 23 listed collaborators have taken the vaccine themselves or given it to family members, with no serious side effects reported, but health experts have warned that untested vaccines could cause serious side effects or instill a false sense of protection.
UPDATED: Tuesday, Sept. 1 at 9:17 a.m. ET
AstraZeneca kicked off its 30,000-person phase 3 clinical trial of its vaccine candidate, AZD1222, in the U.S. with 62 out of a total 80 sites selected. The company expects to extend trial sites into Chile and Peru, the British drugmaker said in a release. AstraZeneca will assess its shot based on the number of participants who contract COVID-19 more than two weeks after getting their second doses. It's already in phase 2/3 testing in the U.K. and India, and phase 3 in Brazil and South Africa. Story
Speaking of AstraZeneca, the British drug major upgraded its vaccine production deal with Oxford Biomedica, throwing down £15 million ($20 million) upfront to reserve capacity at the CDMO's Oxbox facility. The pact includes an option for another £35 million ($47 million), Oxford Biomedica said.
GlaxoSmithKline and Vir Biotechnology dosed the first patient in a phase 1/2 study of the partners' COVID-fighting monoclonal antibody, designed to treat patients early and keep them out of the hospital. The study will enroll around 1,300 patients with early symptomatic infection. Early data may be available before year-end, while a full readout is expected in the first quarter of 2021.
Regeneron could snare as much as $6 billion in sales next year from its COVID-fighting antibody cocktail, investment research firm Morningstar figures. The firm also pegged the cocktail's chance of winning approval in the U.S. at 60%. Roche recently teamed up with the New York-based biotech to help churn out antibody doses, while Regeneron added 400 jobs at its plant in Limerick, Ireland, as it pivots to antibody production in the U.S.
The U.S. ought to share doses of an approved COVID-19 shot with other countries rather than hoarding supplies, Eli Lilly CEO David Ricks told Axios. The pandemic is a shared public health risk, not an independent one, Ricks said, adding that countries should help one another vaccinate high-risk populations after they've inoculated those patient groups themselves.
An emergency use authorization (EUA) for a vaccine that is ineffective or potentially unsafe could hamstring recruitment for other COVID-19 vaccine trials, NIAID director Anthony Fauci told Reuters. The warning comes on the heels of an EUA for convalescent plasma, which won an emergency nod without passing through a randomized, placebo-controlled trial. An EUA has never before been used to green light a vaccine intended for widespread use.
Meanwhile, Fauci broke down monoclonal antibody therapies in the works in an interview with MedPage Today. While antibodies in clinical trials from Regeneron and Eli Lilly are being tested intravenously, they could ultimately be formulated for subcutaneous or intramuscular injection, Fauci said. Plus, monoclonal antibodies are likely safer than convalescent plasma, which carry a risk of allergic reaction or side effects with each treatment.
Australian drugmaker Starpharma deployed its drug delivery technology, DEP, to create a long-lasting, water-soluble version of Gilead Sciences' Veklury, also known as remdesivir. Designed as a subcutaneous injection, Starpharma's formulation could enable less frequent dosing and provide an option for treatment outside the hospital—a potential boon for nursing homes, care facilities and countries without developed healthcare systems, Starpharma CEO Jackie Fairley said.
UPDATED: Monday, Aug. 31 at 3:20 p.m. ET
Johnson & Johnson pledged to supply up to 38 million doses of its adenovirus-based shot to Canada on a not-for-profit basis for emergency use during the pandemic. The parties are still hashing out the final terms of the advanced purchase deal, the drugmaker said in a release. J&J has kicked off phase 1/2a trials of its shot in Belgium and the U.S.
Gilead Sciences' Veklury, also known as remdesivir, won an expanded emergency use authorization for all hospitalized COVID-19 patients, broadening the antiviral's green light beyond those hospitalized with severe disease. The new authorization follows phase 3 data showing moderate patients on a 5-day course of Veklury, plus standard care, were 65% more likely to see their condition improve over those on standard care alone, while moderate patients on a 10-day course did not see statistically meaningful improvement. A JAMA editorial that accompanied the data release added that the most suitable patient group and length of treatment remain unclear. Story
Thermo Fisher Scientific set up a new, $40 million manufacturing facility in just six weeks to churn out viral transport media for COVID-19 diagnostics. The new plant at Thermo Fisher's Lenexa, Kansas, site brings on more than 300 full-time staff and has boosted production at the site—which previously made a range of media, collection and transport products—to 8 million units per week, the company said. Story
The Department of Health and Human Services axed its $646.7 million COVID-19 ventilator contract with medtech giant Philips, which originally agreed to deliver 43,000 ventilators to the U.S. national stockpile by year-end. Philips will complete its orders for August toward a total 12,300 delivered EV300 ventilator bundles, while another 30,700 will be left on the table. Last month, Democrats from the House Oversight Committee argued that the White House may have overpaid by as much as $500 million for the Philips contract. Story
With public opinion on the FDA in free fall over miscommunications and the appearance of political meddling, some health experts are calling for an independent commission to parse COVID-19 vaccine trial data before a shot snares approval. Even as the FDA seeks to reassure the public that scientific rigor, not politics, will drive its approval process, experts like NYU bioethicist Arthur Caplan argue that public faith in expert opinion has already waned, citing a "desperate need" for an independent review body. Meanwhile, the agency will convene its vaccines advisory panel—a set of external experts that routinely reviews immunizations—on Oct. 22 to discuss available data.
A drug developed to treat a coronavirus that can cause feline infectious peritonitis (FIP)—a viral disease in cats—blocked viral replication of human coronaviruses, too, preclinical data from researchers at the University of Alberta showed. California-based biotech Anivive Lifesciences in 2018 licensed the drug from Kansas State University to develop it as an antiviral to treat FIP, and last month announced it had launched two preclinical trials to test the drug against COVID-19. Story
UPDATED: Monday, Aug. 31 at 9:15 a.m. ET
Early data has boosted Sanofi's confidence in its GlaxoSmithKline-partnered recombinant protein shot and the mRNA vaccine it has in the works with U.S. drugmaker Translate Bio, CEO Paul Hudson told Reuters. Translate unveiled data last week showing its shot—slated to enter human trials in November—triggered an immune response in animals. Meanwhile, the Sanofi-GSK jab is pegged to enter clinical studies next month. Sanofi could have one or two vaccines ready next year, Hudson said.
Novavax clinched a deal to supply up to 76 million doses of its recombinant protein shot to Canada, the Maryland-based biotech said in a release. The partners are still working to finalize the terms of the advanced purchase pact, which would see Novavax supply doses as early as 2021's second quarter. Novavax in August kicked off the phase 2 portion of its phase 1/2 vaccine study in Australia and the U.S.
Daiichi Sankyo's mRNA-based vaccine candidate, DS-5670, was tapped by Japan's Agency for Medical Research and Development to enter a COVID-19 drug discovery program. Daiichi will partner with the University of Tokyo on clinical trials of its vaccine, which it aims to kick off around March of next year.
The FDA may authorize a COVID-19 vaccine phase 3 trial data are in, Commissioner Stephen Hahn told the Financial Times. But the FDA chief said his agency will not speed up the regulatory process for political reasons. It's up to the vaccine makers to apply for authorization or approval, and it's possible that a vaccine could first win an emergency use authorization in certain high-risk groups ahead of a blanket approval, Hahn said. Story
An April amendment to the Public Readiness and Emergency Preparedness (PREP) Act, which shields drugmakers from liabilities linked to treatments used in the fight against public health crises, states that companies cannot be sued for money damages in court over injuries from COVID-19 countermeasures, including drugs, vaccines and respiratory devices, unless those firms are guilty of "wilful misconduct." Now, health experts are concerned patients will have little recourse if presented with an ineffective—or worse, unsafe—COVID-19 treatment.
Seventy-two percent of American adults fear politics are taking a leading role in COVID-19 vaccine approval at the FDA, but that won't stop the majority from getting an approved jab, a new survey by STAT and The Harris Poll found. On party lines, 72% of Republicans and 82% of Democrats said they were concerned about political meddling at the FDA in the 2,067-person poll. Still, 67% of adults surveyed said they'd get a shot as soon as one is approved, while 62% were very or somewhat likely to take a vaccine cleared before the Presidential election.
UPDATED: Friday, Aug. 28 at 9:59 a.m. ET
Moderna confirmed that it's in talks with Japan to potentially supply at least 40 million doses of its mRNA vaccine candidate, which the biotech would deliver for distribution in-country by Japan's Takeda Pharmaceutical starting in 2021, the company said in a release. The cost of the prospective vaccine order remains under wraps.
Johnson & Johnson will kick off a phase 2 vaccine trial in Spain, Germany and the Netherlands next week, Spain's health minister, Salvador Illa, said Friday. Across the three countries, the study will enroll 550 healthy participants between the ages of 18 and 55, plus a group of patients over 65, Illa said. The trial marks the first coronavirus vaccine study approved in Spain, where J&J has recruited 190 participants.
Montreal-based biopharma Laurent Pharmaceuticals got a thumbs-up to run a phase 2 trial of its experimental drug, LAU-7b, in COVID-19. The trial will enroll about 200 hospitalized COVID-19 patients who will receive either a once-daily oral dose of the drug or placebo, and will test the candidate's ability to slow disease progression, prevent patients from moving to ventilators and cut death rates.
China's Sinovac won approval for emergency use of its vaccine candidate in July, Reuters reported, citing a source close to the matter. The nod cleared the shot for use in high-risk groups like healthcare workers. Meanwhile, China National Biotec Group, part of the state-owned pharma giant Sinopharm, also snared an emergency nod for one of its shots, the company said Sunday on social media.
Hong Kong generics maker Jacobson Pharma signed a letter of intent with Fosun Industrial to help market and supply BioNTech's mRNA vaccine candidate in Hong Kong and Macau. If the shot is approved, Jacobson would leverage its sales and distribution networks in hospitals and clinics to smooth the rollout, CEO Derek Sum said in a release. Fosun and BioNTech first teamed up in March to develop and sell the mRNA vaccine for use in the greater China region.
The University of Arizona's wastewater testing system on Tuesday detected possible COVID-19 cases in an on-campus dorm. The school sent a team to run tests on the dorm's roughly 311 residents, which yielded two confirmed coronavirus infections. The students, both asymptomatic, were sent to a quarantine dorm, the university said. The school kicked off its fall semester Monday, with only a few essential classes allowed to meet in-person.
UPDATED: Thursday, Aug. 27 at 3:21 p.m. ET
The European Commission made a €336 million ($396 million) down payment to AstraZeneca to lock down at least 300 million doses of the British drugmaker's University of Oxford-partnered shot, with the option to order another 100 million doses later on. All 27 EU member states will have the option to buy the AZ doses should the vaccine win out in the clinic, though the amount each country will pay has not been revealed. Elsewhere, AZ has agreed to supply 300 million doses to the U.S. for $1.2 billion and up to 30 million doses to the U.K. for £65.5 million ($86.5 million).
Given that Pfizer is halfway toward its goal of recruiting 30,000 patients for its mRNA vaccine phase 3, the company could complete enrollment by the end of next month, teeing up an early data reveal in mid-September and a potential full readout by mid-October, Mizuho Securities analyst Vamil Divan figures. That timeline grooves well with the FDA's plan to convene its vaccine advisory committee on Oct. 22, and, if Pfizer's shot passes muster in the clinic, it could win a green light before U.S. voters hit the polls Nov. 3. Story
Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) launched a joint effort, dubbed Blue Knight, to fund and mentor an initial seven startups working on tools and meds to fight COVID-19 and future pandemics. The startups, based in the U.S., Canada and Europe, will receive up to $500,000 in support, plus assistance on R&D and potential regulatory hurdles. Meanwhile, J&J will continue to review applications for additional startups on a rolling basis. Story
On the heels of its antibody team-up with Roche, Regeneron CEO Len Schleifer talked potential staff increases to meet the goal of tripling production on the company's COVID-19-fighting antibody cocktail. Now, it's official: Regeneron will add up to 400 jobs at its Limerick, Ireland, manufacturing plant to help churn out supplies of Regeneron's regular meds while the New York drugmaker gears up elsewhere to pump out its antibody cocktail at global scale. Story
Vaccitech, which helped develop AstraZeneca and the University of Oxford's vaccine front-runner AZD1222, picked up a grant worth upward of £2.3 million ($3.0 million) to develop a separate COVID-19 vaccine candidate that the company thinks could serve as a standalone jab or an add-on treatment for first-generation shots. The cash was furnished by the U.K. government, plus other funders like the National Institute for Health Research and the World Health Organization. Vaccitech expects to launch a phase 1 trial of its asset next year. Story
Florida-based CDMO Ology Bioservices snagged a $106 million contract with the U.S. Army to perform fill-finish work on targeted COVID-19 vaccines and therapeutics. Ology will receive $53.1 million upfront to reserve capacity for around 187 million drug or vaccine doses, the company said in a release. Story
Abbott scored a green light for a rapid antigen test that runs for $5 and fits entirely on a device about the size of a credit card. The BinaxNOW test can deliver a nasal swab readout within 15 minutes and works with an optional smartphone app, Navica, that can log and display results to potentially clear people for entry into schools, hospitals and other locales. Abbot plans to ship tens of millions of the prescription-based tests next month and will start producing 50 million tests per month in October. Story
UPDATED: Thursday, Aug. 27 at 9:17 a.m. ET
Pfizer and BioNTech have recruited more than half of the 30,000 participants planned for their phase 3 vaccine trial, Nicholas Kitchin, M.D., a top Pfizer vaccine research and development scientist, said at the CDC’s Advisory Committee on Immunization Practices meeting Wednesday. Pfizer had enrolled more than 11,000 volunteers last week, according to a company statement.
Johnson & Johnson Wednesday confirmed it would add Chile, Argentina and Peru to the list of Latin American countries where it's plotting phase 3 vaccine trials. All told, J&J's Latin American tests will involve around 60,000 volunteers from Brazil, Chile, Colombia, Peru, Argentina and Mexico, with the drugmaker still awaiting regulatory approval in Chile, Argentina and Mexico, J&J told Reuters.
Novavax expects to file its vaccine candidate for U.S. approval in December, CEO Stanley Erck told Czech newspaper Hospodářské noviny. The Maryland-based shot maker will produce part of the vaccine at its Czech plant and supply doses to the Czech Republic if the shot nets approval, Erck said. On Monday, Novavax enrolled the first subjects in a phase 2 trial of its recombinant vaccine, with plans to asses the shot's benefit in older adults.
The U.K.'s Scancell Holdings, which develops immunotherapies for cancers and infectious diseases, snared funding from Innovate UK to kick off a phase 1 trial of its DNA-based COVID-19 vaccine in 2021. Scancell is expected to receive around £2 million ($2.64 million) through the UK Research & Innovation Ideas to Address Covid-19 initiative; that cash will cover most development and phase 1 trial costs, the company said. Scancell's vaccine targets the virus' spike protein and nucleocapsid protein to trigger both T cell and neutralizing antibody response.
UPDATED: Wednesday, Aug. 26 at 2:45 p.m. ET
Moderna’s mRNA vaccine candidate was the first U.S. shot to enter late-stage testing, but that doesn’t necessarily mean it has the brightest future of all. The high possibility of multiple emergency authorizations for coronavirus vaccines by year-end spells plenty of competition—and an outlook for Moderna that's less rosy than some expected, SVB Leerink analysts wrote in an investor note, citing R&D and vaccine experts. Story
The shot does have some new data in older adults, a key demographic for vaccination. Moderna followed up last month's phase 1 data reveal with numbers from a small group of participants over 55—and they look promising. Run by the National Institute of Allergy and Infectious Diseases, the study is testing three dose levels of mRNA-1273 in two injections a month apart. Among 10 patients aged 56 to 70 and 10 patients over 71, the middle dose triggered neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19. Story
New, more restrictive COVID-19 testing guidelines issued by the CDC this week were handed down from higher-ups in the Trump administration, according to media reports. The new policy raises the bar on who should be tested, advising that people exposed to someone with the virus, but without symptoms themselves, shouldn't be tested. The change follows complaints from President Donald Trump that the U.S. is testing too much.
The EU's vaccine supply negotiations with drugmakers have hit snags over potential liability for side effects, Reuters reports. So far, only AstraZeneca has made a deal, promising to supply 400 million doses if its shot succeeds. Johnson & Johnson, Sanofi and GSK, CureVac and Moderna are still in “advanced” discussions, but those deals haven't yet been finalized, and liability risks could play into the talks. Story
UPDATED: Wednesday, Aug. 26 at 9:16 a.m. ET
Two doses of an mRNA vaccine candidate developed by Translate Bio and Sanofi triggered high levels of neutralizing antibodies in animals, a company filing showed. Sanofi is also working on a recombinant vaccine with GlaxoSmithKline, which recently snagged a $2.1 billion cash infusion from the U.S.' Operation Warp Speed vaccine program.
Merck expects to deliver phase 2 results on its antiviral pill, MK-4482, in a matter of weeks, and if the results are strong, the drug could snare an emergency authorization before year-end, an SVB Leerink analyst predicted. The pill, developed by scientists at Emory University, could have a convenience edge over Gilead's remdesivir and blood plasma, both given via infusion; plus, Merck's drug could treat patients before their symptoms put them in the hospital.
In a statement, Gilead said its decision to test remdesivir rather than a similar molecule called GS-441524 for COVID-19 was based on evidence showing the now-authorized drug was more effective in lab tests and animal models at generating the substance that blocks viral replication, and more active in vitro against "multiple coronaviruses.” Also, GS-441524 has never been studied in humans, while remdesivir had been tested in clinical trials for Ebola. The company has started new preclinical studies to further compare the two compounds. The NIH has said it will run its own studies on GS-441524.
Spain is set to receive 30 million AstraZeneca vaccine doses through the British drugmaker's centralized purchase deal with the European Commission. It remains unclear how much Spain or any other EU member state is expected to pay, but the commission locked down 400 million doses of the AZ-University of Oxford jab for equitable distribution across EU nations.
Meanwhile, Estonia got in on the EU-AstraZeneca vaccine deal, too, calling dibs on 1.3 million doses—enough to inoculate 665,000 people. The country aims to vaccinate half its population of around 1.3 million, with the initial focus on high-risk groups like the elderly, the chronically ill, and health and social care workers, Estonia's Minister of Social Affairs said.
UPDATED: Tuesday, Aug. 25 at 3:43 p.m. ET
FDA Commissioner Stephen Hahn corrected his claim that convalescent plasma from COVID-19 patients—granted an emergency use authorization Sunday—led to a "35% improvement in survival," clarifying that the data from an observational trial show a "relative" risk reduction rather than an "absolute" one. Health experts weren't convinced, and leaders of the House Committee on Energy and Commerce sent Hahn a letter Monday voicing concern over recent White House attacks on the agency. Story
With the recent whiplash of rumors and authorizations around hydroxychloroquine, blood plasma and a debunked plan to fast track AstraZeneca's shot, the FDA is facing a reputation crisis, with critics concerned that politics have infected the agency. “FDA's credibility has never been more important and more threatened simultaneously,” said Mark Senak, a public relations professional and Eye on FDA blogger. Others, like Obama administration health official Andy Slavitt, claimed Stephen Hahn was "wasting trust" in the FDA at a time when it needs public support to ensure people receive an eventual vaccine. Story
Qiagen plans to launch a digital COVID-19 antibody test that can run up to eight samples at once and deliver results in about 10 minutes. Developed in collaboration with Australian test maker Ellume, the portable eHub test boasts a small digital hub and interchangeable testing stick system. Plus, it can automate and standardize readouts, potentially freeing up lab staff. Qiagen submitted the device for emergency review and has already preordered 900,000 tests, Ellume said. Story
Medtech titan Medtronic posted a 13.2% revenue dip for the first quarter of its 2021 fiscal year—all told, a 17% decline when accounting for foreign currency exchanges, fiscal calendar quirks and benefits from its acquisition of Titan Spine. Still, the company is on the upswing compared to the previous quarter, which saw a 26% revenue decline during the early phases of the pandemic. Story
One thing that's improved during the pandemic? Doctor relationships with pharma sales reps, an Accenture study found. Fifty-five percent of doctors polled said they had more time to learn about new therapies, and 53% said they were interested in doing so; meanwhile, physicians are tapping sales reps to learn more about pharma support services, financial assistance, and local access and care programs, the study showed. Story
UPDATED: Tuesday, Aug. 25 at 9:26 a.m. ET
AstraZeneca kicked off a phase 1 trial testing the safety of its two-antibody cocktail in healthy adults. Like other antibody developers, AZ hopes its combo can serve as both a treatment and preventive measure for COVID-19; plus, the British drugmaker is aiming its formulation at six months of protection. AZ expects to share data from the study before year-end. Story
Speaking of AstraZeneca, the drugmaker made headlines on reports that the U.S. was looking to fast track its shot ahead of the Presidential election, but AZ sees things differently: "AstraZeneca has not discussed emergency use authorization with the U.S. government and it would be premature to speculate on that possibility," a spokesperson said via email, adding that AZ doesn't expect efficacy results until later this year. Story
The National Institutes of Health will run independent studies on a Gilead Sciences compound that could work similarly to remdesivir—and, as researchers at the University of Texas MD Anderson Cancer Center have argued, could do so at doses that cause fewer side effects. The NIH aims to conduct a preclinical study swiftly and share its findings with the research community, the agency said. Gilead is sticking by redmesivir and will not participate in the NIH trial.
Blood plasma from recovered COVID-19 patients is still an experimental therapy, not a new standard of care, the World Health Organization warned during a press briefing. The treatment won an emergency use authorization (EUA) from the FDA Sunday, backed by data from an observational study, not a placebo-controlled trial, the gold standard for approvals. The WHO has labeled the data "very low-quality." Meanwhile, health experts worry patients will demand blood plasma as a treatment rather than enrolling in ongoing trials to assess its benefit.
British clinical research capacity may have plunged as much as 87% in April, when the virus peaked in England, a study led by University College London found. Given a population infection rate of 10% that month, less than 400 of the 3,200 full-time clinical academics in England would have been able to conduct research, the researchers estimated. Those results stress the need to plan for and preserve clinical research to tackle COVID-19 and other diseases, too, the research authors said.
UPDATED: Monday, Aug. 24 at 3:24 p.m. ET
Moderna wrapped up "advanced exploratory talks" with the European Commission to supply up to 160 million doses of its mRNA-based vaccine to the EU, the company said in a release. If the deal closes, Moderna would ship an initial 80 million doses to EU member states, with another 80 million shots up for purchase at a later date. Story
President Donald Trump is eyeing an emergency use authorization (EUA) for AstraZeneca and the University of Oxford's vaccine candidate ahead of the U.S. Presidential election, the Financial Times reported. The plan would grant AstraZeneca an EUA upon completion of a 10,000-person study in the U.K., possibly allowing the U.S. to deploy vaccines to some people before they hit the polls. AZ is recruiting a planned 30,000 patients for its late-stage trial. Story
Speaking of AstraZeneca, the British drugmaker expanded its manufacturing deal with New Jersey's Catalent to cover drug substance production, including viral vectors, at the CDMO's gene therapy facility in Harmans, Maryland. Catalent will kick off production in the year's third quarter, the companies said in a release. In June, AZ tapped Catalent to complete fill-finish and packaging work on the University of Oxford-partnered shot at its Anagni, Italy, site. Story
Pharma TV advertising held up in July despite pandemic headwinds. Last month, spending from the top 10 pharma advertisers dipped 5% to $136 million—less than the $144 million advertisers spent last July, but far from the 20% decrease experts anticipated, according to the real-time TV ad tracker iSpot.tv. As for the rankings, AbbVie's anti-inflammatory Humira kept its spot at the top, while Roche's multiple sclerosis med Ocrevus, missing from the list last month, shot all the way to second place with $16.2 million in estimated spending. Story
Older Americans are unlikely to receive—and may not even know about—the vaccines recommended for adults over 50, a survey conducted by The Harris Poll on GlaxoSmithKline's behalf showed. A quarter of the 3,000 U.S. adults polled, all between the ages of 50 and 79, were unfamiliar with adult vaccines for shingles, tetanus, diphtheria and other diseases. Meanwhile, demand for adult vaccines plunged more than 60% during the height of the pandemic, the poll found, making a case for redoubling efforts to ensure the elderly are fully immunized, Judy Stewart, GSK's U.S. vaccine head, said.
UPDATED: Monday, Aug. 24 at 11:15 a.m. ET
The FDA could expand its emergency use authorization of remdesivir to include patients hospitalized with moderate COVID-19, Gilead Sciences said. Company data published Friday showed 70% of moderately ill patients on a 5-day course left the hospital 11 days after starting treatment, compared to 65% of patients in the 10-day arm, but a JAMA editorial accompanying the data questioned the drug's benefit overall. Story
Novartis has M&A funds to spare, but acquisitions have slowed because of COVID-19, CEO Vas Narasimhan told the Swiss newspaper Neue Zuercher Zeitung. Meanwhile, the company plans to hold onto its Sandoz generics unit, currently supplying drugs for patients hit with the disease, despite some recent in-house failures to develop or repurpose meds to fight the coronavirus, including the antimalarial hydroxychloroquine, Narasimhan said.
When the University of Oxford jumped into the vaccine game in April, the school pledged to donate the rights to its candidate to any drugmaker in a bid to provide the final shot at low cost or free of charge. Then AstraZeneca entered the scene and Oxford University changed course. AZ has promised to sell its vaccine at no profit, but once the pandemic wanes, all bets are off, drawing fire from health and financial experts hoping to witness a reversal of for-profit vaccine development in the era of COVID-19.
In the blood plasma will-they-or-won't-they, the FDA decided it would: On Sunday, the U.S. regulator granted emergency use authorization for convalescent plasma to treat COVID-19. The FDA cited early data from an observational study—not a controlled trial—showing the treatment could decrease mortality and improve the health of patients treated in the first three days of their hospitalization. Trump hailed the decision, which was put on pause last week over calls for more clinical data demonstrating plasma's benefit. Story
Former FDA chief Scott Gottlieb deflected criticism levied by President Trump Saturday that "[t]he deep state, or whoever, over at the FDA" was intentionally delaying COVID-19 drug and vaccine trials to harm the President's chances at reelection this November. Gottlieb suggested that calls for more clinical data on blood plasma were warranted and noted that vaccine trials from major drugmakers have enrolled patients "very fast." Story
Meanwhile, the U.S. government could boost those clinical studies by expanding the National Institutes of Health's COVID trial networks to include large-scale, practical studies like the U.K.'s Recovery Trial, which randomly assigns patients to treatment candidates via a clear protocol, Gottlieb and fellow ex-FDA commissioner Mark McClellan wrote in a Wall Street Journal opinion piece. That framework would require prioritization of treatments shown to have the most benefit against COVID-19, Gottlieb and McClellan added.
Plus, clinical trials on blood plasma in COVID-19 may take some time complete. Some common hurdles? Convalescent plasma must be collected from recovered patients and it needs to go through testing to make sure it contains the necessary antibodies to fight the virus. Meanwhile, patients may be unwilling enroll in blood plasma studies if they believe they're going to receive a placebo rather than the real thing, Johns Hopkins' associate professor of medicine Dr. Shmuel Shoham said.
UPDATED: Friday, Aug. 21 at 3:20 p.m. ET
Canada's AbCellera snared a new bispecifics platform, OrthoMab, from Dualogics that can combine any two of the antibodies it discovers. Earlier this year, the company partnered with Eli Lilly on a COVID-19-fighting antibody, LY-CoV555, the current subject of a phase 1 trial in hospitalized patients and a phase 3 study in nursing homes. Story
COVID-19 pooled testing, which combines samples from multiple patients to save time and resources, has become worthless in many parts of the U.S. as case counts climb. The strategy, touted by NIAID director Anthony Fauci, M.D., and Adm. Brett Giroir, only works when the majority of samples are negative. Meanwhile, pooled tests have made headway in regions where cases are under control; last week, the State University of New York was cleared to batch test up to 25 samples at once.
Scientists at Rutgers University developed a tool to track changes in RNA at the single-cell level, a potential boon for researchers on the hunt for COVID-19 drug targets. The surface-enhanced Raman spectroscopy (SERS) tool was first tested on influenza A, where it managed to detect RNA mutations so small they only covered two nucleotides, the Rutgers team reported. Now, the team is seeking funding to run additional studies on SERS in SARS-CoV-2. Story
Russia backpedaled slightly on its world-first COVID-19 vaccine approval, now reclassified as a "conditional registration certificate"—though it still plans to roll out a mass vaccination campaign in October. Meanwhile, Russia will expand late-stage testing on the shot, dubbed Sputnik V, to include roughly 40,000 patients as well as a control group, putting the trial closer in line with phase 3 vaccine studies from the likes of Moderna, Pfizer and AstraZeneca.
UPDATED: Friday, Aug. 21 at 9:23 a.m. ET
Pfizer and BioNTech turned out additional phase 1 safety data on one mRNA shot candidate and maintained that they're on track to seek regulatory review as early as October. The vaccine was generally safe, with mild to moderate fever cropping up in less than 20% of subjects, and spurred a strong immune response in both younger and older participants. Story
Lab-developed COVID-19 tests will no longer require premarket review from the FDA, updated HHS guidance states. The decision is aimed at boosting testing, which has stalled in recent weeks despite case surges in states like Texas and Florida. Critics say it could lead to inaccurate tests. Story
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, overseeing the review of a potential COVID-19 vaccine, said he has not faced any political pressure but would "feel obligated" to resign if the Trump administration tries to push—or withhold—a vaccine candidate for approval before it's deemed safe and effective, Reuters reported. “You have to decide where your red line is, and that’s my red line,” Marks said.
Rep. Lloyd Doggett, D-Texas, and Rep. Katie Porter, D-California, pushed the Trump administration for full financial details on its vaccine deals with Moderna. The representatives argue that taxpayers are the vaccine's chief investors, following Moderna's admission that federal money makes up "100% funding of the program" and that all Americans should therefore be entitled to a shot once it is proven safe and effective.
Patients infected with a new variant of the coronavirus experienced a stronger immune response and had better clinical outcomes, with fewer developing low blood oxygen or requiring intensive care, a Lancet study found. The mutation, which likely came from Wuhan, China, could have a positive impact on development of COVID treatments and vaccines, the Singapore-based authors wrote.
UPDATED: Thursday, Aug. 20 at 3:05 p.m. ET
Johnson & Johnson plans to kick off its late-stage vaccine study in September, the New Jersey-based drugmaker said Thursday. J&J aims to enroll up to 60,000 participants, which would make its trial the largest COVID-19 vaccine study to date. Moderna and Pfizer, which both launched phase 3 shot trials last month, are looking to recruit upward of 30,000 subjects each. Story
Oragenics tapped CDMO Avid Bioservices to perform process development and drug substance manufacturing for its spike protein vaccine, Terra CoV-2. In March, Oragenics licensed Terra-CoV-2 from the NIH and now, with Avid's help, hopes to push its shot into human testing by early 2021.
Congress should consider barring the FDA from granting an emergency use authorization (EUA) to any COVID-19 vaccine candidate, a report from the George Consortium's Public Health Law Watch argued. The report, backed by some 50 legal and policy experts, cited a common concern: Overwhelming social and political pressure could drive the FDA to allow emergency use of a shot before it's proven safe and effective.
The FDA approved its third antigen test for COVID-19, this time a speedy, nasal swab-based assay from the London-headquartered diagnostics firm LumiraDx. Like rapid flu tests, Lumira's diagnostic detects fragments of specific proteins found in the virus and can deliver on-site results within 12 minutes. LumiraDx hopes to scale up manufacturing to crank out 10 million tests per month by year's end, the company said. Story
Roche's Genentech unit could get manufacturing work on Regeneron's antibody cocktail up and running in a matter of months, Regeneron CEO Leonard Schleifer told CNBC. With their forces combined, Schleifer said, the drugmakers could churn out at least 4 million to 8 million preventative doses per year, if not more. Regeneron will also put a "squeeze" on other drugs and staff up to support the manufacturing push, Schleifer said.
The U.S. Department of Energy's Argonne National Laboratory is using AI to build physics-based models of proteins and their cell interactions to help researchers uncover COVID-19 drug targets. Meanwhile, BenevolentAI is using artificial intelligence to sift through tens of thousands of therapies to find a match, like Eli Lilly and Incyte's rheumatoid arthritis med Olumiant, now in COVID-19 testing. Plus, other companies such as Insilico are turning to AI to create purpose-built molecules to fight the virus. Story
Housing Secretary Ben Carson, who days earlier was reported to have attended an Oval Office meeting where the unproven drug oleandrin was brought up as a potential COVID treatment, joined NIAID Director Anthony Fauci and NIH chief Francis Collins in calling for clinical testing before any sort of authorization is considered.
UPDATED: Thursday, Aug. 20 at 9:15 a.m. ET
German biotech CureVac and the European Union wrapped up the first round of talks for at least 225 million potential vaccine doses. The talks include an option for the EU to snare an additional 180 million shots, CureVac said. Under the deal, CureVac's mRNA-based hopeful would go out to all 27 EU member states. Story
Cuba plans to start testing its own COVID-19 vaccine, a receptor-binding domain shot created by the state-run Finlay Institute of Vaccines, in humans next week, according to the country's registry of clinical trials. Cuba aims to enroll 676 adults between the ages of 19 and 80 in the phase 1 and 2 studies. Results aren't expected until February.
President Donald Trump suggested the FDA's decision to postpone emergency use authorization (EUA) for blood plasma treatment was politically motivated, saying regulators were looking to delay an OK until after Election Day. The FDA held back authorizing convalescent plasma treatment after government experts, including NIAID director Anthony Fauci and NIH chief Francis Collins, called for more data. Story
After running oleandrin through a battery of tests against COVID-19, the U.S. Army Institute of Infectious Diseases found "inconclusive" benefits and halted further studies. The oleander extract caught the Trump administration's attention through MyPillow CEO Mike Lindell, who invested in a company producing it. Trump said the White House would "look" at the treatment Monday, while Lindell has continued to tout the President's oleandrin "enthusiasm."
The call for improved trial diversity has been a common refrain during the pandemic, and now a number of health experts—including one of the founders of Boston's Black COVID-19 Coalition, Dianne Wilkerson—are pushing for increased enrollment of people of color in ongoing vaccine studies. That diversity is key to ensuring an eventual shot works in multiple populations.
Daewoong Pharmaceutical teamed up with Institut Pasteur Korea (IPK) and the Korea Institute of Radiological and Medical Sciences (KIRAMS) to run overseas tests on the esophagitis drug Foistar in COVID-19. IPK and KIRAMS will help facilitate clinical studies, while Daewoong provides the drugs and, if warranted, will handle regulatory filings. The drug's main ingredient, camostat, was shown to block the virus from infecting healthy cells in a primate study published in Cell.
UPDATED: Wednesday, Aug. 19 at 3:30 p.m. ET
Fitbit's activity tracker picked up nearly half of COVID-19 cases at least one day before participants showed any symptoms, early data from a study of more than 100,000 subjects showed. Fitbit is developing an algorithm that tracks subtle changes in a person's heart rate, breathing, physical activity and sleep that can ID potential cases before symptoms start. So far, that algorithm has worked with 70% specificity, or a 30% rate of false positives, but it could push people to seek testing or quarantine sooner, Fitbit thinks. Story
Qiagen launched a new sequencing panel, plus a piece of companion software, to help researchers track mutations in the novel coronavirus. The single-day, next-generation panel uses reverse transcription tech to create complementary DNA from a sample of the virus' RNA code, in turn generating libraries compatible with sequencing hardware from genetic analysis firm Illumina. Qiagen's software then creates a visual map of the virus' evolution across different populations and regions. Story
The Center for Health Security at Johns Hopkins Bloomberg School of Public Health laid out a blueprint for vaccine allocation, separating those with the highest need into two tiers. Tier 1 includes typical vaccination targets such as healthcare workers and the immunocompromised, while tier 2 aims to get shots to more overlooked groups, including essential workers outside the healthcare field and people who face greater barriers to treatment.
Hospitals spent nearly $2,000 less on medicated COVID-19 patients in July than they did in May, with costs plunging thanks to shortened hospital stays and fewer medications used, Reuters reported, citing health data firm IllumiCare. Despite those treatment advances, costs could rise again now that Gilead Sciences is charging for its antiviral remdesivir, Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said.
Questions over the durability of COVID-19 immunity have plagued scientists since the start of the pandemic, but a recent slate of studies—many still awaiting peer review—show that human immune response to the disease is "robust" and may protect against repeat infections, even in people who only suffered mild symptoms. Exactly how long that immune response lasts remains unclear.
UPDATED: Wednesday, Aug. 19 at 9:18 a.m. ET
The FDA put its emergency authorization for convalescent plasma therapy on hold after the country's largest plasma study, run by the Mayo Clinic, failed to show the treatment could slash death rates in COVID-19 patients. In the eleventh hour before last week's planned OK, top health experts including Anthony Fauci and National Institutes of Health director Francis Collins urged the agency pump the brakes, citing the lack of a control group in the Mayo trial and a need for more data to confirm plasma's benefits.
Roche joined forces with Regeneron to help develop and sell the New York-based biotech's antibody cocktail, REGN-COV2, outside the U.S. The collaboration is expected to more than triple capacity for the antibody therapy, with the potential for further expansion moving forward, the companies said. Roche will also support an ongoing phase 3 prevention study and help fund future trials; plus, the Swiss drugmaker is on the hook to secure regulatory approval outside of the U.S. Story
Australia struck a deal with AstraZeneca for enough vaccine doses for the entire country, with plans to distribute the final shots free of charge, Prime Minister Scott Morrison said Wednesday. If the vaccine passes muster in the clinic, the Australian government will begin churning out doses in-country "straight away," Morrison said. The financial terms of the deal weren't disclosed.
Dr. Reddy's Laboratories launched its version of the flu med Avigan (favipiravir) in India as a COVID-19 treatment. The rollout covers 200 mg tablets of the drug under license from Japan's Fujifilm. To further boost access, Dr. Reddy's kicked off a free home delivery service to supply Avigan to patients in 42 cities across the country.
Moderna could reap a whopping $8.125 billion from its U.S. vaccine supply deal if all options are exercised, a company securities filing showed. Under the base agreement, the U.S. called dibs on 100 million doses for $1.225 billion, with the option to order 400 million more; each of those 100 million-dose follow-up shipments would cost the government an additional $1.65 billion. Meanwhile, Moderna stands to gain a $300 million bonus if its shot snares approval before the end of January. Story
UPDATED: Tuesday, Aug. 18 at 3:20 p.m. ET
Sinopharm expects to price its inactivated vaccine hopefuls at a little under 1,000 yuan ($145) for two doses, company Chairman Liu Jingzhen told Chinese state media. It remains unclear whether Liu was referring to out-of-pocket-cost or list price, but if that quote does reflect what patients should expect to pay, it would put Sinopharm's shot price well above those of U.S. hopefuls from vaccine players such as Johnson & Johnson, AstraZeneca and Pfizer. Story
The Serum Institute of India (SII) is gunning for $1 billion in vaccine fundraising by September, the Economic Times of India reported. Private equity investors Blackstone and KRR are reportedly in talks to finance the cause, which would boost vaccine manufacturing and support clinical trials, the Times said. The world's largest vaccine producer to developing nations, SII is advancing five COVID-19 hopefuls, including frontrunners from AstraZeneca and Novavax. Story
A cadre of drugmakers led by Johnson & Johnson and Takeda launched a new research effort to advance COVID-19 drugs in the EU, with €77.7 million ($92.5 million) to start. The Corona Accelerated R&D in Europe (CARE) initiative sets out with a trio of goals: repurpose existing drugs, ID new small molecules and develop antibodies to combat COVID-19. The Bill & Melinda Gates Foundation has signed on to coordinate CARE work and prevent overlap with the Gates-backed COVID-19 Therapeutics Accelerator. Story
The Aug. 31 deadline for wealthier nations to join the COVAX Global Vaccines Facility is fast approaching, and countries that choose to keep shots for themselves will only extend the pandemic, World Health Organization chief Tedros Adhanom Ghebreyesus said Tuesday. Under the COVAX pact, those countries would share vaccine hopefuls with developing nations, a needed step to "prevent vaccine nationalism," Ghebreyesus said.
Forty-four percent of Americans said they would get an approved COVID-19 vaccine, an NBC poll showed. Twenty-two percent ruled out the shot entirely, while another 32% were unsure. Some other trends in inoculation opinion? Shot comfort seemed to rise with income and education level, and split along political party lines as well. Meanwhile, Asian Americans were the only racial group where a majority of adults polled said they would get an approved vaccination.
UPDATED: Tuesday, Aug. 18 at 9:30 a.m. ET
The FDA has a threefold strategy for advancing therapeutics to fight COVID-19: provide support for new drugs through its Coronavirus Treatment Acceleration Program; secure expanded access to potential therapies; and increase trial flexibility for the pandemic age. By July's end, the agency had supported the rollout of more than 270 clinical trials and boasted 570 more clinical tests under review for launch.
Thermo Fisher's TaqPath COVID-19 test may yield false results, the FDA warned Monday. The problem comes down to misuse of lab equipment and software woes, the agency said; Thermo Fisher has devised a new set of instructions that should allow labs to use the technology correctly. Meanwhile, many labs need to update the software used on Thermo Fisher's testing platform. Nearly a month ago, public health officials in Connecticut raised flags about 90 patients who had received false positives from TaqPath PCR swab tests. Story
With a second wave of COVID-19 infections expected to collide with flu season this fall and winter, Sanofi is working with partners to distribute flu shots safely and easily in the U.S. The French drugmaker's blueprint calls for walk-up or curbside vaccine stations. Sanofi will ship 80 million flu shots to the U.S. this year.
Kiran Mazumdar-Shaw, the high-profile managing director and chairperson of Indian biopharma Biocon, tested positive for COVID-19. Shaw confirmed the readout Monday evening and added that her symptoms were mild.
Plus, health officials have urged the Trump administration to pump the brakes on any support it might have offered oleandrin, touted by MyPillow CEO and ardent Trump supporter Mike Lindell as a COVID treatment and preventative. Made from the toxic oleander plant, the extract has shown some promise in lab dishes, but it would need animal testing before it's considered for COVID-19 trials in humans, health experts told CNN.
UPDATED: Monday, Aug. 17 at 3:39 p.m. ET
The U.S.' National Institute of Allergy and Infectious Diseases is weighing the logistics needed to run challenge trials of COVID-19 vaccines, including development of a suitable strain of SARS-CoV-2, drafting trial protocol and spotlighting the resources needed for the potential studies, Reuters reported. Challenge trials see healthy patients injected with vaccine and then deliberately infected with the virus to speed up the review process—typically when a virus is no longer widely circulating. The NIAID said it will continue to prioritize field trials in the hunt for an inoculation.
The rapid SalivaDirect COVID-19 test used to screen players in the NBA "bubble" will now be available to the public, thanks to country-wide FDA authorization. Created by Yale University's school of public health, the speedy spit test bypasses the need for a specific swab or collection device and doesn't require additional chemicals to extract the virus' RNA from a sample. The move could boost testing efficiency and ease demand for crucial testing supplies like reagents, FDA commissioner Stephen Hahn said. Story
The forthcoming COVID-19 vaccine market could pull in a total of $20 billion next year, Bernstein analyst Ronny Gal figures, predicting that "six players" will compete in the field for years. Gal estimates that developed countries will receive vaccines in parallel with the U.S., with similar pricing and availability trends; as vaccination rates in developed countries near 50%, which Gal thinks could happen by mid-2021, demand will slow and doses will be redirected to low- and middle-income nations. Once the pandemic wanes, Gal thinks the market will dwindle to $5 billion to $6 billion per year. Story
Hyderabad, India-based Biological E picked up a vaccine plant from Akorn India that could add more than 165 million doses to its annual capacity. Last week, Johnson & Johnson announced a technology transfer deal with Biological E to churn out upwards of 500 million vaccine doses per year in India. Story
Philips launched an initiative to help hospitals expand ICU capacity through delivery of its rapid equipment deployment kits. The ramp-up kits contain fully-configured ICU monitors and vital sign measurement servers, allowing hospitals to connect 20 beds to a central patient monitoring system in a matter of hours—a potential boon when hit with surges of COVID-19 cases. After a crisis has passed, the kits can be disinfected and stored, or shipped from hospital to hospital as needed. Story
A manmade version of COVID-fighting "nanobodies" found in llamas successfully stopped the virus from infecting healthy cells, in-vitro studies from the University of California, San Francisco, showed. Dubbed AeroNabs, the aerosolized treatment is made from a trio of synthetic nanobodies capable of interacting with various parts of the virus' spike protein. The university is plotting human trials for AeroNabs and thinks the inhaled drug could provide a "stopgap" until a vaccine wins approval. Story
Vaccine makers predict that a record 98 million flu shots will be given in the U.S. this year as public health officials call for increased inoculation ahead of a COVID-complicated flu season, The New York Times reported. Now, officials are tapping local healthcare systems and corporations, including pharmacy chains and supermarkets, to lock down vaccination sites. Meanwhile, publicity campaigns will urge the public to embrace the traditionally under-administered shot.
UPDATED: Monday, Aug. 17 at 9:22 a.m. ET
Novavax launched a mid-stage trial on its vaccine in South Africa, with the goal to recruit 2,665 healthy adults, plus another 240 adults who have tested positive for HIV whose disease is well-controlled by medication. The phase 2b aims to test the vaccine's safety and efficacy, and it could tee up entry into late-stage testing by September, Novavax said. The company plans to roll out another mid-stage trial in Australia and the U.S.
German shot maker CureVac won't sell its vaccine at cost, instead eyeing an "ethical margin" to give shareholders some return on their investments, Pierre Kemula, chief financial officer, said. Unlike other mRNA-based shots, currently trialed at higher doses, CureVac's shot is undergoing testing at doses of 2, 4, 6 and 8 micrograms—potentially allowing the company to do more with less. On Friday, the company ginned up $213 million through a U.S. stock market listing; those funds will mainly support COVID-19 shot trials, the company said.
The U.S. tapped medical supplier McKesson Friday to distribute COVID-19 vaccines once a candidate snares approval, with the company set to receive nearly $178 million under the deal, a spokesperson for the U.S. Department of Health and Human Services said. The distribution pact falls under a prior pandemic vaccine contract awarded to McKesson by the Centers for Disease Control in 2016—significant given recent news that the U.S. Defense Department would oversee vaccine distribution in lieu of the CDC. Story
Mexico is already working with AstraZeneca and Argentina to crank out 150 million doses of the British drugmaker's Oxford University-partnered shot by 2021, and to further meet national vaccine supply, the country is looking to run trials with Johnson & Johnson and Sanofi, deputy foreign minister Martha Delgado said. Mexican health authorities are evaluating early and mid-stage data on those companies' shots to work out potential Mexican phase 3 studies, Delgado said.
A COVID-19 vaccine must boast an efficacy rate of at least 50% and confer immunity for a minimum of six months to win approval in China, the country's drug regulator said, putting its shot standards roughly in line with guidance from the Centers for Disease Control and the U.S. FDA. China will also consider authorizing emergency use of vaccines that have yet to complete late-stage testing, the country's Centre for Drug Evaluation added. Story
With the hydroxychloroquine debacle still fresh in many peoples' minds, President Donald Trump is pushing for FDA approval of another unproven drug in COVID-19—this time, the botanical extract oleandrin, Axios reported. A non peer-reviewed study from July showed the extract, taken from the oleander plant, could inhibit the virus in monkeys; so far, FDA commissioner Stephen Hahn has resisted the oleandrin push, Axios said. Story
UPDATED: Friday, Aug. 14 at 9:20 a.m. ET
Johnson & Johnson advanced talks to supply 200 million vaccine doses to the European Union, with an option for another 200 million shots if the vaccine passes muster in the clinic. Last week, J&J reached a $1 billion deal for 100 million U.S. vaccine doses. Story
Speaking of J&J, the New Jersey-based drug major pledged 30 million vaccine doses to the U.K. at no profit, the company said. The supply deal provides the option for another 22 million doses. Separately, the U.K. tapped Novavax for 60 million doses of its vaccine hopeful, with some of those shots slated for production at Fujifilm Diosynth facilities in northern England, the company said.
Plus, the EU inked an advance purchase deal with AstraZeneca, locking down at least 300 million doses of its Oxford University-partnered vaccine hopeful. The deal, which covers 27 EU states, includes an option to purchase 100 million more doses if the vaccine proves safe and effective. In June, AZ reached a deal with Europe's Inclusive Vaccines Alliance to secure shots for France, Germany, Italy and the Netherlands.
Sinopharm's inactivated virus vaccine triggered an antibody response on par with other shot candidates and turned out a favorable safety profile, too, according to data published by JAMA. The vaccine delivered its strongest antibody response after a third injection, making booster doses likely. One possible hitch? Unlike other vaccine trials, Sinopharm's lacked a comparison arm featuring samples from patients with confirmed infections. Story
The U.S. government will foot the vaccine bill for uninsured patients and work with commercial health insurers to offer shots with zero copay, Paul Mango, HHS' deputy chief of staff for policy, said. With initial supplies likely to be limited, the government will prioritize doses for healthcare workers, the elderly, nursing home residents and others at higher risk of infection, NIH director Francis Collins said.
The FDA rejected the Henry Ford Health System's bid for approval to use hydoxychloroquine in certain COVID-19 patients. The health system's filing came on the heels of its study showing the drug lowered death rates in patients, but a number of top health experts, including NIAID director Anthony Fauci, called the trial "flawed." Henry Ford will continue to test the drug as a preventive treatment.
Top Russian doctor Alexander Chuchalin quit the Health Ministry's ethics council after the country's rapid-fire approval of COVID-19 vaccine Sputnik V ahead of late-stage testing. Chuchalin slammed the director of the Gamaleya Research Institute—which developed the vaccine—and the Russian army's top virologist, Sergey Borisevich, for flouting the usual regulatory process.
UPDATED: Thursday, Aug. 13 at 3:16 p.m. ET
SK bioscience will churn out antigen for Novavax's shot hopeful at its L-House vaccine facility in Andong, South Korea, starting this month, the companies said. The deal falls under the drugmakers' prior arrangements with the Coalition for Epidemic Preparedness Innovations to lock down global supply, and "significant amounts" of the final vaccine product will be distributed through the alliance's COVAX facility, also backed by Gavi, the Vaccine Alliance and WHO, the companies said.
On top of its vaccine licensing deal with Baylor, Biological E will produce 400 million to 500 million annual doses of Johnson & Johnson's shot hopeful for India, the Economic Times reported, quoting J&J chief scientist Paul Stoffels. The Indian drugmaker has already started manufacturing work to shore up global supply ahead of an approval, Stoffels said; Biological E can turn out around 50 million vaccine doses per month at its Hyderabad-based plant.
All told, COVID-19 vaccines should bring in $100 billion in sales and $40 billion in post-tax profits, with Moderna scooping up 40% of the market, Evercore ISI analyst Josh Schimmer figures. Novavax will likely take another 20%, while other vaccine players split the rest, he wrote in a note to clients. Some investors took issue with the Evercore estimate, challenging Schimmer's bets on Moderna's shot price, market share and more. Story
With flu season about to bump up against a pandemic, AstraZeneca plans to produce nearly 8 million U.S. doses of its nasal flu vaccine FluMist this year, a major leap from the 757,000 doses it shipped last season. Other top players Sanofi, GlaxoSmithKline and Seqiris will furnish a combined 190 million doses to the U.S. amid calls for increased flu vaccinations to prevent strain on COVID-fatigued healthcare systems. Story
Dutch manufacturer Qiagen rebuffed Thermo Fisher's $12.5 billion takeover offer, citing skyrocketing demand for its COVID-19 diagnostic reagents and molecular testing supplies. Now, Qiagen is eyeing a buyout of its own, with plans to pick up the remaining stake of NeuMoDx Molecular. The $234 million deal would grant Qiagen access to the company's own COVID-19 test, plus a multiplexed assay that can differentiate among coronavirus infections, influenza and respiratory syncytial virus. Story
Mylan took coronavirus support to Big Bird and the gang with a $1 million contribution to Sesame Workshop's Caring For Each Other effort, aimed at helping children and their families cope with tough pandemic-related topics. The donation will support the rollout of digital content kits this fall, planned for debut on YouTube, WhatsApp and through local providers in more remote locations around the globe. Story
UPDATED: Thursday, Aug. 13 at 9:50 a.m. ET
Doctors have Moderna's mRNA vaccine on their minds—and most expect it will be the first approved, a survey by market researcher InCrowd found. Of physicians polled, 45% said they expect the Massachusetts-based biotech's shot to clear the FDA first. Twenty percent figured Moderna's vaccine would help society return to normal, compared with 12% for AstraZeneca and 5% for Pfizer and BioNTech. As for name recognition, 63% of physicians quoted Moderna's efforts when asked which companies were working on vaccines, while AZ came in second at 42% recall.
Amid complaints over remdesivir's price tag, Gilead Sciences launched preclinical studies to compare the drug against another, potentially cheaper antiviral in its portfolio, GS-441524. Last week, watchdog Public Citizen and experts from the MD Anderson Cancer Center pushed Gilead to test the antiviral, which "could offer significant advantages over remdesivir," along with a lower price, they said. But experts noted preclinical work now would put GS-441524 far behind remdesivir, which Gilead filed for FDA approval earlier this week.
AstraZeneca inked production deals for its Oxford-partnered shot with Mexico and Argentina, which will churn out 150 million to 250 million initial doses for the Latin American market, Argentine President Alberto Fernandez and Mexican Foreign Minister Marcelo Ebrard said. The countries aim to have shots on hand by the first half of 2021, with initial doses going to the elderly, medical workers and those with prior health conditions, Fernandez said. Story
Arcturus Therapeutics dosed the first group in a phase 1/2 study of its mRNA-based vaccine candidate, run in partnership with CTI Clinical Trial and Consulting Services and Singapore's Duke-NUS Medical School. The shot could work after a single, low dose, the company said, unlike other mRNA hopefuls from drugmakers like Moderna. Phase 1 will test dosing in younger adults, and phase 2 will add older patients; initial results are expected in the fourth quarter, Arcturus said.
Indian drugmaker Biological E penned a licensing pact with Baylor College of Medicine to develop and market its recombinant protein vaccine hopeful. If the shot wins out in the clinic, Biological E aims to crank out "several hundred million" doses per year, the company's novel vaccine initiative head, Narender Dev Mantena, said.
Zydus Cadila launched its version of remdesivir, marketed as Remdac, in India Thursday, setting the lowest in-country price for the antiviral at INR 2,800 ($37.44) per 100-milligram vial. Zydus is the fifth Indian firm to roll out a remdesivir copy under license from Gilead, following Hetero Labs, Cipla, Mylan and Jubilant Life Sciences.
Over 100 generic drugs have been flagged as potential COVID-fighters, but lack of financial incentive for testing low-cost generics could stymie innovation, a Bloomberg op-ed argued. To deliver U.S. treatments ahead of a vaccine, the government needs to set up programs to repurpose off-patent drugs, author Rena Conti stated, citing health and financial experts from Stanford University, Harvard University and the Massachusetts Institute of Technology.
Researchers at the University of California, Riverside developed machine learning models of human proteins to ID approved drugs that could fight COVID-19. The team has used the algorithms to pinpoint several candidates already—and they believe screening vast numbers of compounds using their computational strategy could prove cheaper and more efficient than using traditional cell-culture assays.
UPDATED: Wednesday, Aug. 12 at 3:30 p.m. ET
Researchers have turned to monoclonal antibody drugs as a potential stopgap ahead of a vaccine, but those treatments are expensive and complex to manufacture, meaning much of the world's population will likely miss out once a therapy is approved. In a report issued Monday, the International AIDS Vaccine Initiative and British research funder Wellcome called for global antibody access via new partnerships and technologies that would allow generic drugmakers to churn out the pricey treatments.
With demand for COVID testing through the roof, Verily Life Sciences set up a lab in its native San Francisco using tech from Thermo Fisher's TaqPath test kit. The aims of the lab are two-fold: Get patients quicker results and help Verily staffers return to work, the company said. Verily has also "verified" Roche's antibody test and filed an emergency use application to use an adaptation of the Thermo Fisher diagnostic on pooled patient samples. Story
Silicon Valley-based biotech ANA Therapeutics got the go-ahead to test a capsule form of niclosamide—used to treat tapeworm infections—in COVID-19 patients. ANA aims to enroll at least 400 subjects from hard-hit U.S. states and will kick off recruitment this month, targeting non-ventilated patients with less severe symptoms. Preclinical data showed the drug halted viral replication and proved more potent than Gilead's remdesivir in the same assay, ANA said.
SAB Biotherapeutics dosed the first subject in a phase 1 study of its polyclonal antibody, SAB-185, shown to neutralize both original and mutated strains of the coronavirus in preclinical testing. The phase 1 trial will test 28 healthy patients at single and multiple ascending dose levels to assess the treatment's safety, SAB said.
Russia plans to deliver its first batch of Sputnik V vaccines in two weeks' time, Health Minister Mikhail Murashko said. Those shots will primarily go to doctors and be administered on a voluntary basis. Despite a green light from Russia this week, the vaccine has only passed through early-stage testing, drawing fire from health experts the world over.
And Russia's vaccine has found a critic in NIAID director Anthony Fauci, who "seriously [doubts]" the country has run adequate testing on the shot. Fauci added that having a shot and proving a shot is effective are two very different things, stating that the U.S. could also deploy one of its vaccine candidates post-haste if it "wanted to take the chance of hurting a lot of people, or giving them something that doesn't work."
UPDATED: Wednesday, Aug. 12 at 9:19 a.m. ET
The U.S. locked down another vaccine purchase deal, this time from Moderna. The government put up $1.5 billion to secure 100 million doses of the Massachusetts-based biotech's mRNA shot, with an option for up to 400 million more. The supply pact comes after Moderna scored a $955 million development deal with the U.S. government's BARDA agency. Story
If COVID-19 infection rates drop before Johnson & Johnson wraps its late-stage vaccine study, the pharma giant may consider challenge trials, Johan Van Hoof, J&J's vaccines chief, said. In challenge trials, healthy patients are injected with vaccine and then deliberately infected with the virus to speed up review of the shot's performance. So, there are ethical issues and logistical challenges J&J must weigh before going that route, Van Hoof noted, such as having effective therapies on hand to tackle subjects' symptoms.
Speaking of J&J, the drugmaker is one of three whose vaccine candidates are slated for testing in Mexico, with the two other shots coming from China's CanSino Biologics and Walvax Biotechnology. The trials are set to begin between September and January, Foreign Minister Marcelo Ebrard said. Plus, CanSino and Walvax are both eyeing Mexico as a production hub for the Latin American market, Ebrard said.
The Bill & Melinda Gates Foundation put up another $150 million in its quest to secure 100 million vaccine doses for low- and middle-income countries. The funding was delivered to Gavi, the Vaccine Alliance, which will provide the up-front capital to the Serum Institute of India to crank out shot hopefuls from AstraZeneca and Novavax.
COVID-19 infections, hospitalizations and deaths have hit people of color especially hard in the U.S., but minorities are woefully underrepresented in clinical vaccine and drug trials, according to a report published in the New England Journal of Medicine. In the nationally funded trial on antiviral remdesivir, Black Americans only accounted for 20% of the patient population, and only one in 10 trial subjects was black in Gilead's own study of the drug. Now, the report's authors are calling for increased trial diversity to offer results relevant to the entire U.S. population. Story
Seventeen drugmakers, including Amgen, AstraZeneca, Gilead and others, were urged by a large pool of investors to price their eventual COVID-19 drugs and vaccines prudently and ensure widespread access. The investors, representing $2.5 trillion in assets, cited the large amount of federal funding that has gone into COVID-19 efforts, in turn making taxpayers the biggest investors in those projects.
Cipla aims to scale production of Gilead Sciences' remdesivir at its Goa, India, plant, to meet increased demand for the antiviral. Cipla kept mum on the volume it plans to produce, but it has partnered with BDR Pharmaceuticals for API supplies and Sovereign Pharma for finishing work. Cipla launched its licensed version of remdesivir, Cipremi, in July at INR 4,000 ($53.52) per vial—the cheapest version of the drug on the Indian market.
Israel may consider buying doses of Russia's Sputnik V vaccine, approved out of left field Tuesday, if the shot turns out to be a "serious product," Israeli Health Minister Yuli Edelstein said. Meanwhile, health experts slammed the approval as a potentially dangerous political stunt. Developed by Moscow's Gamaleya Research Institute, the shot got a green light from Russia Tuesday despite its lack of late-stage data.
UPDATED: Tuesday, Aug. 11 at 3:15 p.m. ET
Novavax expects to have capacity for "well over a couple billion" COVID-19 vaccines next year—enough to single-handedly meet U.S. demand, pegged at 500 million to 600 million doses, chief medical officer Filip Dubovsky said. Novavax aims to start a phase 2 study in Australia and the U.S. this month and kick off large-scale production in early 2021. Story
Russia announced the world-first approval of a COVID-19 vaccine Tuesday, but health experts blasted the move as a political stunt and warned about the potential dangers of an unproven inoculation. Dubbed Sputnik V, the shot was developed by Moscow's Gamaleya Research Institute and has only gone through phase 1 testing, according to the WHO's vaccine tracker. Experts say the move puts healthcare workers and others at risk, and former FDA commissioner Scott Gottlieb said it could be an attempt "to goad [the] U.S. into early action on [its] vaccine." Story
Merck has focused on proven tech, not speed, in its hunt for a COVID-19 vaccine, and now it's aiming for convenience, too, hoping to churn out a shot that works after a single dose, EVP and R&D chief Roger Perlmutter said. Other major shot makers like Moderna and Pfizer are eyeing two doses for their vaccines to work, while Johnson & Johnson is testing its shot in single and multidose regimens.
In a bid to boost blood plasma donations, testing giant LabCorp is offering a "no charge" COVID-19 antibody testing program for the next three months, using Roche's Elecsys Anti-SARS-CoV-2 test. Several biopharmas—such as Takeda—are eyeing convalescent plasma as a COVID-19 treatment. Story
With demand for Samsung's therapeutics skyrocketing amid the COVID-19 pandemic, the company has plotted a $2 billion "Super Plant" at its Incheon, South Korea, hub, plus an additional campus in Incheon that will serve as a global R&D center, the company said. In April, Samsung penned a $362 million deal with Vir Biotechnology to boost manufacturing of the biotech's COVID-fighting monoclonal antibody program, with plans to potentially start commercial production in 2021—and that's just one of the deals spurring the company to expand. Story