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 milli