Roche's rheumatoid arthritis drug Actemra delivered a qualified win in COVID-19 pneumonia patients after a previous failure. Meanwhile, the Swiss drugmaker launched a new antibody test outside the U.S. and plans to ask the FDA to grant its emergency green light.
Sanofi and GlaxoSmithKline inked a deal to sell up to 300 million vaccine doses to the EU. China's Sinovac teamed up with Alibaba Health to build a platform for COVID-19 inoculations, and Cellex paired with Gauss to create a rapid, at-home coronavirus test that double-checks results through a companion app.
Plus, Moderna and Pfizer may pivot their mRNA platforms to develop better flu shots, the drugmakers said at separate investor events.
The worldwide case count passed 30.2 million Friday morning, with more than 946,000 reported deaths, according to Johns Hopkins University's COVID-19 dashboard.
UPDATED: Friday, Sept. 18 at 9:21 a.m. ET
Patients with COVID-19 pneumonia who received Roche's rheumatoid arthritis med tocilizumab, or Actemra, plus standard of care were 44% less likely to move onto mechanical ventilation or die compared to those on standard care alone, phase 3 data showed. But that top-line win was driven by patients staying off ventilators, Roche said; there was no statistically significant difference in death rates between the two arms of the trial. Story
Speaking of Roche, the Swiss drugmaker launched its Elecsys COVID-19 antibody test in markets accepting the CE mark Friday and filed for an emergency nod from the U.S. FDA. The test, which targets and measures antibodies directed against a certain region of the virus' infamous spike protein, could track vaccine-induced immune response in clinical trials and help screen blood plasma donations, Roche said in a release.
The European Union locked in a deal for up to 300 million doses of Sanofi and GlaxoSmithKline's recombinant protein-based vaccine candidate, European Health Commissioner Stella Kyriakides tweeted. The agreement comes on the heels of an earlier EU deal to purchase up to 400 million AstraZeneca doses and coincides with the deadline for World Health Organization members to join the agency's equitable shot distribution scheme, COVAX. Story
Moderna and Pfizer may tap the mRNA platforms they've used to develop COVID-19 vaccines to create better flu shots, the drugmakers said at separate investor events this week. Moderna thinks it could build a vaccine to surpass the typical 40% to 60% efficacy bar by swapping out genetic sequences according to sampling done at the height of flu season, CEO Stephane Bancel said. Meanwhile, Pfizer said it hoped to expand its mRNA work to develop a shot against multiple strains of the flu by 2022.
Chinese vaccine maker Sinovac tapped Alibaba's Health Information Technology unit to set up a platform for COVID-19 inoculations, including online appointment booking and post-vaccination health tracking, Alibaba said Thursday. Sinovac's shot, CoronaVac, is in phase 3 testing in China, Brazil, Indonesia and Turkey.
Diagnostics firm Cellex plans to develop a rapid COVID-19 test that patients can perform at home. The test is designed to deliver results in 15 minutes and double-check readouts through a companion smartphone app developed by Gauss. The app will also guide patients through the nasal swab collection process and send results straight to health authorities. Cellex and Gauss hope to win FDA approval for the test this fall. Story
The pharma industry's reputation is gaining as drugmakers hustle COVID-19 drugs and vaccines through the clinic, but companies need to make real changes if they want public goodwill to last, Interbrand Health Executive Director Barry Silverstein said. “This is a moment in time for a reset and for a new dialogue—one that emphasizes people, one that is mission-based, and one that’s inspiring to their employees, the public and investors,” Silverstein said. Story
UPDATED: Thursday, Sept. 17 at 3:29 p.m. ET
After Moderna on Thursday unveiled its vaccine phase 3 trial protocol, Pfizer followed suit later in the day. The New York drugmaker released a 137-page document outlining all of the details of the trial, which has already enrolled about 29,000 people.
A group of 11 state treasurers from both political parties asked Gilead Sciences to reconsider its pricing on antiviral remdesivir. The treasurers say taxpayers "have already paid the price" and "deserve an affordable treatment when loved ones" face severe COVID-19 cases. Gilead's treatment carries a list price of $3,120 per course.
CDC director Robert Redfield on Wednesday said that COVID-19 vaccines won't be available to most Americans until the middle of 2021, prompting the president to say otherwise. As Stat News points out, the episode was just the latest instance of the CDC mishandling public health messaging amid the pandemic.
UPDATED: Thursday, Sept. 17 at 9:20 a.m. ET
The safety scare that triggered AstraZeneca's clinical hold "is considered unlikely to be related to the vaccine," according to an Oxford University document on the shot trial. AZ's studies were put on pause last week after a patient in the U.K. was hit with a serious potential reaction—inflammatory spinal cord condition transverse myelitis, according to a New York Times source. Trials have resumed in the U.K., Brazil, South Africa and India, while the U.S. study remains on pause.
Moderna will consider an emergency use authorization for its shot in high risk groups if interim phase 3 data show the vaccine is at least 70% effective, CEO Stéphane Bancel told Reuters. An independent safety board is set to look over Moderna's data as soon as a total of 53 subjects in the trial are infected with COVID-19; Moderna expects that review to take place in November, but it could happen as early as October, the company has said.
BioNTech is buying a German manufacturing facility from Novartis with capacity to produce 750 million vaccine doses per year. BioNTech kept mum on the financial details, but it expects the deal to close in 2020's fourth quarter. The site is pegged to supply 250 million doses in the first half of next year, scaling up to the 750-million dose count once it's fully operational. It will help BioNTech boost production of its Pfizer-partnered shot, "[p]articularly in the first half of 2021," CEO Ugur Sahin said.
Meanwhile, Pfizer hit its 30,000-patient recruitment goal for the phase 3 trial of its BioNTech-partnered vaccine, the drugmaker said Wednesday. Pfizer submitted an "amended protocol" to the FDA over the weekend to add another 14,000 subjects to its trial. If Pfizer wins approval for the expansion, it will look to recruit younger patients, plus those with chronic conditions such as stable HIV, Hepatitis B and Hepatitis C.
Eli Lilly tapped Amgen to boost supply capacity for its potential COVID-19 therapies, including the antibody treatment LY-CoV-555. The drugmakers did not provide details on how the work would break down, but with their forces combined, they hope to crank out millions of antibody doses as early as next year, Lilly said in a release. Eli Lilly published data this week linking its antibody treatment to reduced hospitalizations in mild to moderate COVID-19 patients.
Takeda and its partners will kick off a late-stage trial of a COVID-19 blood plasma therapy this month after initial delays. The Takeda-led group, known as the CoVIg-19 Plasma Alliance, will run the trial in partnership with the NIAID in the U.S., with plans to recruit 500 subjects from the United States, Britain, Argentina and Denmark, an NIH posting said. The partners aim to compare outcomes from the plasma-based product against Gilead's Veklury (remdesivir) and a placebo.
Germany's Merck KGaA, which supplies lab equipment and has a part in more than 50 global COVID-19 vaccine projects, has overcome production shortages as it looks to meet a surge in demand from companies tackling the pandemic, Reuters reports. Merck has rushed to clear order backlogs on filtration products, while the team has shifted working hours to contend with a shortage of single-use, plastic bioreactors, CEO Stefan Oschmann said. Plus, the company has reportedly overcome low supplies of speciality chemicals used in COVID-19 diagnostics.
UPDATED: Wednesday, Sept. 16 at 3:17 p.m. ET
Pfizer and BioNTech's vaccine hopeful boasted a mild to moderate safety profile, with rare instances of severe reactions, phase 3 data through Aug. 27 showed. In 5,664 people ages 18 to 64 who received one dose, 38% reported fatigue, while 35% experienced headache and 16% had chills; the side effect rate was lower among another group of 1,816 older patients. Most side effects after the second dose were also mild to moderate, though more severe reactions did crop up after a second injection, Pfizer reported. Story
Meanwhile, BioNTech and fellow mRNA-based shot maker CureVac snared a combined $745 million in vaccine development funding from the German government. BioNTech scored $445 million in milestone-based funding, the drugmaker said Tuesday, while CureVac bagged $299 million in German funding earlier this month. Based on the government-set milestones, CureVac expects to grab $122 million of that total by the end of the year. Story
French drugmaker Valneva tapped Berkeley's Dynavax to help churn out enough adjuvant for 190 million COVID-19 vaccine doses by 2025, the partners said this week. Dynavax aims to deliver an initial adjuvant order—enough for 100 million doses—by 2021, with an option for the equivalent of 90 million doses by 2025. Earlier this week, Valneva inked a supply pact worth up to $1.63 billion with the UK to deliver upward of 190 million vaccine doses by 2025. Story
Only 27% of Americans said they would get a COVID-19 vaccine as soon as it's ready, down 6 percentage points from a month ago, weekly tracking surveys by the media and marketing services company Engine showed. Seventy-seven percent of respondents plan to get the jab eventually—but half of those people said they aim to wait for more research and safety data first. Meanwhile, 32% of those polled had "significantly reduced" confidence in a vaccine after news of AstraZeneca's clinical hold broke. Story
The FDA published data outlining the sensitivity of 58 molecular coronavirus tests, measured according to each diagnostic's limit of detection—a metric that describes the lowest amount of viral particles needed in a sample for a test to yield a correct result. That stat is different from analytical sensitivity, used to measure a test's rate of false negatives. PerkinElmer’s detection kit topped the list, followed closely by tests from ScienCell, BioCore, DiaCarta and others. Meanwhile, Qiagen’s respiratory disease panel ranked last. Story
Plus, Siemens Healthineers will team up with the CDC and the EU’s Joint Research Centre to help standardize international antibody tests for COVID-19. The triple effort aims to peg each viral protein of SARS-CoV-2, along with those proteins' associated antibody levels needed to thwart infection. Current antibody tests cover a wide range of viral proteins, and under the FDA's validation guidelines, companies often test assays against their own internal standards, rather than compare them with a common scientific benchmark. Story
Eli Lilly's anti-COVID-19 antibody curbed hospitalizations in patients with mild to moderate disease, but the lowest and highest doses out of three tested failed to beat placebo, interim phase 2 data showed. The BLAZE-1 study tested three doses against placebo in 452 patients by comparing subjects' viral load from baseline to day 11; only the middle, 2,800-mg dose met its primary endpoint, and Lilly has yet to release full data. Meanwhile, the company said its antibody led to a 72% risk reduction in hospitalizations, but that stat was based on a small group: five members from the 302-subject antibody arm went to the hospital, compared with nine from the 150-person placebo group. Story
A drug based on an antibody fragment 10 times smaller than a full-sized antibody was highly effective in treating and preventing COVID-19 in mice and hamsters, a team at the University of Pittsburgh School of Medicine found. Several of the researchers have since launched the startup Abound Bio to push the candidate into clinical trials, potentially as an inhaled COVID-19 drug. The fragment's small size could better penetrate infection sites and provide an alternative to infusion-based antibody treatments, the researchers said. Story
UPDATED: Wednesday, Sept. 16 at 10:33 a.m. ET
The U.S. FDA plans to work closely with AstraZeneca to parse through the safety scare that triggered last week's clinical hold, Commissioner Stephen Hahn said. He added that the FDA still doesn't know the cause of the side effect, reportedly the inflammatory spinal cord condition transverse myelitis. AZ's U.S. trial remains on hold pending FDA and safety panel investigations, Reuters reported Monday.
Meanwhile, the Serum Institute of India (SII) got the go-ahead from India's drug regulator to resume local trials of AstraZeneca's shot, a source close to the matter said Wednesday. The Drugs Controller General of India (DCGI) issued the green light after talks with U.K. authorities and AstraZeneca itself, the source said. SII will also boost safety monitoring of its trials and inform participants of any new findings, a DCGI source added.
AstraZeneca also restarted its vaccine trial in South Africa, Reuters reported, citing the South African health department's director of affordable medicines. Trials have also kicked back off in the U.K. and Brazil.
It's "unlikely, but certainly not impossible" that Pfizer will have enough phase 3 vaccine data to bring its shot before an FDA advisory committee on Oct. 22, CEO Albert Bourla told CNBC. Despite his cautious language, Bourla went on to say the drugmaker has a "very good sense" it will be able to offer an efficacy readout before the end of October. Meanwhile, Pfizer also thinks its shot could surpass the 50% efficacy bar required by the FDA, Bourla said.
Plus, the U.S. government plans to kick off vaccine distribution as early as one day after a shot wins authorization, an official from the Department of Health and Human Services said Wednesday. The Centers for Disease Control and Prevention will be on the hook to decide how to allocate and distribute the limited number of initial doses.
Russia will supply 100 million doses of its Sputnik V vaccine to Dr. Reddy's Laboratories in India, where the drugmaker plans to run a phase 3 trial on the Gamaleya Institute-made shot, the Russian Direct Investment Fund (RDIF) said Wednesday. The RDIF previously struck a deal with Indian manufacturers to churn out 300 million doses of the vaccine in-country; those shot deliveries could start later this year, subject to completion of trials and Indian approval.
An undisclosed number of volunteers dropped out of Johnson & Johnson's phase 2 vaccine trial in Spain, lead investigator Alberto Borobia told Reuters, though he added that there were enough reserve volunteers to keep the trial moving. The patients hit the exit over side effect concerns following AstraZeneca's clinical hold last week, Borobia said. J&J kicked off its Spanish phase 2 Monday, with tests expected to wrap on Sept. 22.
UPDATED: Tuesday, Sept. 15 at 3:30 p.m. ET
While the U.S. weighs whether to restart its AstraZeneca vaccine trial, Brazil's health regulator Anvisa on Tuesday gave the British drugmaker the OK to test its vaccine on an additional 5,000 patients, the Sao Paulo university running the phase 3 trial said. Last month, the Brazilian government set aside $360 million to secure an initial 100 million AZ doses, plus licensing rights to produce the Oxford University-partnered shot at the Oswaldo Cruz Foundation.
Some health officials are praising AZ for initiating the trial hold last week. “This is what we want to see with trials, it is a well-run trial. Safety is always critical, it is crucial and they have looked at that in an appropriate manner,” World Health Organization official Margaret Harris told Swiss journalists Tuesday.
Don't look for a global vaccine rollout anytime soon, even with the combined might of Big Pharma and major government investments, the CEO of the Serum Institute of India, Adar Poonawalla, told the Financial Times. Poonawalla predicts it will take four to five years for manufacturers to crank out the roughly 15 billion doses he thinks will be needed for a global inoculation push—and those manufacturers currently lack the capacity to meet that demand. "I have not heard of anyone coming even close to that [level] right now,” Poonawalla said.
South Korea plans to shell out $146 million to secure COVID-19 vaccines for around 60% of its population, or about 30 million people. $70 million from that fund will go toward 20 million doses from the WHO's COVAXX facility, while the rest will be put toward an initial 40 million doses from private drugmakers, South Korean health authorities said. Meanwhile, South Korea's SK Bioscience in July signed on to help manufacture AstraZeneca's shot, and it's also penned a deal to produce part of Novavax's jab last month.
The nose could make up prime real estate for COVID-19 therapeutics, scientists from Johns Hopkins University found. In a recent study, researchers ID'd large amounts of the protein ACE2—one of the pathways the novel coronavirus may use to infect healthy cells—in the back of the nasal cavity, providing a potential foothold for the virus. But a simple iodine solution could help rinse the virus out of the nose and throat, early evidence published in Ear, Nose & Throat Journal showed.
UPDATED: Tuesday, Sept. 15 at 9:02 a.m. ET
Novavax inked a manufacturing agreement with the Serum Institute of India, the world's largest vaccine producer by doses, that takes the company's peak global capacity to more than 2 billion doses annually. Serum Institute will start producing doses in 2021. For Novavax, the deal follows others with Fujifilm and AGC Biologics to boost manufacturing.
BioNTech, partnered with Pfizer and Fosun Pharma, picked up a €375 million ($445 million) funding commitment from the German government for its COVID-19 vaccine work. Under the deal, BioNTech aims to bolster its German manufacturing presence. The German government plans to spend €750 million in total funding vaccine candidates.
Aside from its current emergency nod in hospitalized patients, Gilead Sciences is testing remdesivir in an outpatient setting by IV and through inhaled administration, CEO Dan O'Day told CNBC.
AstraZeneca has scored $1.2 billion in federal funding for its COVID-19 vaccine work, but the company also raised drug prices this year more than its peers, an analysis by 46brooklyn Research shows. Many companies only raised prices once this year, but AstraZeneca raised prices for some medicines twice. LA Times story
Meanwhile, AstraZeneca's phase 3 COVID-19 vaccine trial has resumed in Brazil. The restart follows a similar development in the U.K., but U.S. officials have not cleared the trial to start again in the States. As the FDA considers allowing the trial to resume, officials at the "highest levels" of the National Institutes of Health are "very concerned" about a safety scare that caused the trial to be paused, Avindra Nath, a viral research expert at NIH, told Kaiser Health News.
With trials "proceeding smoothly" in China, citizens there may be able to get vaccines as early as November, a government official said.
Lonza has entered a manufacturing pact with Humanigen to help bolster capacity for lenzilumab, which is in phase 3 testing. Reuters story
Aside from COVID-19's devastating death toll, the pandemic has reversed two decades of progress in immunizing children globally. Tens of millions have slipped into extreme poverty, the Gates Foundation found. Wall Street Journal story
UPDATED: Monday, Sept. 14 at 2:40 p.m. ET
The U.K.'s Recovery Trial will run a phase 3 study of Regeneron's antibody cocktail, REGN-COV2, in hospitalized COVID-19 patients, the New York-based drugmaker said Monday. The trial, which aims to dose at least 2,000 subjects with Regeneron's cocktail, will assess its effect on mortality, length of hospital stay and need for ventilation. The company itself is testing the duo in two phase 2/3 COVID-19 treatment trials and a phase 3 prevention trial.
The FDA will likely issue an emergency use authorization (EUA) for a COVID-19 shot in targeted groups before granting a full approval—and that's a good thing, ex-FDA commissioners Scott Gottlieb and Mark McClellan wrote in a Wall Street Journal op-ed. Gottlieb and McClellan stressed that an EUA would still require a shot to prove its safety in clinical trials, adding that the process gives the FDA power to request additional data as a condition of approval. The biggest downside, according to the former chiefs? A staged vaccine rollout wouldn't quickly provide herd immunity.
South San Francisco's Vaxart got the go-ahead to test the safety of its oral vaccine candidate in a phase 1 trial. Vaxart will start recruiting this month and expects to launch its trial within a few weeks, a company spokesperson said in an email; results are expected early next year. The company aims to share vaccine data next month from a challenge trial in hamsters and is awaiting results from a challenge trial in monkeys.
AbbVie ordered workers in R&D, sales and marketing to return to work on-site Monday in a bid to re-establish its "face-to-face" work environment, CNBC reported, citing an Aug. 27 email to AbbVie staffers. The drugmaker has put precautions in place to prevent on-site spread of COVID-19, but many employees told CNBC they remain nervous about returning to work while the pandemic rolls on. Story
Thirty-four percent of Americans hold a positive view of the pharma industry, Gallup's 2020 image survey showed—a seven-point increase over last year's 27%. Still, 49% of respondents said they view the industry negatively, earning it the second-to-last spot in the annual poll, just behind the federal government. That's better than the 58% who reported a negative view in 2019; opinions may have shifted thanks to greater appreciation for the industry amid the pandemic, Gallup senior editor Lydia Saad said. Story
UPDATED: Monday, Sept. 14 at 9:30 a.m. ET
AstraZeneca got the go-ahead to resume its phase 3 vaccine trial in the U.K. after last week's clinical hold, thanks to a green light from the country's Medicines Health Regulatory Authority. AZ said it “cannot disclose further medical information” related to the hold, but the New York Times last week reported that a patient in the U.K. was found to have transverse myelitis, an inflammatory spinal cord condition that can be caused by viral infection. Tests elsewhere, including in the U.S., remain on hold. Story
Pfizer and BioNTech aim to scale up enrollment in their phase 3 vaccine trial to include around 44,000 participants, the partners said Saturday, adding that they expect to hit their current 30,000-subject recruitment goal this week. The expansion would also boost trial diversity, including patients as young as 16 years old, plus those with chronic, stable HIV and hepatitis B and C, the partners said. Story
Pfizer and BioNTech also think they have a 60% chance at knowing whether their lead mRNA vaccine candidate works by October, Pfizer CEO Albert Bourla told CBS on Sunday. Bourla trumpeted the diversity of Pfizer's phase 3 trial: Globally, 60% of participants are caucasian, while minorities make up the other 40%; plus, 44% of the enrollment population consists of older patients, the CEO said. He added that the company would aim to recruit more LatinX and African American subjects in its proposed recruitment scale-up.
Merck & Co. started dosing patients in a phase 1/2 trial of its vaccine candidate in Belgium. The 260-subject trial will test the viral vector-based shot's safety and ability to trigger an immune response against COVID-19 in healthy volunteers, the company said. Merck snapped up the vaccine candidate in May through its buyout of Themis Bioscience. The pharma giant aims to provide coronavirus protection using a proven vaccine platform that works with a single dose, the drugmaker has said.
The U.K. shelled out €470 million ($558 million) for 60 million doses of Valneva's inactivated vaccine candidate, slated for delivery in the second half of 2021, the French biotech said in a release. The country has the option to purchase another 40 million doses for 2022, plus an additional 30 million to 90 million doses across 2023 to 2025. Altogether, those purchases could amount to €900 million (about $1 billion) in revenue. The government will also invest upfront in Valneva's Livingston, Scotland, manufacturing plant, with those funds recouped against the U.K.'s supply pact. Story
Eli Lilly plans to file its Incyte-licensed rheumatoid arthritis med, Olumiant, known generically as baricitinib, for an emergency use authorization in COVID-19, the company said Monday. Paired with Gilead's Veklury, also known as remdesivir, Olumiant reduced recovery time by a median of one day for hospitalized COVID-19 patients, compared with those on Veklury alone, data published Monday from the NIAID-sponsored Adaptive COVID-19 Treatment Trial showed. Story
Meanwhile, scientists and health experts are calling for greater transparency around vaccine trials, arguing that Americans deserve to know more about the programs funded with billions of dollars in taxpayer money. Last week, nine pharmas, including AstraZeneca and Pfizer, pledged to "stand with science" in the hunt for a vaccine, but critics pointed out the joint statement lacked a promise to share vital details with scientists and the public.
The Trump administration put up $16 million toward a new data system to help public health officials schedule COVID-19 vaccinations and manage shot supplies. The Vaccine Administration Management System was developed by Deloitte using technology from Salesforce and tested in a series of pilot projects over the summer. Health experts blasted the move for bypassing U.S. states' established vaccine trackers, which have been honed over decades. Meanwhile, healthcare providers who may use the the new federal system have not been given a chance to preview it, a group of lobbyists and trade groups said.
UPDATED: Friday, Sept. 11 at 3:22 p.m. ET
Verily snared FDA approval to begin pooled testing for COVID-19 on up to 12 samples at once at its coronavirus-dedicated testing lab in San Francisco, which runs an adapted version of Thermo Fisher's TaqPath RT-PCR testing kit and boasts a stated capacity of several thousand tests per day. The company also published guidance for others looking to tap its sample collection methods and laboratory processes. Story
Celltrion's COVID-fighting monoclonal antibody, CT-P59, was well-tolerated in healthy patients and did not trigger any side effects at the highest dose, interim phase 1 data showed. Celltrion has also launched a phase 1 trial of the drug in mild COVID-19 patients, with plans to conduct further phase 2 and 3 trials in 500 subjects from 12 countries. The South Korean drugmaker also aims to recruit around 3,000 total subjects, including some from its earlier prevention trial, to test the treatment as a preventive for those in close contact with COVID-19 patients. Story
Sinopharm subsidiary China National Biotec Group has injected hundreds of thousands of people with two of its COVID-19 vaccine candidates under an emergency OK from Beijing issued in July, the company said this week. Meanwhile, Sinovac has given its shot to around 3,000 of its employees and their family members, including the company's CEO. All three candidates are still in phase 3 testing.
Country-specific efforts to lock down vaccine supplies could prolong the pandemic and hamstring efforts to provide broad access to an eventual jab, United Nations Secretary General Antonio Guterres warned at a meeting about the WHO's Access to COVID-19 Tools (ACT) Accelerator program. The WHO on Tuesday said that 78 countries had pledged to join the vaccine pillar of the ACT Accelerator, COVAX. Meanwhile, the U.S. said it would not join the program, while China, with four vaccine candidates in phase 3 testing, has yet to sign on.
President Donald Trump acknowledged the dangers of the COVID-19 pandemic back in February and admitted to downplaying the threat during a March interview with journalist Bob Woodward, according to an audio clip posted Wednesday by the Washington Post. Trump said Wednesday that he'd done so in order to prevent panic; meanwhile, Democratic nominee Joe Biden called the move a "life-and-death betrayal of the American people."
Meanwhile, as flu season approaches and the pandemic rages on, NIAID director Anthony Fauci cautioned against underestimating the virus. "We've been through this before," Fauci said, likening the pandemic to the early days of the AIDS epidemic, which over the past few decades has resulted in millions of deaths and more than 70 million infections. "Don't ever, ever underestimate the potential of the pandemic. And don't try and look at the rosy side of things."
Britain plans to launch a new COVID-19 contact tracing app across England and Wales later this month that will allow people to check into venues by scanning a QR code displayed at the entrances of bars, restaurants, movie theaters and other places where people gather. The National Health Service will then use that info for its Test and Trace program in a bid to boost contact tracing efforts. Currently, people in the U.K. must manually fill in their contact information when they enter a venue.
UPDATED: Friday, Sept. 11 at 9:30 a.m. ET
Eight FDA career executives, including the director of the agency's Center for Biologics Evaluation and Research, Peter Marks, pledged to make decisions on the basis of sound science in a USA Today opinion piece. The FDA execs conceded that the agency exists within a political environment, stressing the importance of regulatory independence amid potential pressures.
The National Institutes of Health (NIH) launched two late-stage clinical trials of blood thinners in COVID-19 patients. In a trial of hospitalized COVID-19 patients, subjects will receive varying doses of the generic blood thinner heparin to test its safety and efficacy in preventing clotting events, the NIH said, while non-hospitalized patients will receive either aspirin or a low dose of Bristol Myers Squibb and Pfizer's Eliquis. Plus, the NIH is plotting a third trial to test blood thinners in moderate to severe COVID-19 patients who've been discharged from the hospital.
United Biomedical's Covaxx penned an agreement with the University of Nebraska Medical Center (UNMC) to run clinical trials on Covaxx-made therapeutics and vaccines, with the initial focus on a phase 1/2 trial of the drugmaker's COVID-19 vaccine, UB-612. In May, Covaxx entered a separate partnership with UNMC to to run large-scale COVID-19 antibody diagnostic testing and processing.
Meanwhile, Covaxx tapped Dasa—Brazil and Latin America's largest diagnostics maker—to run phase 2/3 trials of its synthetic multitope vaccine candidate in Brazil, the companies announced Wednesday. Covaxx will supply doses of UB-612 to Dasa, which will head up clinical testing once it wins approval from Brazil's drug regulator, ANVISA. Trials will take place at public and private laboratories and hospitals, and will also be carried out by contract research organizations, Covaxx said.
China, which has four vaccine candidates in the final stage of testing, is leveraging its inoculation efforts to repair damaged ties and bolster alliances with countries in Latin America, Africa and more. The country has already promised the Philippines priority access to a vaccine, while China's Sinovac will provide over 110,000 free shot doses to Bangladesh. Meanwhile, India has sought to counter China's move on South Asia by pledging its own doses to countries like Nepal and Bangladesh.
Speaking of China, the country on Wednesday approved a phase 1 trial of Beijing Wantai Biological's nasal spray vaccine for COVID-19, co-developed by researchers at Xiamen University and Hong Kong University. The spray contains contains a weakened form of the flu that carries segments of the coronavirus' spike protein. A vaccine delivered through the nose may have a better shot at thwarting the virus in the respiratory tracts, some researchers think.
UPDATED: Thursday, Sept. 10 at 3:14 p.m. ET
British companies iAbra and TT Electronics are set to debut their 20-second COVID test at London's Heathrow Airport. The device uses a digital microscope and artificial intelligence to search a mouth swab sample for signs of the novel coronavirus. Validation studies have shown it's highly accurate. FierceMedTech story
More than half of Americans—62%—are worried the FDA will approve a vaccine prematurely under political pressure from the Trump administration, a new Kaiser Family Foundation survey shows. The survey also shows lower levels of trust in the CDC and NIAID director Anthony Fauci from April.
As COVID vaccines move forward, FDA's Center for Biologics Evaluation and Research director Peter Marks confirmed that any emergency use authorization would require an advisory committee meeting to review data.
While experts have raised warnings about the possibility of flu and COVID-19 circulating simultaneously this fall and winter, good news is emerging from the Southern Hemisphere. COVID-19 mitigation measures have "all but eliminated" the flu season, The Economist reports.
In convincing people to get COVID vaccines when they're available, analytics firm Civis found personal stories resonate the most. People were 5% more likely to say yes to a vaccine if they were shown a story about a young healthy person who contracted COVID-19 and died, the firm found. Story
UPDATED: Thursday, Sept. 10 at 9:23 a.m. ET
AstraZeneca still expects to learn by year-end whether its vaccine candidate works, so long as it's able to resume its trial soon, CEO Pascal Soriot said Thursday. AZ put its phase 3 vaccine study on hold this week after a U.K. trial participant reported a potentially serious side effect. While an official diagnosis has not been made, the patient showed symptoms of transverse myelitis, a spinal cord inflammatory condition; a positive diagnosis would ultimately be submitted to an independent safety committee, who would then make the call on whether to resume the trial, Soriot said. Story
Plus, the Serum Institute of India paused testing on AstraZeneca's shot following the British drugmaker's clinical hold, the company said Thursday. The news comes after the Serum Institute announced Wednesday it had not faced any safety issues and would continue trials on the AZ vaccine. Meanwhile, India's drug regulator issued a show-cause notice to the Serum Institute for failing to inform it of AstraZeneca's clinical hold in other countries.
Meanwhile, Emergent BioSolutions, on the hook to help produce bulk drug substance for AstraZeneca's vaccine, won't suffer financially if the University of Oxford-partnered shot fails to cross the finish line, Cantor analysts figure. Emergent's contract with AZ includes protections that will see the company reap most of the $174 million it's owed under the first year of the deal; plus, $87 million has already come Emergent's way for tech transfer and preparation, the analysts noted. Story
Gilead Sciences' Veklury, also known as remdesivir, is in short supply in the U.S., according to a slate of doctors around the country, despite the fact that other nations like India and the Philippines report ample stores of the COVID-fighting antiviral. One reason for that supply imbalance? Many of those countries are able to purchase generic remdesivir, while Gilead has exclusive license to sell Veklury in the U.S.
National Institutes of Health director Francis Collins on Wednesday diverged from the Trump Administration's suggestion that a vaccine might be ready by Election Day. “Certainly, to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you," Collins said, adding that the recent AstraZeneca hold reinforced the need to maintain safety over speed.
UPDATED: Wednesday, Sept. 9 at 3:00 p.m. ET
AstraZeneca's clinical hold could play out a number of ways: If the spinal cord condition transverse myelitis is confirmed as a reaction to the shot, AZ may have to "terminate" its program, SVB Leerink analyst Andrew Berens figures. Meanwhile, the AZ hold could position Moderna's mRNA shot to beat AstraZeneca's to market, fellow SVB analyst Mani Foroohar said. Plus, other drugmakers testing adenovirus-based vaccines will likely face delays as they rework consent forms and patient brochures. Story
Pfizer and BioNTech's leading mRNA vaccine hopeful triggered a neutralizing antibody response in macaques, as well as antigen-specific T cell responses in both monkeys and mice, data published Wednesday on the preprint site BioRxiv showed. After receiving two doses of the vaccine, macaques who were challenged with COVID-19 had no viral RNA in their lower respiratory tracts, whereas most non-immunized animals did, Pfizer reported. Story
Sinovac's COVID-19 shot CoronaVac yielded a safe immune response in patients over the age of 60, phase 1/2 data published Wednesday showed. Sinovac gave two doses to 421 healthy adults between 60 and 89 years of age and found that the shot was well-tolerated at low, medium and high-doses. The immune response in the older volunteers was comparable with results previously published on patients between 18 and 59 years old, Sinovac said in a release.
New Jersey CDMO Catalent will pump $130 million into its gene and cell therapy manufacturing facility in Harmans, Maryland, adding five late-stage clinical and commercial manufacturing suites to the site. Along with a cell and gene therapy foothold, the expansion could support Catalent's COVID-19 vaccine production efforts. AstraZeneca last month tapped Catalent to help churn out bulk drug substance and viral vectors for its shot at the Harmans site. Story
Qiagen plans to roll out a rapid antigen test in the fourth quarter that leverages the diagnostics firms' portable testing hub. Co-developed with Australia's Ellume, the digital hub can process up to eight test sticks at once, or more than 30 swab samples per hour, and aims to turn out results in less than 15 minutes, Qiagen said. The hub can also run antibody and antigen tests at the same time. Qiagen hopes to make two versions of the test available later this year. Story
OncoImmune raised $56 million in its second round of funding as it looks to push its experimental drug CD24Fc through late-stage trials for leukemia and COVID-19. Designed to regulate inflammatory responses to tissue injures and mainly tested in graft-versus-host disease, the drug is in phase 3 tests to see whether it can prevent immune destruction in severe and critical COVID-19 patients. The trial is close to its 270-subject enrollment goal and top-line readouts are "expected soon," the biotech said. Story
UPDATED: Wednesday, Sept. 9 at 9:45 a.m. ET
AstraZeneca placed its phase 3 vaccine trial on hold after a U.K. participant suffered a severe reaction—potentially transverse myelitis, or inflammation of the spinal cord, a New York Times source reported. AstraZeneca has not revealed the timeline to complete its investigation and resume dosing but said it would move fast to limit trial disruptions. Story
Pfizer and BioNTech wrapped talks with the European Commission to provide an initial 200 million vaccine doses to the EU, with the option to supply another 100 million doses at a later date, the partners said in a release. Slated for delivery by year's end, doses will be made at BioNTech's German manufacturing sites and Pfizer's Belgian plant. The deal marks the partners' largest initial vaccine order to date. Story
Russia will supply 32 million doses of its Sputnik V vaccine to Mexico's Landsteiner Scientific, the Russian Direct Investment Fund (RDIF) said. Vaccine deliveries are pegged to start in November, pending Mexican approval, and Landsteiner will be on the hook for distribution duties. The RDIF thinks the vaccine delivery could cover around 25% of Mexico's population.
On the topic of Sputnik V, Venezuelan President Nicolas Maduro proposed that nearly 15,000 political candidates receive the Gamaleya Institute-made jab in a bid to campaign safely during the country's upcoming legislative elections. An undisclosed amount of Russian vaccines are pegged for delivery in September for clinical trials, Maduro said, adding that "other vaccines" would arrive in October.
Australia's Starpharma pivoted its dendrimer-based drug delivery platform to develop a long-acting, water-soluble version of Gilead Sciences' Veklury, also known as remdesivir, that can be administered via subcutaneous injection. The under-the-skin approach could take Veklury beyond the hospital—where it's approved for COVID-19 patients as an infusion—and expand access to the antiviral in countries with less-developed healthcare systems, CEO Jackie Fairley said. Story
UPDATED: Tuesday, Sept. 8 at 3:45 p.m. ET
Moderna may not hit the $4 billion to $5 billion annual vaccine sales highs that consensus estimates have predicted, SVB Leerink analyst Mani Faroohar figures. A strong phase 3 update and emergency nod for the shot in the fourth quarter are "broadly expected," but Big Pharma competition and dampened vaccine demand could prove major stumbling blocks. For its part, SVB Leerink has pegged Moderna's annual COVID-19 shot sales at around $2 billion or less. Story
Meanwhile, Moderna and Pfizer's phase 3 trials are expected to complete enrollment by September's end, NIAID director Anthony Fauci told PBS NewsHour's Judy Woodruff. It will then take another month or more for the drugmakers to test a second dose in patients, putting prospective vaccine readouts well past election day in the U.S. Sufficient data for a vaccine approval likely wouldn't arrive until year-end, Fauci added.
Six of Sanofi's clinical trials across 31 countries have hit COVID-19 snags, analytics firm GlobalData found. Those six trials have faced disruption due to trial delay or slower enrollment issues brought on by the pandemic and could hamper the French drugmaker's ability to file and win approvals for various drugs, GlobalData said. Plus, two phase 3 pivotal trials testing sarilumab, marketed as Kevzara, in non-COVID-19 indications have been suspended.
LabCorp aims to launch an at-home version of its Pixel self-collection kit, which can test a single sample for COVID-19, respiratory syncytial virus (RSV) and influenza. The test, offered through hospitals and other healthcare providers under a COVID-19 green light issued in May, uses a short nasal swab designed for the lower portion of the nostril. Pending FDA review, LabCorp thinks the at-home version could help people distinguish between COVID-19, RSV and the flu, which often present with similar symptoms. Story
AstraZeneca tapped fitness guru and heart attack survivor Bob Harper to star in its "Survive Today" TV spot, encouraging viewers to call 911 at the first sign of heart attack symptoms—even if those patients are concerned about catching COVID-19 at the hospital. The PSA fits into AZ's "Our Hearts Are Open" campaign, which aims to support people with cardiovascular, chronic kidney disease and diabetes during the pandemic. Story
UPDATED: Tuesday, Sept. 8 at 9:23 a.m. ET
A suite a drugmakers—including Pfizer, Moderna, GlaxoSmithKline, Sanofi and Johnson & Johnson—released a joint statement pledging to follow a scientifically rigorous approval process for their vaccines. The statement aims to reassure the public that the companies won't seek accelerated approval amid political pressure to OK a shot before the U.S. presidential election. Story
Pfizer and BioNTech plan to push a fifth vaccine candidate into a phase 1/2 study this month, an SVB Leerink analyst Daina Graybosch said Friday. The shot, which falls under the partners' BNT162 program and uses nucleoside-modified RNA, or modRNA, showed preclinical promise and could work as a follow-on candidate to the partners' leading shots, Graybosch said, quoting company management. Story
CSL inked a deal with the Australian government to crank out 51 million doses of the University of Queensland's "molecular clamp"-based coronavirus vaccine, with the first doses slated for release in mid-2021, the company said in a release. Meanwhile, CSL also signed on to manufacture around 30 million doses of AstraZeneca's jab in Australia, with delivery expected early next year if the vaccine wins out in the clinic. Story
The U.K. health service thinks AstraZeneca and the University of Oxford's COVID-19 vaccine hopeful will likely be available in the first few months of 2021, health secretary Matt Hancock said Monday. AZ has already pledged 30 million vaccine doses to the U.K. and started production on those shots ahead of approval; plus, the British pharma major kicked off its phase 3 vaccine trial in the U.S. last week.
Sanofi's GlaxoSmithKline-partnered vaccine candidate will likely cost less than €10 ($11.80) in Europe if it passes muster in the clinic, the drugmaker's French president Olivier Bogillot told France Inter radio. Meanwhile, a Sanofi spokesperson told Reuters that a final price would only emerge once the shot moves into the final stage of testing. AstraZeneca, on the other hand, is expected to price its shot at about €2.50 in Europe.
The Japanese government on Tuesday OK'd an expenditure of ¥671.4 billion ($6.32 billion) from its emergency budget reserves to lock down coronavirus vaccine supplies, the country's Ministry of Finance said. Japan's government hopes to secure enough vaccine doses to provide shots to all its citizens free of charge by mid-2021.
Around 90% of Sinovac employees and their families have taken the Chinese drugmaker's experimental COVID-19 vaccine, Reuters reported, citing the company's CEO, Yin Weidong. The shot launched in July under a Chinese emergency use program that targets medical workers, food market employees, and those who work in the transportation and service sectors. Sinovac's CoronoVac shot, currently in phase 3, has been pegged for the emergency scheme and offered to around 2,000 to 3,000 employees and their families on a voluntary basis, Yin said.
Speaking of Sinovac, the drugmaker's shot proved safe in older patients, but also triggered a slightly weaker immune response in that group than it did younger subjects, according to preliminary data from a phase 1/2 trial shared with Reuters. Full data from that trial, launched in May, have not been released. Ninety percent of patients from three groups who took two shots of a low-, mid- and high-dose of Sinovac's vaccine experienced a significant antibody response, with the lower levels in older patients in line with expectations, a company spokesperson said.
South Korea's Celltrion will kickstart commercial production of its COVID-fighting antibody drug this month, with the aim to churn out roughly 1 million doses ahead of approval. Celltrion completed a 32-subject phase 1 study of the treatment in South Korea and is recruiting another nine patients for an additional phase 1. Meanwhile, the company has also launched a human study in the U.K.
UPDATED: Friday, Sept. 4 at 9:15 a.m. ET
With AstraZeneca's vaccine now in phase 3 testing in the U.S., the Department of Defense pledged five of its military sites to help the British drugmaker run trials on the University of Oxford-partnered jab. The study will take place at Naval Medical Center and Wilford Hall Ambulatory Surgical Center in San Diego, Joint Base San Antonio, Walter Reed National Military Medical Center in Bethesda, Maryland, and Fort Belvoir Community Hospital in Fort Belvoir, Virginia, the Pentagon said.
Johnson & Johnson's vaccine hopeful triggered an antibody immune response and curbed disease progression in a group of hamsters, the drugmaker said Thursday. The rodents received a single dose of the vaccine and were then exposed to the coronavirus four weeks later. In addition to an antibody response, vaccinated hamsters appeared to lose less weight than their unvaccinated peers and avoided serious clinical outcomes like pneumonia or death.
Merck & Co., slow to start in the COVID-19 vaccine race, may push its Themis-bought measles vector-based candidate into human testing "fairly soon," CEO Ken Frazier said Thursday, adding that the drugmaker's second shot hopeful from IAVI could enter trials later this year.
Germany's CureVac thinks it could produce its mRNA-based vaccine at scale by year-end, investor Dietmar Hopp told German business paper Handelsblatt. The biotech aims to turn out 100 million doses before 2020's close and hopes to win regulatory approval in spring or summer of 2021, Hopp added. CureVac may also look to boost its deal with Grohmann, part of Elon Musk's Tesla, to create RNA printers for decentralized vaccine distribution, Hopp said.
In the meantime, CureVac may receive up to €252 million ($297 million) from the German Federal Ministry of Education and Research to boost development and rapidly expand production of its mRNA-based COVID-19 hopeful, the biotech said in a release. Payments are contingent on predefined milestones, and CureVac expects to snag up to €103 ($121 million) million in 2020, followed by another €149 million ($176 million) next year.
Russia's recently approved Sputnik V vaccine spurred an antibody response in 100% of patients with minimal side effects, data from two trials—each enrolling 38 healthy adults—showed. The data were published Friday in the Lancet. Faced with criticism for its approval of the Gamaleya Institute-developed shot ahead of phase 3 trial data, Russia last week teed off a late-stage vaccine study that aims to recruit around 40,000 subjects.
Speaking of Russia's vaccine, the Philippines health ministry is set to hold talks with the Russian embassy and representatives from Pfizer to potentially lock down vaccine doses for the Southeast Asian country. President Rodrigo Duterte has been angling for affordable shots from Russia and China in a bid to restore the country to normalcy by December. The Philippines aims to buy 40 million doses worth $400 million from multiple drugmakers, and it's also plotting an October trial of Russia's shot, a spokesman for Duterte said in August.
Meanwhile, the World Health Organization doesn't expect widespread vaccination against COVID-19 to start until next year, citing a lack of strong, late-stage data from front-runners like Pfizer and Moderna, plus Russia, with its recently approved shot, that meet the agency's 50% efficacy standard, spokeswoman Margaret Harris said Friday.
Even if a shot wins approval in the U.S. this year, two-thirds of Americans said they won't get the jab immediately, and a quarter said they wouldn't ever get the vaccine, a new poll by USA Today and Suffolk University found. Of the 1,000 people polled, the remaining third were split between 27% who wanted to get the shot as soon as it was made available and 6% who were undecided. Respondents 75 years of age or older were most likely to say they would get the vaccine straightaway.
UPDATED: Thursday, Sept. 3 at 2:55 p.m. ET
AstraZeneca tapped New York-based CDMO Albany Molecular Research to perform fill-finish work on “millions of doses” of the drugmaker’s University of Oxford-partnered shot at its Albuquerque, New Mexico, site. Financial terms were not disclosed, but Albany Molecular said it would shore up production of the adenovirus-based vaccine through 2021 on “unprecedented manufacturing timelines.” Story
The NIH pegged nine more test makers to advance through its “Shark Tank”-style COVID-19 diagnostics competition and put up $129.3 million in new funding. Lab-based test makers Illumina and the Broad Institute of MIT and Harvard won the NIH's blessing, among others. Meanwhile, the NIH backed three point-of-care test makers, including MatMaCorp and MicroGEM International, working on a cartridge-based spit test that can also detect respiratory diseases like the flu. Story
The U.S. won’t join the WHO’s COVID-19 Vaccine Global Access Facility, or COVAX, White House spokesman Judd Deere said. WHO Secretary-General Tedros Adhanom Ghebreyesus has made repeated calls for developed countries to join the initiative to combat “vaccine nationalism." Meanwhile, the White House in July sent a letter to the U.N. saying Washington would begin the formal process of withdrawing from the WHO.
California’s legislature approved a measure Monday that would allow the state’s top health agency to partner with drugmakers by January to produce generic or biosimilar drugs, including insulin. The measure seeks to make state-developed generics “widely” available at a time when COVID-19 has exposed “glaring gaps” in the ability of hospitals, government drug purchasers and other entities to maintain stable supplies of drugs and medical equipment, the bill’s author, Sen. Richard Pan, D-Sacramento, said.
Up to 45 U.S. hospitals may look to join a clinical trial on blood plasma in COVID-19 run by Vanderbilt University Medical Center, the study’s lead investigator, Todd Rice, M.D., told Kaiser Health News. Several hospitals, like the Ohio State University Wexner Medical Center, aim to prioritize patient enrollment in the trial and limit plasma’s use outside of studies, citing concerns over the observational data that won the treatment its emergency nod last month.
The Serum Institute of India and Biological E have penned major shot manufacturing deals with pharma giants AstraZeneca and Johnson & Johnson, respectively, but experts fear those companies may struggle to make and distribute enough vaccines to curb India's COVID-19 outbreak. Given the country's massive size and the cold storage needs of many front-runner shots, India's vaccination campaign could take years, Gagandeep Kang, a vaccine expert at the Christian Medical College in Vellore, India, told Nature.
UPDATED: Thursday, Sept. 3 at 9:12 a.m. ET
Sanofi and GlaxoSmithKline pushed their vaccine candidate into phase 1/2 testing, with plans to enroll 440 people across 11 U.S. clinical trial sites. The partners hope to deliver safety and efficacy results by December and move into phase 3 that same month, teeing up a potential approval for the shot in the first half of 2021. Sanofi and GSK have already pledged supplies to the U.S. and are in talks to supply doses to the U.K. and EU. Story
Novavax's recombinant vaccine safely triggered an immune response on day 35 of testing, phase 1 data published Wednesday in the New England Journal of Medicine showed. The drugmaker tested 5-microgram and 25-microgram doses in 131 healthy adults; 83 subjects received the shot with an adjuvant, while 25 received an non-adjuvanted shot and 23 got placebo. Novavax has now kicked off its phase 2 and aims to advance the shot into phase 3 in October.
The World Health Organization issued new guidance urging doctors to use low-cost, widely available steroids like dexamethasone, hydrocortisone and methylprednisolone to treat severely ill COVID-19 patients, after a slew of trials confirmed their benefit in that group. JAMA on Wednesday posted a pooled analysis of seven studies evaluating the three steroids in more than 1,700 patients, concluding that each drug curbed the risk of death. Story
CDC Director Robert Redfield, M.D., called on states to expedite applications for COVID-19 vaccine distribution facilities and "consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020," McClatchy reported, characterizing Redfield's letter as part of an ongoing push to jump-start U.S. vaccinations. Others, like Larry Corey, M.D., an expert who is co-leading vaccine studies in the U.S., doubt the shots currently in phase 3 trials can definitively prove safety and efficacy within that time frame. Story
Speaking of the CDC, the agency sent planning documents to public health agencies around the U.S. last week detailing plans to roll out two shots, dubbed Vaccine A and Vaccine B, possibly by October or November. According to the document, Vaccine A—most likely Pfizer's jab, The New York Times estimated—may be available in October, with 10 million to 20 million potential doses ready the next month, while 10 million doses of Vaccine B, most likely Moderna's, could be available by November.
A slate of biotech CEOs urged their peers running clinical trials on COVID-19 drugs and vaccines to release data through peer-reviewed journals and well-respected scientific meetings rather than press releases alone. In an open letter organized by the Biotechnology Innovation Organization, the CEOs, who come from companies such as Alnylam and Alkermes, also stressed the need for an independent FDA and a depoliticized national pandemic response. Story
Boynton Beach, Florida, resident Jacob Serrano—who has lost seven family members to the coronavirus—became the first American dosed with AstraZeneca and the University of Oxford's COVID-19 vaccine candidate last Friday.
UPDATED: Wednesday, Sept. 2 at 3:20 p.m. ET
New Jersey-based CDMO Catalent will invest $50 million into a third high-speed filling line at its Bloomington, Indiana, plant, expected to boost capacity by an additional 80 million vials per year. Catalent in April teamed up with Johnson & Johnson to handle fill-finish duties on the drugmaker's COVID vaccine at its Bloomington site. The CDMO will also shore up work on J&J's shot at its Anagni, Italy, plant, and has agreed to help with drug substance production and fill-finish work on AstraZeneca's vaccine at its Anagni and Harmans, Maryland, sites, respectively. Story
If interim phase 3 data are strong enough, the independent data and safety monitoring board overseeing COVID-19 vaccines would have a "moral obligation" to end the trial early and speed up the review process, NIAID director Anthony Fauci told Kaiser Health News. Fauci's comments come amid a firestorm of criticism over potential political interference at the FDA, although Fauci added that he trusts the members of the board, who are not government employees. Story
The U.S. Department of Health and Human Services tapped the Washington D.C. consulting firm Fors Marsh Group to head up its $250 million public messaging campaign to help the Trump administration “defeat despair, inspire hope and achieve national recovery" in the face of COVID-19. Reactions to the plan on social media late Tuesday were largely negative, painting the campaign as a political maneuver by the White House and a misuse of funds. Story
A seven-day treatment of the low-cost, widely-available steroid hydrocortisone gave severely ill COVID-19 patients a 93% better chance at recovery than those who didn't receive the steroid, a study from Imperial College London and the U.K.'s Intensive Care National Audit & Research Centre found, prompting the U.K.'s National Health Service (NHS) to recommend the drug in COVID-19 patients. The NHS previously green lit dexamethasone in COVID-19 after the U.K.-run Recovery Trial showed the steroid slashed death rates in hospitalized patients.
When it comes to COVID-19 news, both Democrats and Republicans hold doctors, nurses and nationally-recognized hospitals in high regard, a new Harris Poll found. Meanwhile, 71% of Republicans trust pandemic news from the White House, but only 28% of Democrats do, while 61% of Democrats trust the national news media compared to 36% of Republicans. As for the pharma industry, 71% of all people polled said they trust drugmakers working on COVID-19 vaccines. Story
Sixty-seven percent of healthcare experts surveyed over the summer plan to use decentralized clinical trials to combat COVID-19 disruptions, analytics firm GlobalData found. Out of 150 respondents, only 34% were already using decentralized trials, many of which were contract research organizations. Meanwhile, virtual trial companies like Science 37 and Medable have racked up funding and partnerships, respectively, for their decentralized trial work. Story
Nocion Therapeutics snared Sage Therapeutics' Christopher Silber, M.D., to serve as chief medical officer at the company. Nocion last month grabbed a speedy approval from the U.K.'s drug regulator to launch a phase 1 trial of its first program, an inhaled treatment for chronic and acute cough, which the company believes could benefit COVID-19 patients and potentially limit the virus' spread by curbing transmission between patients, family members and hospital staff. Story
UPDATED: Wednesday, Sept. 2 at 9:30 a.m. ET
Roche will launch a rapid antigen test in late September for countries accepting Europe's CE mark, with plans to pursue an emergency use authorization from the U.S. FDA, the drugmaker said in a release. The nasal swab-based test can turn out results in 15 minutes and will be used in point-of-care settings for symptomatic and asymptomatic patients. Roche has pegged its supply at 40 million tests per month at launch and hopes to double that by year-end.
Convalescent plasma, granted a controversial emergency use authorization in COVID-19 based on an observational study, not a placebo-controlled trial, should not be considered standard of care for patients with the disease, the National Institutes of Health said, citing a lack of data to recommend either for or against the treatment. The NIH called for more clinical trials on plasma and encouraged the public and healthcare providers to take part in those studies. Story
A fast-tracked vaccine authorization ahead of the U.S. Presidential election is unlikely, former FDA Commissioner Scott Gottlieb, M.D., told CNBC. By Gottlieb's estimation, a shot would need to boast around "70% to 80%" efficacy to yield a readout in October strong enough to warrant a green light before November 3. It's more likely that the ongoing phase 3 trials could deliver enough data for analysis in November, Gottlieb added. Earlier this week, current FDA Commissioner Stephen Hahn, M.D., said the agency would consider fast-tracking a shot before phase 3 trials are complete, if the benefits outweigh the risks.
EU member states could purchase vaccines through the World Health Organization's distribution scheme COVAX, separate from the current EU procurement plan, which so far has locked down an initial 300 million doses from AstraZeneca, the European Commission said. The policy shift would potentially allow EU members to tap doses from companies such as Merck & Co., Inovio and Novavax. Meanwhile, those countries would not be allowed to angle for doses from drugmakers already in talks with the EU, including Johnson & Johnson and Sanofi.
Chinese customs officials failed to approve shipments of CanSino Biologics' vaccine candidate to Canada for a prospective phase 3 trial—potentially due to political tensions between the two countries, Guy Saint-Jacques, a former Canadian ambassador to China said. CanSino, which early this year was at the forefront of the vaccine race, has yet to begin phase 3 trials on its shot. Meanwhile, some health experts worry the shot's immune response may fall short of rival vaccines.
California-based biopharma MediciNova is working on a number of vaccine candidates, including an intranasal vaccine that uses a viral vector platform from Japan's Mie University and MediciNova's development partner BioComo. MediciNova narrowed down its candidates by inoculating mice with a single intranasal dose, and it's now gearing up production for safety tests and clinical trials.
UPDATED: Tuesday, Sept. 1 at 3:17 p.m. ET
Sanofi and Regeneron are pulling the plug on Kevzara in COVID-19 after the rheumatoid arthritis med failed to significantly shorten patients' hospital stays or speed up their improvement in a phase 3 trial, Sanofi said Tuesday. Kevzara is one of two high-profile IL-6 inhibitors to stumble in COVID studies: In late July, Roche said its IL-6 inhibitor Actemra had also failed to meet its endpoints in a coronavirus phase 3, though the Swiss drugmaker remains committed to researching the drug in COVID-19, potentially in combination with Gilead's Veklury (remdesivir). Story
Meanwhile, Actemra, known generically as tocilizumab, blunted the activity of proteins called cytokines that can lead to deadly immune reactions in COVID-19 patients, data from Osaka University researchers show. The drug also put a damper on the protein PAI-1, which causes small blood clots throughout the body, including the lungs, the study found. All seven COVID-19 patients dosed with Actemra in the study recovered "promptly" from fever and malaise, and their PA-1 levels rapidly declined, the team said.
CanSino Biologics' COVID-19 vaccine, approved for military use in China, and Russia's green-lit shot from the Gamaleya Institute may share a common weakness: both vaccines are based on a common cold virus—adenovirus type 5, or Ad5—that many people already have some immunity to. Those people's immune systems could attack the viral vector itself, rather than the coronavirus, hampering the vaccines' efficacy.
United Biomedical's COVAXX division is developing the first multitope peptide-based vaccine against COVID-19, slated to enter human trials in Taiwan by summer's end and expected to start phase 1/2 studies at the University of Nebraska Medical Center this fall. COVAXX believes its B- and T-cell vaccine candidate will be easily scalable and won't require cold storage, and the company expects to be able to produce up to 100 million doses by next year's first quarter.
The Department of Health and Human Services (HHS) will spend $250 million on a media-spanning ad campaign with the goal to "defeat despair and inspire hope" around COVID-19, Politico reported. More than 10 communications companies are allegedly interested in spearheading the big money effort, whose budget for a five-month push towers over spending on other public health awareness initiatives. The CDC, for instance, has spent $93 million on public health TV ads since mid-March, data from the real-time TV ad tracker iSpot.tv shows. Story
In the hunt for a COVID-19 shot, several scientists have skipped drug regulators altogether and whipped up their own D.I.Y. vaccines. One such effort, the Rapid Deployment Vaccine Collaborative, or RadVac, backed by Harvard geneticist George Church, has developed a nasal spray vaccine using viral proteins called peptides. Many of RadVac's 23 listed collaborators have taken the vaccine themselves or given it to family members, with no serious side effects reported, but health experts have warned that untested vaccines could cause serious side effects or instill a false sense of protection.
UPDATED: Tuesday, Sept. 1 at 9:17 a.m. ET
AstraZeneca kicked off its 30,000-person phase 3 clinical trial of its vaccine candidate, AZD1222, in the U.S. with 62 out of a total 80 sites selected. The company expects to extend trial sites into Chile and Peru, the British drugmaker said in a release. AstraZeneca will assess its shot based on the number of participants who contract COVID-19 more than two weeks after getting their second doses. It's already in phase 2/3 testing in the U.K. and India, and phase 3 in Brazil and South Africa. Story
Speaking of AstraZeneca, the British drug major upgraded its vaccine production deal with Oxford Biomedica, throwing down £15 million ($20 million) upfront to reserve capacity at the CDMO's Oxbox facility. The pact includes an option for another £35 million ($47 million), Oxford Biomedica said.
GlaxoSmithKline and Vir Biotechnology dosed the first patient in a phase 1/2 study of the partners' COVID-fighting monoclonal antibody, designed to treat patients early and keep them out of the hospital. The study will enroll around 1,300 patients with early symptomatic infection. Early data may be available before year-end, while a full readout is expected in the first quarter of 2021.
Regeneron could snare as much as $6 billion in sales next year from its COVID-fighting antibody cocktail, investment research firm Morningstar figures. The firm also pegged the cocktail's chance of winning approval in the U.S. at 60%. Roche recently teamed up with the New York-based biotech to help churn out antibody doses, while Regeneron added 400 jobs at its plant in Limerick, Ireland, as it pivots to antibody production in the U.S.
The U.S. ought to share doses of an approved COVID-19 shot with other countries rather than hoarding supplies, Eli Lilly CEO David Ricks told Axios. The pandemic is a shared public health risk, not an independent one, Ricks said, adding that countries should help one another vaccinate high-risk populations after they've inoculated those patient groups themselves.
An emergency use authorization (EUA) for a vaccine that is ineffective or potentially unsafe could hamstring recruitment for other COVID-19 vaccine trials, NIAID director Anthony Fauci told Reuters. The warning comes on the heels of an EUA for convalescent plasma, which won an emergency nod without passing through a randomized, placebo-controlled trial. An EUA has never before been used to green light a vaccine intended for widespread use.
Meanwhile, Fauci broke down monoclonal antibody therapies in the works in an interview with MedPage Today. While antibodies in clinical trials from Regeneron and Eli Lilly are being tested intravenously, they could ultimately be formulated for subcutaneous or intramuscular injection, Fauci said. Plus, monoclonal antibodies are likely safer than convalescent plasma, which carry a risk of allergic reaction or side effects with each treatment.
Australian drugmaker Starpharma deployed its drug delivery technology, DEP, to create a long-lasting, water-soluble version of Gilead Sciences' Veklury, also known as remdesivir. Designed as a subcutaneous injection, Starpharma's formulation could enable less frequent dosing and provide an option for treatment outside the hospital—a potential boon for nursing homes, care facilities and countries without developed healthcare systems, Starpharma CEO Jackie Fairley said.
UPDATED: Monday, Aug. 31 at 3:20 p.m. ET
Johnson & Johnson pledged to supply up to 38 million doses of its adenovirus-based shot to Canada on a not-for-profit basis for emergency use during the pandemic. The parties are still hashing out the final terms of the advanced purchase deal, the drugmaker said in a release. J&J has kicked off phase 1/2a trials of its shot in Belgium and the U.S.
Gilead Sciences' Veklury, also known as remdesivir, won an expanded emergency use authorization for all hospitalized COVID-19 patients, broadening the antiviral's green light beyond those hospitalized with severe disease. The new authorization follows phase 3 data showing moderate patients on a 5-day course of Veklury, plus standard care, were 65% more likely to see their condition improve over those on standard care alone, while moderate patients on a 10-day course did not see statistically meaningful improvement. A JAMA editorial that accompanied the data release added that the most suitable patient group and length of treatment remain unclear. Story
Thermo Fisher Scientific set up a new, $40 million manufacturing facility in just six weeks to churn out viral transport media for COVID-19 diagnostics. The new plant at Thermo Fisher's Lenexa, Kansas, site brings on more than 300 full-time staff and has boosted production at the site—which previously made a range of media, collection and transport products—to 8 million units per week, the company said. Story
The Department of Health and Human Services axed its $646.7 million COVID-19 ventilator contract with medtech giant Philips, which originally agreed to deliver 43,000 ventilators to the U.S. national stockpile by year-end. Philips will complete its orders for August toward a total 12,300 delivered EV300 ventilator bundles, while another 30,700 will be left on the table. Last month, Democrats from the House Oversight Committee argued that the White House may have overpaid by as much as $500 million for the Philips contract. Story
With public opinion on the FDA in free fall over miscommunications and the appearance of political meddling, some health experts are calling for an independent commission to parse COVID-19 vaccine trial data before a shot snares approval. Even as the FDA seeks to reassure the public that scientific rigor, not politics, will drive its approval process, experts like NYU bioethicist Arthur Caplan argue that public faith in expert opinion has already waned, citing a "desperate need" for an independent review body. Meanwhile, the agency will convene its vaccines advisory panel—a set of external experts that routinely reviews immunizations—on Oct. 22 to discuss available data.
A drug developed to treat a coronavirus that can cause feline infectious peritonitis (FIP)—a viral disease in cats—blocked viral replication of human coronaviruses, too, preclinical data from researchers at the University of Alberta showed. California-based biotech Anivive Lifesciences in 2018 licensed the drug from Kansas State University to develop it as an antiviral to treat FIP, and last month announced it had launched two preclinical trials to test the drug against COVID-19. Story
UPDATED: Monday, Aug. 31 at 9:15 a.m. ET
Early data has boosted Sanofi's confidence in its GlaxoSmithKline-partnered recombinant protein shot and the mRNA vaccine it has in the works with U.S. drugmaker Translate Bio, CEO Paul Hudson told Reuters. Translate unveiled data last week showing its shot—slated to enter human trials in November—triggered an immune response in animals. Meanwhile, the Sanofi-GSK jab is pegged to enter clinical studies next month. Sanofi could have one or two vaccines ready next year, Hudson said.
Novavax clinched a deal to supply up to 76 million doses of its recombinant protein shot to Canada, the Maryland-based biotech said in a release. The partners are still working to finalize the terms of the advanced purchase pact, which would see Novavax supply doses as early as 2021's second quarter. Novavax in August kicked off the phase 2 portion of its phase 1/2 vaccine study in Australia and the U.S.
Daiichi Sankyo's mRNA-based vaccine candidate, DS-5670, was tapped by Japan's Agency for Medical Research and Development to enter a COVID-19 drug discovery program. Daiichi will partner with the University of Tokyo on clinical trials of its vaccine, which it aims to kick off around March of next year.
The FDA may authorize a COVID-19 vaccine phase 3 trial data are in, Commissioner Stephen Hahn told the Financial Times. But the FDA chief said his agency will not speed up the regulatory process for political reasons. It's up to the vaccine makers to apply for authorization or approval, and it's possible that a vaccine could first win an emergency use authorization in certain high-risk groups ahead of a blanket approval, Hahn said. Story
An April amendment to the Public Readiness and Emergency Preparedness (PREP) Act, which shields drugmakers from liabilities linked to treatments used in the fight against public health crises, states that companies cannot be sued for money damages in court over injuries from COVID-19 countermeasures, including drugs, vaccines and respiratory devices, unless those firms are guilty of "wilful misconduct." Now, health experts are concerned patients will have little recourse if presented with an ineffective—or worse, unsafe—COVID-19 treatment.
Seventy-two percent of American adults fear politics are taking a leading role in COVID-19 vaccine approval at the FDA, but that won't stop the majority from getting an approved jab, a new survey by STAT and The Harris Poll found. On party lines, 72% of Republicans and 82% of Democrats said they were concerned about political meddling at the FDA in the 2,067-person poll. Still, 67% of adults surveyed said they'd get a shot as soon as one is approved, while 62% were very or somewhat likely to take a vaccine cleared before the Presidential election.
UPDATED: Friday, Aug. 28 at 9:59 a.m. ET
Moderna confirmed that it's in talks with Japan to potentially supply at least 40 million doses of its mRNA vaccine candidate, which the biotech would deliver for distribution in-country by Japan's Takeda Pharmaceutical starting in 2021, the company said in a release. The cost of the prospective vaccine order remains under wraps.
Johnson & Johnson will kick off a phase 2 vaccine trial in Spain, Germany and the Netherlands next week, Spain's health minister, Salvador Illa, said Friday. Across the three countries, the study will enroll 550 healthy participants between the ages of 18 and 55, plus a group of patients over 65, Illa said. The trial marks the first coronavirus vaccine study approved in Spain, where J&J has recruited 190 participants.
Montreal-based biopharma Laurent Pharmaceuticals got a thumbs-up to run a phase 2 trial of its experimental drug, LAU-7b, in COVID-19. The trial will enroll about 200 hospitalized COVID-19 patients who will receive either a once-daily oral dose of the drug or placebo, and will test the candidate's ability to slow disease progression, prevent patients from moving to ventilators and cut death rates.
China's Sinovac won approval for emergency use of its vaccine candidate in July, Reuters reported, citing a source close to the matter. The nod cleared the shot for use in high-risk groups like healthcare workers. Meanwhile, China National Biotec Group, part of the state-owned pharma giant Sinopharm, also snared an emergency nod for one of its shots, the company said Sunday on social media.
Hong Kong generics maker Jacobson Pharma signed a letter of intent with Fosun Industrial to help market and supply BioNTech's mRNA vaccine candidate in Hong Kong and Macau. If the shot is approved, Jacobson would leverage its sales and distribution networks in hospitals and clinics to smooth the rollout, CEO Derek Sum said in a release. Fosun and BioNTech first teamed up in March to develop and sell the mRNA vaccine for use in the greater China region.
The University of Arizona's wastewater testing system on Tuesday detected possible COVID-19 cases in an on-campus dorm. The school sent a team to run tests on the dorm's roughly 311 residents, which yielded two confirmed coronavirus infections. The students, both asymptomatic, were sent to a quarantine dorm, the university said. The school kicked off its fall semester Monday, with only a few essential classes allowed to meet in-person.
UPDATED: Thursday, Aug. 27 at 3:21 p.m. ET
The European Commission made a €336 million ($396 million) down payment to AstraZeneca to lock down at least 300 million doses of the British drugmaker's University of Oxford-partnered shot, with the option to order another 100 million doses later on. All 27 EU member states will have the option to buy the AZ doses should the vaccine win out in the clinic, though the amount each country will pay has not been revealed. Elsewhere, AZ has agreed to supply 300 million doses to the U.S. for $1.2 billion and up to 30 million doses to the U.K. for £65.5 million ($86.5 million).
Given that Pfizer is halfway toward its goal of recruiting 30,000 patients for its mRNA vaccine phase 3, the company could complete enrollment by the end of next month, teeing up an early data reveal in mid-September and a potential full readout by mid-October, Mizuho Securities analyst Vamil Divan figures. That timeline grooves well with the FDA's plan to convene its vaccine advisory committee on Oct. 22, and, if Pfizer's shot passes muster in the clinic, it could win a green light before U.S. voters hit the polls Nov. 3. Story
Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) launched a joint effort, dubbed Blue Knight, to fund and mentor an initial seven startups working on tools and meds to fight COVID-19 and future pandemics. The startups, based in the U.S., Canada and Europe, will receive up to $500,000 in support, plus assistance on R&D and potential regulatory hurdles. Meanwhile, J&J will continue to review applications for additional startups on a rolling basis. Story
On the heels of its antibody team-up with Roche, Regeneron CEO Len Schleifer talked potential staff increases to meet the goal of tripling production on the company's COVID-19-fighting antibody cocktail. Now, it's official: Regeneron will add up to 400 jobs at its Limerick, Ireland, manufacturing plant to help churn out supplies of Regeneron's regular meds while the New York drugmaker gears up elsewhere to pump out its antibody cocktail at global scale. Story
Vaccitech, which helped develop AstraZeneca and the University of Oxford's vaccine front-runner AZD1222, picked up a grant worth upward of £2.3 million ($3.0 million) to develop a separate COVID-19 vaccine candidate that the company thinks could serve as a standalone jab or an add-on treatment for first-generation shots. The cash was furnished by the U.K. government, plus other funders like the National Institute for Health Research and the World Health Organization. Vaccitech expects to launch a phase 1 trial of its asset next year. Story
Florida-based CDMO Ology Bioservices snagged a $106 million contract with the U.S. Army to perform fill-finish work on targeted COVID-19 vaccines and therapeutics. Ology will receive $53.1 million upfront to reserve capacity for around 187 million drug or vaccine doses, the company said in a release. Story
Abbott scored a green light for a rapid antigen test that runs for $5 and fits entirely on a device about the size of a credit card. The BinaxNOW test can deliver a nasal swab readout within 15 minutes and works with an optional smartphone app, Navica, that can log and display results to potentially clear people for entry into schools, hospitals and other locales. Abbot plans to ship tens of millions of the prescription-based tests next month and will start producing 50 million tests per month in October. Story
UPDATED: Thursday, Aug. 27 at 9:17 a.m. ET
Pfizer and BioNTech have recruited more than half of the 30,000 participants planned for their phase 3 vaccine trial, Nicholas Kitchin, M.D., a top Pfizer vaccine research and development scientist, said at the CDC’s Advisory Committee on Immunization Practices meeting Wednesday. Pfizer had enrolled more than 11,000 volunteers last week, according to a company statement.
Johnson & Johnson Wednesday confirmed it would add Chile, Argentina and Peru to the list of Latin American countries where it's plotting phase 3 vaccine trials. All told, J&J's Latin American tests will involve around 60,000 volunteers from Brazil, Chile, Colombia, Peru, Argentina and Mexico, with the drugmaker still awaiting regulatory approval in Chile, Argentina and Mexico, J&J told Reuters.
Novavax expects to file its vaccine candidate for U.S. approval in December, CEO Stanley Erck told Czech newspaper Hospodářské noviny. The Maryland-based shot maker will produce part of the vaccine at its Czech plant and supply doses to the Czech Republic if the shot nets approval, Erck said. On Monday, Novavax enrolled the first subjects in a phase 2 trial of its recombinant vaccine, with plans to asses the shot's benefit in older adults.
The U.K.'s Scancell Holdings, which develops immunotherapies for cancers and infectious diseases, snared funding from Innovate UK to kick off a phase 1 trial of its DNA-based COVID-19 vaccine in 2021. Scancell is expected to receive around £2 million ($2.64 million) through the UK Research & Innovation Ideas to Address Covid-19 initiative; that cash will cover most development and phase 1 trial costs, the company said. Scancell's vaccine targets the virus' spike protein and nucleocapsid protein to trigger both T cell and neutralizing antibody response.
UPDATED: Wednesday, Aug. 26 at 2:45 p.m. ET
Moderna’s mRNA vaccine candidate was the first U.S. shot to enter late-stage testing, but that doesn’t necessarily mean it has the brightest future of all. The high possibility of multiple emergency authorizations for coronavirus vaccines by year-end spells plenty of competition—and an outlook for Moderna that's less rosy than some expected, SVB Leerink analysts wrote in an investor note, citing R&D and vaccine experts. Story
The shot does have some new data in older adults, a key demographic for vaccination. Moderna followed up last month's phase 1 data reveal with numbers from a small group of participants over 55—and they look promising. Run by the National Institute of Allergy and Infectious Diseases, the study is testing three dose levels of mRNA-1273 in two injections a month apart. Among 10 patients aged 56 to 70 and 10 patients over 71, the middle dose triggered neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19. Story
New, more restrictive COVID-19 testing guidelines issued by the CDC this week were handed down from higher-ups in the Trump administration, according to media reports. The new policy raises the bar on who should be tested, advising that people exposed to someone with the virus, but without symptoms themselves, shouldn't be tested. The change follows complaints from President Donald Trump that the U.S. is testing too much.
The EU's vaccine supply negotiations with drugmakers have hit snags over potential liability for side effects, Reuters reports. So far, only AstraZeneca has made a deal, promising to supply 400 million doses if its shot succeeds. Johnson & Johnson, Sanofi and GSK, CureVac and Moderna are still in “advanced” discussions, but those deals haven't yet been finalized, and liability risks could play into the talks. Story
UPDATED: Wednesday, Aug. 26 at 9:16 a.m. ET
Two doses of an mRNA vaccine candidate developed by Translate Bio and Sanofi triggered high levels of neutralizing antibodies in animals, a company filing showed. Sanofi is also working on a recombinant vaccine with GlaxoSmithKline, which recently snagged a $2.1 billion cash infusion from the U.S.' Operation Warp Speed vaccine program.
Merck expects to deliver phase 2 results on its antiviral pill, MK-4482, in a matter of weeks, and if the results are strong, the drug could snare an emergency authorization before year-end, an SVB Leerink analyst predicted. The pill, developed by scientists at Emory University, could have a convenience edge over Gilead's remdesivir and blood plasma, both given via infusion; plus, Merck's drug could treat patients before their symptoms put them in the hospital.
In a statement, Gilead said its decision to test remdesivir rather than a similar molecule called GS-441524 for COVID-19 was based on evidence showing the now-authorized drug was more effective in lab tests and animal models at generating the substance that blocks viral replication, and more active in vitro against "multiple coronaviruses.” Also, GS-441524 has never been studied in humans, while remdesivir had been tested in clinical trials for Ebola. The company has started new preclinical studies to further compare the two compounds. The NIH has said it will run its own studies on GS-441524.
Spain is set to receive 30 million AstraZeneca vaccine doses through the British drugmaker's centralized purchase deal with the European Commission. It remains unclear how much Spain or any other EU member state is expected to pay, but the commission locked down 400 million doses of the AZ-University of Oxford jab for equitable distribution across EU nations.
Meanwhile, Estonia got in on the EU-AstraZeneca vaccine deal, too, calling dibs on 1.3 million doses—enough to inoculate 665,000 people. The country aims to vaccinate half its population of around 1.3 million, with the initial focus on high-risk groups like the elderly, the chronically ill, and health and social care workers, Estonia's Minister of Social Affairs said.
UPDATED: Tuesday, Aug. 25 at 3:43 p.m. ET
FDA Commissioner Stephen Hahn corrected his claim that convalescent plasma from COVID-19 patients—granted an emergency use authorization Sunday—led to a "35% improvement in survival," clarifying that the data from an observational trial show a "relative" risk reduction rather than an "absolute" one. Health experts weren't convinced, and leaders of the House Committee on Energy and Commerce sent Hahn a letter Monday voicing concern over recent White House attacks on the agency. Story
With the recent whiplash of rumors and authorizations around hydroxychloroquine, blood plasma and a debunked plan to fast track AstraZeneca's shot, the FDA is facing a reputation crisis, with critics concerned that politics have infected the agency. “FDA's credibility has never been more important and more threatened simultaneously,” said Mark Senak, a public relations professional and Eye on FDA blogger. Others, like Obama administration health official Andy Slavitt, claimed Stephen Hahn was "wasting trust" in the FDA at a time when it needs public support to ensure people receive an eventual vaccine. Story
Qiagen plans to launch a digital COVID-19 antibody test that can run up to eight samples at once and deliver results in about 10 minutes. Developed in collaboration with Australian test maker Ellume, the portable eHub test boasts a small digital hub and interchangeable testing stick system. Plus, it can automate and standardize readouts, potentially freeing up lab staff. Qiagen submitted the device for emergency review and has already preordered 900,000 tests, Ellume said. Story
Medtech titan Medtronic posted a 13.2% revenue dip for the first quarter of its 2021 fiscal year—all told, a 17% decline when accounting for foreign currency exchanges, fiscal calendar quirks and benefits from its acquisition of Titan Spine. Still, the company is on the upswing compared to the previous quarter, which saw a 26% revenue decline during the early phases of the pandemic. Story
One thing that's improved during the pandemic? Doctor relationships with pharma sales reps, an Accenture study found. Fifty-five percent of doctors polled said they had more time to learn about new therapies, and 53% said they were interested in doing so; meanwhile, physicians are tapping sales reps to learn more about pharma support services, financial assistance, and local access and care programs, the study showed. Story
UPDATED: Tuesday, Aug. 25 at 9:26 a.m. ET
AstraZeneca kicked off a phase 1 trial testing the safety of its two-antibody cocktail in healthy adults. Like other antibody developers, AZ hopes its combo can serve as both a treatment and preventive measure for COVID-19; plus, the British drugmaker is aiming its formulation at six months of protection. AZ expects to share data from the study before year-end. Story
Speaking of AstraZeneca, the drugmaker made headlines on reports that the U.S. was looking to fast track its shot ahead of the Presidential election, but AZ sees things differently: "AstraZeneca has not discussed emergency use authorization with the U.S. government and it would be premature to speculate on that possibility," a spokesperson said via email, adding that AZ doesn't expect efficacy results until later this year. Story
The National Institutes of Health will run independent studies on a Gilead Sciences compound that could work similarly to remdesivir—and, as researchers at the University of Texas MD Anderson Cancer Center have argued, could do so at doses that cause fewer side effects. The NIH aims to conduct a preclinical study swiftly and share its findings with the research community, the agency said. Gilead is sticking by redmesivir and will not participate in the NIH trial.
Blood plasma from recovered COVID-19 patients is still an experimental therapy, not a new standard of care, the World Health Organization warned during a press briefing. The treatment won an emergency use authorization (EUA) from the FDA Sunday, backed by data from an observational study, not a placebo-controlled trial, the gold standard for approvals. The WHO has labeled the data "very low-quality." Meanwhile, health experts worry patients will demand blood plasma as a treatment rather than enrolling in ongoing trials to assess its benefit.
British clinical research capacity may have plunged as much as 87% in April, when the virus peaked in England, a study led by University College London found. Given a population infection rate of 10% that month, less than 400 of the 3,200 full-time clinical academics in England would have been able to conduct research, the researchers estimated. Those results stress the need to plan for and preserve clinical research to tackle COVID-19 and other diseases, too, the research authors said.
UPDATED: Monday, Aug. 24 at 3:24 p.m. ET
Moderna wrapped up "advanced exploratory talks" with the European Commission to supply up to 160 million doses of its mRNA-based vaccine to the EU, the company said in a release. If the deal closes, Moderna would ship an initial 80 million doses to EU member states, with another 80 million shots up for purchase at a later date. Story
President Donald Trump is eyeing an emergency use authorization (EUA) for AstraZeneca and the University of Oxford's vaccine candidate ahead of the U.S. Presidential election, the Financial Times reported. The plan would grant AstraZeneca an EUA upon completion of a 10,000-person study in the U.K., possibly allowing the U.S. to deploy vaccines to some people before they hit the polls. AZ is recruiting a planned 30,000 patients for its late-stage trial. Story
Speaking of AstraZeneca, the British drugmaker expanded its manufacturing deal with New Jersey's Catalent to cover drug substance production, including viral vectors, at the CDMO's gene therapy facility in Harmans, Maryland. Catalent will kick off production in the year's third quarter, the companies said in a release. In June, AZ tapped Catalent to complete fill-finish and packaging work on the University of Oxford-partnered shot at its Anagni, Italy, site. Story
Pharma TV advertising held up in July despite pandemic headwinds. Last month, spending from the top 10 pharma advertisers dipped 5% to $136 million—less than the $144 million advertisers spent last July, but far from the 20% decrease experts anticipated, according to the real-time TV ad tracker iSpot.tv. As for the rankings, AbbVie's anti-inflammatory Humira kept its spot at the top, while Roche's multiple sclerosis med Ocrevus, missing from the list last month, shot all the way to second place with $16.2 million in estimated spending. Story
Older Americans are unlikely to receive—and may not even know about—the vaccines recommended for adults over 50, a survey conducted by The Harris Poll on GlaxoSmithKline's behalf showed. A quarter of the 3,000 U.S. adults polled, all between the ages of 50 and 79, were unfamiliar with adult vaccines for shingles, tetanus, diphtheria and other diseases. Meanwhile, demand for adult vaccines plunged more than 60% during the height of the pandemic, the poll found, making a case for redoubling efforts to ensure the elderly are fully immunized, Judy Stewart, GSK's U.S. vaccine head, said.
UPDATED: Monday, Aug. 24 at 11:15 a.m. ET
The FDA could expand its emergency use authorization of remdesivir to include patients hospitalized with moderate COVID-19, Gilead Sciences said. Company data published Friday showed 70% of moderately ill patients on a 5-day course left the hospital 11 days after starting treatment, compared to 65% of patients in the 10-day arm, but a JAMA editorial accompanying the data questioned the drug's benefit overall. Story
Novartis has M&A funds to spare, but acquisitions have slowed because of COVID-19, CEO Vas Narasimhan told the Swiss newspaper Neue Zuercher Zeitung. Meanwhile, the company plans to hold onto its Sandoz generics unit, currently supplying drugs for patients hit with the disease, despite some recent in-house failures to develop or repurpose meds to fight the coronavirus, including the antimalarial hydroxychloroquine, Narasimhan said.
When the University of Oxford jumped into the vaccine game in April, the school pledged to donate the rights to its candidate to any drugmaker in a bid to provide the final shot at low cost or free of charge. Then AstraZeneca entered the scene and Oxford University changed course. AZ has promised to sell its vaccine at no profit, but once the pandemic wanes, all bets are off, drawing fire from health and financial experts hoping to witness a reversal of for-profit vaccine development in the era of COVID-19.
In the blood plasma will-they-or-won't-they, the FDA decided it would: On Sunday, the U.S. regulator granted emergency use authorization for convalescent plasma to treat COVID-19. The FDA cited early data from an observational study—not a controlled trial—showing the treatment could decrease mortality and improve the health of patients treated in the first three days of their hospitalization. Trump hailed the decision, which was put on pause last week over calls for more clinical data demonstrating plasma's benefit. Story
Former FDA chief Scott Gottlieb deflected criticism levied by President Trump Saturday that "[t]he deep state, or whoever, over at the FDA" was intentionally delaying COVID-19 drug and vaccine trials to harm the President's chances at reelection this November. Gottlieb suggested that calls for more clinical data on blood plasma were warranted and noted that vaccine trials from major drugmakers have enrolled patients "very fast." Story
Meanwhile, the U.S. government could boost those clinical studies by expanding the National Institutes of Health's COVID trial networks to include large-scale, practical studies like the U.K.'s Recovery Trial, which randomly assigns patients to treatment candidates via a clear protocol, Gottlieb and fellow ex-FDA commissioner Mark McClellan wrote in a Wall Street Journal opinion piece. That framework would require prioritization of treatments shown to have the most benefit against COVID-19, Gottlieb and McClellan added.
Plus, clinical trials on blood plasma in COVID-19 may take some time complete. Some common hurdles? Convalescent plasma must be collected from recovered patients and it needs to go through testing to make sure it contains the necessary antibodies to fight the virus. Meanwhile, patients may be unwilling enroll in blood plasma studies if they believe they're going to receive a placebo rather than the real thing, Johns Hopkins' associate professor of medicine Dr. Shmuel Shoham said.
UPDATED: Friday, Aug. 21 at 3:20 p.m. ET
Canada's AbCellera snared a new bispecifics platform, OrthoMab, from Dualogics that can combine any two of the antibodies it discovers. Earlier this year, the company partnered with Eli Lilly on a COVID-19-fighting antibody, LY-CoV555, the current subject of a phase 1 trial in hospitalized patients and a phase 3 study in nursing homes. Story
COVID-19 pooled testing, which combines samples from multiple patients to save time and resources, has become worthless in many parts of the U.S. as case counts climb. The strategy, touted by NIAID director Anthony Fauci, M.D., and Adm. Brett Giroir, only works when the majority of samples are negative. Meanwhile, pooled tests have made headway in regions where cases are under control; last week, the State University of New York was cleared to batch test up to 25 samples at once.
Scientists at Rutgers University developed a tool to track changes in RNA at the single-cell level, a potential boon for researchers on the hunt for COVID-19 drug targets. The surface-enhanced Raman spectroscopy (SERS) tool was first tested on influenza A, where it managed to detect RNA mutations so small they only covered two nucleotides, the Rutgers team reported. Now, the team is seeking funding to run additional studies on SERS in SARS-CoV-2. Story
Russia backpedaled slightly on its world-first COVID-19 vaccine approval, now reclassified as a "conditional registration certificate"—though it still plans to roll out a mass vaccination campaign in October. Meanwhile, Russia will expand late-stage testing on the shot, dubbed Sputnik V, to include roughly 40,000 patients as well as a control group, putting the trial closer in line with phase 3 vaccine studies from the likes of Moderna, Pfizer and AstraZeneca.
UPDATED: Friday, Aug. 21 at 9:23 a.m. ET
Pfizer and BioNTech turned out additional phase 1 safety data on one mRNA shot candidate and maintained that they're on track to seek regulatory review as early as October. The vaccine was generally safe, with mild to moderate fever cropping up in less than 20% of subjects, and spurred a strong immune response in both younger and older participants. Story
Lab-developed COVID-19 tests will no longer require premarket review from the FDA, updated HHS guidance states. The decision is aimed at boosting testing, which has stalled in recent weeks despite case surges in states like Texas and Florida. Critics say it could lead to inaccurate tests. Story
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, overseeing the review of a potential COVID-19 vaccine, said he has not faced any political pressure but would "feel obligated" to resign if the Trump administration tries to push—or withhold—a vaccine candidate for approval before it's deemed safe and effective, Reuters reported. “You have to decide where your red line is, and that’s my red line,” Marks said.
Rep. Lloyd Doggett, D-Texas, and Rep. Katie Porter, D-California, pushed the Trump administration for full financial details on its vaccine deals with Moderna. The representatives argue that taxpayers are the vaccine's chief investors, following Moderna's admission that federal money makes up "100% funding of the program" and that all Americans should therefore be entitled to a shot once it is proven safe and effective.
Patients infected with a new variant of the coronavirus experienced a stronger immune response and had better clinical outcomes, with fewer developing low blood oxygen or requiring intensive care, a Lancet study found. The mutation, which likely came from Wuhan, China, could have a positive impact on development of COVID treatments and vaccines, the Singapore-based authors wrote.
UPDATED: Thursday, Aug. 20 at 3:05 p.m. ET
Johnson & Johnson plans to kick off its late-stage vaccine study in September, the New Jersey-based drugmaker said Thursday. J&J aims to enroll up to 60,000 participants, which would make its trial the largest COVID-19 vaccine study to date. Moderna and Pfizer, which both launched phase 3 shot trials last month, are looking to recruit upward of 30,000 subjects each. Story
Oragenics tapped CDMO Avid Bioservices to perform process development and drug substance manufacturing for its spike protein vaccine, Terra CoV-2. In March, Oragenics licensed Terra-CoV-2 from the NIH and now, with Avid's help, hopes to push its shot into human testing by early 2021.
Congress should consider barring the FDA from granting an emergency use authorization (EUA) to any COVID-19 vaccine candidate, a report from the George Consortium's Public Health Law Watch argued. The report, backed by some 50 legal and policy experts, cited a common concern: Overwhelming social and political pressure could drive the FDA to allow emergency use of a shot before it's proven safe and effective.
The FDA approved its third antigen test for COVID-19, this time a speedy, nasal swab-based assay from the London-headquartered diagnostics firm LumiraDx. Like rapid flu tests, Lumira's diagnostic detects fragments of specific proteins found in the virus and can deliver on-site results within 12 minutes. LumiraDx hopes to scale up manufacturing to crank out 10 million tests per month by year's end, the company said. Story
Roche's Genentech unit could get manufacturing work on Regeneron's antibody cocktail up and running in a matter of months, Regeneron CEO Leonard Schleifer told CNBC. With their forces combined, Schleifer said, the drugmakers could churn out at least 4 million to 8 million preventative doses per year, if not more. Regeneron will also put a "squeeze" on other drugs and staff up to support the manufacturing push, Schleifer said.
The U.S. Department of Energy's Argonne National Laboratory is using AI to build physics-based models of proteins and their cell interactions to help researchers uncover COVID-19 drug targets. Meanwhile, BenevolentAI is using artificial intelligence to sift through tens of thousands of therapies to find a match, like Eli Lilly and Incyte's rheumatoid arthritis med Olumiant, now in COVID-19 testing. Plus, other companies such as Insilico are turning to AI to create purpose-built molecules to fight the virus. Story
Housing Secretary Ben Carson, who days earlier was reported to have attended an Oval Office meeting where the unproven drug oleandrin was brought up as a potential COVID treatment, joined NIAID Director Anthony Fauci and NIH chief Francis Collins in calling for clinical testing before any sort of authorization is considered.
UPDATED: Thursday, Aug. 20 at 9:15 a.m. ET
German biotech CureVac and the European Union wrapped up the first round of talks for at least 225 million potential vaccine doses. The talks include an option for the EU to snare an additional 180 million shots, CureVac said. Under the deal, CureVac's mRNA-based hopeful would go out to all 27 EU member states. Story
Cuba plans to start testing its own COVID-19 vaccine, a receptor-binding domain shot created by the state-run Finlay Institute of Vaccines, in humans next week, according to the country's registry of clinical trials. Cuba aims to enroll 676 adults between the ages of 19 and 80 in the phase 1 and 2 studies. Results aren't expected until February.
President Donald Trump suggested the FDA's decision to postpone emergency use authorization (EUA) for blood plasma treatment was politically motivated, saying regulators were looking to delay an OK until after Election Day. The FDA held back authorizing convalescent plasma treatment after government experts, including NIAID director Anthony Fauci and NIH chief Francis Collins, called for more data. Story
After running oleandrin through a battery of tests against COVID-19, the U.S. Army Institute of Infectious Diseases found "inconclusive" benefits and halted further studies. The oleander extract caught the Trump administration's attention through MyPillow CEO Mike Lindell, who invested in a company producing it. Trump said the White House would "look" at the treatment Monday, while Lindell has continued to tout the President's oleandrin "enthusiasm."
The call for improved trial diversity has been a common refrain during the pandemic, and now a number of health experts—including one of the founders of Boston's Black COVID-19 Coalition, Dianne Wilkerson—are pushing for increased enrollment of people of color in ongoing vaccine studies. That diversity is key to ensuring an eventual shot works in multiple populations.
Daewoong Pharmaceutical teamed up with Institut Pasteur Korea (IPK) and the Korea Institute of Radiological and Medical Sciences (KIRAMS) to run overseas tests on the esophagitis drug Foistar in COVID-19. IPK and KIRAMS will help facilitate clinical studies, while Daewoong provides the drugs and, if warranted, will handle regulatory filings. The drug's main ingredient, camostat, was shown to block the virus from infecting healthy cells in a primate study published in Cell.
UPDATED: Wednesday, Aug. 19 at 3:30 p.m. ET
Fitbit's activity tracker picked up nearly half of COVID-19 cases at least one day before participants showed any symptoms, early data from a study of more than 100,000 subjects showed. Fitbit is developing an algorithm that tracks subtle changes in a person's heart rate, breathing, physical activity and sleep that can ID potential cases before symptoms start. So far, that algorithm has worked with 70% specificity, or a 30% rate of false positives, but it could push people to seek testing or quarantine sooner, Fitbit thinks. Story
Qiagen launched a new sequencing panel, plus a piece of companion software, to help researchers track mutations in the novel coronavirus. The single-day, next-generation panel uses reverse transcription tech to create complementary DNA from a sample of the virus' RNA code, in turn generating libraries compatible with sequencing hardware from genetic analysis firm Illumina. Qiagen's software then creates a visual map of the virus' evolution across different populations and regions. Story
The Center for Health Security at Johns Hopkins Bloomberg School of Public Health laid out a blueprint for vaccine allocation, separating those with the highest need into two tiers. Tier 1 includes typical vaccination targets such as healthcare workers and the immunocompromised, while tier 2 aims to get shots to more overlooked groups, including essential workers outside the healthcare field and people who face greater barriers to treatment.
Hospitals spent nearly $2,000 less on medicated COVID-19 patients in July than they did in May, with costs plunging thanks to shortened hospital stays and fewer medications used, Reuters reported, citing health data firm IllumiCare. Despite those treatment advances, costs could rise again now that Gilead Sciences is charging for its antiviral remdesivir, Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said.
Questions over the durability of COVID-19 immunity have plagued scientists since the start of the pandemic, but a recent slate of studies—many still awaiting peer review—show that human immune response to the disease is "robust" and may protect against repeat infections, even in people who only suffered mild symptoms. Exactly how long that immune response lasts remains unclear.
UPDATED: Wednesday, Aug. 19 at 9:18 a.m. ET
The FDA put its emergency authorization for convalescent plasma therapy on hold after the country's largest plasma study, run by the Mayo Clinic, failed to show the treatment could slash death rates in COVID-19 patients. In the eleventh hour before last week's planned OK, top health experts including Anthony Fauci and National Institutes of Health director Francis Collins urged the agency pump the brakes, citing the lack of a control group in the Mayo trial and a need for more data to confirm plasma's benefits.
Roche joined forces with Regeneron to help develop and sell the New York-based biotech's antibody cocktail, REGN-COV2, outside the U.S. The collaboration is expected to more than triple capacity for the antibody therapy, with the potential for further expansion moving forward, the companies said. Roche will also support an ongoing phase 3 prevention study and help fund future trials; plus, the Swiss drugmaker is on the hook to secure regulatory approval outside of the U.S. Story
Australia struck a deal with AstraZeneca for enough vaccine doses for the entire country, with plans to distribute the final shots free of charge, Prime Minister Scott Morrison said Wednesday. If the vaccine passes muster in the clinic, the Australian government will begin churning out doses in-country "straight away," Morrison said. The financial terms of the deal weren't disclosed.
Dr. Reddy's Laboratories launched its version of the flu med Avigan (favipiravir) in India as a COVID-19 treatment. The rollout covers 200 mg tablets of the drug under license from Japan's Fujifilm. To further boost access, Dr. Reddy's kicked off a free home delivery service to supply Avigan to patients in 42 cities across the country.
Moderna could reap a whopping $8.125 billion from its U.S. vaccine supply deal if all options are exercised, a company securities filing showed. Under the base agreement, the U.S. called dibs on 100 million doses for $1.225 billion, with the option to order 400 million more; each of those 100 million-dose follow-up shipments would cost the government an additional $1.65 billion. Meanwhile, Moderna stands to gain a $300 million bonus if its shot snares approval before the end of January. Story
UPDATED: Tuesday, Aug. 18 at 3:20 p.m. ET
Sinopharm expects to price its inactivated vaccine hopefuls at a little under 1,000 yuan ($145) for two doses, company Chairman Liu Jingzhen told Chinese state media. It remains unclear whether Liu was referring to out-of-pocket-cost or list price, but if that quote does reflect what patients should expect to pay, it would put Sinopharm's shot price well above those of U.S. hopefuls from vaccine players such as Johnson & Johnson, AstraZeneca and Pfizer. Story
The Serum Institute of India (SII) is gunning for $1 billion in vaccine fundraising by September, the Economic Times of India reported. Private equity investors Blackstone and KRR are reportedly in talks to finance the cause, which would boost vaccine manufacturing and support clinical trials, the Times said. The world's largest vaccine producer to developing nations, SII is advancing five COVID-19 hopefuls, including frontrunners from AstraZeneca and Novavax. Story
A cadre of drugmakers led by Johnson & Johnson and Takeda launched a new research effort to advance COVID-19 drugs in the EU, with €77.7 million ($92.5 million) to start. The Corona Accelerated R&D in Europe (CARE) initiative sets out with a trio of goals: repurpose existing drugs, ID new small molecules and develop antibodies to combat COVID-19. The Bill & Melinda Gates Foundation has signed on to coordinate CARE work and prevent overlap with the Gates-backed COVID-19 Therapeutics Accelerator. Story
The Aug. 31 deadline for wealthier nations to join the COVAX Global Vaccines Facility is fast approaching, and countries that choose to keep shots for themselves will only extend the pandemic, World Health Organization chief Tedros Adhanom Ghebreyesus said Tuesday. Under the COVAX pact, those countries would share vaccine hopefuls with developing nations, a needed step to "prevent vaccine nationalism," Ghebreyesus said.
Forty-four percent of Americans said they would get an approved COVID-19 vaccine, an NBC poll showed. Twenty-two percent ruled out the shot entirely, while another 32% were unsure. Some other trends in inoculation opinion? Shot comfort seemed to rise with income and education level, and split along political party lines as well. Meanwhile, Asian Americans were the only racial group where a majority of adults polled said they would get an approved vaccination.
UPDATED: Tuesday, Aug. 18 at 9:30 a.m. ET
The FDA has a threefold strategy for advancing therapeutics to fight COVID-19: provide support for new drugs through its Coronavirus Treatment Acceleration Program; secure expanded access to potential therapies; and increase trial flexibility for the pandemic age. By July's end, the agency had supported the rollout of more than 270 clinical trials and boasted 570 more clinical tests under review for launch.
Thermo Fisher's TaqPath COVID-19 test may yield false results, the FDA warned Monday. The problem comes down to misuse of lab equipment and software woes, the agency said; Thermo Fisher has devised a new set of instructions that should allow labs to use the technology correctly. Meanwhile, many labs need to update the software used on Thermo Fisher's testing platform. Nearly a month ago, public health officials in Connecticut raised flags about 90 patients who had received false positives from TaqPath PCR swab tests. Story
With a second wave of COVID-19 infections expected to collide with flu season this fall and winter, Sanofi is working with partners to distribute flu shots safely and easily in the U.S. The French drugmaker's blueprint calls for walk-up or curbside vaccine stations. Sanofi will ship 80 million flu shots to the U.S. this year.
Kiran Mazumdar-Shaw, the high-profile managing director and chairperson of Indian biopharma Biocon, tested positive for COVID-19. Shaw confirmed the readout Monday evening and added that her symptoms were mild.
Plus, health officials have urged the Trump administration to pump the brakes on any support it might have offered oleandrin, touted by MyPillow CEO and ardent Trump supporter Mike Lindell as a COVID treatment and preventative. Made from the toxic oleander plant, the extract has shown some promise in lab dishes, but it would need animal testing before it's considered for COVID-19 trials in humans, health experts told CNN.
UPDATED: Monday, Aug. 17 at 3:39 p.m. ET
The U.S.' National Institute of Allergy and Infectious Diseases is weighing the logistics needed to run challenge trials of COVID-19 vaccines, including development of a suitable strain of SARS-CoV-2, drafting trial protocol and spotlighting the resources needed for the potential studies, Reuters reported. Challenge trials see healthy patients injected with vaccine and then deliberately infected with the virus to speed up the review process—typically when a virus is no longer widely circulating. The NIAID said it will continue to prioritize field trials in the hunt for an inoculation.
The rapid SalivaDirect COVID-19 test used to screen players in the NBA "bubble" will now be available to the public, thanks to country-wide FDA authorization. Created by Yale University's school of public health, the speedy spit test bypasses the need for a specific swab or collection device and doesn't require additional chemicals to extract the virus' RNA from a sample. The move could boost testing efficiency and ease demand for crucial testing supplies like reagents, FDA commissioner Stephen Hahn said. Story
The forthcoming COVID-19 vaccine market could pull in a total of $20 billion next year, Bernstein analyst Ronny Gal figures, predicting that "six players" will compete in the field for years. Gal estimates that developed countries will receive vaccines in parallel with the U.S., with similar pricing and availability trends; as vaccination rates in developed countries near 50%, which Gal thinks could happen by mid-2021, demand will slow and doses will be redirected to low- and middle-income nations. Once the pandemic wanes, Gal thinks the market will dwindle to $5 billion to $6 billion per year. Story
Hyderabad, India-based Biological E picked up a vaccine plant from Akorn India that could add more than 165 million doses to its annual capacity. Last week, Johnson & Johnson announced a technology transfer deal with Biological E to churn out upwards of 500 million vaccine doses per year in India. Story
Philips launched an initiative to help hospitals expand ICU capacity through delivery of its rapid equipment deployment kits. The ramp-up kits contain fully-configured ICU monitors and vital sign measurement servers, allowing hospitals to connect 20 beds to a central patient monitoring system in a matter of hours—a potential boon when hit with surges of COVID-19 cases. After a crisis has passed, the kits can be disinfected and stored, or shipped from hospital to hospital as needed. Story
A manmade version of COVID-fighting "nanobodies" found in llamas successfully stopped the virus from infecting healthy cells, in-vitro studies from the University of California, San Francisco, showed. Dubbed AeroNabs, the aerosolized treatment is made from a trio of synthetic nanobodies capable of interacting with various parts of the virus' spike protein. The university is plotting human trials for AeroNabs and thinks the inhaled drug could provide a "stopgap" until a vaccine wins approval. Story
Vaccine makers predict that a record 98 million flu shots will be given in the U.S. this year as public health officials call for increased inoculation ahead of a COVID-complicated flu season, The New York Times reported. Now, officials are tapping local healthcare systems and corporations, including pharmacy chains and supermarkets, to lock down vaccination sites. Meanwhile, publicity campaigns will urge the public to embrace the traditionally under-administered shot.
UPDATED: Monday, Aug. 17 at 9:22 a.m. ET
Novavax launched a mid-stage trial on its vaccine in South Africa, with the goal to recruit 2,665 healthy adults, plus another 240 adults who have tested positive for HIV whose disease is well-controlled by medication. The phase 2b aims to test the vaccine's safety and efficacy, and it could tee up entry into late-stage testing by September, Novavax said. The company plans to roll out another mid-stage trial in Australia and the U.S.
German shot maker CureVac won't sell its vaccine at cost, instead eyeing an "ethical margin" to give shareholders some return on their investments, Pierre Kemula, chief financial officer, said. Unlike other mRNA-based shots, currently trialed at higher doses, CureVac's shot is undergoing testing at doses of 2, 4, 6 and 8 micrograms—potentially allowing the company to do more with less. On Friday, the company ginned up $213 million through a U.S. stock market listing; those funds will mainly support COVID-19 shot trials, the company said.
The U.S. tapped medical supplier McKesson Friday to distribute COVID-19 vaccines once a candidate snares approval, with the company set to receive nearly $178 million under the deal, a spokesperson for the U.S. Department of Health and Human Services said. The distribution pact falls under a prior pandemic vaccine contract awarded to McKesson by the Centers for Disease Control in 2016—significant given recent news that the U.S. Defense Department would oversee vaccine distribution in lieu of the CDC. Story
Mexico is already working with AstraZeneca and Argentina to crank out 150 million doses of the British drugmaker's Oxford University-partnered shot by 2021, and to further meet national vaccine supply, the country is looking to run trials with Johnson & Johnson and Sanofi, deputy foreign minister Martha Delgado said. Mexican health authorities are evaluating early and mid-stage data on those companies' shots to work out potential Mexican phase 3 studies, Delgado said.
A COVID-19 vaccine must boast an efficacy rate of at least 50% and confer immunity for a minimum of six months to win approval in China, the country's drug regulator said, putting its shot standards roughly in line with guidance from the Centers for Disease Control and the U.S. FDA. China will also consider authorizing emergency use of vaccines that have yet to complete late-stage testing, the country's Centre for Drug Evaluation added. Story
With the hydroxychloroquine debacle still fresh in many peoples' minds, President Donald Trump is pushing for FDA approval of another unproven drug in COVID-19—this time, the botanical extract oleandrin, Axios reported. A non peer-reviewed study from July showed the extract, taken from the oleander plant, could inhibit the virus in monkeys; so far, FDA commissioner Stephen Hahn has resisted the oleandrin push, Axios said. Story
UPDATED: Friday, Aug. 14 at 9:20 a.m. ET
Johnson & Johnson advanced talks to supply 200 million vaccine doses to the European Union, with an option for another 200 million shots if the vaccine passes muster in the clinic. Last week, J&J reached a $1 billion deal for 100 million U.S. vaccine doses. Story
Speaking of J&J, the New Jersey-based drug major pledged 30 million vaccine doses to the U.K. at no profit, the company said. The supply deal provides the option for another 22 million doses. Separately, the U.K. tapped Novavax for 60 million doses of its vaccine hopeful, with some of those shots slated for production at Fujifilm Diosynth facilities in northern England, the company said.
Plus, the EU inked an advance purchase deal with AstraZeneca, locking down at least 300 million doses of its Oxford University-partnered vaccine hopeful. The deal, which covers 27 EU states, includes an option to purchase 100 million more doses if the vaccine proves safe and effective. In June, AZ reached a deal with Europe's Inclusive Vaccines Alliance to secure shots for France, Germany, Italy and the Netherlands.
Sinopharm's inactivated virus vaccine triggered an antibody response on par with other shot candidates and turned out a favorable safety profile, too, according to data published by JAMA. The vaccine delivered its strongest antibody response after a third injection, making booster doses likely. One possible hitch? Unlike other vaccine trials, Sinopharm's lacked a comparison arm featuring samples from patients with confirmed infections. Story
The U.S. government will foot the vaccine bill for uninsured patients and work with commercial health insurers to offer shots with zero copay, Paul Mango, HHS' deputy chief of staff for policy, said. With initial supplies likely to be limited, the government will prioritize doses for healthcare workers, the elderly, nursing home residents and others at higher risk of infection, NIH director Francis Collins said.
The FDA rejected the Henry Ford Health System's bid for approval to use hydoxychloroquine in certain COVID-19 patients. The health system's filing came on the heels of its study showing the drug lowered death rates in patients, but a number of top health experts, including NIAID director Anthony Fauci, called the trial "flawed." Henry Ford will continue to test the drug as a preventive treatment.
Top Russian doctor Alexander Chuchalin quit the Health Ministry's ethics council after the country's rapid-fire approval of COVID-19 vaccine Sputnik V ahead of late-stage testing. Chuchalin slammed the director of the Gamaleya Research Institute—which developed the vaccine—and the Russian army's top virologist, Sergey Borisevich, for flouting the usual regulatory process.
UPDATED: Thursday, Aug. 13 at 3:16 p.m. ET
SK bioscience will churn out antigen for Novavax's shot hopeful at its L-House vaccine facility in Andong, South Korea, starting this month, the companies said. The deal falls under the drugmakers' prior arrangements with the Coalition for Epidemic Preparedness Innovations to lock down global supply, and "significant amounts" of the final vaccine product will be distributed through the alliance's COVAX facility, also backed by Gavi, the Vaccine Alliance and WHO, the companies said.
On top of its vaccine licensing deal with Baylor, Biological E will produce 400 million to 500 million annual doses of Johnson & Johnson's shot hopeful for India, the Economic Times reported, quoting J&J chief scientist Paul Stoffels. The Indian drugmaker has already started manufacturing work to shore up global supply ahead of an approval, Stoffels said; Biological E can turn out around 50 million vaccine doses per month at its Hyderabad-based plant.
All told, COVID-19 vaccines should bring in $100 billion in sales and $40 billion in post-tax profits, with Moderna scooping up 40% of the market, Evercore ISI analyst Josh Schimmer figures. Novavax will likely take another 20%, while other vaccine players split the rest, he wrote in a note to clients. Some investors took issue with the Evercore estimate, challenging Schimmer's bets on Moderna's shot price, market share and more. Story
With flu season about to bump up against a pandemic, AstraZeneca plans to produce nearly 8 million U.S. doses of its nasal flu vaccine FluMist this year, a major leap from the 757,000 doses it shipped last season. Other top players Sanofi, GlaxoSmithKline and Seqiris will furnish a combined 190 million doses to the U.S. amid calls for increased flu vaccinations to prevent strain on COVID-fatigued healthcare systems. Story
Dutch manufacturer Qiagen rebuffed Thermo Fisher's $12.5 billion takeover offer, citing skyrocketing demand for its COVID-19 diagnostic reagents and molecular testing supplies. Now, Qiagen is eyeing a buyout of its own, with plans to pick up the remaining stake of NeuMoDx Molecular. The $234 million deal would grant Qiagen access to the company's own COVID-19 test, plus a multiplexed assay that can differentiate among coronavirus infections, influenza and respiratory syncytial virus. Story
Mylan took coronavirus support to Big Bird and the gang with a $1 million contribution to Sesame Workshop's Caring For Each Other effort, aimed at helping children and their families cope with tough pandemic-related topics. The donation will support the rollout of digital content kits this fall, planned for debut on YouTube, WhatsApp and through local providers in more remote locations around the globe. Story
UPDATED: Thursday, Aug. 13 at 9:50 a.m. ET
Doctors have Moderna's mRNA vaccine on their minds—and most expect it will be the first approved, a survey by market researcher InCrowd found. Of physicians polled, 45% said they expect the Massachusetts-based biotech's shot to clear the FDA first. Twenty percent figured Moderna's vaccine would help society return to normal, compared with 12% for AstraZeneca and 5% for Pfizer and BioNTech. As for name recognition, 63% of physicians quoted Moderna's efforts when asked which companies were working on vaccines, while AZ came in second at 42% recall.
Amid complaints over remdesivir's price tag, Gilead Sciences launched preclinical studies to compare the drug against another, potentially cheaper antiviral in its portfolio, GS-441524. Last week, watchdog Public Citizen and experts from the MD Anderson Cancer Center pushed Gilead to test the antiviral, which "could offer significant advantages over remdesivir," along with a lower price, they said. But experts noted preclinical work now would put GS-441524 far behind remdesivir, which Gilead filed for FDA approval earlier this week.
AstraZeneca inked production deals for its Oxford-partnered shot with Mexico and Argentina, which will churn out 150 million to 250 million initial doses for the Latin American market, Argentine President Alberto Fernandez and Mexican Foreign Minister Marcelo Ebrard said. The countries aim to have shots on hand by the first half of 2021, with initial doses going to the elderly, medical workers and those with prior health conditions, Fernandez said. Story
Arcturus Therapeutics dosed the first group in a phase 1/2 study of its mRNA-based vaccine candidate, run in partnership with CTI Clinical Trial and Consulting Services and Singapore's Duke-NUS Medical School. The shot could work after a single, low dose, the company said, unlike other mRNA hopefuls from drugmakers like Moderna. Phase 1 will test dosing in younger adults, and phase 2 will add older patients; initial results are expected in the fourth quarter, Arcturus said.
Indian drugmaker Biological E penned a licensing pact with Baylor College of Medicine to develop and market its recombinant protein vaccine hopeful. If the shot wins out in the clinic, Biological E aims to crank out "several hundred million" doses per year, the company's novel vaccine initiative head, Narender Dev Mantena, said.
Zydus Cadila launched its version of remdesivir, marketed as Remdac, in India Thursday, setting the lowest in-country price for the antiviral at INR 2,800 ($37.44) per 100-milligram vial. Zydus is the fifth Indian firm to roll out a remdesivir copy under license from Gilead, following Hetero Labs, Cipla, Mylan and Jubilant Life Sciences.
Over 100 generic drugs have been flagged as potential COVID-fighters, but lack of financial incentive for testing low-cost generics could stymie innovation, a Bloomberg op-ed argued. To deliver U.S. treatments ahead of a vaccine, the government needs to set up programs to repurpose off-patent drugs, author Rena Conti stated, citing health and financial experts from Stanford University, Harvard University and the Massachusetts Institute of Technology.
Researchers at the University of California, Riverside developed machine learning models of human proteins to ID approved drugs that could fight COVID-19. The team has used the algorithms to pinpoint several candidates already—and they believe screening vast numbers of compounds using their computational strategy could prove cheaper and more efficient than using traditional cell-culture assays.
UPDATED: Wednesday, Aug. 12 at 3:30 p.m. ET
Researchers have turned to monoclonal antibody drugs as a potential stopgap ahead of a vaccine, but those treatments are expensive and complex to manufacture, meaning much of the world's population will likely miss out once a therapy is approved. In a report issued Monday, the International AIDS Vaccine Initiative and British research funder Wellcome called for global antibody access via new partnerships and technologies that would allow generic drugmakers to churn out the pricey treatments.
With demand for COVID testing through the roof, Verily Life Sciences set up a lab in its native San Francisco using tech from Thermo Fisher's TaqPath test kit. The aims of the lab are two-fold: Get patients quicker results and help Verily staffers return to work, the company said. Verily has also "verified" Roche's antibody test and filed an emergency use application to use an adaptation of the Thermo Fisher diagnostic on pooled patient samples. Story
Silicon Valley-based biotech ANA Therapeutics got the go-ahead to test a capsule form of niclosamide—used to treat tapeworm infections—in COVID-19 patients. ANA aims to enroll at least 400 subjects from hard-hit U.S. states and will kick off recruitment this month, targeting non-ventilated patients with less severe symptoms. Preclinical data showed the drug halted viral replication and proved more potent than Gilead's remdesivir in the same assay, ANA said.
SAB Biotherapeutics dosed the first subject in a phase 1 study of its polyclonal antibody, SAB-185, shown to neutralize both original and mutated strains of the coronavirus in preclinical testing. The phase 1 trial will test 28 healthy patients at single and multiple ascending dose levels to assess the treatment's safety, SAB said.
Russia plans to deliver its first batch of Sputnik V vaccines in two weeks' time, Health Minister Mikhail Murashko said. Those shots will primarily go to doctors and be administered on a voluntary basis. Despite a green light from Russia this week, the vaccine has only passed through early-stage testing, drawing fire from health experts the world over.
And Russia's vaccine has found a critic in NIAID director Anthony Fauci, who "seriously [doubts]" the country has run adequate testing on the shot. Fauci added that having a shot and proving a shot is effective are two very different things, stating that the U.S. could also deploy one of its vaccine candidates post-haste if it "wanted to take the chance of hurting a lot of people, or giving them something that doesn't work."
UPDATED: Wednesday, Aug. 12 at 9:19 a.m. ET
The U.S. locked down another vaccine purchase deal, this time from Moderna. The government put up $1.5 billion to secure 100 million doses of the Massachusetts-based biotech's mRNA shot, with an option for up to 400 million more. The supply pact comes after Moderna scored a $955 million development deal with the U.S. government's BARDA agency. Story
If COVID-19 infection rates drop before Johnson & Johnson wraps its late-stage vaccine study, the pharma giant may consider challenge trials, Johan Van Hoof, J&J's vaccines chief, said. In challenge trials, healthy patients are injected with vaccine and then deliberately infected with the virus to speed up review of the shot's performance. So, there are ethical issues and logistical challenges J&J must weigh before going that route, Van Hoof noted, such as having effective therapies on hand to tackle subjects' symptoms.
Speaking of J&J, the drugmaker is one of three whose vaccine candidates are slated for testing in Mexico, with the two other shots coming from China's CanSino Biologics and Walvax Biotechnology. The trials are set to begin between September and January, Foreign Minister Marcelo Ebrard said. Plus, CanSino and Walvax are both eyeing Mexico as a production hub for the Latin American market, Ebrard said.
The Bill & Melinda Gates Foundation put up another $150 million in its quest to secure 100 million vaccine doses for low- and middle-income countries. The funding was delivered to Gavi, the Vaccine Alliance, which will provide the up-front capital to the Serum Institute of India to crank out shot hopefuls from AstraZeneca and Novavax.
COVID-19 infections, hospitalizations and deaths have hit people of color especially hard in the U.S., but minorities are woefully underrepresented in clinical vaccine and drug trials, according to a report published in the New England Journal of Medicine. In the nationally funded trial on antiviral remdesivir, Black Americans only accounted for 20% of the patient population, and only one in 10 trial subjects was black in Gilead's own study of the drug. Now, the report's authors are calling for increased trial diversity to offer results relevant to the entire U.S. population. Story
Seventeen drugmakers, including Amgen, AstraZeneca, Gilead and others, were urged by a large pool of investors to price their eventual COVID-19 drugs and vaccines prudently and ensure widespread access. The investors, representing $2.5 trillion in assets, cited the large amount of federal funding that has gone into COVID-19 efforts, in turn making taxpayers the biggest investors in those projects.
Cipla aims to scale production of Gilead Sciences' remdesivir at its Goa, India, plant, to meet increased demand for the antiviral. Cipla kept mum on the volume it plans to produce, but it has partnered with BDR Pharmaceuticals for API supplies and Sovereign Pharma for finishing work. Cipla launched its licensed version of remdesivir, Cipremi, in July at INR 4,000 ($53.52) per vial—the cheapest version of the drug on the Indian market.
Israel may consider buying doses of Russia's Sputnik V vaccine, approved out of left field Tuesday, if the shot turns out to be a "serious product," Israeli Health Minister Yuli Edelstein said. Meanwhile, health experts slammed the approval as a potentially dangerous political stunt. Developed by Moscow's Gamaleya Research Institute, the shot got a green light from Russia Tuesday despite its lack of late-stage data.
UPDATED: Tuesday, Aug. 11 at 3:15 p.m. ET
Novavax expects to have capacity for "well over a couple billion" COVID-19 vaccines next year—enough to single-handedly meet U.S. demand, pegged at 500 million to 600 million doses, chief medical officer Filip Dubovsky said. Novavax aims to start a phase 2 study in Australia and the U.S. this month and kick off large-scale production in early 2021. Story
Russia announced the world-first approval of a COVID-19 vaccine Tuesday, but health experts blasted the move as a political stunt and warned about the potential dangers of an unproven inoculation. Dubbed Sputnik V, the shot was developed by Moscow's Gamaleya Research Institute and has only gone through phase 1 testing, according to the WHO's vaccine tracker. Experts say the move puts healthcare workers and others at risk, and former FDA commissioner Scott Gottlieb said it could be an attempt "to goad [the] U.S. into early action on [its] vaccine." Story
Merck has focused on proven tech, not speed, in its hunt for a COVID-19 vaccine, and now it's aiming for convenience, too, hoping to churn out a shot that works after a single dose, EVP and R&D chief Roger Perlmutter said. Other major shot makers like Moderna and Pfizer are eyeing two doses for their vaccines to work, while Johnson & Johnson is testing its shot in single and multidose regimens.
In a bid to boost blood plasma donations, testing giant LabCorp is offering a "no charge" COVID-19 antibody testing program for the next three months, using Roche's Elecsys Anti-SARS-CoV-2 test. Several biopharmas—such as Takeda—are eyeing convalescent plasma as a COVID-19 treatment. Story
With demand for Samsung's therapeutics skyrocketing amid the COVID-19 pandemic, the company has plotted a $2 billion "Super Plant" at its Incheon, South Korea, hub, plus an additional campus in Incheon that will serve as a global R&D center, the company said. In April, Samsung penned a $362 million deal with Vir Biotechnology to boost manufacturing of the biotech's COVID-fighting monoclonal antibody program, with plans to potentially start commercial production in 2021—and that's just one of the deals spurring the company to expand. Story