The Food and Drug Administration is trying to issue an emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine Friday evening, a source familiar with the process told USA TODAY.
White House Chief of Staff Mark Meadows on Friday told the head of the FDA to submit his resignation if the agency does not authorize the vaccine by day’s end, according to multiple reports, first revealed by The Washington Post.
Commissioner Stephen Hahn, however, said the reports presented an “untrue representation of the phone call with the Chief of Staff” and that the FDA “was encouraged to continue working expeditiously.”
If the FDA authorizes a vaccine Friday, mass vaccinations could begin within days in hundreds of thousands of frontline heath care workers and nursing home residents, a potential turning point in the country’s bitter battle against the virus. The vaccine authorization process is taking place as U.S. death toll from the novel coronavirus moves closer to 300,000.
More news to know today:
- New York City will shut down indoor dining starting Monday due to an uptick in “infection rates,” Gov. Andrew Cuomo said.
- There’s been a delay in the vaccine being developed by Sanofi and GlaxoSmithKline. The companies said that study results found older patients failed to demonstrate a sufficient immune response against the virus.
- The nation topped 292,000 total deaths from COVID-19 on Thursday, several hundred more than the number of battlefield deaths in World War II, according to the U.S. Department of Veterans Affairs. The U.S. surpassed 3,000 deaths in a single day for the first time on Wednesday, a count higher than the 9/11 terrorist attacks.
- In one small Kansas town, officials resisted a mask mandate. Now, its residents — along with other rural areas reluctant to impose precautionary measures — are paying the price, as COVID-19 rates skyrocket with an intensity not seen in urban counties.
What we’re reading: He could’ve gone home to family for Thanksgiving and is glad he didn’t: A reporter recounts what it was like to call his mom about his positive COVID-19 test amid a holiday gathering.
📈 Today’s numbers: The U.S. has reported nearly 15.7 million cases and more than 293,000 deaths, according to Johns Hopkins University data. The global totals: 70million cases and more than 1.5 million deaths.
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US buys another 100M doses of Moderna’s vaccine
The Trump administration announced Friday that it had purchased an additional 100 million doses of a coronavirus vaccine made by Moderna, bringing the federal government’s total order from the company to 200 million doses. The additional doses would “provide for continuous delivery through the end of June 2021,” the U.S. Department of Health and Human Services said in a press release.
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” HHS Secretary Alex Azar said in a statement. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
Moderna became the second vaccine maker in the U.S. to request authorizationfrom the FDA at the end of last month. The company’s latest findings showed that of 196 people in the clinical trial who caught COVID-19, 185 of them had received the placebo, while only 11 received the active vaccine. That works out to an effectiveness rate above 94%.
Reports of White House threatening FDA chief’s job could undercut agency’s credibility, scientists worry
Reports Friday that the White House was pressuring the FDA to authorize a coronavirus vaccine comes as the agency has already faced tremendous pressure over the past months to both approve COVID-19 drugs that it was less than convinced of and to speed the vaccine approval process. Despite some early stumbles, the FDA has worked to hold firm on its timeline to following the science rather than succumbing to politics.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August that he would quit if he were under political pressure to speed a vaccine to market before it was ready.
By all accounts, the FDA had been ready to issue the Emergency Use Authorization by Saturday or Sunday, so the effort from Trump is not likely to make an enormous different. Scientists worry what it could do is undercut faith in the agency’s process and the COVID-19 vaccine itself, already fragile due to early and misinformation.
“If the story is accurate, then indeed I am concerned that it will undermine public confidence in the science-based process of authorization by the FDA and recommendation by the CDC’s Advisory Committee on Immunization practices,” said L.J. Tan, chief strategy officer for the Immunization Action Coalition, a nonprofit that works with the CDC to distribute information about vaccines.
The FDA is clearly trying to do a thorough review in very difficult circumstances, said Gillian Woollett, a senior vice president and expert on FDA guidance and regulatory issues at the health care consulting firm Avalere Health.
“Commissioner Hahn should know that his efforts to keep FDA focused on the scientific and data-driven basis for their decisions is greatly appreciated by many; this will vastly increase the public confidence in the vaccine when it becomes available.”
– Elizabeth Weise
Biden calls for leadership in ‘teeth’ of COVID-19 crisis
President-elect Joe Biden led off his announcement of administration appointees Friday with warnings about “a grim milestone” in the COVID-19 crisis and sought to promote confidence in the vaccines federal regulators are considering for approval.
“This is serious business,” Biden said. “We’re in the teeth of a crisis right now.”
Biden said that President Donald Trump should be offering more leadership now to provide a national strategy for dealing with the virus and to prepare more for distributing vaccines.
“This nation needs presidential leadership right now,” Biden said. “We can wish this away, but we have to face it head on.”
– Bart Jansen and John Fritze
FDA authorization of Pfizer COVID-19 vaccine expected Friday evening
A person familiar with the FDA approval process told USA TODAY on Friday afternoon that the agency was working to ready its authorization for Friday evening. Authorization had been expected Saturday morning. The news was first reported by the New York Times.
President Donald Trump sent an angry tweet berating the agency for not moving faster at 7:11 a.m. Friday. “While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!”
The FDA will stop short of fully approving either the Pfizer vaccine or one developed with similar technology by Moderna, which is expected to cleared for use next week. Although it has received all the standard short-term safety and effectiveness data, the vaccines have not been tested for the two years typical of an approved vaccine – so it is not yet clear how long protection will last.
A meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention had been scheduled to vote on vaccine allocation on Sunday. During a discussion meeting Friday, CDC’s Amanda Cohen said if FDA issued the Pfizer authorization by 10 a.m. Saturday, the vote would be moved up to that day.
ACIP committee recommendations are signed off on by the director of CDC.
Reimbursement for vaccines from federal and private medical programs is only available to ACIP-recommended vaccines, so its vote is a key part of the distribution process.
Per: USAToday
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