That was fast.
Just over 24 hours after an FDA advisory panel recommended emergency use of Pfizer and BioNTech’s COVID-19 vaccine, the agency followed through, authorizing the first coronavirus pandemic shot for emergency use in the U.S.
The FDA had planned to authorize the vaccine on Saturday, but moved the timeline up after pressure from the White House.
With the Emergency Use Authorization in hand, Pfizer can now speed millions of doses to providers. The first vaccinations will begin Monday or Tuesday, HHS Secretary Alex Azar said Friday morning.
Pfizer CEO Albert Bourla promised last month that the first doses would be on their way to providers “within hours" of authorization.
The company has been prepping a distribution network to handle the vaccine, which must be kept at minus 94 degrees Farenheit until just days before use. Mass shipments started arriving in the U.S. last week, and providers around the country have been rehearsing for the arrival of their allotted doses, according to media reports.
Amid all this activity, FDA Commissioner Stephen Hahn, M.D., has urged an impatient public—and White House—to be patient while the review process played out, first with Thursday's advisory panel meeting, and then agency deliberation after that.
Then, on Friday, Hahn told officials at the agency's Center for Biologics Evaluation and Research to issue an authorization by the end of the day, a person familiar with his instructions told The New York Times. The move came after White House Chief of Staff Mark Meadows told Hahn to look for another job if the vaccine was not authorized Friday, The New York Times and the Washington Post reported.
A White House spokesperson declined to comment on the threat, but Hahn told the Post it was an "untrue representation of the phone call with the Chief of Staff," who "encouraged" the FDA to "continue working expeditiously" on Pfizer and BioNTech's emergency use authorization request. It is unclear if moving the authorization from Saturday to Friday would speed up the delivery of vaccine doses.
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Bourla told Sky News in November that Pfizer and BioNTech would begin shipping doses to countries as soon as their regulators OK’d the vaccine. At the time, the partners had produced 20 million doses of the vaccine, with another 50 million slated before the end of the year and 1.3 billion to follow in 2021.
Though Bourla acknowledged at the time the strategy could tee up a “race to regulate”—with authorities trying to quickly review data and secure early doses for their countries—the “ethical thing to do is to start sending vaccines to citizens of this jurisdiction because every day means lives," Bourla said at the time.
The U.K. became the first country to OK the vaccine last Thursday, followed by Bahrain, Canada, Saudi Arabia and now, the U.S.
The emergency FDA nod comes after the agency’s Vaccines and Related Biologics Products Advisory Committee on Thursday voted 17-4, with one panel member abstaining, that the benefits of the vaccine outweighed its risks for use in people 16 and older.
The favorable vote was widely expected given the vaccine's 95% efficacy rate and the heaps of praise from FDA staffers in briefing documents published Tuesday. But some panel members wished to exclude people aged 16 or 17 from the emergency use authorization because of the relatively small number of trial participants from that age group.
At least one analyst speculated that concern about the 16- and 17-year-olds was the reason behind some "no" votes.
"While 'No' votes were left unexplained, some may have had to do with the '16 years of age and older' wording of the question, as several panelists believed that 16 and 17 year olds should be excluded,” RBC Capital Markets analyst Randall Stanicky wrote in a note to clients Thursday evening.
It was certainly the case for one panelist.
“My ‘no’ vote was because of the inclusion of 16-17 year-olds. Unfortunately I and other members who had also voted 'no' did not have an opportunity to explain our positions before the meeting was adjourned,” David Kim, M.D., director of the Division of Vaccines in the Office of Infectious Disease and HIV/AIDS Policy in the Department of Health and Human Services, told CNBC's Meg Tirrell.
The panelists weren’t given a chance to explain their vote. One of the four who voted no, David Kim, tells us:
— Meg Tirrell (@megtirrell) December 10, 2020
“My “no” vote was because of the inclusion of 16-17 year-olds. Unfortunately, I and other members who had also voted “no” did not have an opportunity to explain...” (1) https://t.co/bQZsVIuYE5
Had the vote been about people 18 years and older, Kim “would have voted ‘yes’ most enthusiastically,” he said.