The FDA granted the EUA — the first ever for a vaccine for use in the general public in the United States — late Friday, just a day after advisers recommended it.
The FDA has been pummeled by a White House clamoring for a fast win and caught between public forces desperate for something — anything — to help fight a pandemic that has killed close to 300,000 Americans, but also deeply suspicious of new scientific technology developed in a highly charged political atmosphere.
FDA Commissioner Dr. Stephen Hahn said his agency’s scientists, considered the best in the world, stayed above the upheaval as they reviewed the data about Pfizer and BioNTech’s vaccine.
“Science and data guided the FDA’s decision,” Hahn told a Saturday morning news conference carried by webcast and broadcast over social media.
The FDA listened to the advice of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of experts with no financial ties to the vaccine process, who voted 17-4 with one abstention to recommend EUA of the vaccine after two pubic meetings.
“We held a public advisory committee on Thursday about the Pfizer and BioNTech application,” Hahn said. “The committee overwhelmingly agreed that the vaccine’s benefits outweighs its risks.”
Hahn said the FDA has been transparent about the data.
“We’ve also posted important information to help health care providers understand the benefits, risks and proper use of this FDA authorized vaccine,” said Hahn.
EUA is a process that’s quicker than full approval — something that can take months or even years for a vaccine. But Dr. Peter Marks, who heads FDA’s vaccine division, the Center for Biologics Evaluation and Research, said repeatedly the EUA standard would only be slightly short of what would be required for full licensure.
After two people who got the vaccine in Britain experienced allergic reactions, the FDA added warning language to the vaccine’s label that cautions about the possibility, and Hahn said the FDA and US Centers for Disease Control and Prevention would make sure that emergency supplies would be on hand at all vaccination sites to handle any allergic reactions.