The FDA granted EUA – the very first vaccine for use by the general public in the United States – on Friday night, just a day after advisers recommended it.
The FDA was struck by a White House demanding a swift victory and caught between law enforcement agencies desperate for something – anything – to help fight a pandemic that has killed nearly 300,000 Americans, but also deeply suspicious of it. ‘regard to the new scientific technology developed in a very charged political atmosphere.
FDA Commissioner Dr Stephen Hahn said scientists at his agency, considered to be the best in the world, have stayed on top of the upheaval by reviewing data on the Pfizer and BioNTech vaccine.
“Science and data guided the FDA’s decision,” Hahn said at a Saturday morning press conference webcast and social media.
“We held a public advisory committee Thursday on the Pfizer and BioNTech app,” Hahn said. “The committee unanimously agreed that the benefits of the vaccine outweigh its risks. ”
Hahn said the FDA has been transparent about the data.
“We have also published important information to help healthcare providers understand the benefits, risks and appropriate use of this FDA cleared vaccine,” Hahn said.
EUA is a faster process than full approval – something that can take months or even years for a vaccine. But Dr Peter Marks, who heads the FDA’s vaccine division, the Center for Biologics Evaluation and Research, has repeatedly said the EUA standard will only be slightly lower than what would be required for a full license.
After two people who received the vaccine in Britain had allergic reactions, the FDA added warning wording to the vaccine label that warns of the possibility, and Hahn said the FDA and the US Centers for Disease Control and Prevention would ensure emergency supplies are activated. hand over all vaccination sites to manage allergic reactions.