By Michael Erman and Manas Mishra
The U.S. Food and Drug Administration has told coronavirus vaccine developers it wants at least two months of safety data from half of their trial volunteers in order to authorize emergency use, a requirement that would likely push any U.S. vaccine availability past the Nov.3 presidential election.
The FDA advice was released on Tuesday as part of documents posted ahead of a meeting of the agency’s panel of outside experts later this month to discuss coronavirus vaccines under development.
The FDA had originally submitted the two-month requirement as official guidelines, which were blocked by White House officials, the New York Times reported on Monday.
The White House could still force authorization of a vaccine without that additional safety data. Doing so would put it in open disagreement with the FDA and its career scientists, and add to the perception that politics was playing a role in pushing out a vaccine.
If the agency follows its own advice, it is unlikely to authorize a vaccine before sometime in late November.
Pfizer Inc <PFE.N> and partner BioNTech <22UAy.F> are currently expected to be the first vaccine developers to announce results from a late-stage U.S. clinical trial.
About half the volunteers in the 44,000-subject Phase III trial had received the second dose of the two-shot vaccine by late September.
Pfizer Chief Executive Albert Bourla tweeted on Tuesday that the company had not discussed the FDA’s standards with the White House, saying that could compromise the agency’s independence.
The FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment,” Bourla said.
The FDA expects to hold separate meetings of its vaccine advisory committee before issuing an emergency use authorization for any experimental shot.
