Pfizer CEO Albert Bourla said Friday that the company may know whether its vaccine is effective by the end of October, but won't have the safety data the FDA wants at least until the end of November.
Amid rising concerns about political pressure on the agency, the FDA released guidance on emergency authorizations that requires vaccine developers to provide two months of safety data on half of the trial participants following the final dose of the vaccine.
Moderna, the other company with a vaccine in a late-stage trial with more than 20,000 enrolled, has also said it won't be ready to file for an emergency authorization before the election.
What's next: Pfizer will soon complete enrollment in its late-stage trial with 44,000 participants, and then will wait for its data safety monitoring board to provide guidance on whether the vaccine is effective