Pfizer will not seek an emergency authorization for its coronavirus vaccine until after the election, the final blow to President Donald Trump’s repeated pledges to make a shot available before Americans cast votes amid the worst pandemic in a century.
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.
“Let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla wrote in an open letter.
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. Other vaccines could be ready for FDA review late this year or early 2021, but not by Nov. 3.
Background: The move by Pfizer continues the company’s push to publicly distance itself from the presidential race, and defuse critics who say the company is falling prey to political pressures.
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. That is based on the number of people in the vaccine and placebo groups who get Covid-19.
