Pfizer announced on Friday that it would not seek emergency authorization of its coronavirus vaccine before the third week of November, dashing President Trump’s hopes that a vaccine could be ready ahead of Election Day.
Pfizer, which has been ahead of other drugmakers in the race to find a vaccine, had originally said it could have proof of its candidate’s efficacy before Election Day, but in an online statement Friday the company’s chief executive, Dr. Albert Bourla, did an about-face.
Bourla said that although Pfizer may have preliminary numbers by the end of this month showing the vaccine’s efficacy, that it would take until at least the third week of November to collect safety and manufacturing data.
Federal health officials have said an effective vaccine would likely come by year’s end or in early 2021.
After President Trump teased the possibility of having a vaccine in early November, Bourla pushed back against accusations saying that the drugmaker’s vaccine timeline was politically motivated, according to the New York Times.
Pfizer and a handful of other vaccine companies signed a pledge last month to “stand with science” and only put forth vaccines that had been thoroughly reviewed.
The FDA recently published new guidance on how it would evaluate a vaccine for emergency authorization. President Trump accused the agency of having a political agenda in a tweet earlier this month.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA
— Donald J. Trump (@realDonaldTrump) October 7, 2020
The next day, Trump posted a video saying that a vaccine should be available before the election, “but frankly, the politics gets involved.”
“They want to play their games,” he said. “It’s going to be right after the election.”
The company’s trial of 44,000 volunteers is one of four late-stage clinical trials for a coronavirus vaccine in the U.S. The other three, for vaccines produced by AstraZeneca, Johnson & Johnson, and Moderna, have estimated timelines similar to what health officials have predicted.
AstraZeneca and Johnson & Johnson’s trials have been paused over potential safety concerns.