Pfizer could apply for emergency use authorization for its potential COVID-19 vaccine next month, its CEO says.
Pfizer CEO Albert Bourla on Friday provided an update on when the company may potentially seek emergency use authorization from the Food and Drug Administration for its coronavirus vaccine candidate, should it prove to be safe and effective.
"In the instance of emergency use authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine," Bourla explained. "Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November."
Bourla added that "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."
With this announcement, The New York Times noted that Pfizer was "ruling out President Trump's assertion that a vaccine would be ready before Election Day." The CEO of Moderna, another company that has a potential COVID-19 vaccine in development, recently told the Financial Times it would likely not have enough data to seek FDA emergency use authorization until at least Nov. 25. At the time of those comments, the Financial Times wrote that this meant that Trump's "most realistic hope of a pre-election vaccine" would be from Pfizer.
Bourla also reiterated on Friday that Pfizer may know whether its vaccine is effective by the end of October, although the data required to make this determination "may come earlier or later based on changes in the infection rates."