Pfizer could apply for US emergency use approval for coronavirus vaccine by late November

Pfizer, one of several companies aiming to develop a coronavirus vaccine, announced early Friday that it and its German partner BioNTech plans on applying for emergency use authorization from the Food and Drug Administration (FDA) by late November.

In a statement shared on Twitter, Pfizer Chairman and CEO Albert Bourla said that as it runs late-stage trials for the potential COVID-19 vaccine, the group may know by the end of October whether the candidate is considered “effective,” meaning it can prevent COVID-19 in a majority of cases. 

Bourla added, however, that this would only meet one of the three requirements needed for the vaccine to be able to apply for public use.

“The second requirement is to prove that the vaccine is safe,” Bourla wrote in the statement. “Our internal standards for vaccine safety and those required by regulators are set high. 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 added that based on Pfizer’s “current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November.”

“Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years,” the CEO added. 

Bourla added that the third requirement would be for the vaccine to provide consistent results in its ability to prevent COVID-19 in most cases. 

The FDA announced earlier this month its two-month safety requirement before companies can apply for emergency approval, prompting pushback from the White House, with President Trump calling the new guidelines a “political move” that would mean a vaccine is not approved by Election Day.

The White House blocked the FDA from issuing a formal release of the guidance, with The New York Times reporting that chief of staff Mark Meadows had questioned the need for two months of safety data. Meadows also suggested that FDA Commissioner Stephen Hahn, a Trump appointee, was being overly influenced by the agency’s career scientists, the Times reported.

Despite this, the FDA shared the guidelines anyway through briefing materials to its vaccine advisory committee, instead of through formal guidance that would need approval from the White House. 

While the Trump administration’s Operation Warp Speed has aimed to deliver a COVID-19 vaccine to the public in record time, experts have said it is highly unlikely that a candidate will be ready for widespread use by Nov. 3. 

On Oct. 6, Bourla tweeted that Pfizer had “never discussed” the FDA’s vaccine guidelines with the White House and “will never do so as it could undermine the agency’s independence.”