(Reuters) – Pfizer Inc said today it may file for authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before U.S. elections as President Donald Trump has promised.
The regulatory filing for the vaccine could come as soon as safety data is available, possibly in the third week of November, Pfizer said, lifting the company’s shares and the broader U.S. stock market.
The timeline now allows for a possible U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.
The U.S. Food and Drug Administration said earlier this month it wants at least two months of safety data on half of the trial participants before authorizing emergency use of any experimental coronavirus vaccine.
While the White House cleared the guidance, Trump has called the new rules a ‘political hit job’ as they undercut hopes of getting a vaccine before voters go to polls on Nov. 3.
Based on current trial enrollment and dosing in a late-stage trial, Pfizer expects to have that safety data in the third week of November, Chief Executive Officer Albert Bourla said in an open letter posted on the company’s website.
Bourla noted in the letter that the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.
He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)
Pfizer’s shares rose 2.4% in premarket trading, while BioNTech’s U.S-listed shares were up 3.3% before the opening bell.