Pfizer Inc announced on Friday that it may apply for approval of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely that a vaccine will be available before the US elections, like President Donald Trump has promised.
Regulatory filing of the vaccine could come as soon as safety data becomes available, possibly by the third week of November, Pfizer said, picking up the company’s stock and the broader US stock market.
The schedule now provides for a possible US approval of a coronavirus vaccine this year. This is an important step in fighting the COVID-19 pandemic, which killed more than a million people and devastated the global economy.
The U.S. Food and Drug Administration announced earlier this month that it would like at least two months of safety data for half of the study participants before approving emergency use of an experimental coronavirus vaccine.
While the White House approved the guidelines, Trump has called the new rules a “political success” as they undermine hopes for a vaccine before voters go to the polls on November 3rd.
Based on the study’s current registration and dosage in a late-stage study, Pfizer expects this safety data to be available by the third week of November, Chairman Albert Bourla said in an open letter posted on the company’s website.
Bourla noted in the letter that the filing is dependent on several other factors, including initial efficacy data that may or may not be available by the end of October.
He said the company plans to release the effectiveness data to the public as soon as possible.
Pfizer’s shares rose 2.4% in premarket trading, while BioNTech’s US-listed shares rose 3.3% before the opening bell.
(This story was not edited by GossipMantri staff and is automatically generated from a syndicated feed.)