Schedule now allows for possible US authorization of a coronavirus vaccine this year
Pfizer Inc said on Friday it could file an authorization application for the COVID-19 vaccine it is developing with its German partner BioNTech in late November, making it unlikely that a vaccine will be available before the US elections, as President Donald Trump has promised.
The vaccine’s regulatory filing could come as soon as safety data becomes available, possibly in the third week of November, Pfizer said, lifting the company’s shares and the broader US stock market.
The schedule now allows for possible US 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 that it wants at least two months of safety data on half of the trial participants before allowing emergency use of any investigational vaccine against the coronavirus.
As the White House clarified the guidelines, Trump called the new rules a “ political success ” because they undermine hopes of getting a vaccine before voters go to the polls on November 3.
Based on the current trial enrollment and dosage in an advanced stage trial, Pfizer expects to have this safety data by the third week of November, CEO Albert Bourla said in a letter. open published on the company’s website.
Bourla noted in the letter that the filing depended 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 share the efficacy data with the public as soon as possible.
Pfizer shares rose 2.4% in pre-market trading, while US-listed shares of BioNTech rose 3.3% before the opening bell.
(This story was not edited by GalacticGaming staff and is auto-generated from a syndicated feed.)
