The schedule now allows for a possible U.S. authorization of a coronavirus vaccine this year.
Pfizer Inc said on Friday that it could apply for authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, so it is unlikely that a vaccine will be available before the US elections, as promised by the president. Donald Trump.
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 US stock market.
The schedule 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 devastated 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 authorizing the emergency use of any experimental coronavirus vaccine.
While the White House approved the guidance, Trump has called the new rules a “successful political job” as they undermine hopes of receiving a vaccine before voters go to the polls on November 3.
Based on current trial enrollment and dosing in a late-stage trial, Pfizer expects to have that safety data by 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 submission depended on several other factors, including initial data on effectiveness that may or may not be available at the end of October.
He said the company plans to share the efficacy data with the public as soon as possible.
Pfizer shares were up 2.4% in premarket trading, while BioNTech shares traded in the United States were up 3.3% before the opening bell.
(This story has not been edited by NDTV staff and is automatically generated from a syndicated feed.)
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