Pfizer sees an emergency submitting for the Covid-19 vaccine after the US elections


A health worker holds blood samples for a Covid-19 vaccine during clinical trials at the Research Centers of America in Hollywood, Florida on Wednesday, September 9, 2020.

Eva Marie Uzcategui | Bloomberg | Getty Images

Pfizer is expected to submit safety data and documents for approval of the Covid-19 vaccine it has developed with German partner BioNTech in late November in order to delay the clarity of the vaccine until after the US presidential election on November 3rd.

Regulatory filing of the vaccine could come as soon as safety data is available in the third week of November, Pfizer said, picking up the company's stock and the broader US stock market.

The schedule now allows for the possible US approval of a coronavirus vaccine this year, a major step in fighting a pandemic that killed more than a million people and devastated the global economy.

The U.S. Food and Drug Administration has announced that it will require at least two months of safety data before approving emergency use of an experimental coronavirus vaccine.

Albert Bourla, Pfizer's chief executive officer, noted in a letter posted on its website that filing is dependent on several factors, including efficacy data that may or may not be available by the end of October.

Based on the current study enrollment and dosing pace, Pfizer expects the safety data to be in by the third week of November, Bourla said.

Filing for emergency use approval with the US Food and Drug Administration could be "soon after" these dates, Bourla said.

According to Bourla, data on the vaccine's effectiveness may come sooner or later, depending on whether enough patients with COVID-19 were accumulated in the vaccine's late-stage study to compare its effectiveness with a placebo.

Pfizer had previously said that late-stage trial data would be expected in October.

BioNTech was not immediately available for comment.

Pfizer shares rose 1% ahead of market trading, while BioNTech's US-listed shares rose 2.4% ahead of the opening bell.


Steven Gregory