In late November, Pfizer Inc expects to provide safety data and the COVID-19 vaccine authorization file that it is developing with German partner BioNTech, delaying further clarity on the vaccine until after the U.S. presidential election on Nov. 3.
As soon as safety data is accessible in the third week of November, the regulatory submission for the vaccine could come, Pfizer said, lifting the company's shares and the larger U.S. stock market.
This year, the timeline now allows for possible U.S. approval of a coronavirus vaccine, a key move toward managing a pandemic that has infected more than a million people and affected the global economy.
Before authorizing the emergency use of any experimental coronavirus vaccine, the U.S. Food and Drug Administration has said it needs at least two months of protection results.
In a letter posted to its website, Pfizer's Chief Executive Officer Albert Bourla noted that the filing relied on many factors, including safety data that may or may not be available by late October.
Pfizer hopes to have the safety data in the third week of November, Bourla said, based on current test attendance and dosing pace.
A request with the U.S. for emergency usage permit The Administration of Food and Drugs could arrive soon after the information is ready, Bourla said.
Bourla said data on the vaccine’s effectiveness may come earlier or later based on whether the late-stage trial of the vaccine had accumulated enough patients with COVID-19 to compare its effectiveness versus a placebo.
Pfizer had said earlier that in October it expected late-stage trial results.
BioNTech was not available for comment immediately.
Before stock trade, Pfizer's shares rose 1 percent, while BioNTech's U.S.-listed shares were up 2.4 percent before the opening bell.
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