By Reuters Staff
(Reuters) – Pfizer Inc PFE.N expects to provide safety data and file for authorization of the COVID-19 vaccine it is developing with German partner BioNTech 22UAy.F in late November, delaying any clarity on the vaccine until after the Nov. 3 U.S. presidential election.
The regulatory filing for the vaccine could come as soon as safety data is available in the third week of November, Pfizer said, lifting the company’s shares and the broader U.S. stock market.
The timeline now allows for possible U.S. authorization of a coronavirus vaccine this year, a key step in controlling a pandemic that has killed more than a million and ravaged the global economy.
The U.S. Food and Drug Administration has said it wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.
Pfizer’s Chief Executive Officer Albert Bourla noted in a letter posted on its website that the filing depended on several factors, including data on effectiveness that may or may not be available by late October.
Based on current trial enrollment and dosing pace, Pfizer expects to have the safety data in the third week of November, Bourla said.
A filing for emergency use authorization with the U.S. Food and Drug Administration could come ‘soon after’ that data is ready, Bourla said. (bit.ly/31bWdpP)
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 previously that it expected late-stage trial data in October.
BioNTech was not immediately available for comment.
Pfizer’s shares rose 1% before market trading, while BioNTech’s U.S-listed shares were up 2.4% before the opening bell.
Reporting by Manojna Maddipatla and Manas Mishra in Bengaluru; Editing by Patrick Graham and Saumyadeb Chakrabarty
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