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Pfizer expects that by the end of November to provide safety data and files on the vaccine with German partner BioNotech, delaying any clarity on the vaccine. 3 After the US presidential election.
Regulatory filings for the vaccine may come as soon as safety data becomes available in the third week of November, Pfizer said, by raising the company’s shares and the broader US stock market.
The timeline now allows for the possible US authorization of a coronavirus vaccine this year, an important step to control an epidemic that has killed more than one million and devastated the global economy.
The US 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 Albert Borla noted in a letter posted on his website that the filing depends on a number of factors, including data on effectiveness that may or may not be available by the end of October.
Borla said Pfizer expects safety data in the third week of November, based on current trial enrollment and dosing speed.
Borla said a filing with the US Food and Drug Administration for the Emergency Use Authority is ‘coming soon’.
Borla stated that data on the effectiveness of the vaccine may come before or after whether the late-stage trial of the vaccine had accumulated enough patients with COVID-19 to compare its effectiveness versus placebo.
Pfizer previously said it expected late-stage trial data in October.
BioNTech was not immediately available for comment.
Pfizer’s shares rose 1% before market trading, while BioNotech’s US-listed shares were up 2.4% before Opening Bell.