Pfizer Inc mentioned on Friday it might file for authorization of the COVID-19 vaccine it’s creating with German companion BioNTech in late November, making it unlikely a vaccine can be obtainable earlier than US elections as President Donald Trump has promised.
The regulatory submitting for the vaccine might come as quickly as security information is obtainable, probably within the third week of November, Pfizer mentioned, lifting the corporate’s shares and the broader US inventory market.
The timeline now permits for a doable US authorization of a coronavirus vaccine this 12 months, a key step in controlling the COVID-19 pandemic, which has killed greater than one million folks and ravaged the worldwide financial system.
The US Meals and Drug Administration mentioned earlier this month it desires at the very least two months of security information on half of the trial members earlier than authorizing emergency use of any experimental coronavirus vaccine.
Whereas the White Home cleared the steerage, Trump has known as the brand new guidelines a ‘political hit job’ as they undercut hopes of getting a vaccine earlier than voters go to polls on November 3.
Primarily based on present trial enrollment and dosing in a late-stage trial, Pfizer expects to have that security information within the third week of November, Chief Govt Officer Albert Bourla mentioned in an open letter posted on the corporate’s web site.
Bourla famous within the letter that the submitting relied on a number of different components, together with preliminary information on effectiveness that will or will not be obtainable by late October.
He mentioned the corporate plans to share efficacy information with the general public as quickly as sensible.
Pfizer’s shares rose 2.4% in premarket buying and selling, whereas BioNTech’s U.S-listed shares have been up 3.3% earlier than the opening bell.
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