Pfizer Inc. said on Friday it could file to authorize the COVID-19 vaccine, which is developing in late November with German partner BioNTech, promising President Donald Trump ahead of the US election This vaccine will not be available.
Regulatory filings for the vaccine will be available as soon as safety data is available, possibly in the third week of November, Pfizer said, by picking up the company’s shares and the broader US stock market.
The timeline now allows for a possible US authorization for this year’s coronavirus vaccine, an important step to control the COVID-19 pandemic that has killed more than one million people and devastated the global economy .
The US Food and Drug Administration said earlier this month it wanted at least two months of safety data on half of the trial participants before authorizing emergency use of any experimental coronavirus vaccine.
While the White House approved the guidance, Trump has called the new rules a ‘political hit job’ as they reduce the expectation of voters getting a vaccine before going to the polls on 3 November.
Based on the current trial enrollment and the dose in the one-day phaseout trial, Pfizer expects safety data in the third week of November, Chief Executive Officer Albert Borla said in an open letter posted on the company’s website.
Borla noted in the letter that the filing depends on a number of other factors, including preliminary data on effectiveness that may or may not be available by the end of October.
He said the company plans to share the efficacy figures with the public as soon as practicable.
Pfizer shares rose 2.4% in premarket trading, while BioNotech’s US-listed shares rose 3.3% before the opening bell.
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