Pfizer to request coronavirus vaccine emergency use authorization ‘within days’

Pfizer completes coronavirus vaccine safety review, will apply for FDA approval

GOP Doctors Caucus member Rep. Buddy Carter and New York City practicing physician Dr. Devi Nampiaparampil react to Pfizer announcement.

Pfizer announced in a tweet on Wednesday that its coronavirus vaccine candidate met all primary efficacy endpoints in a phase 3 clinical trial, and that it planned to file for emergency use authorization “within days.”

The company, along with BioNTech, said the study reached 170 confirmed coronavirus cases, and that the vaccine, BNT162b2, had demonstrated “95% efficacy beginning 28 days after the first dose.” It added that no serious safety concerns had been reported.

“Within days, we plan to submit a request to the @US_FDA for an EUA based on the totality of safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the vaccine candidate,” Pfizer tweeted. “We also plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.

This is a developing story. 

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