Pfizer Seeks November Emergency Approval For COVID Vaccine - TheStreet

Pfizer Will Seek Emergency Use Approval From FDA For its  COVID Vaccine in November; Shares Leap

Pfizer CEO Albert Boula said Friday that while the drugmaker is operating "at the speed of science ... we may know whether or not our vaccine is effective by the end of October."
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Pfizer Inc.  (PFE) - Get Report said Friday it could apply for emergency use approval of its developing coronavirus vaccine treatment as early as next month if data from ongoing trials shows its safe and effective.

Pfizer's timeline for Emergency Use Authorization (EUA) approval from the U.S. Food & Drug Administration is the most specific of any of the dozens of experimental cornonavirus vaccines undergoing testing and follows pauses in trials from rivals AstraZeneca  (AZN) - Get Report and Johnson & Johnson  (JNJ) - Get Report over safety concerns. 

Earlier this month, European health authorities launched a 'rolling review' of the experimental coronavirus vaccine the drugmaker is developing with Germany-based BioNTech  (BNTX) - Get Report, and said they were evaluating the first batch of data from non-clinical studies of BNT162b2, the pair's mRNA-based coronavirus vaccine.

"In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine," Pfizer CEO Albert Bourla said in a blogpost. "Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years."

Pfizer shares were marked 2.2% higher in early trading following news of the EUA timeline to change hands at $37.35 each. BioNTech's U.S.-listed shares, meanwhile, rose 1.9% to $92.10 each in early trading on the Nasdaq.

Pfizer received 'fast track' designation from the FDA in July based on preliminary data from Phase 1 and Phase 2 studies.

Last month, Pfizer and BioNTech reached an agreement with the European Union to supply as many as 300 million doses of the vaccine -- and said it could have as many as 1.3 billion doses ready by the end of 2021 -- if and when it is ultimately approved by health officials.