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Pfizer Files For Emergency FDA Approval For COVID Vaccine, Says Can Distribute in December

Pfizer and its German partner, BioNTech, said they could start distributing their coronavirus vaccine 'within hours' of approval by the FDA.

Pfizer Inc.  (PFE) - Get Pfizer Inc. Report shares extended gains Friday after the drugmaker formally applied for Emergency Use Authorization for its developed coronavirus vaccine from the Food & Drug Administration and said it could be available for high-risk patients as early as December.

Pfizer and its German partner, BioNTech  (BNTX) - Get BioNTech SE Report, said earlier this week that the vaccine, known as BNT162b2, reached a 95% efficacy rate across all age and race demographics and based on a total case cohort of 170 and reiterated their aim of having 1.3 billion doses available next year and 50 million doses before the end of the year.  

Pfizer also said it would be ready to distribute the vaccine 'within hours' of approval by the FDA, with the Centers for Disease Control taking the final decision on allocation at both a state and national level. 

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," said CEO Albert Bourla. "Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," 

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“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible,” Bourla added.  

Pfizer shares were marked 2.5% higher in early trading Friday at $37.10 each. BioNTech's U.S.-listed shares, meanwhile, rose 7.2% on the Nasdaq to $101.77 each. 

Moderna said Monday that its messenger RNA-based vaccine hit a 94.5% efficacy rate and noted that it can last for up to six months when stored at standard freezer temperatures of -4 degrees Fahrenheit, compared to the -94 degree temperatures required for the Pfizer vaccine.

Pfizer and BioNTech dosed half of their 43,538 trial participants with a placebo, and the other half with their vaccine candidate, on two separate occasions as part of their three-stage study. Of the 170 confirmed cases of COVID-19 that resulted from the blinded trial, the pair said, more than 95% -- or 162 -- came from the placebo group.

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