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Nov. 20, 2020, 5:26 p.m. EST

Pfizer, BioNTech make it official: COVID-19 vaccine EUA submitted

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By Claudia Assis

Pfizer Inc. /zigman2/quotes/202877789/composite PFE +0.56% and BioNTech /zigman2/quotes/214419716/composite BNTX +1.10% on Friday submitted an application for an emergency use authorization for their trial COVID-19 vaccine candidate, making their vaccine candidate the first in line with U.S. regulators. The two companies had said earlier Friday that the submission to the Food and Drug Administration was coming. The companies earlier this week said the vaccine, called BNT162b2, had an efficacy rate of 95% in a late-stage clinical trial. "It is with great pride and joy and even a little relief that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA's hands," Pfizer Chief Executive Albert Boula said on a company's tweet announcing the development. Shares of Pfizer rose 0.4% and American depositary receipts of BioNTech 0.1% in the extended session Friday, after ending the regular trading day up 1.4% and 9.6%. Later Friday, the FDA said its advisory committee will meet to discuss the companies' vaccine candidate on Dec. 10. Details will be available next week, it said.

/zigman2/quotes/202877789/composite
US : U.S.: NYSE
$ 34.39
+0.19 +0.56%
Volume: 30.59M
March 5, 2021 4:02p
P/E Ratio
20.11
Dividend Yield
4.54%
Market Cap
$191.81 billion
Rev. per Employee
$533,860
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/zigman2/quotes/214419716/composite
US : U.S.: Nasdaq
$ 96.20
+1.05 +1.10%
Volume: 1.69M
March 5, 2021 4:00p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$23.16 billion
Rev. per Employee
$92,777
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