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Aug. 16, 2021, 11:49 a.m. EDT

Pfizer, BioNTech submit trial data on COVID-19 booster shot to FDA

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By Tomi Kilgore

Pfizer Inc. /zigman2/quotes/202877789/composite PFE +6.11% and partner BioNTech SE /zigman2/quotes/214419716/composite BNTX +14.19% announced Monday that data from a Phase 1 study has been submitted to the U.S. Food and Drug Administration, for the evaluation of a third, booster dose of their COVID-19 vaccine. The companies said they will also submit the data to the European Union's version of the FDA, the European Medicines Agency, as well as other regulatory authorities, in the coming weeks. In the U.S., Pfizer-BioNTech plan to seek licensure of a third dose in people at least 16 years old. Last week, the FDA authorized an extra COVID-19 shot for some people with compromised immune systems. "This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine," said BioNTech Chief Executive Ugur Sahin. "A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season." Shares of Pfizer slipped 0.6% in midday trading and BioNTech's stock dropped 10.6%, while the S&P 500 /zigman2/quotes/210599714/realtime SPX -2.27% eased 0.4%.

/zigman2/quotes/202877789/composite
US : U.S.: NYSE
$ 54.00
+3.11 +6.11%
Volume: 66.56M
Nov. 26, 2021 1:10p
P/E Ratio
16.03
Dividend Yield
2.89%
Market Cap
$285.64 billion
Rev. per Employee
$533,860
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/zigman2/quotes/214419716/composite
US : U.S.: Nasdaq
$ 348.00
+43.24 +14.19%
Volume: 11.03M
Nov. 26, 2021 1:00p
P/E Ratio
10.05
Dividend Yield
N/A
Market Cap
$73.91 billion
Rev. per Employee
$283,276
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/zigman2/quotes/210599714/realtime
US : S&P US
4,594.62
-106.84 -2.27%
Volume: 2.10B
Nov. 26, 2021 2:12p
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