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Pfizer, BioNTech COVID-19 Shot Gets FDA Nod for Emergency Use in Adolescents

05/10/2021 23:43

03:35 AM EDT, 05/11/2021 (MT Newswires) -- Pfizer (PFE) and BioNTech's (BNTX) COVID-19 vaccine has received approval from the US Food and Drug Administration for its emergency use in adolescents aged 12 to 15 years, the companies said late Monday.

The emergency use authorization was based on a late-stage study, which showed that the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15. Data were also submitted to the European Medicines Agency and other global regulators for potential authorization.

A study of the vaccine's safety and efficacy in children 6 months to 11 years of age is ongoing, according to the statement.

Pfizer shares gained 0.3% Monday in after-hours activity, while BioNTech American depositary shares were up 3.3%.

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