Pfizer files for full FDA approval of COVID-19 vaccine in adolescents

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Pfizer files for full FDA approval of COVID-19 vaccine in adolescents
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Pfizer Inc and its German partner BioNTech SE said on Thursday they have filed for full approval of their COVID-19 vaccine with the U.S. Food and Drug Administration to include adolescents aged 12 to 15.

A vial labelled with the Pfizer-BioNTech coronavirus disease vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvicand its German partner BioNTech SE said on Thursday they have filed for full approval of their COVID-19 vaccine with the U.S. Food and Drug Administration to include adolescents aged 12 to 15.

The vaccine received full approval for ages 16 and above in the United States in August. The shot also has an emergency use authorization for 5 to 15 year olds.. The company said in November the two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose.The company is seeking clearance for a 30 micrograms dose of the vaccine for those aged 12 and above.

Pfizer said it expects to file for approval with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.Register now for FREE unlimited access to Reuters.comOur Standards:Subscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.

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