Pfizer files for full FDA approval of Covid-19 vaccine in adolescents
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[BENGALURU] Pfizer and its German partner BioNTech said on Thursday (Dec 16) they have filed for full approval of their Covid-19 vaccine with the US Food and Drug Administration (FDA) 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 authorisation for 5 to 15 year olds.
Pfizer is seeking for an approval based on long-term data from a late-stage study conducted among adolescents.
The company said in November the 2-dose series of the vaccine was 100 per cent effective against Covid-19, measured 7 days through over 4 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/BioNTech's vaccine is the only Covid-19 vaccine authorised for the given age group in the US.
Pfizer said it expects to file for approval with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.
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The FDA gave the 2-dose vaccine emergency-use authorisation for adolescents in May.
REUTERS
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