Dec 16 (Reuters) - 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.
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.
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 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/BioNTech's vaccine is the only COVID-19 vaccine authorized for the given age group in the U.S.
Pfizer said it expects to file for approval with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.
The FDA gave the two-dose vaccine emergency-use authorization for adolescents in May.
精彩评论