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

ADVERTISEMENT

dpo-dps-seal
Welcome, Kapamilya! We use cookies to improve your browsing experience. Continuing to use this site means you agree to our use of cookies. Tell me more!

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

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

Reuters

 | 

Updated Dec 17, 2021 04:01 PM PHT

Clipboard

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.

ADVERTISEMENT

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.

Watch more in iWantv or TFC.tv

ADVERTISEMENT

ADVERTISEMENT

It looks like you’re using an ad blocker

Our website is made possible by displaying online advertisements to our visitors. Please consider supporting us by disabling your ad blocker on our website.

Our website is made possible by displaying online advertisements to our visitors. Please consider supporting us by disabling your ad blocker on our website.