US FDA grants full approval to Pfizer Covid-19 vaccine for ages 12-15

US FDA grants full approval to Pfizer Covid-19 vaccine for ages 12-15
A teenager receives a dose of Pfizer Covid-19 vaccine during a vaccination program for teenagers under 18-year-old in Shah Alam, outside Kuala Lumpur, Malaysia, 06 October 2021. EPA-EFE/FAZRY ISMAIL

July 8 (Reuters) - The U.S. Food and Drug Administration said on Friday it has granted full approval to Pfizer PFE.N and BioNTech's BNTX.O COVID-19 vaccine for adolescents aged between 12 and 15 years.

The vaccine, sold under the brand name Comirnaty for adults, has been available under an emergency use authorization since May 2021 for the 12-15 age group. It will now be sold under the same brand name for adolescents as well.

The FDA said on Friday the full approval follows a rigorous analysis and evaluation of the safety and effectiveness data. The vaccine was approved for use in those aged 16 and older in August last year.

Roughly 67% of the total U.S. population has been fully vaccinated against COVID-19, according to federal data.

The FDA last month had asked vaccine manufacturers, including Pfizer and rival Moderna Inc MRNA.O, to change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus.

(Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)


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