U.S. FDA grants full approval to Pfizer COVID vaccine for ages 12-15

The U.S. Food and Drug Administration said on Friday it has granted full approval to Pfizer and BioNTech's COVID-19 vaccine for adolescents aged between 12 and 15 years. 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 U.S. Food and Drug Administration said on Friday it has granted full approval to Pfizer and BioNTech's 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, 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.