Pfizer to Ask FDA to Authorize COVID Vaccine Booster for Ages 5-11

On Tuesday, Pfizer announced that it would be asking the FDA to authorize a COVID-19 vaccine booster shot for children aged 5-11. The pharmaceutical giant, along with its partner firm BioNTech, said it will submit an application to the Food and Drug Administration (FDA) for emergency use authorization in the “coming days.”

Pfizer presented data from a trial of 140 subjects and claimed there was a sixfold increase in antibodies against the original coronavirus strain one month after the booster shot when compared with levels seen one month after the second shot. A further showed a 36-fold increase in Omicron antibodies, Pfizer claimed.

“Clinical and real-world data continue to prove that a COVID-19 vaccine booster dose can keep individuals protected against severe disease,” Pfizer CEO Albert Bourla wrote in a tweet Thursday. “We now have new, positive data in children 5 to 11 that show high immune response following a booster.”

Clinical and real-world data continue to prove that a COVID-19 vaccine booster dose can keep individuals protected against severe disease. We now have new, positive data in children 5 to 11 that show high immune response following a booster: https://t.co/AChLyBJiih

— Albert Bourla (@AlbertBourla) April 14, 2022

Last October, the FDA granted emergency use authorization for children aged 5-11 to receive the first two doses of a COVID-19 vaccine. The Pfizer doses given to children contain a smaller amount of the vaccine than those given to adults.

Federal regulators already allow children over 12 to receive a booster dose. The FDA recently green lit a fourth vaccine dose for those over the age of 50 while a third booster, or fifth shot, has been approved for immunocompromised individuals. Additionally, Pfizer is expected to ask the FDA to approve a third booster for all age brackets in the fall.

 

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