Pfizer-BioNTech seeks FDA authorization for a COVID booster shot for kids 5-11




  • In Health
  • 2022-04-27 00:04:27Z
  • By USA TODAY
 

Pfizer and BioNTech have requested that the Food and Drug Administration authorize a COVID-19 booster shot for children ages 5-11.

The companies announced Tuesday they submitted for an emergency use authorization from the FDA after a study showed a strong immune response to a booster shot among healthy children in that age group.

Pfizer-BioNTech's vaccine is the only COVID-19 shot authorized for children. Children who are 5 to 11 years old and have already completed their primary series of two shots would be eligible to receive a booster six months after the last dose, if approved.

Children in that age group get a 10-microgram dose, which is one-third of the dose given to adults.

NEW: After omicron winter surge, CDC finds nearly 60% of all Americans and 75% of kids have been infected by the coronavirus

PREVIOUSLY: Pfizer COVID-19 booster provides strong immune boost in kids ages 5-11, new study shows

The study in the booster trial included 400 children. In 30 children, blood samples showed a 36-fold increase in antibodies to the omicron variant; 140 children had a sixfold increase in antibodies to the original coronavirus strain.

There is still no vaccine approved for children under 5 years old. Pfizer and BioNTech found that vaccines for children ages 2-4 were safe, but did not boost immune response enough to be considered effective.

More than 8 million children ages 5-11 have received both COVID shots, according to the Centers for Disease Control and Prevention.

This article originally appeared on USA TODAY: Pfizer seeks authorization for COVID booster for kids 5-11

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