Pfizer and BioNTech announced Monday morning they have applied for emergency use authorization from the Food and Drug Administration for COVID-19 booster shots that target the BA.4 and BA.5 omicron subvariants in children ages 5 to 11.


What You Need To Know

  • Pfizer and BioNTech announced Monday morning they have applied for emergency use authorization from the Food and Drug Administration for COVID-19 booster shots that target the BA.4 and BA.5 omicron subvariants in children ages 5 to 11

  • U.S. regulators earlier this month approved updated boosters by Pfizer and BioNTech as well as Moderna for older age groups

  • The FDA and Centers for Disease Control and Prevention will consider Pfizer’s application for the children’s booster before making a decision

  • The shots would be a dosage of 10 micrograms — a third of what is given to adults and consistent with the existing vaccine dosage for kids that age

U.S. regulators earlier this month approved updated boosters by Pfizer and BioNTech as well as Moderna. Both of the shots are bivalent, targeting the original 2019 strain as well as BA.4 and BA.5, which today account for 96% of new COVID-19 infections in the United States. The Pfizer shot is authorized for people ages 12 and older, while the Moderna booster is approved for 18 and older.

The FDA and Centers for Disease Control and Prevention will consider Pfizer’s application for the children’s booster before making a decision.

The shots would be a dosage of 10 micrograms — a third of what is given to adults and consistent with the existing vaccine dosage for kids that age.

Earlier this year, Pfizer and Moderna approached the FDA with bivalent boosters that targeted the original version of the virus as well as the first strain of the omicron variant, BA.1. However, the FDA in June directed the vaccine makers to change their designs to start targeting BA.4 and BA.5.

Pfizer’s vaccine for the kids’ booster includes safety and efficacy data on 5- to 11-year-olds for the BA.1-adapted vaccine as well as nonclinical, preclinical and manufacturing data on the BA.4/BA.5 shots, Pfizer said.

Pfizer and BioNTech said they will submit their application to European regulators “in the coming days.”

The companies, meanwhile, have begun clinical trials for the BA.4 and BA.5 shots to determine the proper dosage for children ages 6 months to 4 years. They also are running clinical trials on the boosters for kids 5 to 11 who previously received two to three doses of the original COVID-19 vaccine.

Nearly a year after COVID-19 vaccines for older adults were rolled out, the shots finally became available to children 5 to 11 in November 2021. Booster shots were approved in that age group in May of this year.

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