Pfizer, BioNTech ask FDA to approve omicron-targeting booster for kids ages 5-11

Pfizer on Monday became the latest COVID-19 vaccine manufacturer to seek federal approval for younger Americans to receive a shot specifically targeting the virus’ omicron strain.

The pharmaceutical company and its partner BioNTech asked the Food and Drug Administration to allow children between 5 and 11 years old to receive its adapted booster in a new submission seeking emergency use authorization.

The 10-milligram booster dose is designed to combat the BA.4 and BA.5 strains of COVID-19 that currently cause the most cases of the deadly virus.

The submission to the FDA came after the companies conducted a study to “evaluate the safety, tolerability and immunogenicity of different doses” of the omicron-focused vaccine.

Booster shots of the Pfizer COVID-19 vaccine are displayed during a vaccine clinic in Townshend, Vt., on Tuesday, Sept. 20, 2022. (Kristopher Radder/)

Pfizer began giving the adapted booster to people ages 12 and older in the U.S. earlier this month.

“An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization in the European Union to include children 5 through 11 years of age will be submitted to the European Medicines Agency in the coming days,” Pfizer and BioNTech added in its announcement Monday.

Last week, fellow vaccine manufacturer Moderna asked the FDA to authorize its omicron-targeting vaccine for kids ages 12 to 17, and to allow emergency use for children ages 5 to 11.

Approximately 4.4 million Americans had received an omicron-targeting booster as of last Thursday, the Centers for Disease Control and Prevention said in an update.

Health officials hope the latest booster will help prevent a large surge in cases this winter.

“No one would go looking at our flu shot uptake at this point and be like, ‘Oh, what a disaster,’” epidemiologist Dr. David Dowdy of Johns Hopkins Bloomberg School of Public Health said last week, according to The Associated Press. “If we start to see a large uptick in cases, I think we’re going to see a lot of people getting the [new COVID] vaccine.”

A decision for the omicron booster approval for kids ages 5 to 11 is expected to be made soon, Dr. Peter Marks of the FDA said last week.

With News Wire Services