FDA authorizes bivalent COVID boosters for young children
FDA decision comes as children return to school
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The Food and Drug Administration said Wednesday that it amended its emergency use authorizations of the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines to use as a single booster dose in younger children.
The Modera vaccine is authorized for administration at least two months after primary or booster vaccination in children down to six years of age.
The Pfizer-BioNTech vaccine is authorized for administration at least two months after primary or booster vaccination in children down to five years of age.
"Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research (CBER), said in a statement.
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The FDA said that, with its announcement, the monovalent Pfizer vaccine was no longer authorized as a booster dose for kids ages 5-11, although both the Moderna and Pfizer vaccine continue to be authorized for primary series administration in individuals ages six months and older.
Until now, Moderna’s updated booster was cleared only for adults. Wednesday's action authorized the booster for teens and children as young as age 6.
FILE - A Jackson, Miss., resident receives a Pfizer booster shot from a nurse at a vaccination site, Feb. 8, 2022. ((AP Photo/Rogelio V. Solis, File) / AP Newsroom)
Next, the Centers for Disease Control and Prevention must sign off.
Pfizer has said it could ship up to 6 million kid-sized doses within a week of authorization.
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This provided by Pfizer in October 2022 shows manufacturing of the company's COVID-19 bivalent vaccine for ages 5-11. ((Pfizer via AP) / AP Newsroom)
The updated booster shots rolled out last month for Americans 12 years and older and are designed to target the current omicron variants.
Officials are urging Americans to seek extra protection ahead of the winter holidays.
Bivalent boosters are designed to broaden immune defense, containing half protection against the dominant BA.4 and BA.5 sublineages.
FILE PHOTO: Syringes are pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, U.S., May 19, 2022. (REUTERS/Hannah Beier / Reuters Photos)
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As of last weekend, around 13 million people have gotten an updated booster, according to White House COVID-19 coordinator Dr. Ashish Jha.
The Associated Press contributed to this report.