FDA authorizes Pfizer’s Covid omicron booster as fourth dose for children under 5

A worker pulls out a syringe containing the Comirnaty vaccine from Biontech and Pfizer for the Omicron-BA.1 variant at the Mainz vaccination center.

Sebastian Christoph Gorno | News Department | Image Alliance | Getty Images

U.S. Food and Drug Administration Tuesday authorized Pfizer’s The omicron booster shot is for children up to five years old who have previously received three doses of the company’s original vaccine.

Children six months to four years old who completed the three-dose primary series of Pfizer and BioNTech’s original monovalent injection just over two months ago are now eligible to receive a single booster dose of the updated injection. The new vaccine is bivalent, meaning it targets the original Covid strain as well as the omicrons BA.4 and BA.5.

Pfizer’s lead series for young children includes three doses, compared with just two for rival drugmaker Moderna’s lead series targeting the same age group.

since december, children in this age group who completed two doses of the original Pfizer vaccine were eligible to receive the omicron booster as their third dose, or the final dose in their main series. Children receiving a third dose of the omicron vaccine are not currently eligible for the bivalent booster, but they should still be protected from severe Covid infection, the agency noted.

The new authorization applies to young children who completed three doses of the vaccine before the new vaccine became available.

“Today’s authorization provides an opportunity for parents and caregivers of children aged 6 months to 4 years who have received the three-dose primary series of the monovalent Pfizer-BioNTech COVID-19 vaccine to renew their child’s protection by receiving a booster dose from Pfizer – BioNTech COVID-19 bivalent vaccine,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

The agency’s decision is aimed at better protecting young children after a dreadful winter in which hospitals were overwhelmed with children suffering from a variety of respiratory ailments, including Covid, RSV and flu.

The FDA said the decision was based in part on data from a clinical trial of 60 children in that age group who had previously received three doses of Pfizer’s original vaccine and one dose of the company’s new booster.One month after the children received the omicron booster, they showed an immune response to the original Covid strain and the omicron BA.5 and BA.5

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