FDA Approves Pfizer’s Covid-Omicron Booster as Fourth Vaccine for Kids Beneath 5

An employee at the Mainz vaccination center draws up a syringe with the Comirnaty vaccine from Biontech and Pfizer, adapted to the Omicron BA.1 variant.

Sebastian Christoph Gollnow dpa | Picture Alliance | Getty Images

The U.S. Food and Drug Administration approved it on Tuesday Pfizers omicron booster shot for children under the age of five who have previously been vaccinated with three doses of the company’s original vaccine.

Children ages six months to four years who completed their three-dose primary series more than two months ago with the original Pfizer and BioNTech monovalent syringes are now eligible for a single booster dose of the updated syringe. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5.

Pfizer’s primary line for young children consists of three doses, while competing drugmaker Moderna’s primary line for the same age group consists of only two doses.

As of December, children in this age group who received two doses of Pfizer’s original vaccine are eligible to receive the omicron booster as the third dose or last dose in their primary series. The agency noted that children who received the Omicron shot as a third dose are not currently eligible for the bivalent booster but should still be protected against a severe case of Covid.

The new approval applies to young children who finished their three doses before the new injection was available.

“Today’s approval offers parents and caregivers of children ages 6 months to 4 years who received the three-dose primary series of monovalent Pfizer-BioNTech COVID-19 vaccine an opportunity to update their child’s protection by providing received a booster dose of Pfizer’s BioNTech vaccine. BioNTech COVID-19 Vaccine, Bivalent,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

The agency’s decision aims to better protect young children after a cruel winter season that has seen hospitals overwhelmed with young children suffering from various respiratory diseases including Covid, RSV and the flu.

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

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