Pfizer Applies for US FDA Approval for Omicron-Adapted Vaccine Booster in Under 5 Kids

Pfizer and BioNTech has submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization of the Omicron-adapted COVID-19 vaccine booster for children under 5 years.

If the vaccine is authorized, the children would receive the primary series of the vaccine consisting of two doses of the original COVID-19 vaccine developed by Pfizer and BioNTech and one shot of the Omicron-adapted bivalent vaccine, says Pfizer.

Pfizer and BioNTech’s bivalent COVID-19 vaccine, which mainly targets the original strain and the BA.4 and BA.5 Omicron subvariants, is currently approved as a booster COVID-19 vaccine dose for children aged 5 years, and older in the European Union and the United States.

In November 2022, a study of more than 360,000 people in the United States found the updated bilvalent COVID-19 boosters, including the vaccine boosters developed by Moderna Inc. The Omicron-adapted vaccine boosters offer increased protection against new and emerging COVID-19 subvariants in people who have already received around four doses of the older COVID-19 vaccines.