Pfizer, BioNTech seek US FDA nod for Omicron-retooled booster for under-5s

Pfizer and its German partner BioNTech said on Monday they have submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization of their Omicron-adapted COVID-19 vaccine booster for children aged 6 months through 4 years.

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

The bivalent COVID-19 vaccine, which targets the original strain and the BA.4/BA.5 Omicron subvariants, is currently authorized as a booster dose for ages 5 years and older in the United States and the European Union (EU).

Last month, a real-world study of more than 360,000 people in the US found the updated bivalent boosters, including those of rival Moderna, offered increased protection against new coronavirus subvariants in people who have received up to four doses of the older vaccine. — Reuters