Pfizer-BioNTech Asks FDA to Authorize Omicron Bivalent COVID-19 Booster for Children Under 5 Years

This morning, Pfizer and BioNTech announced they submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for children 6 months-5 years of age.

The EUA would be to administer the bivalent vaccine as a third 3-µg COVID-19 shot, or booster dose, in the youngest children authorized to receive a Pfizer-BioNTech primary COVID-19 vaccine series.

“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” Pfizer commented in an announcement of the EUA filing.

If the FDA issues the EUA, children 6 months-4 years old would receive a primary vaccination series with an original wild-type, monovalent COVID-19 vaccine before being eligible for the bivalent Omicron-adapted booster.

Thus far, all individuals 5 years and older are authorized under EUA to receive an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in the US and European Union (EU). Pfizer-BioNTech’s bivalent booster may be administered at least 2 months after completing a primary vaccine series with any approved monovalent COVID-19 vaccine, or at least 2 months after receiving an approved monovalent COVID-19 booster dose.

Click here to learn more about the Pfizer-BioNTech Omicron-adapted booster shot, or here to read about the latest COVID-19 vaccine developments.