Pfizer, BioNTech submit application to USFDA for emergency use nod of Omicron BA.4/BA.5-adapted bivalent COVID booster in children under 5 years

The Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorized as the third dose of the three-dose primary series for children in this age group. Authorization of a booster dose would give families the option to further protect their young children against more recently circulating Omicron sublineages.

If the FDA authorizes the bivalent vaccine as a booster (fourth) dose, young children who have completed their primary series – either with three doses of the companies’ original vaccine or with two doses of the companies’ original and one dose of the bivalent vaccine – would be eligible to receive a 3-µg booster dose of the bivalent vaccine at least two months after the completion of their primary series.

The submission is based on data from substudies within the companies’ Phase 1/2/3 study (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth dose of the bivalent vaccine in children 6 months through 4 years of age. Among a subset of study participants 6 months through 4 years of age (n=60), a fourth dose of the Omicron BA.4/BA.5-adapted bivalent booster elicited a higher Omicron BA.4/BA.5 neutralizing response compared to participants who received three doses of the companies’ original vaccine. The safety and tolerability profile of the bivalent vaccine remained similar to that of the original vaccine.

The companies also plan to submit an application to the European Medicines Agency (EMA) and other regulatory authorities worldwide to extend the Omicron BA.4/BA.5-adapted bivalent vaccine’s marketing authorization to include use in children 6 months through 4 years as both primary series and booster (fourth dose) vaccination. In the European Union (EU), the Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorized as a booster dose for ages 5 years and older who have completed at least the primary vaccination course against COVID-19.

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.