Pfizer and BioNTech have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children aged 6 months through 4 years. This submission seeks to expand the availability of updated COVID-19 protection to the youngest population, addressing concerns over rising respiratory illnesses in this age group.
The application proposes a three-dose primary series. Children would initially receive two 3-µg doses of the original Pfizer/BioNTech COVID-19 vaccine, followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine. This approach aims to provide broad protection against both the original SARS-CoV-2 strain and the more recent Omicron subvariants.
The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for individuals aged 5 years and older in the United States and the European Union. The companies believe that extending authorization to younger children will help prevent severe illness and hospitalization, particularly in light of increased circulation of respiratory viruses.
Comirnaty, the Pfizer/BioNTech COVID-19 vaccine, utilizes mRNA technology. BioNTech holds the Marketing Authorisation for BNT162b2 (Original) and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in several regions, including the US, EU, and UK. They also jointly hold EUAs with Pfizer in the US and other countries.
Comirnaty is approved for active immunization against COVID-19 caused by SARS-CoV-2 in individuals 12 years and older. It is also authorized under EUA as a third primary series dose for immunocompromised individuals in the same age group. The bivalent vaccine has EUA for use as a single booster dose in individuals 5 years and older, administered at least two months after completing a primary vaccination series or receiving the most recent booster dose with any authorized monovalent COVID-19 vaccine.
It is important to note that EUAs are authorized only for the duration of the declared emergency justifying the authorization of emergency use of the medical product, as outlined in Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or the authorization is revoked sooner.
