On Oct. 12, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use Authorization for a 10-ﾵg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-ﾵg doses were shipped immediately.

The authorization of the bivalent COVID-19 vaccine for children 5 through 11 years of age is supported by safety and immunogenicity data from Pfizer and BioNTech’s 30-µg Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and pre-clinical data from the 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech’s 30-µg Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus.

The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 5 through 11 years of age are anticipated to start subject to and after the CDC endorses a potential recommendation. Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines.

Pfizer and BioNTech have submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies’ marketing authorization in the European Union to include a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group. Similar applications are planned for submission with regulatory authorities around the world in the coming weeks. A Phase 1/2/3 pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY^®) 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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.