FDA Authorizes Pfizer, BioNTech Omicron Adapted COVID-19 Vax Booster

Pfizer Inc. and BioNTech SE was granted Emergency Use Authorization (EUA) by the U.S. FDA for a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older. An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to the FDA in early October. The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age. 
 
The bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike -protein of SARS-CoV-2, which is present in the original Pfizer-BioNTech COVID-19 vaccine and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 subvariants contain identical spike protein amino acid sequences, both can be targeted at once with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged. 
   
The authorization is based on clinical data from Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine as well as preclinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of the Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies’ current COVID-19 vaccine. Preclinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including 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 12 years of age and older are anticipated to start subject to and after the Centers for Disease Control and Prevention (CDC) endorse a potential recommendation by the Advisory Committee on Immunization Practices (ACIP). Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. 
 
Pfizer and BioNTech have submitted data on their Omicron-adapted bivalent vaccines to the European Medicines Agency (EMA) and other regulatory authorities around the world.