Pfizer and BioNTech Submit Data to EMA for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer and BioNTech have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older.

The companies previously announced safety, tolerability, and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate produced a superior immune response against Omicron BA.1, as compared to the companies’ current COVID shot. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.

The involved parties previously shared these data with FDA to support a potential variant-adapted vaccine, and they continue to submit additional data as advised by the agency.