BRIEF—Pfizer and BioNTech complete EMA filing for Omicron BA.4/BA.5 adapted bivalent vaccine

BioNTech and Pfizer just announced that they completed their submission to the European Medicines Agency (EMA) for a variation of the conditional marketing authorization to include a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older.

This application for a variation of the conditional marketing authorization (cMA) follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing Omicron-adapted bivalent vaccines.

The bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike-protein of SARS-CoV-2, which is present in Comirnaty (the original Pfizer-BioNTech COVID-19 Vaccine) and 15µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 variants.

Pfizer and BioNTech also  filed an application with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July which is currently under review by the Agency.

Both the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and be available for use as early as September, pending regulatory approval.

Local supply may vary based on individual country government requests.