Pfizer and BioNTech today announced they submitted to the European Medicines Agency (EMA) for an omicron-adapted bivalent COVID-19 vaccine candidate based on the BA.1 sub-lineage.
The application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to develop an omicron-adapted bivalent vaccine candidate to address the spread of SARS-CoV-2.
Pfizer recently 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 had a superior immune response against omicron BA.1 as compared to its current COVID-19 vaccine. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.
Pfizer and BioNTech previously shared the data with the FDA to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.