A Conditional Marketing Authorization application has also been initiated with the European Medicines Agency (EMA) and is expected to be completed in the coming days.
Distribution of the new vaccine will start next month, pending authorization.
Bivalent vaccine
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.
In the US, Pfizer and BioNTech are seeking authorization for a 30-µg booster dose for people aged 12+.
Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.
The companies previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein. The Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine. The Omicron BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.