Pfizer and BioNTech’s 30µg booster dose of their Omicron BA.1 bivalent COVID-19 vaccine booster – Comirnaty – has been recommended for conditional marketing authorisation (CMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older, the companies announced.
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein – present in the original Pfizer/BioNTech COVID-19 vaccine – together with mRNA encoding the spike protein of the Omicron BA.1 subvariant.
“Compared to a booster dose of our COVID-19 vaccine, which is currently approved for use in the EU, the bivalent vaccine with mRNA encoding the wild-type and the BA.1 spike proteins provides higher neutralising antibody titers against the Omicron BA.1 and BA.4/BA.5 sublineages,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
If an authorisation is granted, doses of the booster will be available within the coming days to all 27 EU member states, supporting the start of the European vaccination campaigns. Local supply may vary based on individual country government requests, Pfizer outlined.
The recommendation is based on clinical data from the Pfizer/BioNTech Omicron BA.1 adapted bivalent vaccine phase 2/3 trial of participants 56 years and older. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine.
The companies have also filed an application, which is currently under review, to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted COVID-19 bivalent vaccine to ‘allow for flexible vaccination strategies’, Pfizer said in a statement.
Albert Bourla, chairman and chief executive officer, Pfizer, said: “As we face another autumn living with COVID-19, our Omicron BA.1-adapted bivalent vaccine presents EU residents, care providers and public health authorities with an immediate avenue to begin boosting immunity against Omicron, pending authorisation.
“This BA.1-adapted bivalent vaccine was clinically shown to have a favourable safety profile with immunogenicity against both wild-type and Omicron strains and may serve as a key component of vaccination strategies for the coming months.”
The CHMP’s positive opinion follows Pfizer/BioNTech’s BA.4/BA.5 adapted bivalent booster being granted Emergency Use Authorisation (EUA) by the US Food and Drug Administration (FDA) for ages 12 years and older.