Pfizer and BioNTech’s 30µg booster dose of the jointly developed Omicron BA.4/BA.5 bivalent COVID-19 vaccine booster – Comirnaty Original/Omicron BA.4/BA.5 15/15 µg – 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.4/BA.5 subvariants.
The booster has already been granted Emergency Use Authorisation (EUA) by the US Food and Drug Administration (FDA) for ages 12 years and older.
“This recommendation marks another major milestone in the ongoing global fight against COVID-19, bolstering our defenses as we prepare for fall and winter with potential increased exposure to the virus,” said Albert Bourla, chairman and chief executive officer, Pfizer.
The recommendation is based on clinical data from the Pfizer/BioNTech Omicron BA.1 adapted bivalent vaccine, as well as pre-clinical data which demonstrated a booster dose of the Pfizer/BioNTech Omicron BA.4/BA.5-adapted bivalent vaccine generated a ‘strong neutralising antibody response’ against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain.
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.
“If the European Commission follows today’s recommendation by the CHMP, EU residents will have access to Omicron-adapted vaccines before the start of the winter season,” said Ugur Sahin, chief executive officer and co-founder BioNTech.
“The bivalent vaccines encode the spike protein of the SARS-CoV-2 wild-type as well as a spike protein of an Omicron subvariant. They aim to provide broader immunisation against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern,” Ugur added.
The announcement follows the CHMP’s recommendation of Pfizer and BioNTech’s 30µg booster dose of their Omicron BA.1 bivalent COVID-19 vaccine booster, also for individuals 12 years and older, earlier this month.