Pfizer and BioNTech announced a 30-µg booster dose of their Omicron BA.1 Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

The Omicron BA.1-adapted bivalent vaccine contains 15 µg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15 µg of mRNA encoding the spike protein of the Omicron BA.1 subvariant. Apart from the addition of the mRNA sequence of the BA.1 spike protein, all other components of the vaccine remain unchanged.

“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 authorization,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “This BA.1-adapted bivalent vaccine was clinically shown to have a favorable 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.”

“Today’s positive opinion by the committee confirms that immunogenicity and safety goals of variant-adapted mRNA vaccines can be met. 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 neutralizing antibody titers against the Omicron BA.1 and BA.4/BA.5 sublineages,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In addition, a booster dose of our Omicron BA.1-adapted bivalent vaccine is anticipated to preserve and expand the breadth of B and T-cell responses with the aim to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron sublineages.”

Today’s recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) to advance a bivalent vaccine candidate, with the goal of making an Omicron-adapted vaccine available to European Union (EU) member states as soon as possible.

The CHMP recommendation is based on previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of participants 56 years of age and older who received a 30-µg booster dose of the Omicron BA.1-adapted bivalent vaccine. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine (n=178) elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine (n=163) as demonstrated by an approximately 9-fold improvement in neutralizing titers. In additional analyses of a SARS-CoV-2 live virus neutralization assay tested on sera from participants in this trial, neutralization titers improved by approximately 4-fold for BA.4/BA.5 (n=100). The BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.

If an authorization is granted, COMIRNATY® Original/Omicron BA.1 15/15 ug doses 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.

The companies have also filed an application 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. This application is currently under review. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.