Comirnaty Omicron XBB.1.5 Vaccine Recommended in Europe

The European Medicines Agency (EMA) today announced the Human Medicines Committee (CHMP) has recommended authorizing an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.

COVID-19 vaccines are being adapted to better match the circulating SARS-CoV-2 variants.

On August 30, 2023, the EMA stated the Comirnaty Omicron XBB.1.5 vaccine is to prevent COVID-19 in adults and children from 6 months of age.

In its decision to recommend the authorization, the CHMP considered all available data on Comirnaty and its other adapted vaccines, including safety, efficacy, and immunogenicity data.

In addition, the CHMP assessed new laboratory data showing a strong response of the adapted vaccine against XBB.1.5 and related strains of the betacoronavirus that causes COVID-19. 

The EMA will now send the CHMP’s recommendation to the European Commission for an EU-wide legally binding decision.

“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants or sublineages to people worldwide to support vaccinations in the upcoming fall and winter season,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, in a press release.

“Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for most COVID-19 cases globally. The updated COVID-19 vaccine aims to improve protection against severe illness and hospitalization further.”

In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control, adults and children from 5 years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history.

Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19.

The EMA stated that more data on emerging variants are expected, and the Committee will assess these data when available.

Pfizer and BioNTech have also filed an application with the U.S. Food and Drug Administration requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine and expect a decision in the coming days. The companies have submitted data for the updated COVID-19 vaccine to other regulatory authorities worldwide.

As with the other eleven WHO-Listed COVID-19 vaccines, national authorities determine how to use vaccines in national vaccination campaigns, considering factors such as infection and hospitalization rates, the risk to vulnerable people, and vaccine availability.