The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorization for Pfizer Inc and BioNTech SE’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. 

The committee also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as a single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.

The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. Following a decision from the European Commission, the updated vaccine will be ready to ship to applicable EU member states immediately, according to a release from Pfizer. Pfizer and BioNTech have been manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.

“This season’s vaccine is ready to ship as soon as the final regulatory decision is made so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” says Albert Bourla, chairman and CEO at Pfizer, in a release. “It’s been nearly a year since many citizens in the European Union were vaccinated against COVID-19, and the updated formulation provides the opportunity for them to receive a vaccine more closely matched to current sublineages.”

Ugur Sahin, MD, CEO and co-founder of BioNTech, adds in a release, “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. Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally. The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalization.”

The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. The application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. 

Additional pre-clinical data demonstrate that serum antibodies induced by the updated COVID-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, also neutralize the globally dominant and recently World Health Organization-designated variant of interest EG.5.1.

Pfizer and BioNTech have also filed an application with the US Food and Drug Administration (FDA) requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older. A decision is expected in the coming days. The companies have submitted data for the updated COVID-19 vaccine to other regulatory authorities around the world

Pfizer-BioNTech COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.