Pfizer and BioNTech’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine has been recommended by the European Medicines Agency’s human medicines committee for individuals aged six months and older.
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended marketing authorisation for a single dose of the vaccine, known as Comirnaty Omicron XBB.1.5, in eligible individuals aged five years and older, regardless of their COVID-19 vaccination history.
The Committee has also recommended that children aged from six months to four years may have one to three doses of the updated vaccine, depending on their previous primary vaccination and whether they have had COVID-19.
The recommendation follows evidence from pre-clinical data that showed that the vaccine generated a substantially improved response against multiple XBB sublineages of the SARS-CoV-2 virus variants, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Efficacy against variants included the globally dominant variant EG.5.1, known as Eris, which was designated as a ‘variant of interest’ by the World Health Organization earlier this month.
The European Commission (EC) will now review the CHMP’s recommendations and is expected to make a final decision soon. Following its decision, the updated COVID-19 vaccine will be ready to be supplied to EU member states immediately.
Albert Bourla, chairman and chief executive officer at Pfizer, said: “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.”
Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said: “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 hospitalisation.”
Pfizer and BioNTech have also filed an application with the US Food and Drug Administration (FDA) for the approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine in individuals aged six months and older.
In June this year, an FDA advisory committee recommended that updated COVID-19 vaccines be developed to target the currently circulating XBB variants.
The Vaccines and Related Biological Products advisory committee voted 21 to zero in favour of the monovalent XBB-lineage vaccines, and generally agreed that vaccines targeting the XBB.1.5 subvariant would be preferred.