Approval has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech Covid-19 vaccine that targets the Omicron XBB 1.5 subvariant.
The new version of Comirnaty was found to meet the UK regulator’s standards of safety, quality and effectiveness and has been approved for use in individuals from six months of age.
The European Commission’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for approval in the EU in August. An application has also been submitted to the US Food and Drug Administration.
“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 Professor Ugur Sahin, CEO and Co-founder of BioNTech.
“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.”
Applications to regulators have included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent Covid-19 vaccine generates a substantially improved response against multiple XBB-related 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 effectively neutralise the globally dominant and recently WHO-designated variant of interest EG.5.1 (or Eris).