Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for active immunisation in individuals aged 12 and older.
The protein-based vaccine has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5.
The MRHA authorisation was based on non-clinical data, which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3.
Furthermore, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, JN.1, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.
Individuals aged 12 years and older who were previously vaccinated with COVID-19 vaccines, as well as those who have not recently received an updated mRNA COVID-19 vaccine, will be eligible to receive a single dose.
Unvaccinated individuals will be eligible to receive two doses of the vaccine.
“[The] MHRA authorisation is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year,” said John Jacobs, president and chief executive officer, Novavax.
He continued: “We are in ongoing conversations with additional UK partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one.
“We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the UK.”
The authorisation follows Nuvaxovid XBB.1.5 receiving an Emergency Use Listing (EUL) by the World Health Organization (WHO) in November last year, allowing all 194 member states of WHO to expedite regulatory approvals to import and administer the vaccine.
The updated vaccine has already received approvals from the European Commission (EC) and the US Food and Drug Administration (FDA), as well as recommendations by the European Medicine’s Agency and the European Centre for Disease Prevention and Control.
The FDA’s EUL was granted after the vaccine’s known and potential benefits outweighed its known and potential risks and the EC’s decision was supported by positive results from the phase 3 PREVENT trial, which evaluated the safety, immunogenicity and efficacy of the vaccine.