Approvals

Approval of an updated version of the Nuvaxovid COVID-19 vaccine, developed by Novavax, has been granted by The Medicines and Healthcare products Regulatory Agency (MHRA), to target the Omicron JN.1 COVID-19 subvariant.

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Designed to stimulate the immune system by producing protective antibodies and blood cells, this adapted Nuvaxovid JN.1 COVID-19 vaccine is authorised for adults and children aged 12 and older. Known as Nuvaxovid JN.1 (PLGB 54180/0004), it builds on the existing Nuvaxovid line-up, which includes formulations for the original virus strain and the XBB.1.5 variant. The approval, granted under the MHRA International Recognition Procedure, confirms the vaccine meets the UK regulator’s standards for safety, quality and efficacy, further enhancing the fight against COVID-19.

Julian Beach, MHRA interim executive director, Healthcare Quality and Access commented, “Keeping patients safe and enabling their access to high quality, safe and effective medicinal products are key priorities for us. We are assured that the appropriate regulatory standards for the approval of this vaccine have been met. As with all products, the MHRA will keep the safety of this vaccine under close review.”

Patients experiencing side effects, including those not listed in the product information or PIL, should consult their doctor, pharmacist, or nurse. Side effects can also be reported directly or on behalf of someone else via the Yellow Card scheme, helping to improve understanding of the vaccine's safety. Noravax is a global biotechnology company based in Gaithersburgh, MA, US.