MHRA approves adapted Nuvaxovid JN.1 COVID-19 vaccines for adults and children aged 12 plus

Press release

MHRA approves adapted Nuvaxovid JN.1 COVID-19 vaccines for adults and children aged 12 plus

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted version of the Nuvaxovid COVID-19 vaccine that targets the Omicron JN.1 COVID-19 subvariant.

This vaccine triggers the production of antibodies and blood cells by the immune system to work against COVID-19.

Nuvaxovid JN.1, developed by Novavax, is a vaccine licensed for adults and those aged 12 years and older.

The vaccine has been approved by the MHRA under the International Recognition Procedure, after confirming it meets the UK regulator's standards of safety, quality, and efficacy.

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:

"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."

A full list of all side effects reported with this medicine is available in the patient information leaflet (PIL) or from the product information published on the MHRA products website.

If a patient experiences any side effects, they should talk to their doctor, pharmacist or nurse. This includes any possible side effects not listed in the product information or the PIL which comes with this vaccine.

Patients can also report suspected side effects themselves, or a report can be made on their behalf by someone else, directly via the Yellow Card scheme. By reporting side effects, patients can help provide more information on the safety of this vaccine.

ENDS

Notes to editor

• The new marketing authorisation (licence) was granted on 13 November 2024 to Novavax CZ a.s., via the International Recognition Procedure
• This Nuvaxovid JN.1 product (PLGB 54180/0004) is a line extension of the existing Nuvaxovid COVID19 vaccine products (original vaccine and XBB.1.5 variant).
• More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
• Covid-19 metrics published by UKHSA: https://ukhsa-dashboard.data.gov.uk/respiratory-viruses/covid-19#cases
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.
• For media enquiries, please contact the [email protected], or call on 020 3080 7651.

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Published 15 November 2024