GovWire

Authorisation has today been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a new version of the Moderna bivalent Covid vaccine (Spikevax) that targets both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants.

This updated vaccine, which can be used as a booster in individuals aged 12 years and above, is the second bivalent vaccine from Moderna to be authorised by the MHRA after it was found to meet the UK regulators standards of safety, quality and effectiveness.

Todays decision, based on the advice of the Commission on Human Medicines, has been taken after a careful review of the evidence.

In each dose, half of the vaccine targets the original virus strain and the other half targets Omicron (BA.4 and BA.5).

The MHRAs decision is based on all available evidence on the original Moderna COVID-19 vaccine and its adapted vaccines. This includes extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent Original/Omicron BA.1 vaccine and safety data from an on-going clinical trial. These show that the common side effects observed with the new bivalent vaccine were the same as those seen for other versions of the vaccine. These side-effects were typically mild and self-resolving, with no new safety concerns identified.

All authorised COVID-19 booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19.

Notes to editors:

• More information about this vaccine can be found on our Product Information page

• The first bivalent vaccine from Moderna (Spikevax) was authorised by the MHRA on 15 August 2022

• This new line extension granted by the MHRA is valid in Great Britain only and was authorised via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMAs Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety and effectiveness of the vaccine.

• 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.

• The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the?Department of Health and S

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