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 regulator's standards of safety, quality and effectiveness.
Today's 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 MHRA's 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.
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