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Bivalent COVID-19 booster vaccine approved in UK

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The COVID-19 vaccine, by Moderna, has been adapted to target two different COVID-19 variants; the original 2020 virus and the Omicron variant. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the bivalent vaccine for adult booster doses in the UK.

Key highlights:

Results came from a clinical trial showing that the bivalent booster generates a “strong immune response” against both the Omicron BA.1 strain and the 2020 strain. The ‘Spikevax bivalent Original/Omicron’ vaccine targets half (25 micrograms) of its dose to each strain.

Also, Omicron sub-variants BA.4 and BA.5 were both targeted by an immune response from the vaccine, a further exploratory analysis showed.

After evaluation of data, the booster vaccine was granted approval by the MHRA once it met the “UK regulator’s standards of safety, quality and effectiveness”.

Safety monitoring found no adverse effects related to the dose. Instead, only the side effects that have been shown in the original Moderna booster dose have been seen, which were considered “mild and self-resolving”.

MHRA chief executive, Dr. June Raine, commented: “I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain.

“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.

Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines said: “The Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality and effectiveness and agrees with the MHRA’s decision.”

“The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines. This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine.”

The Joint Committee on Vaccination and Immunisation (JCVI) will advise on the next steps of bringing the booster to the vaccine deployment programme.

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