The Medicines and Healthcare products Regulatory Agency (MHRA) has today approved a new updated version of the Moderna COVID-19 vaccine that targets both the original variant of the virus and Omicron, the variant now circulating worldwide. This type of vaccine designed to tackle two coronavirus variants is known as a ‘bivalent’ vaccine.
The approval – for use of the vaccine in the UK as a booster for adults – came as the MHRA found the vaccine to have met its standards of safety, quality and effectiveness. The decision was endorsed by the Government's independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.
In each dose of the new vaccine, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms) targets Omicron.
The MHRA's decision is based on data from a clinical trial which showed that the vaccine triggered a strong immune response against both variants, including the Omicron sub-variants BA.4 and BA.5, which are currently dominant in much of the world.
Side effects seen in the trial were similar to those for the original Moderna vaccine, and were typically mild and short-lived. No serious safety concerns were identified.
Dr June Raine, MHRA Chief Executive said:
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.
We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this will include the vaccine approved today.
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 how this vaccine should be offered as part of the vaccine programme.