The UK is the first country to approve the Moderna vaccine that targets the original COVID-19 virus and the Omicron variant. It’s known as the “Spikevax bivalent Original/Omicron” vaccine.
It has been given conditional approval on Monday 15th August for adult doses by the Medicine and Healthcare Products Regulatory Agency (MHRA) as it met all the standards in the UK such as safety, quality, and effectiveness.
The Commission on Human Medicines, which is the government’s independent, expert scientific advisory body, was the one that endorsed this decision to grant approval after carefully receiving the evidence. Now Britain’s joint community on Vaccination and Immunisation (JCVI) are expected to issue a recommendation on how the vaccine should be deployed throughout the country.
It should be available in the planned autumn booster programme, starting in September, and give better protection against the other variants. Moderna has announced that supply could be out in the next few weeks but who will get them is yet to be said. But all over-50s and high risk could be offered a booster by next month.
The BBC also stated that 13 million doses by Moderna will be available this year but 26 million are eligible for some form of a booster.
In each dose of Spikevax bivalent Original/Omicron, one half of the vaccine (25 micrograms recorded by the British Government) targets the original virus from 2020 and the other half (25 micrograms) targets Omicron.
The decision of the MHRA was based on data from a clinical trial. It showed a booster, containing the bivalent vaccine, provided a strong, immune response against both Omicron (BA.1) and the virus strain from 2020. In a trial in June, Moderna said that given the fourth dose, the shot raised virus-neutralising antibodies 1.69 times higher (reported by Reuters) against Omicron and other sub variants (BA 4 and 5).
However, it remains unclear the correlation between the levels of neutralising antibodies and vaccine effectiveness against disease.
The side effects were also the same as those from the first Moderna booster (mild and self-resolving) with no serious concerns identified.
Dr June Raine, MHRA Chief Executive stated that “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.
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