A bivalent COVID-19 vaccine, targeting the original strain and the Omicron variant, has been approved for use in the UK for the first time.
Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Spikevax bivalent vaccine, manufactured by Moderna, for adult booster doses this autumn.
Half of the vaccine – 25 micrograms – targets the original virus strain from 2020 while the other 25 micrograms targets Omicron.
The MHRA approved the vaccine after a clinical trial showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. It was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.
The UK Health Security Agency, which is considering which vaccines to use this winter, said it produces a “marginally” greater immune response than the company’s original mRNA vaccine.
The bivalent vaccine is to be offered routinely in Wales to over 18s in the group’s targeted for vaccination. Scotland announced its booster campaign on Sunday before the announcement of the bivalent vaccine.
Dr June Raine, MHRA chief executive, said: “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, added: “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.”
Safety monitoring showed that side effects were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving. No serious safety concerns were identified.
The Joint Committee on Vaccination and Immunisation (JCVI) will now advise on how the bivalent vaccine should be offered as part of the booster programme.
Dr Mary Ramsay, Head of Immunisation at the UK Health Security Agency, said: “Although cases of COVID-19 are relatively low at present, we are expecting to see the virus circulating more widely during the winter months.
“The booster is being offered to those at higher risk of severe illness and by taking up the booster vaccine this autumn, you will increase your protection ahead of the winter months, when respiratory viruses are typically at their peak.”
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