In a First, Updated Moderna Vaccine That Targets Both 2020 & Omicron Variants Approved in UK

The UK has approved an updated Covid-19 vaccine which can target both, the original and the Omicron variant of the virus, becoming the first country to do so.

The ‘bivalent vaccine’, as it is known, made by US drug company Moderna, was approved by the UK medicines regulator (MHRA) as a booster for adults, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness. The decision to grant approval for this booster vaccine was endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence, the MHRA said in a statement.

The agency’s decision was based on clinical trial data that showed the booster triggered “a strong immune response” against both Omicron (BA.1) and the original virus variant, it said, also citing an exploratory analysis in which the vaccine was found to generate a good immune response against both Omicron offshoots BA.4 and BA.5, which are currently dominant.

“The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives,” MHRA Chief Executive June Raine said in the statement. “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,” Raine 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,” Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said. “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.”

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In each dose of the booster vaccine, ‘Spikevax bivalent Original/Omicron’, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms) targets Omicron.

(With agency inputs)

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