MHRA approves Spikevax bivalent Original/Omicron booster that targets two COVID-19 variants
An updated version of the COVID-19 bivalent vaccine made by Moderna that targets two coronavirus variants has been approved for adult booster doses by the Medicines and Healthcare products Regulatory Agency (MHRA) 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 in the UK 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 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.
The MHRA’s decision is based on data from a clinical trial which showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. In an exploratory analysis the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5. Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified.
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