UK approves Moderna’s bivalent COVID-19 vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster.

The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. The decision was also endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after a careful review of the evidence.

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

The MHRA’s decision is based on data from a clinical trial which showed that a booster dose of 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. No serious safety concerns were identified.

Dr June Raine, MHRA Chief Executive commented: “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.”

The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme.

The European Commission (EC) recently amended its supply agreement with Moderna to convert contractually agreed doses of the Spikevax vaccine to the Omicron-containing bivalent version for supply in 2022, pending regulatory approval. The EC also agreed to purchase an additional 15 million doses of Omicron-containing vaccine booster candidates from Moderna.