“The Medicines and Healthcare Products Regulatory Agency (MHRA) has today approved an updated version of Moderna’s COVID-19 vaccine that targets two variants of the coronavirus (known as a ‘bivalent’ vaccine) for booster doses for adults. to meet the safety, quality and efficacy standards of the UK regulator,” read an official government statement on Monday.
Half of the booster, called “Bivalent Spikevax Original/Omicron,” targets the original coronavirus strain, while the other half targets Omicron, he said.
The UK government said the decision to approve the shot was endorsed by the MHRA, the government’s independent expert scientific advisory body, after a careful review of the evidence.
It was approved following the results of a clinical trial, where Moderna reported that its Omicron-targeted booster showed a stronger immune response against the variant. The company said its updated booster also showed a “powerful” response against the BA.4 and BA.5 sub-variants.
The side effects were described by the MHRA as the same as for the original Moderna booster dose and were found to be “usually mild and self-resolving”.
“No serious security issues were identified,” the UK government statement said.
As Covid-19 continues to mutate, MHRA chief executive Dr June Raine said Moderna’s new booster will help keep communities protected.
“The first generation of the COVID-19 vaccine in use in the UK continues to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharp tool in our armory to help us protect us from this disease while the virus continues. to evolve.”
It is not yet clear who will provide the reinforcement or when. The UK’s Joint Committee on Vaccination and Immunization (JCVI) will advise on the roll-out of the vaccine.
Stéphane Bancel, CEO of Moderna, said on Twitter that he was “delighted” that the vaccine has been approved.
“This represents the first authorization of a bivalent vaccine containing Omicron, this bivalent vaccine has an important role to play in protecting people in the UK from Covid-19 as we enter the winter months,” he said.