The regulatory body in the United Kingdom, the Medicines and Healthcare products Regulatory Agency, approved Moderna’s updated Covid-19 booster this week. The first bivalent vaccine for Covid-19 is now authorized for use and is effective against both the original SARS-CoV-2 strain and Omicron.
The update vaccine, developed by Moderna, has been approved for additional doses in adults after confirming it meets safety, quality, and efficacy standards set by the regulator.
Each dose of the Spikevax bivalent Original/Omicron booster contains 25 micrograms targeting the original virus and 25 micrograms targeting the Omicron variant, based on the composition announced for the 2020 strain.
The MHRA based its decision on clinical trial data showing a Moderna bivalent booster produced a strong immune response against both Omicron BA.1 and the original 2020 virus.
effective against Omicron BA.4 and BA.5
Early findings indicate the bivalent vaccine also prompts a solid immune response against Omicron sub-variants BA.4 and BA.5.
Side effects have mirrored those seen with the original Moderna booster and are generally mild. No serious safety concerns have been reported.
The MHRA Chief Executive Officer stated the approval of the Moderna bivalent booster vaccine offers a robust immune response against Omicron BA.1 and the original 2020 strain in clinical trials. He noted that this vaccine adds a refined tool to protect against evolving variants while first generation vaccines continue to save lives.
Experts highlighted that this development marks a step forward in vaccine strategy, expanding coverage against a broader range of virus variants and enhancing protection as the virus continues to evolve.
In front of the British agency EMA
The United Kingdom has shared its decision with the European Medicines Agency which is reviewing Moderna’s bivalent version alongside a Pfizer-BioNTech variant. The EMA has signaled an ongoing assessment of these updated vaccines as part of its broader review.
Recent statements indicated that vaccines adapted to the BA.1 and BA.4/5 variants were expected to be ready for fall booster campaigns. This alignment with other major regulators underscores a coordinated approach to updating vaccines in response to evolving variants.