The Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement that it had approved the vaccine for adult booster doses “after it was found to meet the UK regulator’s safety, quality and efficacy standards.”
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the modified Modern coronavirus vaccine, which targets the Omicron variation in addition to the original version, has been licensed after it was found to meet the UK regulator’s safety, quality, and efficacy requirements.
After carefully evaluating the data, the government’s independent expert scientific advisory body, the Commission for Human Medicines, endorsed the decision to license this booster vaccination in the UK.
Half of each dose of the booster vaccine, ‘Spikevax bivalent Original/Omicron’, targets the original 2020 viral strain, while the other half (25 micrograms) targets Omicron.
The @MHRAgovuk has authorized the use of our #Omicron-containing bivalent #COVID19 booster vaccine, mRNA-1273.214, as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.https://t.co/0AkLiAhkEs pic.twitter.com/CxhhNjFZ50
— Moderna (@moderna_tx) August 15, 2022
Based on the results of a clinical trial, the MHRA concluded that a booster dose of the Moderna bivalent vaccine produces a strong immune response against Omicron (BA.1) and the original 2020 strain. The report found that the bivalent vaccination was effective in eliciting an immune response against the BA.4 and BA.5 subvariants of Omicron.
None of the adverse effects observed were considered substantial, and those were consistent with those found with the baseline Moderna booster dose.
Dr. June Raine, executive director of MHRA, said, “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 COVID-19 vaccine used in the UK continues to provide significant protection against the disease and save lives. What this bivalent vaccine gives us is a sharp tool in our arsenal to help us protect against this disease as the virus continues to evolve,” he said.
“We have a comprehensive safety surveillance strategy in place to monitor the safety of all COVID-19 vaccines approved in the UK and this will include the vaccine approved today,” he added.
To provide Spikevax Bivalent Original/Omicron Spikevax to the UK population, Moderna is working with the Vaccine Working Group, the UK Health Safety Agency, and the National Health Service. Further licensing decisions for mRNA-1273.214 are expected from Australia, Canada, and the EU, all of which Moderna has submitted for approval.