Updated Moderna vaccine which targets Omicron gets UK nod: Know all about the 'bivalent' booster jab

Medicines and Healthcare products Regulatory Agency (MHRA) announced that the modified Moderna vaccine against coronavirus, which targets the Omicron variation in addition to the original version, has been authorised after being determined to fulfil UK regulator's requirements for safety, quality, and efficacy.

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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

After carefully assessing the data, the government's independent expert scientific advisory body, the Commission on Human Medicines, backed the decision to provide authorisation for this booster vaccination in the UK.

Half of each dosage of the booster vaccine, 'Spikevax bivalent Original/Omicron,' targets the original viral strain from 2020, while the other half (25 micrograms) targets Omicron.

Based on the results of a clinical trial, the MHRA has concluded that a booster dose of the bivalent Moderna vaccine produces a strong immune response against both Omicron (BA.1) and the original 2020 strain. The report found that the bivalent vaccination was effective in provoking an immunological response against the Omicron sub-variants BA.4 and BA.5.

None of the adverse effects seen were considered to be substantial, and those that were were consistent with those found with the baseline Moderna booster dosage.

Dr June Raine, MHRA Chief Executive 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 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," she said.

“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,” she added.T

To provide Spikevax Bivalent Original/Omicron to the people of the United Kingdom, Moderna is working with the Vaccine Taskforce, the UK Health Security Agency, and the National Health Service. Further authorization decisions for mRNA-1273.214 are expected from Australia, Canada, and the EU, all of which Moderna has submitted to for approval.