UK’s medicine regulator approves first bivalent COVID-19 booster vaccine

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first bivalent COVID-19 booster vaccine.

According to June Raine, MHRA Chief Executive, ”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 “bivalent” vaccine, made by Moderna, targets two coronavirus variants and targets the original virus strain from 2020 and the Omicron variant.

In particular, the booster with the bivalent  Moderna vaccine generates a good immune response against the Omicron sub-variants BA.4 and BA.5 which were spreading rapidly across Europe.

The variant-adapted shot raised virus-neutralising antibodies by eight-fold against Omicron during its fourth dose as per trial data by Moderna.

The antibody levels generated by the variant-adapted booster against sub-variants were 1.69 times higher than those given the original booster, according to Moderna.

With no serious safety concerns, 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.

The decision regarding the deployment of the vaccine will be made by Britain’s Joint Committee on Vaccination and Immunisation (JCVI).

Vaccine effectiveness has taken a hit as the virus has evolved even though existing COVID-19 vaccines continue to provide good protection against hospitalisation and death.

(With inputs from agencies)

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