The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above.
The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group.
It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1 Omicron variant of concern.
After the vaccine was found to meet the standards of safety and quality, the regulatory agency granted the authorisation.
The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints.
In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) versus the 50µg mRNA-1273 booster dose.
Furthermore, neutralising geometric mean titers (GMT) against Omicron rose by nearly eight-fold above baseline levels following dosing with the booster shot of mRNA-1273.214.
Irrespective of previous infection or age, the vaccine-induced potent neutralising antibody responses against the BA.4 and BA.5 Omicron subvariants versus the presently authorised booster of mRNA-1273.
According to the safety monitoring, side effects were generally mild and self-resolving, as well as in line with those reported for the original Moderna booster dose.
In addition, no serious safety concerns linked to the vaccine were observed.
MHRA chief executive Dr June Raine 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.”
In June, Moderna signed an agreement in principle with the UK Government to build a new mRNA vaccine manufacturing facility in the country.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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