UK's medicines regulator has granted Moderna conditional authorization for the use of its Omicron-containing bivalent COVID-19 booster vaccine, marking the first global approval for an Omicron-targeted shot.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorized mRNA-1273.214 (Spikevax Bivalent Original/Omicron) — a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern (BA.1) — as a booster dose to prevent COVID-19 in individuals 18 years of age and older.
The decision from the MHRA is based on clinical trial data from a phase 2/3 trial, in which the new booster met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers against Omicron approximately 8-fold above baseline levels. In addition, the booster elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster, regardless of prior infection status or age.
Britain's Joint Committee on Vaccination and Immunisation (JCVI) is now expected to issue a recommendation soon on how the vaccine should be deployed in the country. Moderna says it has also completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the EU and expects further authorization decisions in the coming weeks.
