The vaccine, mRNA-1273.214, has been granted conditional authorization in individuals aged 18+ as a booster dose by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Moderna announced yesterday.
In each dose of the booster vaccine, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms) targets Omicron.
Phase 2/3 trial
The decision from the MHRA was based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 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 (GMT) against Omicron approximately 8-fold above baseline levels.
In addition, mRNA-1273.214 elicited ‘potent neutralizing antibody’ responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.
“We are delighted with the MHRA’s authorization of Spikevax Bivalent Original/Omicron, our next-generation COVID-19 vaccine. This represents the first authorization of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic,” said Stéphane Bancel, CEO of Moderna.
“mRNA-1273.214 has consistently shown superior breadth of immune response over mRNA-1273 in clinical trials. This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.”