Moderna, Inc ., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted conditional authorization for the use of the Omicron-containing bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron▼) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern (BA.1).
"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, Chief Executive Officer 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."
The decision from the MHRA is 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.
Moderna is working with The Vaccine Taskforce, UK Health Security Agency, and NHS to make Spikevax Bivalent Original/Omicron available to the UK public. Moderna has completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the EU and expects further authorization decisions in the coming weeks.
Spikevax bivalent Original/Omicron is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.