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MHRA authorises Moderna’s omicron-containing bivalent booster

Study results show the candidate has demonstrated significantly higher antibodies against Omicron.

Moderna has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted conditional authorisation for the use of Omicron-containing bivalent COVID-19 booster vaccine, mRNA-1273.214

The treatment, which is also known as Spikevax Bivalent Original/Omicron – will be used as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains mRNA-1273 (the currently authorised booster) and is a vaccine candidate targeting the Omicron variant of concern.

“We are delighted with the MHRA’s authorisation 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 at Moderna.

“mRNA-1273.214 has consistently shown a 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 neutralising antibody response against Omicron when compared to a dose of mRNA-1273 in baseline participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titres against Omicron approximately eight-fold above baseline levels.

In addition, mRNA-1273.214 elicited neutralising antibody responses against Omicron sub-variants compared to the currently authorised booster regardless of prior infection status or age.

Moderna is currently working with The Vaccines 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 authorisation decisions in the coming weeks.