UK Approves First Bivalent mRNA COVID-19 Booster Vaccine

Massachusetts-based Moderna, Inc. today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorization for using the Omicron-containing bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax Bivalent Original/Omicron) targeting the variant of concern BA.1.

The MHRA's Conditional Marketing Authorisation for the SpikeVax bivalent booster vaccine is valid in Great Britain only.

An emergency use authorization has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. 

Dr. June Raine, MHRA Chief Executive, said in a press statement issued on August 15, 2022, "The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives."

"What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve."

The decision from the MHRA is based on clinical trial data from a multi-part phase 2/3 clinical trial, in which a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers 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 SpikeVax booster (mRNA-1273) regardless of prior infection status or age.

Note: These announcements were manually aggregated and curated for mobile readers.