MHRA Grants Conditional Authorization to Moderna’s Bivalent COVID-19 Booster Vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorization to Moderna’s Omicron-targeted bivalent COVID-19 booster vaccine for individuals 18 years and older.

The bivalent vaccine is a combination of the company’s original Spikevax COVID-19 vaccine and a vaccine candidate targeting the Omicron BA.1 variant of concern.

The agency’s decision was based on data from a phase 2/3 clinical trial in which the booster showed an improved neutralizing antibody response against Omicron BA.1.

The bivalent vaccine also elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the Spikevax booster, Moderna said.