Vaxxinity, Inc. has initiated a rolling submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for conditional marketing authorization of its UB-612 COVID-19 vaccine as a heterologous boost to authorized primary series vaccines. UB-612 is currently being assessed in a Phase 3 pivotal trial as a booster vaccine for subjects who have received primary immunization with mRNA, adenovirus vector, or inactivated virus vaccines. Vaxxinity reiterates its plan to have a topline readout of the Phase 3 trial in the fourth quarter of 2022.
“Authorizations by stringent regulatory authorities such as the MHRA could open the pathway for UB-612 to reach countries with high unmet needs,” said Mei Mei Hu, CEO of Vaxxinity. “Because so many low and middle income (LMIC) countries look to stringent regulators' decisions as a reference, we anticipate that MHRA authorization, if achieved, could ultimately enable Vaxxinity to market UB-612 in a number of LMIC countries across the globe, which is the heart of Vaxxinity’s mission. Additionally, this authorization is a pathway to grant WHO emergency use listing (EUL), which would provide another option for getting UB-612 to countries through the COVAX program.”
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