Global Phase III topline data is expected later this year for a new class of Covid-19 booster vaccine.
Vaxxinity has completed enrollment for the trial, co-sponsored by the Coalition for Epidemic Preparedness Innovations (CEPI). Its UB-612 will be evaluated as a heterologous booster vaccine to mRNA, adeno-vectored, and inactivated primary series vaccinations.
“Completing enrollment in a pivotal Covid-19 vaccine trial is a tremendous accomplishment in today’s environment and we are extremely grateful to all the participants, investigators, and CRO partners involved in this milestone. We look forward to announcing topline immunogenicity data that will serve as the basis for future authorisation applications,” said Mei Mei Hu, CEO of Vaxxinity.
The company has applied to the Therapeutic Goods Administration (TGA) in Australia for provisional approval of UB-612 after being granted provisional determination from the TGA in September 2022.
A rolling submission to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) was initiated in September.
“The review and potential approval by these two regulatory agencies will allow us to pursue our mission of democratising health by bringing UB-612 to the countries that are most in need of next generation Covid-19 vaccines,” Hu added.