VAXX - Vaxxinity initiates rolling submission for its COVID-19 shot with UK's drug regulator
- Vaxxinity ( NASDAQ: VAXX ) on Monday said it had started a rolling submission to UK's drug regulator for conditional marketing approval of its UB-612 COVID-19 vaccine for use as a booster dose.
- The shot is currently being evaluated in a phase 3 trial as a booster dose for subjects who have received primary immunization with mRNA, adenovirus vector or inactivated virus vaccines, VAXX said in a statement .
- VAXX reiterated its expectation of having a readout from the late-stage trial in Q4 2022.
- "Authorizations by stringent regulatory authorities such as the (UK's Medicines and Healthcare products Regulatory Agency) could open the pathway for UB-612 to reach countries with high unmet needs," VAXX CEO Mei Mei Hu said.
- Class A shares of VAXX were 0.5% lower at $2.15 in morning trading.
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Vaxxinity initiates rolling submission for its COVID-19 shot with UK's drug regulator