Posted by Michael Wonder on 23 Aug 2022
Moderna completes application to US FDA for emergency use authorisation of omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222
23 August 2022 - Clinical data available for Moderna's bivalent COVID-19 booster vaccines have met all primary endpoints and support request for emergency use authorisation.
Moderna today announced that it has completed its submission to the US FDA for emergency use authorisation for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222.
The application is for a 50 mcg booster dose for adults 18 years of age and older, and is based on preclinical data as well as clinical trial data available for the company's BA.1 omicron-targeting bivalent booster candidate, mRNA-1273.214.
