The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.
Pfizer and BioNTech have submitted an emergency use authorization (EUA) request to the FDA for a booster dose of their COVID-19 vaccine that has been adapted specifically for the omicron BA.4/BA.5 variants for those 12 years and older. If authorized the update vaccine will be available to ship immediately.
The application follows guidance from the FDA to include clinical data from the companies’ bivalent omicron BA.1-adapted vaccine and preclinical and manufacturing data from the companies’ bivalent omicron BA.4/BA.5-adapted vaccine to address the continued evolution of COVID-19 virus.
A conditional marketing authorization application has also been initiated with the European Medicines Agency for the omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.
“In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the United States with the possibility to get a booster adapted to the currently most dominant strain of the virus,” Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech, said in a press release.
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein together with mRNA encoding the spike protein of the omicron BA.4/BA.5 variant. Preclinical data showed a booster dose of Pfizer and BioNTech’s micron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of this booster in people 12 years of age and older is expected to start this month.
The companies previously announced safety, tolerability and immunogenicity data from a phase 2/3 trial of a 30-µg booster dose of their omicron BA.1-adapted bivalent vaccine candidate.