Pfizer and BioNTech Announce Submission for Emergency Use Authorization from the U.S. Food and Drug Administration for omicron BA.4 and BA.5 COVID-19 Booster Vaccine Tailored for Persons 12 Years and Older .
The request is in line with FDA guidelines to include clinical data for the bivalent vaccine, the two companies said in a joint statement. Pfizer and BioNTech have also applied to the European Medicines Agency for a conditional authorization for the vaccine.
According to the release, preclinical data showed that a booster dose of the Omicron BA.4/BA.5 adapted bivalent vaccine elicited a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA variants. .5, as well as the original wild-type strain. A clinical study examining the safety, tolerability, and immunogenicity of this vaccine in people 12 years of age and older is expected to begin this summer.
Source: BFM TV
