Pfizer and BioNTech released data associated with their Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine. The companies have been criticized, along with the government, for releasing the product to the market prior to the completion of clinical trials.
Typically, before such products are authorized on an emergency basis or formally approved, they are subjected to extensive testing in randomized controlled trials. In the case of this Omicron subvariant-focused booster, the regulatory authorities, such as the U.S. Food and Drug Administration (FDA), in America accepted the investigational product on an emergency use authorization (EUA) basis due to animal data and risk-based assessments of the mRNA technology platform (e.g., prior clinical trials and real-world data). Both BioNTech and Pfizer are sponsoring a clinical trial (NCT05472038) evaluating the safety, tolerability, and immunogenicity of the BNT162b2-based bivalent booster based on a 30-µg booster of the investigational product (product still investigational as it’s under EUA).