COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age.
The booster can be administered at least two months after completing the primary vaccination series with three doses of the original Pfizer-BioNTech COVID-19 vaccine. Additionally, FDA has authorized the bivalent vaccine for use as the third dose in a primary series for the same age group. The agency, however, has not yet authorized a fourth booster dose.
Trial data Supports bivalent vaccine safety and efficacyThe EUA is based on data from substudies within the companies’ Phase 1/2/3 trial (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth bivalent vaccine dose in 300 children aged 6 months to 4 years. A subset of 60 study participants within the same age group demonst…