FDA Emergency Use Authorization for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children under 5 years

Children in this age group can receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the bivalent vaccine to complete the primary series. Vaccine doses can be delivered immediately upon receipt of a recommendation from the U.S. Centers for Disease Control and Prevention.

On top of a persistent stream of COVID-19 cases, surging seasonal respiratory illnesses in young children are straining health systems across the U.S., with many states reporting more than 90% of their pediatric hospital beds are occupied. Updated COVID-19 vaccines may improve protection against severe illness and hospitalization caused by SARS-CoV-2 in this age group.

The amendment to the EUA is supported by clinical data from adults who received the Omicron BA.4/BA.5-adapted bivalent vaccine, post-authorization experience with this bivalent vaccine among ages 5 years and older, and post-authorization experience with the original Pfizer-BioNTech COVID-19 Vaccine as a three-dose primary series for children 6 months through 4 years of age. Additional support is provided by clinical data from the companies’ Omicron BA.1-adapted bivalent vaccine in adults as well as pre-clinical and manufacturing data from the companies’ 3-µg Omicron BA.4/BA.5-adapted bivalent vaccine. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the U.S. and European Union (EU).