A master phase 1/2/3 protocol to investigate the safety, tolerability, and immunogenicity of variant-adapted BNT162b2 RNA-based vaccine candidate(s) in healthy children (H-52466 41890277.0)

We are conducting a clinical trial for our updated COVID-19 vaccine designed to protect against the newer variant called Omicron KP.2. The study vaccine has been authorized by the United States Food and Drug Administration for children at least 6 months of age.

The goal of this study is to better understand how well the updated COVID-19 vaccine works in children who have not been previously vaccinated and to see if the number of recommended doses can potentially be reduced for children 6 to 23 months of age.

Children enrolled in this study will receive 2 doses of the updated COVID-19 vaccine. Doses will be given as an injection in the thigh.

Your child will be enrolled for 8-9 months and will need to attend at least 2 study visits. Parents/guardians will also have at least 3 scheduled phone calls with the study team.