NEW YORK -- Pfizer on Tuesday announced they are moving into phase 2/3 trials in younger children at lower doses than with adults.
Based on the safety, tolerability, and immunogenicity from their Phase 1 study, they've selected a dose of 10 micrograms to advance in children from ages 5-11 and 3 micrograms between 6 months to below the age of five.
Each child will still receive two doses.
The study will enroll up to 4,500 children at more than 90 clinical sites in the U.S., Finland, Poland, and Spain.
"Today marks an important next step in our efforts to understand the safety and immune response of our COVID-19 vaccine as we initiate the Phase 2/3 trial in children 5-11 years of age. Informed by the results from our Phase 1 study, we are moving forward with a 10 g dose level for this age group in a two-dose regimen," said Bill Gruber, M.D., Senior Vice President of Clinical Research and Development at Pfizer. "In the coming weeks, we plan to initiate Phase 2/3 in children 2-4 years of age and in children as young as six months to <2 years of age with a 3 g dose level in a two-dose regimen. We take a deliberate and careful approach to help us understand the safety and how well the vaccine can be tolerated in younger children. Children younger than 12 make up a significant portion of the total global population and can develop COVID-19 disease, and also can spread the virus to others. If successful, we believe vaccinating children will help further protect our communities and contribute to the evolving herd immunity."
(Video in media player above is from a previous report)