Pfizer/BioNTech Evaluate COVID-19 Shot in Kids Aged 6 Months to 11 Years Old
The Pfizer/BioNTech COVID-19 vaccine is being assessed in a newly launched study in children as young as six months old.
The companies have begun a clinical trial of their COVID-19 vaccine in children six months to 11 years old, with phase 1 expected to enroll 144 participants. The study will initially seek to identify the preferred dose level (10, 20 or 30 micrograms) in three age groups ― five to 11 years, two to five years and six months to two years.
Once the dose level is confirmed, the phase 2/3 portion of the study will enroll up to 4,500 participants who will receive either the vaccine or a placebo, a Pfizer spokesperson told FDAnews.