ORANGE COUNTY, Fla. — Part of the data the FDA will analyze when it reviews Pfizer’s bid for emergency use of its COVID-19 vaccine for children under 12 will come from Central Florida.
Nearly 100 local children are being called superheroes for their role in the pivotal study.
It’s just one of dozens of clinical studies underway at CNS Healthcare, but this one can’t help but stand out as part of a 90-site trial for Pfizer, which is testing a third of its adult dose in children under 12 across the world.
Many of the 96 children in the research are children of volunteers in Pfizer’s 800-subject adult study last year.
The site is reporting no adverse reactions for any child, and study-wide results show a 95% immune response.
If and when the emergency authorization comes, all children who received the placebo in this study will then get the two-dose regimen and follow-up.
About 4,500 children in several countries took part in the study. Pfizer is expected to submit its emergency-use application before Oct. 1.