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.
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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.
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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.
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About 4,500 children in several countries took part in the study. Pfizer is expected to submit its emergency-use application before Oct. 1.
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