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COVID-19 Vaccines: Pediatric Effectiveness Bridging Not Dependent Upon Immune Correlates

 
• By Sue Sutter

Ability to bridge from adult effectiveness data to children in the absence of an identified correlate of protection could be affected by proposed dosing regimen and expected similarity in pediatric response, US FDA official says.

Teenagers
Adolescent studies are underway for some COVID-19 vaccines. • Source: Shutterstock

Identifying immune correlates of protection would make it easier to expand the use of COVID-19 vaccines into children, but the absence of such markers is not necessarily a bar to bridging from adult efficacy data to the pediatric population, a US Food and Drug Administration official said.

Doran Fink, deputy director for clinical review in the FDA’s Division of Vaccines Research and Review, said the agency is talking to COVID-19 vaccine manufacturers about the contours of their pediatric programs, including studies that are underway as well as those in the planning stages

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