Moderna Targets 2021 Back-To-School Season For Pediatric Data On COVID-19 Vaccine
Sponsors are moving to younger populations as the adult clinical trials near enrollment goals; Moderna’s CEO says data in children younger than 12 will be slow to emerge.
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J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.
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.
However, recruitment for adult trials remains robust, OWS’ Slaoui says.