Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
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Patient confidentiality and trial blinding precluded a Janssen official from sharing specifics about the safety event that led to a study enrollment pause, but Advisory Committee on Immunization Practices representatives say the lack of detailed, publicly disclosed information is not helping vaccine confidence.
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.
US FDA will be cautious about development of a COVID-19 vaccine for children, Commissioner Hahn says at the Financial Times US Pharma And Biotech Summit.