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Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors

 
• By Brenda Sandburg

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.

adolescent with mask vaccinated (source: iStock / Getty Images Plus)
FDA advisory committee discusses when COVID-19 vaccines should be tested in adolescents • Source: iStock/Getty Images Plus

Vaccine experts disagree on whether children should be included in COVID-19 vaccine clinical trials, as some contend more safety data must be gathered in adults before extending enrollment to the pediatric population.

The issue was raised during the first meeting of the US Food and Drug Administration’s Vaccines and Related Biologics Advisory Committee on coronavirus vaccines. Currently, Pfizer Inc

“There’s a lot of discussions ongoing right now between product developers and FDA about enrollment of these younger populations” and what that will look like, Robert Johnson, director of the division of influenza and emerging infectious diseases at the

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