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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Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.
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.
An ex-member of the strategic advisory group to WHO's Global Vaccine Safety Initiative and infectious diseases expert shares his views on COVID-19 vaccines, shaping pediatric trials and areas that may need attention.