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US FDA Vaccine Advisors Leave Door Open For COVID Emergency Use Authorizations For Young Children

 
• By Sarah Karlin-Smith

Many members of FDA’s Vaccines Related and Biologic Products Advisory Committee were emphatic about not closing off the EUA pathway for COVID-19 vaccines for younger children – a bit of a contrast to FDA’s unsureness in its briefing documents for the panel. However, the committee also had a solid minority of vocal opponents to speeding up pediatric approval of COVID vaccines given new myocarditis concerns and lower risk of poor COVID outcomes.

young child walking through partially open door
Most VRBPAC members wanted flexibility to use EUA pathway for pediatric COVID vaccines • Source: Cultura Creative RF / Alamy Stock Photo

A majority of US Food and Drug Administration vaccine advisors cautioned against closing off the emergency use authorization pathway for COVID-19 vaccines in children over concerns that the pandemic’s trajectory in the US may again get worse, even as they also encouraged FDA to push sponsors for larger pre-authorization pediatric studies.

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