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US FDA Not Yet Sold On COVID Vaccine Emergency Use Authorization For Children Under 12

 
• By Sarah Karlin-Smith

Advisory committee will discuss merits of longer-term safety data for COVID-19 vaccines in children under 12, which could leave EUA pathway out of reach for this population. Immunobridging studies may also be more challenging in this population due to potential need for dose reductions.

young children playing
COVID-19 vaccine clearance in younger children presents more challenges than older pediatric populations • Source: MBI / Alamy Stock Photo

The US Food and Drug Administration appears uncertain as to whether COVID-19 vaccines for people under 12 should be granted an emergency use authorization or whether this indication must go through the full licensure process, preview documents released ahead of a 10 June agency advisory committee meeting on COVID vaccines in pediatrics indicate.

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