1. Pink Sheet

Pfizer/BioNTech’s COVID-19 Vaccine Moves Into Adolescents; Adcomm To Weigh Broader Pediatric Issues

 
• By Sue Sutter

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.

Teenagers
US teenagers 12-15 years old are now eligible to receive Pfizer/BioNTech's COVID vaccine. • Source: Alamy

The US Food and Drug Administration expanded the authorized use of Pfizer Inc. and BioNTech SE’s COVID-19 vaccine to adolescents on 10 May, just hours after announcing plans for a June advisory committee meeting to discuss pediatric data requirements for vaccines directed against the SARS-CoV-2 virus.

The FDA granted Pfizer’s request to expand the vaccine’s emergency use authorization to include individuals ages 12-15 years old, making...

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