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GSK’s RSV Vaccine Prospects In Youngest Pediatric Patients Looks Unlikely Per US FDA Label

 
• By Sarah Karlin-Smith

Arexvy is the first vaccine approved for the respiratory virus, but GSK's RSV program may lose out on a key population due to safety concerns for individuals younger than two. For Arexvy, CDC’s advisory committee could limit recommendation to 65 and up at June meeting.

baby getting treated for respiratory disease
GSK will need a next generation RSV vaccine for infants and toddlers. • Source: Shutterstock

GlaxoSmithKline Pharmaceuticals Ltd.won the first US approval for a respiratory syncytial virus vaccine on 3 May in older adults but looks like it may not be able to claim the same crown in the other key population impacted by the virus – infants and young children.

The Food and Drug Administration approval letter for GSK’s Arexvy says the agency is waiving the pediatric study requirement for children ages 0 to 2 “because there is evidence strongly suggesting

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