GSK’s RSV Vaccine Prospects in Youngest Pediatric Patients Looks Unlikely, per FDA Label
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May 11, 2023
GlaxoSmithKline Pharmaceuticals Ltd. won the first US approval for a respiratory syncytial virus vaccine on May 3 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 that the biological product would be unsafe in this pediatric group.”
The label for Arexvy, which is indicated for adults 60 and older, says “evidence from an animal model strongly suggests that Arexvy would be unsafe in individuals younger than 2 years of age because of increased risk of enhanced respiratory disease.”
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