GSK’s RSV Vaccine Prospects in Youngest Pediatric Patients Looks Unlikely, per FDA Label

  • 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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  • Sarah Karlin-Smith

    Sarah is a senior writer with Pink Sheet and has covered U.S. regulation and reimbursement policy for the biopharma industry since 2004, starting with the establishment of the Medicare Part D program. Since then, she has written extensively about developments in all major sectors of the U.S. insurance market (Medicare, Medicaid and commercial plans). She has covered key legislation affecting biopharma, including the Medicare Prescription Drug, Improvement, and Modernization Act which created Part D, health care reform under President Obama, and the Inflation Reduction Act. She has closely followed the increasing influence of pharmacy benefit managers and their use of formulary negotiations and rebates to control pricing. Cathy also has covered developments in health technology assessments and has monitored industry progress on novel drug contracting that reflects value-based pricing.

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