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AstraZeneca’s Nirsevimab: US FDA Wants Input On How It Would Fit With Pediatric RSV Vaccines

Executive Summary

Proposed RSV prevention treatment for infants and neonates showed efficacy with few safety concerns, but with pediatric vaccines in development, FDA wants the Antimicrobial Drugs Advisory Committee to discuss what data would be needed to determine appropriate use in vaccinated infants and mothers.

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