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

 
• By Derrick Gingery

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.

RSV Vaccine
The FDA and CDC could co-develop educational materials for nirsevimab similar to Vaccine Information Statements. • Source: Shutterstock

AstraZeneca PLC and Sanofi’s proposed RSV prevention treatment nirsevimab did not appear to present any major problems for the US Food and Drug Administration with an advisory committee meeting approaching, but the agency does have questions about it should be used if pediatric RSV vaccines were to reach the market.

Nirsevimab, also known as Beyfortus, is proposed for prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and children up...

Key Takeaways

  • Nirsevimab efficacy and safety appeared to raise no major issues with the FDA

  • The pharmacovigilance plan includes vaccine-like information for parents

  • The...

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