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US FDA Rethinking Requirements For Pediatric RSV Vax Studies After Indication-Wide Holds

 
• By Sarah Karlin-Smith

The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.

baby being treated with nebulizer
The FDA is looking for advice for continuing RSV vaccine development in infants and toddlers while avoiding the risk of vaccine-associated enhanced respiratory disease. (Shutterstock)
Key Takeaways
  • Concerns about vaccine-associated enhanced respiratory disease (VAERD) in two Moderna pediatric RSV vaccine candidates caused the FDA to place a hold on their Phase I study and ultimately expand it to all RSV vaccine programs in children younger than 2 and RSV naïve children age 2 through 5, advisory committee preview documents revealed.
  • VAERD has been a concern with RSV vaccines since the 1960s, but Moderna’s data suggest the FDA may need to update requirements intended to protect study participants.
  • The FDA also wants its vaccines advisory committee to help determine how to assess the interaction of new prophylactic RSV antibodies for infants and investigational RSV vaccines.

More clinical and nonclinical safeguards may be needed before studies of respiratory syncytial virus (RSV) vaccine candidates in infants and toddlers can continue.

Enrollment of children younger than 2 and RSV-naïve children age 2 through 5 in all RSV vaccine trials was put on hold after data from two Moderna RSV...

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