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Pediatric RSV Vaccine Research Should Resume Cautiously US FDA Advisers Say

 
• By Sarah Karlin-Smith

A safety signal may be platform or even Moderna-specific, the Vaccines and Related Biological Products Advisory Committee said.

baby being provided oxygen
The VRBPAC said more research is needed to determine if additional safety precautions could be taken to mitigate the risk of VAERD with RSV vaccines. (Shutterstock)
Key Takeaways
  • The FDA's VRBPAC seems to believe the VAERDS safety signal with Moderna's RSV vaccines may be unique to the sponsor's program or the mRNA platform.
  • The panel said more research is needed on the natural immune response to RSV and patients who experience VAERDS versus those that do not to devise better protections for future vaccine candidates.
  • Despite not suggesting new safety measures, the advisory committee generally felt the current RSV research precautions were strong and did not recommend the current clinical holds remain in place.

The US Food and Drug Administration’s vaccine advisers were not particularly confident, but seemed to feel the safety signal observed in a Moderna respiratory syncytial virus (RSV) vaccine...

The sentiment led the Vaccines and Related Biological Products Advisory Committee to conclude, without voting, that research of other platforms in the space, including potentially in very young children, could...

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