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)

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