An FDA advisory committee said it wants to see more data to understand the implications of what the FDA called an “imbalance” in cases of severe respiratory syncytial virus among infants participating in an early-stage RSV vaccine trial.
In a briefing document published ahead of Thursday’s meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA announced that it was putting a hold on enrolling children aged younger than 2 years in any clinical studies of RSV vaccines being developed in the United States.
The pause was in response to five