The FDA has launched a safety review of approved respiratory syncytial virus therapies for infants, including Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck, Reuters reported Dec. 9.
Senior executives from the three companies were informed last week that the agency would seek further data on the therapies following internal concerns raised by FDA officials appointed under Health and Human Services Secretary Robert F. Kennedy Jr. Tracy Høeg, MD, PhD, recently named acting director of the FDA’s Center for Drug Evaluation and Research, initiated the safety inquiry over the summer. As a noted vaccine skeptic, the appointment of Dr. Høeg has raised serious concerns among healthcare experts.
While multiple safety studies have not identified a seizure risk, concerns were amplified after vaccine skeptics raised questions about potential side effects. The FDA said it is “rigorously reviewing the available data” and will update labeling if warranted.
Beyfortus has been available in the U.S. since July 2023. Enflonsia received FDA approval earlier in 2024. Together, the therapies have shown potential to reduce RSV-related hospitalizations by up to 43% during the 2024-25 season, according to a CDC analysis. Sanofi said Beyfortus’ safety and effectiveness have been demonstrated in more than 50 studies involving over 400,000 infants.
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