What is the FDA's current action regarding infant RSV drugs like Beyfortus?

The FDA has initiated a safety review for two approved infant RSV drugs, Beyfortus and Enflonsia.

Have any safety issues been reported for the infant RSV drugs Beyfortus and Enflonsia?

No safety issues have been reported by the drugmakers for either Beyfortus or Enflonsia.

Why is the American Academy of Pediatrics concerned about the FDA's RSV drug review?

The American Academy of Pediatrics fears the review may sow distrust in immunizations and lead to increased infant hospitalizations.

Home / Health / FDA Probes Infant RSV Drugs Amid Safety Review

FDA Probes Infant RSV Drugs Amid Safety Review

9 Dec

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Summary

FDA reviews safety of two approved infant RSV drugs.
Drugmakers report no safety issues with Beyfortus and Enflonsia.
Expert fears review may sow distrust in vital immunizations.

FDA Probes Infant RSV Drugs Amid Safety Review

The Food and Drug Administration (FDA) has launched a safety review concerning two recently approved respiratory syncytial virus (RSV) drugs intended for infants: Beyfortus and Enflonsia. Both medications are monoclonal antibodies that provide passive immunization against RSV. Despite the ongoing review, both Sanofi, maker of Beyfortus, and Merck, maker of Enflonsia, have affirmed that no safety concerns have been identified with their respective products.

Company representatives highlighted the extensive safety data supporting their drugs, with Sanofi noting over 400,000 infants involved in clinical and real-world studies and Merck emphasizing the high standards for preventive therapies. The FDA, through a Department of Health and Human Services spokesperson, stated that it routinely evaluates all products to ensure decisions are evidence-based and in patients' best interests, with labeling updates considered if warranted.