Moderna's RSV Vaccine Approval Faces Setback as FDA Delays Decision

  • 28 days ago
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" at the agency. The FDA was originally expected to make a decision on approving the vaccine by this Sunday. Moderna says the FDA has not informed them of any issues related to the vaccine's safety, efficacy, or quality that would prevent approval. Approval of the RSV vaccine would be Moderna's second FDA-approved product after its COVID-19 vaccine. Moderna shares have risen over 20% this year.