Moderna said the Food and Drug Administration has delayed the approval of its vaccine for respiratory syncytial virus to the end of May due to "administrative constraints" at the agency.The agency has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its approval, the biotech company said in a release.The FDA was expected to make a decision on the RSV shot on Sunday.
Moderna said its RSV vaccine is still on track to be reviewed by an advisory panel to the Centers for Disease Control and Prevention during aon June 26 and 27. That panel will vote on recommendations for the shot's use and intended population, which is necessary before it enters the market. "Moderna is very grateful to the FDA for their continued efforts and diligence," said Dr. Stephen Hoge, president of Moderna, said in a release. "We look forward to helping the agency complete the review of our application, and to the June meeting."
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