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 has been testing the shot in older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors every year and results in 60,000 to 120,000 hospitalizations, according to CDC data. The approval would demonstrate the versatility of Moderna's messenger RNA platform beyond treating Covid. The biotech company is using that technology to tackle a range of diseases. Those include RSV, cancer and a highly contagious stomach bug known as norovirus.