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Modern said Friday that the Food and Drug Administration has delayed approval of its respiratory syncytial virus vaccine until the end of May due to “administrative constraints” at the agency.
The FDA was expected to make a decision on the RSV shot on Sunday. The agency did not notify Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its approval, the biotech company said in a news release.
Investors are closely watching the upcoming approval as Moderna tries to recover from the rapid decline in its Covid business last year. If approved, the RSV shot would become the company's second product to launch in the US, following the once-successful Covid vaccine. It would also be the third RSV vaccine to come onto the market after vaccinations Pfizer And GSK rolled out last year.
Moderna said its RSV vaccine is still on track to be reviewed by a Centers for Disease Control and Prevention advisory panel at a meeting on June 26 and 27. That panel will vote on recommendations for the use of the vaccine and its intended population, which is necessary. before it hits the market.
Moderna tested the shot in older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 seniors each year and results in 60,000 to 120,000 hospitalizations, according to CDC data.
“Moderna is very grateful to the FDA for their continued efforts and dedication,” said Dr. Stephen Hoge, president of Moderna, said in a press release. “We look forward to helping the agency complete its review of our application, and into June [advisory] meeting.”
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. These include RSV, cancer and a highly contagious stomach virus known as norovirus.
Investors have high hopes for the long-term potential of Moderna's mRNA product pipeline: The company's shares are up more than 20% this year, after falling nearly 45% in 2023.