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modern On Friday it said the Food and Drug Administration delayed approval of its respiratory syncytial virus vaccine until late May due to “administrative limitations” at the agency.
The FDA was expected to make a decision on the RSV vaccine on Sunday. The agency has not informed Moderna of any issues related to the safety, efficacy or quality of the vaccine that would prevent its approval, the biotechnology company said in a statement.
Investors are closely watching the upcoming approval as Moderna tries to recover from the rapid decline of its Covid business last year. If approved, the RSV vaccine would become the company's second product to be launched in the US after its once-successful Covid vaccine. It would also be the third RSV vaccine to enter the market after the Pfizer and GSK released last year.
Moderna said its RSV vaccine is still on track to be reviewed by a Centers for Disease Control and Prevention advisory panel during a June 26-27 meeting. That panel will vote on recommendations for the shot's use and intended population, which is necessary. before entering the market.
Moderna has been testing the vaccine in older adults, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 older people each year and causes between 60,000 and 120,000 hospitalizations, according to CDC data.
“Moderna is very grateful to the FDA for its continued efforts and diligence,” Dr. Stephen Hoge, president of Moderna, said in a statement. “We look forward to helping the agency complete the review of our application and to the June meeting [advisory] meeting.”
Approval would demonstrate the versatility of Moderna's messenger RNA platform beyond Covid treatment. The biotech company is using that technology to address a variety 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 portfolio: The company's shares are up more than 20% this year after falling nearly 45% in 2023.
