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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 vaccination on Sunday. The agency did not inform Moderna of any issues related to the vaccine's safety, effectiveness or quality that would prevent its approval, the biotech company said in a news release.
Investors are closely watching the pending approval as Moderna tries to recover from the rapid decline in its Covid business last year. If approved, the RSV shot would be the company's second product to hit the U.S. market, following its once-successful Covid vaccine. It would also be the third RSV vaccine to come onto the market after vaccinations Pfizer And GSK introduced 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 meeting on June 26 and 27. This committee will vote on recommendations for the use of the vaccine and the intended population, which is necessary before it is put on the market.
Moderna tested the vaccine in older adults, who are more susceptible to severe RSV cases. According to CDC data, the virus kills between 6,000 and 10,000 seniors each year and results in 60,000 to 120,000 hospitalizations.
“Moderna is very grateful to the FDA for their continued efforts and diligence,” 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 look forward to June [advisory] meet.”
The approval would demonstrate the versatility of Moderna's messenger RNA platform beyond treating Covid. The biotech company uses this technology to combat a range of diseases. These include RSV, cancer and a highly contagious gastrointestinal virus known as norovirus.
Investors have high hopes for the long-term potential of Moderna's mRNA product pipeline: The company's shares have risen more than 20% this year after falling nearly 45% in 2023.
