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modern The U.S. 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, it said on Friday.
The FDA is expected to make a decision on the RSV shot on Sunday. The agency has not notified Moderna of any issues related to the safety, effectiveness or quality of the vaccine that could prevent its approval, the biotech said in a news release.
Investors are keeping a close eye on the upcoming approval as Moderna attempts to recover from a rapid decline in business last year due to the coronavirus pandemic. If approved, the RSV vaccine would be the company’s second product to be launched in the U.S., following its once-viral COVID-19 vaccine. This will also be the third RSV vaccine to enter the market after RSV injection. Pfizer and GSK Launched last year.
Moderna said its RSV vaccine remains on schedule for review by a Centers for Disease Control and Prevention advisory panel. Meeting June 26-27.
Moderna has been testing the vaccine in older adults because they are more susceptible to severe respiratory syncytial virus infections. The virus kills 6,000 to 10,000 older adults each year and causes 60,000 to 120,000 hospitalizations, according to the CDC.
“Moderna greatly appreciates the FDA’s continued efforts and diligence,” Moderna President Dr. Stephen Hoge said in a press release. “We look forward to helping the agency complete its review of our application and the (advisory) meeting in June.”
The approval will demonstrate the versatility of Moderna’s messenger RNA platform beyond treating COVID-19. The biotech company is using the technology to tackle a range of diseases. These include respiratory syncytial virus, cancer and a highly contagious stomach virus known as norovirus.
Investors have high hopes for the long-term potential of Moderna’s mRNA product line: The company’s shares are up more than 20% this year after falling nearly 45% in 2023.
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