According to Moderna, the FDA has delayed approval of the RSV vaccine until the top of May

Modern said Friday that the Food and Drug Administration has delayed approval of its respiratory syncytial virus vaccine until the top of May on account of “administrative constraints” on the agency.

The FDA was expected to make a call on the RSV vaccination on Sunday. The agency didn’t inform Moderna of any issues related to the security, effectiveness or quality of the vaccine that will prevent its approval, the biotech company said in a news release.

Investors are closely watching the pending approval as Moderna looks to get better from the rapid decline in its Covid business last 12 months. If approved, the RSV shot could be the corporate's second product to hit the U.S. market, following its once-successful Covid vaccine. It would even be the third RSV vaccine to come back onto the market after vaccinations Pfizer And GSK introduced last 12 months.

Moderna said its RSV vaccine continues to be on course to be reviewed by a Centers for Disease Control and Prevention advisory panel inside a 12 months meet on June twenty sixth and twenty seventh. This panel will vote on recommendations for the usage of the vaccine and the intended population needed before it involves market.

Moderna tested the vaccine in older adults, who’re more vulnerable to severe RSV cases. According to CDC data, the virus kills between 6,000 and 10,000 seniors every year and ends 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 stay up for helping the agency complete its review of our application and stay up for 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.