Moderna, a biotech company known for its mRNA technology, has announced that the Food and Drug Administration (FDA) has delayed the approval of its vaccine for respiratory syncytial virus (RSV) until the end of May. This delay is attributed to “administrative constraints” at the FDA and not due to any safety or efficacy concerns with the vaccine. The FDA was originally expected to make a decision on the RSV shot on Sunday.
Investors are closely monitoring this approval process as Moderna aims to recover from the decline of its Covid business last year. If approved, the RSV shot would be Moderna’s second product to launch in the U.S., following its successful Covid vaccine. It would also be the third RSV vaccine to enter the market, joining the offerings from Pfizer and GSK that rolled out last year.
Moderna’s RSV vaccine remains on track for review by an advisory panel to the Centers for Disease Control and Prevention (CDC) during a meeting scheduled for June 26 and 27. This panel will vote on recommendations for the vaccine’s use and intended population, which is a necessary step before it can be launched in the market.
The RSV vaccine has been tested primarily in older adults, who are more vulnerable to severe cases of RSV. According to CDC data, the virus is responsible for the deaths of 6,000 to 10,000 seniors every year and leads to 60,000 to 120,000 hospitalizations.
Dr. Stephen Hoge, the president of Moderna, expressed gratitude to the FDA for their efforts and diligence in reviewing the application. He emphasized Moderna’s commitment to assisting the agency in completing the review process and looked forward to the advisory meeting in June.
For Moderna, the approval of the RSV vaccine would showcase the versatility of its mRNA platform beyond just treating Covid. The company is leveraging this technology to tackle various diseases, including RSV, cancer, and norovirus, a highly contagious stomach bug.
Investors have high expectations for Moderna’s mRNA product pipeline and have shown confidence in the company’s long-term potential. After experiencing a significant decline of nearly 45% in 2023, Moderna’s shares have rebounded this year, rising over 20%.
In conclusion, the FDA’s delay in approving Moderna’s RSV vaccine is not due to any safety concerns but rather administrative constraints. If approved, the RSV shot would be Moderna’s second product in the U.S. and the third RSV vaccine on the market. The vaccine is scheduled for review by an advisory panel in June. Moderna’s mRNA platform has shown promise in addressing a range of diseases, and investors have expressed optimism about the company’s future prospects.
