In a recent announcement, Moderna revealed that the FDA has postponed the approval of its respiratory syncytial virus (RSV) vaccine until the end of May. The delay was attributed to “administrative constraints” within the agency, with the decision originally expected to be made on Sunday. Despite this setback, Moderna clarified that there were no concerns regarding the safety, efficacy, or quality of the vaccine that would hinder its approval.
Investors are closely monitoring the progress of Moderna’s RSV vaccine approval, especially following the decline in the company’s Covid-related business last year. If approved, the RSV shot would mark Moderna’s second product to launch in the U.S. following its successful Covid vaccine. Additionally, it would be the third RSV vaccine to enter the market, with Pfizer and GSK already having released their versions in the previous year.
Advisory Panel Review
Despite the delay in FDA approval, Moderna’s RSV vaccine is still scheduled for review by an advisory panel at the Centers for Disease Control and Prevention (CDC) on June 26 and 27. This panel will assess the shot’s recommended use and target population before it can be introduced to the market. Moderna has been primarily testing the vaccine in older adults, a demographic at higher risk of severe RSV cases.
Implications for Moderna
Dr. Stephen Hoge, president of Moderna, expressed gratitude towards the FDA for their diligence in reviewing the vaccine application. He emphasized the company’s commitment to assisting the agency in completing the approval process and participating in the upcoming advisory meeting in June. The approval of the RSV vaccine would showcase the versatility of Moderna’s mRNA platform, demonstrating its potential in addressing various diseases beyond Covid, such as cancer and norovirus.
Investors remain optimistic about the long-term prospects of Moderna’s mRNA product pipeline, with shares of the company already up more than 20% this year. This positive trend comes after a significant decline of nearly 45% in 2023. The approval of the RSV vaccine could further bolster investor confidence in Moderna’s innovative technology and diversified disease targets, paving the way for future growth and development in the healthcare industry.