Biotech
Friday, May 10th, 2024 3:22 pm EDT
Key Points
- Moderna’s FDA approval for its respiratory syncytial virus (RSV) vaccine has been delayed until the end of May due to administrative constraints at the agency, despite the decision expected earlier.
- Investors are closely monitoring this delay as Moderna seeks to recover from last year’s decline in its Covid business. If approved, the RSV shot would mark Moderna’s second product launch in the U.S. and the third RSV vaccine on the market after Pfizer and GSK’s versions.
- Moderna’s RSV vaccine remains on track for review by an advisory panel to the CDC, focusing on recommendations for its use in older adults, who are particularly vulnerable to severe RSV cases, showcasing the potential of Moderna’s mRNA platform beyond Covid treatment. Investors are optimistic about the long-term prospects of Moderna’s mRNA product pipeline, reflected in the company’s share performance.
Moderna announced that the Food and Drug Administration (FDA) has postponed the approval of its respiratory syncytial virus (RSV) vaccine until the end of May due to “administrative constraints” within the agency. Originally expected to be decided upon on Sunday, the FDA has not cited any safety, efficacy, or quality concerns regarding the vaccine, as per Moderna’s statement. This delay is closely monitored by investors as Moderna endeavors to recover from the decline of its Covid business last year. If approved, the RSV shot would mark Moderna’s second product launch in the U.S., following its Covid vaccine, and the third RSV vaccine on the market after Pfizer and GSK’s versions rolled out last year. Moderna’s RSV vaccine remains slated for review by an advisory panel to the Centers for Disease Control and Prevention (CDC) on June 26 and 27, which will assess recommendations for its use and target population. The vaccine, primarily tested in older adults who face higher risks from severe RSV cases, targets a virus responsible for thousands of senior deaths and hospitalizations annually, according to CDC data. Dr. Stephen Hoge, Moderna’s president, expressed gratitude to the FDA and anticipated assisting in completing the application review, looking forward to the June advisory meeting. This approval would showcase Moderna’s mRNA platform’s versatility beyond Covid, with the company leveraging this technology to address various diseases, including cancer and norovirus. Investors are optimistic about Moderna’s mRNA product pipeline, with shares up over 20% this year after a significant dip in 2023, reflecting high expectations for its long-term potential.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/05/10/moderna-says-rsv-vaccine-fda-approval-delayed-to-end-of-may.html
