Moderna announced on Friday that the Food and Drug Administration (FDA) has postponed the approval of its respiratory syncytial virus (RSV) vaccine to the end of May. This delay was attributed to “administrative constraints” within the agency, causing the anticipated decision on the RSV shot to be pushed back from Sunday as originally expected. Despite the setback, the FDA has not raised any concerns regarding the safety, efficacy, or quality of the vaccine that would hinder its approval process, according to a statement released by the biotech company.
The upcoming approval of the RSV vaccine holds significant importance for Moderna as it aims to recover from the steep decline in its Covid business from the previous year. If the RSV shot receives clearance, it would mark the company’s second product launch in the United States, following its once-prominent Covid vaccine. Additionally, the RSV vaccine would be the third of its kind to enter the market, following the release of similar shots from Pfizer and GSK in the previous year.
Moderna indicated that its RSV vaccine remains on schedule for evaluation by an advisory panel at the Centers for Disease Control and Prevention during a meeting set for June 26 and 27. The panel’s role is to vote on recommendations concerning the vaccine’s usage and target population, which is a vital step before the product can be introduced into the market. The company has been conducting trials of the RSV shot in older adults, a demographic more susceptible to severe RSV cases, which are known to cause thousands of fatalities and hospitalizations annually among seniors.
Dr. Stephen Hoge, Moderna’s president, expressed gratitude to the FDA for its ongoing diligence in the review process while emphasizing the company’s commitment to assisting in the completion of the application assessment. The approval of the RSV vaccine would not only showcase Moderna’s mRNA platform’s adaptability beyond addressing Covid but also highlight its potential in combatting various diseases, including cancer, norovirus, and RSV itself. Investors are optimistic about the long-term prospects of Moderna’s mRNA product pipeline, as evidenced by the company’s stock which has risen by over 20% this year after a significant decline of nearly 45% in 2023.