Approval Imminent: Moderna Set to Launch RSV Shot in U.S. Market After Success of Covid Vaccine

Boston, Massachusetts – Moderna is on the cusp of an important milestone as investors eagerly await the approval of its RSV vaccine, marking a potential comeback from its struggles during the COVID-19 pandemic last year. The company’s RSV shot, if authorized, would be its second product to enter the market in the United States following the success of its COVID-19 vaccine. This would also make Moderna the third company to introduce an RSV vaccine, after Pfizer and GSK rolled out their versions last year.

Scheduled for review by an advisory panel at the Centers for Disease Control and Prevention, Moderna’s RSV vaccine is slated for evaluation on June 26 and 27. The panel’s recommendations on the vaccine’s usage and target population are crucial steps before the product can be deployed to the public. Moderna has been focusing its RSV vaccine trials on older adults, a demographic particularly vulnerable to severe RSV cases. According to CDC statistics, RSV claims the lives of thousands of seniors annually while leading to tens of thousands of hospitalizations.

In anticipation of the vaccine’s approval, Dr. Stephen Hoge, Moderna’s president, expressed gratitude towards the FDA for their meticulous review process. He emphasized the company’s commitment to supporting the FDA’s assessment of their vaccine application leading up to the advisory meeting in June. Moderna’s success with the RSV vaccine would not only showcase the flexibility of its mRNA platform beyond addressing COVID-19 but also highlight its potential in combating various diseases like cancer and norovirus.

Investors remain optimistic about Moderna’s future prospects, as reflected in the significant increase in the company’s shares by more than 20% this year. This growth contrasts with the downturn experienced in 2020, where Moderna faced a nearly 45% decline. The market eagerly awaits the outcome of the FDA’s review of Moderna’s RSV vaccine application, underscoring the significance of this potential breakthrough in the biotech industry.