Moderna’s RSV Vaccine Approval Delayed by FDA

Moderna announced on Friday that the Food and Drug Administration (FDA) has postponed the approval of its vaccine for respiratory syncytial virus (RSV) to the end of May. This delay is reportedly due to “administrative constraints” at the agency, pushing back the expected decision date from Sunday. Despite this setback, the FDA has not raised any concerns regarding the safety, efficacy, or quality of the RSV vaccine that would hinder its approval.

Investors are eagerly awaiting the approval of Moderna’s RSV vaccine, as the company seeks to recover from the decline of its Covid business last year. If the RSV shot secures approval, it will mark Moderna’s second product launch in the U.S. following its once-popular Covid vaccine. Additionally, the RSV vaccine will be the third of its kind in the market, with Pfizer and GSK having already rolled out their versions last year.

Advisory Panel Review

Despite the FDA delay, 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, a crucial step before it can be released to the market. Moderna has primarily tested the RSV shot in older adults, a demographic more susceptible to severe cases of the virus.

The approval of the RSV vaccine would showcase the versatility of Moderna’s messenger RNA platform beyond Covid treatment. The biotech company is leveraging this technology to address a variety of ailments, including RSV, cancer, and norovirus, a highly contagious stomach bug. Investors are optimistic about the long-term potential of Moderna’s mRNA product pipeline, with the company’s shares rising by more than 20% this year after a significant drop of almost 45% in 2023.

While the delay in FDA approval may present a short-term challenge for Moderna, the potential launch of its RSV vaccine holds promise for the company’s future growth and the continued advancement of mRNA technology in combating various diseases.