Moderna Updates on RSV Vaccine Trial

Moderna, Inc. has been informed by the U.S. Food and Drug Administration (FDA) that the agency will not meet the previously established Prescription Drug User Fee Act (PDUFA) date of May 12, 2024, to complete its review of the Biologics License Application (BLA) for mRNA-1345. This investigational vaccine targets respiratory syncytial virus (RSV). The delay is due to administrative constraints, with the FDA now aiming to complete its evaluation by the end of May 2024.

Despite this delay, the FDA has not raised any concerns regarding the safety, effectiveness, or quality of mRNA-1345 that would obstruct its approval. This development ensures that Moderna remains on schedule for the vaccine to be evaluated by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) during their meeting on June 26-27, 2024. This review is a critical step before the vaccine can be commercially launched.

Stephen Hoge, M.D., President of Moderna, expressed gratitude towards the FDA for their ongoing efforts and emphasized the company’s anticipation of completing the review process and participating in the upcoming ACIP meeting.

Moderna, renowned for its pioneering work in mRNA technology, continues to innovate in the field of medicine. The company has revolutionized the development of treatments and preventive measures with unprecedented speed and efficiency, notably including one of the earliest and most effective COVID-19 vaccines. Leveraging its mRNA platform, Moderna has developed an array of therapeutics and vaccines addressing infectious diseases, immuno-oncology, rare diseases, and autoimmune disorders.

Moderna's global team, driven by a unique culture and values, aims to make significant impacts on human health through mRNA-based medicines. The company continues to push the boundaries of science and technology in medicine, aspiring to transform healthcare globally.