FDA Delay Halts Moderna's RSV Vaccine Plans

Moderna's efforts to broaden its revenue base beyond COVID-19 have encountered a setback due to a delay in the FDA's review of its respiratory syncytial virus (RSV) vaccine, mRNA-1345. The FDA attributed the delay to "administrative constraints," which will push the review past the original target date of May 12. Despite this setback, Moderna remains hopeful that the FDA will complete its evaluation by the end of May, potentially allowing for a fall launch.

The company emphasized that the FDA has not raised any concerns about the vaccine's safety, efficacy, or quality that would hinder its approval. Moderna is still anticipating that mRNA-1345 will be reviewed by the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) during their meeting on June 26-27. The ACIP's vote on the vaccine's usage and target demographic is a crucial step before the product can be introduced to the market.

Industry analysts are cautiously optimistic about the timeline. Michael Yee from Jefferies stated that he does not foresee significant delays from this point forward and expects the FDA to approve the vaccine by the end of May. Myles Minter from William Blair highlighted the vaccine's potential significance in contributing to Moderna's growth trajectory in 2025 and 2026. Analysts project that the vaccine could generate approximately $340 million in sales this year, with potential sales exceeding $800 million by 2025.

If approved, mRNA-1345 would be the third RSV vaccine available in the market, following GSK's Arexvy and Pfizer's Abrysvo, both of which were launched last year for older adults. Pfizer's vaccine is also authorized for maternal immunization to protect infants up to six months old, and the company is seeking to expand its use to all at-risk adults for RSV-associated lower respiratory tract disease. However, Pfizer's Abrysvo still trails GSK's Arexvy in sales performance.

Securing approval for mRNA-1345 would underscore the versatility of Moderna's mRNA technology, demonstrating its applicability beyond COVID-19. The company is leveraging this platform to address a range of illnesses, including RSV, influenza, and cancer. Moderna's COVID-19 vaccine, Spikevax, has experienced a significant decline in sales, generating only $167 million in the first quarter of this year compared to $1.2 billion in the same period last year.

The successful approval and launch of mRNA-1345 would not only validate Moderna's mRNA platform but also potentially set the stage for future mRNA-based vaccines targeting various diseases. As Moderna navigates these challenges, the company remains focused on advancing its pipeline and delivering innovative solutions to address unmet medical needs.