FDA approval of Moderna’s mRESVIA paves way for mRNA vaccines in more indications

The recent approval by the US Food and Drug Administration (FDA) of Moderna’s (Nasdaq: MRNA) respiratory syncytial virus (RSV) vaccine mRESVIA represents a significant development in the field and will likely encourage the use of mRNA technology across other disciplines, says pharma analytics company GlobalData.

The approval was granted under a breakthrough therapy designation and supported by positive results from the global Phase III conquerRSV trial. The vaccine demonstrated an efficacy of 83.7% against RSV-associated lower respiratory tract disease (LRTD) in patients with at least two symptoms and 82.4% against LRTD in patients with at least three symptoms. Additionally, a long-term analysis, extending over 8.6 months median follow-up, found that the vaccine displayed prolonged protection against RSV LRTD.

“mRESVIA will be the third prophylactic RSV vaccine to enter the US market following the launches of GSK’s Arexvy and Pfizer’s Abrysvo in 2023. However, mRESVIA is differentiated by being the first mRNA vaccine to provide protection against RSV. mRNA vaccines have the advantage of being able to be quickly designed and produced,” commented GlobalData’s infectious disease analyst Anaelle Tannen.