Moderna’s mRESVIA FDA approval paves way for mRNA vaccines across multiple indications: GlobalData

The drug 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

Moderna’s respiratory syncytial virus (RSV) vaccine mRESVIA has received FDA approval for use in adults aged 60 years and older, marking reportedly, the first time that an mRNA vaccine has been approved for a disease other than COVID-19. This approval represents a significant development in the field and will likely encourage the use of mRNA technology across other disciplines, says 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 per cent against RSV-associated lower respiratory tract disease (LRTD) in patients with at least two symptoms and 82.4 per cent 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.

Anaelle Tannen, Infectious Disease Analyst at GlobalData states, “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.”

According to the release, mRESVIA is the only RSV product available in a single-dose prefilled syringe, which the company hopes will save vaccinators’ time and reduce the risk of administrative error. Moderna expects to have mRESVIA available for eligible populations in the US by the 2024/2025 RSV season, and the vaccine is also under regulatory review in multiple other markets around the world. Moreover, this vaccine is also being investigated to protect additional patient populations against RSV, including pregnant women and infants, so there is potential for label expansion.

“This is the first time that the mRNA technology has been approved for use for an indication other than COVID-19, and it is Moderna’s second mRNA vaccine to receive approval, the first being its COVID-19 vaccine SpikeVax,” adds Tannen.

According to GlobalData’s pipeline drugs database, mRNA vaccines are currently in late-stage development (pre-registration, phase III and phase II) for a range of other infectious diseases including cytomeglovirus, influenza, mpox, shingles, and Lyme disease, as well as COVID-19.

Key opinion leaders (KOLs) interviewed by GlobalData have expressed that while there is some uncertainty regarding the mRNA technology due to the novel mechanism of action that could lead to some vaccine hesitancy, the safety and efficacy results for mRESVIA have been very reassuring with minimal side-effects.

Tannen concludes, “The RSV market landscape has witnessed substantial change in recent years owing to the emergence of novel vaccines and monoclonal antibodies for prophylaxis, and the approval of mRESVIA now represents another important addition. The improved options for RSV prophylaxis will benefit physicians by providing more choice and tailoring vaccine administration for the individual.”