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NEW YORK — Moderna’s respiratory syncytial virus (RSV) vaccine mRESVIA was recently approved by the FDA for use in adults aged 60 years and older. The development marks the first time that an mRNA vaccine has been approved for a disease other than COVID-19.
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 in patients with at least two symptoms and 82.4% 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,” said Anaelle Tannen, infectious disease analyst at GlobalData. Moderna’s vaccine paves the way for the field, likely encouraging the use of mRNA technology across other disciplines, according to GlobalData.
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. The vaccine is expected to be available in the US for eligible populations by the 2024 RSV season. It is also under regulatory review for worldwide markets and well as being investigated to protect additional patient populations against RSV, including pregnant women and infant.
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.
“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,” Tannen concluded.
