Moderna’s respiratory syncytial virus (RSV) vaccine mRESVIA has received US Food and Drug Administration (FDA) approval for use in adults ages 60 years and older, 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 is likely to encourage the use of mRNA technology across other disciplines.
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. 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 protect against RSV. mRNA vaccines have the advantage of being able to be quickly designed and produced, as mRNA molecules are easily made. They are also safe and effective at preventing the development of specific infections. However, the shelf-life is often shorter than traditional vaccines as the mRNA degrades much faster and requires very cold temperatures to remain intact.
Moderna expects roll-out by the 2024/2025 RSV season
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. It is also being investigated to protect additional patient populations against RSV, including pregnant women and infants, so there is potential for label expansion.
Key Opinion Leaders interviewed by GlobalData have expressed that whilst there is some uncertainty regarding the mRNA technology due to the novel mechanism of action which could lead to some vaccine hesitancy, safety and efficacy results for mRESVIA have been very reassuring with minimal side effects.
More choice and tailored vaccine administration
According to GlobalData’s pipeline drugs database, mRNA vaccines are also currently in late-stage development (pre-registration, Phase III and Phase II) for a range of other infectious diseases including cytomegalovirus, influenza, mpox, shingles and Lyme disease, as well as Covid-19.
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The RSV market has altered substantially 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.
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- Source: https://www.clinicaltrialsarena.com/analyst-comment/mresvias-fda-approval-mrna-vaccines/