Moderna’s mRESVIA, an mRNA vaccine, has received FDA approval, a significant milestone in the fight against respiratory syncytial virus (RSV).
June 9th, 2024: In a significant development for public health, Moderna has received approval from the U.S. Food and Drug Administration (FDA) for its new respiratory syncytial virus (RSV) vaccine, mRESVIA. This marks a major milestone, as mRESVIA is the first mRNA vaccine to be approved for a disease other than COVID-19. The vaccine is designed to specifically protect adults aged 60 and older, a population particularly vulnerable to RSV complications.
What is Respiratory Syncytial Virus (RSV)?
RSV, or respiratory syncytial virus, is a common respiratory illness that typically causes mild, cold-like symptoms. RSV transmission occurs primarily through two routes: airborne transmission via respiratory droplets generated by coughing or sneezing and contact transmission through direct contact with contaminated surfaces or fomites. Populations at heightened risk for severe RSV disease include infants, young children, and older adults.
According to the CDC report from 2023, RSV is responsible for 58,000–80,000 hospitalizations and 100–300 deaths in children under the age of 5 and 60,000–160,000 hospitalizations and 6,000–10,000 deaths among patients over the age of 60, each year globally.
What is mRNA vaccine?
mRNA vaccines use messenger RNA that codes a specific antibody to trigger adaptive immune system against it. It leverages the body’s own cellular machinery to produce specific proteins and stimulate a targeted immune response. The first mRNA vaccines were developed against the deadly Ebola virus, but it wasn’t until the COVID-19 pandemic that mRNA vaccine technology got its moment to shine. Building on the pioneering work of scientists Katalin Karikó and Drew Weissman, Moderna rapidly developed and manufactured one of the first mRNA vaccines approved for emergency use against COVID-19, demonstrating the potential for swift response to emerging threats.
What is exciting about mRESVIA?
As the first mRNA vaccine to be given the green light for a disease besides COVID-19, Moderna gets a first mover advantage makring a significant step forward in harnessing the potential of this new vaccine technology. The vaccine specifically targets adults aged 60 and older, a population most at risk of serious complications from RSV infection.
Conveniently, mRESVIA comes in a single-dose pre-filled syringe, making it a easier for healthcare providers to administer and reducing the risk of errors. This can significantly improve vaccination adherence among older adults. A successful clinical trial with an impressive 83.7% efficacy rate has proven that mRESVIA to be effective in preventing RSV infection in older adults.
Clinical Studies, Efficacy and and Side Effects
The clinical trial for mRESVIA, known as ConquerRSV, was a global Phase III trial conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The trial demonstrated an efficacy of 83.7% against RSV-associated lower respiratory tract disease (LRTD) in participants with at least two symptoms and 82.4% against LRTD in participants 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. No serious safety concerns were identified in the Phase 3 trial, and the most reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.
Future of the battle against RSV
IModerna’s mRESVIA isn’t a lone warrior in the fight against RSV. It joins GSK’s Arexvy and Pfizer’s Abrysvo, both offering protection to older adults, while Abrysvo uniquely shields infants through maternal vaccination. Sanofi & AstraZeneca’s Beyfortus throws another punch with a monoclonal antibody therapy specifically for infants.
In conclusion, this FDA approval marks a landmark moment in the fight against RSV. This first-of-its-kind vaccine protects elder adults from RSV-associated lower respiratory tract disease, offering hope to millions. It solidifies Moderna’s leadership in innovative vaccine development and a marks significant step forward in public health.
Dr. Avraneel Paul, Ph.D.
