The European Commission has given the green light to the marketing of ‘mRESVIA’, an mRNA-based vaccine designed to protect people over 60 years of age against respiratory syncytial virus (RSV). This authorisation follows the Positive Opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
RSV has a significant impact in terms of morbidity, especially in infants and older adults. In the European Union, this virus is estimated to be responsible for around 160,000 hospitalisations in adults each year, with 92% of these cases occurring in people over 65 years of age.
The efficacy of the new RSV vaccine exceeded 80%
The approval of mRESVIA is based on positive results from the Phase 3 ConquerRSV clinical trial, which was conducted globally in approximately 37,000 adults aged 60 years or older in 22 countries. The primary analysis, conducted with an average follow-up of 3.7 months, showed the vaccine was 83.7% effective against lower respiratory tract illness (LRTI) caused by RSV, according to data published in The New England Journal of Medicine.
In an additional analysis with a median follow-up of 8.6 months, mRESVIA demonstrated sustained efficacy, with 63.3% effectiveness against RSV-related ETRI, including the presence of two or more symptoms. Efficacy was 74.6% against RSV-related ETRI with two or more symptoms, including dyspnea, and 63.0% against RSV-related ETRI with three or more symptoms.
The study met strict statistical criteria, with a lower limit of the 95% confidence interval greater than 20%, thus meeting both endpoints. The most common adverse reactions observed were injection site pain, fatigue, headache, myalgia and arthralgia.
“The authorization of mRESVIA is the first in Europe for an mRNA vaccine targeting a disease other than COVID-19”
In May 2024, the U.S. Food and Drug Administration (FDA) also approved mRESVIA (mRNA-1345) for people aged 60 and older under a Breakthrough Therapy Designation, marking Moderna’s second such approval.
“The approval of mRESVIA by the European Commission (EC) marks a significant step forward in public health and underlines Moderna’s leadership in mRNA technology. This authorization is the first in Europe for an mRNA vaccine targeting a disease other than COVID-19,” said Stéphane Bancel, CEO of Moderna.
Bancel also highlighted that mRESVIA protects older adults against the severe effects of RSV and that it comes in a prefilled syringe, which makes it easy to administer and can reduce both preparation time and administrative errors.
