This follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid across all 27 EU member states, as well as Liechtenstein, Iceland and Norway.
The approval of mRESVIA is underpinned by the Phase III ConquerRSV clinical trial, which involved roughly 37,000 adults aged 60 or above across 22 countries.
The trial’s primary analysis indicated an 83.7% vaccine efficacy against RSV lower respiratory tract disease after a median follow-up of 3.7 months.
Further analysis with a median follow-up of 8.6 months showed that mRNA-1345 maintained its efficacy, demonstrating a sustained vaccine efficacy of 63.3% against RSV-LRTD, including cases with two or more symptoms.
The vaccine also showed 74.6% efficacy against RSV-LRTD with shortness of breath and 63.0% against RSV LRTD with three or more symptoms, meeting the stringent statistical criterion of the study.
It utilises an mRNA sequence that encodes for the prefusion F glycoprotein, a key component in the RSV infection process.
This glycoprotein is essential for the virus’s entry into host cells and is a primary target for neutralising antibodies. The vaccine’s lipid nanoparticles are the same as those used in Moderna’s Covid-19 vaccines.
Moderna CEO Stéphane Bancel said: “This approval marks the first time an mRNA vaccine has been approved for a disease beyond Covid-19 in Europe.
“mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can reduce vaccine preparation time and administrative errors.”
In May 2024, mRESVIA received the US FDA approval to protect adults aged 60 years and above from RSV infection, marking it as Moderna’s second approved mRNA product.
Moderna is seeking marketing authorisation for mRNA-1345 in multiple global markets.