European Commission Approves Moderna's RSV Vaccine mRESVIA

Moderna, Inc., a pioneer in mRNA technology, has received marketing authorization from the European Commission (EC) for its mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA® (mRNA-1345). This vaccine is designed to protect adults aged 60 years and older from lower respiratory tract infections caused by RSV. The authorization applies across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. This approval is a significant milestone for Moderna, highlighting its leadership in mRNA technology and marking the first time an mRNA vaccine has been approved in Europe for a disease other than COVID-19.

Stéphane Bancel, CEO of Moderna, expressed the significance of this milestone, emphasizing that mRESVIA provides critical protection for older adults against severe RSV outcomes. The vaccine is uniquely presented in a pre-filled syringe, which simplifies administration by reducing preparation time and potential errors.

RSV is a seasonal virus that poses a high risk of causing lower respiratory tract infections and pneumonia, particularly among infants and older adults. In the European Union, RSV leads to approximately 160,000 hospitalizations annually, with the majority of these cases involving adults aged 65 and above.

The approval of mRESVIA is based on data from the Phase 3 ConquerRSV trial, which was a global study involving around 37,000 participants aged 60 years and older across 22 countries. The primary analysis of the trial, with a median follow-up of 3.7 months, demonstrated a vaccine efficacy (VE) of 83.7% against RSV lower respiratory tract disease (LRTD). These findings were published in The New England Journal of Medicine. A supplementary analysis with a median follow-up of 8.6 months showed that mRNA-1345 maintained durable efficacy, with a VE of 63.3% against RSV-LRTD, including two or more symptoms. Specifically, the VE was 74.6% against RSV-LRTD with two or more symptoms, such as shortness of breath, and 63.0% against RSV-LRTD with three or more symptoms. The study's stringent statistical criterion was met for both endpoints, ensuring reliability in its findings. The most commonly reported side effects included injection site pain, fatigue, headache, muscle pain, and joint pain.

In May 2024, the U.S. Food and Drug Administration (FDA) also approved mRESVIA for protecting adults aged 60 years and older from lower respiratory tract disease caused by RSV. This approval was granted under a breakthrough therapy designation, marking Moderna’s second approved mRNA product. Moderna has submitted applications for marketing authorization for mRNA-1345 in multiple markets worldwide.

mRESVIA is an RSV vaccine that uses an mRNA sequence encoding a stabilized prefusion F glycoprotein, which is essential for the virus to enter host cells. This glycoprotein is a significant target for neutralizing antibodies and is conserved across RSV-A and RSV-B subtypes. The vaccine incorporates the same lipid nanoparticles (LNPs) used in Moderna's COVID-19 vaccines, ensuring a robust delivery mechanism.

Moderna is a leader in mRNA medicine, utilizing this technology to revolutionize the development and production of medicines. Over the past decade, Moderna has advanced mRNA technology to create treatments and vaccines for various conditions, including infectious diseases, immuno-oncology, rare diseases, and autoimmune disorders. The company aims to deliver significant health benefits through its innovative mRNA platform, driven by a commitment to improving human health globally.