EMA Committee Recommends Authorization for Moderna's RSV Vaccine

Moderna, Inc., based in Cambridge, Massachusetts, has announced a significant milestone in the fight against respiratory syncytial virus (RSV). On June 28, 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for the marketing authorization of Moderna's mRNA-based RSV vaccine, mRESVIA (mRNA-1345), for adults aged 60 and older in the European Union. This marks a crucial step forward in addressing the burden of RSV-related lower respiratory tract diseases among older adults.

Stéphane Bancel, Moderna’s Chief Executive Officer, emphasized the importance of this development, noting the innovative nature of their mRNA platform. He highlighted that mRESVIA not only protects older adults from severe RSV outcomes but also simplifies administration through its pre-filled syringe delivery system. This format aims to streamline the vaccination process for healthcare professionals, potentially reducing both time and administrative errors.

RSV is a highly contagious virus that leads to significant health issues, particularly lower respiratory tract infections and pneumonia. It poses a substantial threat to the health of infants and older adults, leading to numerous hospital admissions annually. In the European Union, it is estimated that around 160,000 adults are hospitalized due to RSV each year, with 92% of these cases occurring in those aged 65 and above.

The positive opinion from the CHMP is based on data from the Phase 3 clinical trial ConquerRSV. This global study, involving approximately 37,000 adults aged 60 and older across 22 countries, demonstrated the vaccine's efficacy. The primary analysis, based on a median follow-up of 3.7 months, showed a vaccine efficacy (VE) of 83.7% against RSV-induced lower respiratory tract disease (LRTD). These findings were published in The New England Journal of Medicine. A supplementary analysis with 8.6 months of median follow-up revealed sustained efficacy, with a VE of 63.3% against RSV-LRTD with two or more symptoms and 74.6% against RSV-LRTD with at least two symptoms including shortness of breath. The study met its stringent statistical criteria, ensuring a lower bound on the 95% confidence interval of greater than 20% for both endpoints. The most commonly reported side effects included injection site pain, fatigue, headache, muscle pain, and joint pain.

In addition to the EMA's positive opinion, mRESVIA received approval from the U.S. Food and Drug Administration (FDA) in May 2024 for adults aged 60 and older. This approval was granted under a breakthrough therapy designation and marks Moderna's second approved mRNA product. The company is also pursuing marketing authorization applications for mRNA-1345 in various markets worldwide.

mRESVIA is composed of an mRNA sequence that encodes a stabilized prefusion F glycoprotein, crucial for the virus's ability to infect host cells. This glycoprotein is a key target for neutralizing antibodies and is conserved across both RSV-A and RSV-B subtypes. The vaccine employs the same lipid nanoparticles used in Moderna's COVID-19 vaccines, ensuring a robust delivery mechanism.

Moderna has been at the forefront of mRNA medicine development for over a decade, revolutionizing how medicines are created and administered. Their mRNA platform has facilitated the rapid and efficient development of vaccines and therapeutics for various diseases, including infectious diseases, cancer, rare diseases, and autoimmune conditions. The company continues to pursue its mission of transforming global health through innovative mRNA solutions.