Moderna Gets FDA Approval for RSV Vaccine mRESVIA

Moderna, Inc. has achieved a significant milestone with the U.S. Food and Drug Administration's (FDA) approval of mRESVIA (mRNA-1345), an mRNA vaccine targeting respiratory syncytial virus (RSV). This vaccine is intended for adults aged 60 years and older to prevent lower respiratory tract disease caused by RSV. The approval highlights the success and adaptability of Moderna's mRNA technology, marking their second approved product and the first mRNA vaccine approved for a disease other than COVID-19.

Stéphane Bancel, CEO of Moderna, emphasized the importance of this approval, stating that mRESVIA provides critical protection for older adults against severe RSV outcomes. He also noted the vaccine's unique pre-filled syringe format, which simplifies administration and minimizes the risk of errors, thereby benefiting healthcare providers.

RSV is a highly contagious seasonal virus known for causing lower respiratory infections and pneumonia, particularly affecting infants and older adults. In the U.S., RSV leads to the hospitalization of approximately 60,000 to 160,000 older adults annually and results in 6,000 to 10,000 deaths.

The FDA’s approval was based on robust data from the Phase 3 ConquerRSV clinical trial, involving around 37,000 adults aged 60 and above across 22 countries. The primary analysis, with a median follow-up of 3.7 months, demonstrated a vaccine efficacy of 83.7% against RSV lower respiratory tract disease. These findings were published in The New England Journal of Medicine. A subsequent analysis, conducted during the FDA review, confirmed these results with a consistent efficacy rate.

Safety data from the Phase 3 trial indicated no serious concerns. The most common side effects included injection site pain, fatigue, headache, muscle pain, and joint pain. Moderna plans to make mRESVIA available in the U.S. by the 2024/2025 respiratory virus season and is seeking approval from regulators in various international markets.

mRESVIA comprises an mRNA sequence that encodes a stabilized prefusion F glycoprotein, a crucial component for RSV infection. This protein is a target for potent neutralizing antibodies and is conserved across RSV-A and RSV-B subtypes. The vaccine uses lipid nanoparticles similar to those in Moderna's COVID-19 vaccines.

Moderna is recognized for pioneering mRNA medicine, having rapidly developed treatments and vaccines for infectious diseases, immuno-oncology, rare diseases, and autoimmune conditions. The company is driven by a commitment to transforming human health through innovative mRNA solutions and has established a reputation for efficiency and effectiveness in drug development.

As mRESVIA becomes available, it is expected to significantly reduce the disease burden from RSV among older adults. Moderna continues to work towards expanding the availability of this vaccine worldwide, reinforcing their role in addressing global public health challenges.

The approval of mRESVIA underscores Moderna’s dedication to leveraging mRNA technology for a broader range of infectious diseases, enhancing global health outcomes through cutting-edge medical advancements.