FDA Approves Moderna's RSV Vaccine for Older Adults

The US Food and Drug Administration (FDA) has approved Moderna's respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), for adults aged 60 and older. This vaccine aims to protect against lower respiratory tract disease (LRTD) caused by RSV infection. RSV is a widespread contagious virus that typically results in mild, cold-like symptoms. While most individuals recover within a week or two, the virus can lead to severe illness in vulnerable groups such as older adults, young infants, and those with weakened immune systems.

The FDA granted approval for Moderna's vaccine under a breakthrough therapy designation. This decision was based on favorable outcomes from the ConquerRSV study, a late-stage clinical trial involving approximately 37,000 adults aged 60 and above across 22 countries. The primary analysis, with a median follow-up of 3.7 months, revealed a vaccine efficacy of 83.7% against RSV LRTD. Further analysis with a median follow-up of 8.6 months indicated continued efficacy.

Moderna expects to make mRESVIA available to eligible individuals in the US by the 2024/2025 respiratory virus season. The company has also submitted regulatory applications for the vaccine's use in various global markets. Notably, mRESVIA is Moderna's second mRNA-based product to receive approval and is the only RSV vaccine available in single-dose pre-filled syringes, a feature designed to save time for vaccinators and minimize administrative errors.

Stéphane Bancel, Moderna's CEO, emphasized that the FDA's approval of mRESVIA underscores the strength and adaptability of their mRNA platform. He highlighted that this marks the first instance of an mRNA vaccine being approved for a disease other than COVID-19.

mRNA, or messenger RNA, is a molecule containing genetic instructions that direct cells to produce a protein, or a fragment of a protein, using the body's natural mechanisms. The potential of mRNA technology gained significant attention during the COVID-19 pandemic, with mRNA vaccines from companies like Moderna and Pfizer/BioNTech being widely used to combat the virus globally.

In November 2023, a coalition of 31 biotechnology, biopharma, and life sciences companies, along with educational institutions, formed the first global organization dedicated to advancing mRNA medicines. The founding members of the Alliance for mRNA Medicines include BioNTech, CSL, CureVac, Ginkgo Bioworks, Ethris, Johns Hopkins University, Mayo Clinic, Replicate Bioscience, and Verve Therapeutics.

Moderna’s progress in developing mRNA vaccines is seen as a significant advancement in the field of biotechnology. The approval of mRESVIA not only demonstrates the effectiveness of mRNA technology beyond COVID-19 but also paves the way for the development of additional mRNA-based treatments for various diseases. This approval is a major step forward in the fight against RSV and highlights the expanding potential of mRNA vaccines to address other infectious diseases and health conditions.