Moderna’s respiratory syncytial virus (RSV) vaccine has been approved by the US Food and Drug Administration (FDA) to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by RSV infection.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, RSV can cause severe illness in certain groups, including older adults, young infants and immunocompromised individuals.
The FDA’s approval of Moderna’s vaccine, mRESVIA (mRNA-1345), was granted under a breakthrough therapy designation and supported by positive results from the late-stage ConquerRSV study, which evaluated the vaccine in approximately 37,000 adults ages 60 years and older in 22 countries.
The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV LRTD of 83.7%, with an additional longer-term analysis demonstrating continued protection against RSV LRTD after 8.6 months of median follow-up.
The company said it expects to have mRESVIA available for eligible individuals in the US by the 2024/2025 respiratory virus season, adding that it has submitted regulatory applications for use of the vaccine in multiple markets globally.
mRESVIA is Moderna’s second approved mRNA product and the only RSV vaccine available in single-dose pre-filled syringes, which the company hopes will save vaccinators’ time and reduce the risk of administrative errors.
Stéphane Bancel, Moderna’s chief executive officer, said: “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.”
Bancel added that the approval also marks the first time that an mRNA vaccine has been approved for a disease other than COVID-19.
mRNA is a molecule that contains genetic instructions that directs the cells to make a protein, or a piece of a protein, using the body’s natural machinery.
The potential of the approach was brought to the fore during the COVID-19 pandemic and mRNA vaccines, including those from Moderna and Pfizer/BioNTech, have now been used globally to protect against the virus.
In November 2023, a group of 31 biotechnology, biopharma and life sciences companies and educational institutions launched the first global organisation dedicated to advancing mRNA medicines.
Founding members of the Alliance for mRNA Medicines included BioNTech, CSL, CureVac, Ginkgo Bioworks, Ethris, Johns Hopkins University, Mayo Clinic, Replicate Bioscience and Verve Therapeutics.