Moderna’s respiratory syncytial virus (RSV) vaccine mRESVIA has been approved by the US Food and Drug Administration (FDA) for use in adults aged 18 to 59 years who are at an increased risk of RSV-caused lower respiratory tract disease (LRTD).
This includes individuals with medical conditions such as diabetes, and those with diseases affecting the heart and lungs.
The authorisation comes just over a year after the FDA approved mRESVIA to protect adults aged 60 years and older.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, it can cause severe illness in certain groups, including older adults, young infants and people with chronic conditions.
The risk of RSV is well recognised in infants and older adults; however, more than one-third of adults aged 18 to 59 years have at least one underlying condition that puts them at increased risk of severe RSV disease. Hospitalisation rates in this population are comparable to, and sometimes exceed, rates observed in older adults.
The FDA’s latest decision on mRESVIA was based on results from a phase 3 trial evaluating the vaccine in adults aged 18 to 59 years with underlying health conditions.
The immune responses against both RSV-A and RSV-B were non-inferior to those previously seen in adults aged 60 years and older, and comparable levels of neutralising antibodies were observed across both the 18 to 49 and 50 to 59 age subgroups.
Moderna’s chief executive officer, Stéphane Bancel, said: “RSV poses a serious health risk to adults with certain chronic conditions, and [this] approval marks an important step forward in our ability to protect additional populations from severe illness from RSV.”
Moderna said it is aiming to make mRESVIA available in the US for both younger and older adults in time for the 2025/2026 respiratory virus season.
The US Centers for Disease Control and Prevention (CDC) currently recommends RSV vaccines for adults aged 75 years and older, as well as adults aged 60 to 74 years who are at increased risk of infection. The CDC’s Advisory Committee on Immunisation Practices is set to discuss the use of the vaccines for the upcoming RSV season later this month.