The US Food and Drug Administration (FDA) has approved the expanded use of Moderna’s respiratory syncytial virus (RSV) vaccine, mRESVIA, in adults aged 18 to 59 years at increased risk of disease. This is the first non-COVID-19 messenger RNA-based (mRNA) vaccine to be approved in the US.
The FDA approval comes after a late-stage trial showed that the shot helped initiate significant immune responses in adults with underlying health conditions. The vaccine was well-tolerated, with no safety concerns reported by Moderna.
RSV typically causes cold-like symptoms but can also lead to pneumonia in toddlers and older adults. In the US, 15,000-20,000 adults aged 50-59 experience RSV-associated hospitalizations annually. Moderna’s mRESVIA was previously approved for adults aged 60 or older with a lower efficacy label.
The Centers for Disease Control and Prevention (CDC) currently recommends the vaccine for adults aged 75 and older, as well as those aged 60-74 at increased risk of infection. However, the CDC panel of experts is scheduled to meet later this month to discuss vaccine recommendations.
Moderna’s expanded approval covers a broader age group, but public health experts warn that appointing new members with anti-vaccine views could undermine confidence in available vaccines. The FDA’s approval paves the way for increased protection against RSV disease in younger adults who are at higher risk.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-expanded-use-modernas-rsv-vaccine-at-risk-adults-2025-06-12