FDA approves Moderna’s mRNA vaccine for RSV

The US Food and Drug Administration has approved a new vaccine to protect older adults from respiratory syncytial virus (RSV). 

The vaccine, made by Moderna, is marketed under the name mResvia. This approval marks Moderna’s second FDA-approved product, following its Covid-19 vaccine, and is the first mRNA vaccine for RSV.

Moderna’s approval is based on clinical trial data from 37,000 adults in 22 countries, showing that the vaccine had an 83.7% efficacy at preventing lower respiratory tract disease four months post-vaccination. 

Longer-term analysis indicated continued protection nearly nine months after vaccination. No serious safety concerns were identified in the trial, with the most common side effects being pain at the injection site, headache, and fatigue.

Moderna’s mResvia is the third RSV vaccine approved for people aged 60 and older, alongside vaccines from GSK and Pfizer. Additionally, the US has an RSV vaccine for pregnant individuals that helps protect infants after birth, as well as a preventive antibody treatment for babies to prevent severe illness.

RSV, typically causes mild infections and most people experience cold-like symptoms and recover within a few weeks. However, RSV can be particularly dangerous for older adults, young children, and people with underlying health conditions. In severe cases, it can lead to pneumonia or exacerbate existing conditions like asthma or COPD. 

Millions are hospitalized each year with lower respiratory tract infections originating from RSV, with seniors, particularly those with heart or lung issues and weakened immune systems, being at the highest risk.

The CDC recommends the existing RSV vaccines for adults 60 and older through shared clinical decision-making, encouraging seniors to consult with their doctors. Moderna expects that its vaccine will be available in the US for eligible groups in time for the 2024-25 RSV season, which typically begins in the fall and peaks in the winter.

In a news release, the chief executive officer of Moderna said: “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform. mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. 

This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”