HQ Team
June 13, 2025: The US drug regulator approved Moderna Inc.’s respiratory syncytial virus vaccine for expanded use among people aged between 18 and 59 years.
The Food and Drug Administration gave the nod for mRESVIA (mRNA-1345) for the prevention of lower respiratory tract disease caused by the virus, according to a company statement.
This approval was supported by results from Moderna’s end-stage trials, which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions.
The vaccine was generally well-tolerated, and the most commonly reported adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia.
Met criteria
The immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those observed in adults aged 60 years and older in the last-stage placebo-controlled safety and efficacy study.
RSV A and RSV B are the two main subtypes of the respiratory syncytial virus.
RSV is classified into these two groups based on antigenic and genetic differences, primarily related to the G glycoprotein. Both subtypes can cause a range of illnesses, from mild cold-like symptoms to severe pneumonia, and they are known to cause outbreaks in certain seasons.
The approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older.
`Protect additional population’
“Respiratory Syncytial Virus poses a serious health risk to adults with certain chronic conditions, and today’s approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,” said Stéphane Bancel, Chief Executive Officer of Moderna.
While the risk of RSV is well recognised in infants and older adult populations, adults aged 18-59 years with chronic conditions are also vulnerable, according to the statement.
Over one-third of adults aged 18-59 years have at least one underlying condition that puts them at increased risk of severe RSV disease, with disease burden and hospitalisation rates in this population being comparable, or even exceeding, those observed in older adults.
Moderna intends to have mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the US for the 2025-2026 respiratory virus season.
60 years or older
Moderna’s RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based vaccine to be approved in the US. The vaccine, which is the company’s second product, is already approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older.
The US Centers for Disease Control and Prevention will have to recommend the shots before they are available for the age group. The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection.
In April, the CDC’s panel of outside experts recommended the use of approved RSV vaccines in at-risk adults aged between 50 and 59 years.
