Moderna RSV vax heads to phase 3 trials

Feb. 23, 2022

Moderna Therapeutics is sending its respiratory syncytial virus (RSV) vaccine to phase 3 of clinical trials after being cleared by the program's Independent Data and Safety Monitoring Board.

The new RSV vaccine, known as mRNA-1345, will use the same mRNA technology used in Moderna’s COVID-19 vaccine. If approved, it will be the first RSV treatment on the market. The company plans to enroll approximately 34,000 candidates aged 60 years and older from multiple countries.

“RSV is one of the most widespread respiratory viruses, causing severe disease and hospitalization in older adults, and yet there is no vaccine available on the market,” said Stéphane Bancel, CEO of Moderna. Bancel says they believe mRNA-1345 has the potential to protect against 1 million infections globally each year.

Although RSV generally causes cold-like symptoms, it can have serious complications, including death, in high-risk populations like older adults and young children, according to Moderna. The virus also puts a strain on health care systems in the U.S., causing over $3 billion in estimated annual medical costs and resulting in approximately 14,000 deaths and 177,000 hospitalizations in adults 65 and older.

Moderna has been exploring other avenues for protecting against RSV. During a panel at the World Economic Forum in January, Bancel announced the company was working on a potential combination vaccine that could offer protection against COVID-19, influenza and RSV. The company could have the vaccine on the market as soon as the fall of 2023.

The mRNA-1345 vaccine has received fast track designation from the U.S. FDA in adults 65 years of age and older. The phase 3 trial will establish the safety and efficacy of the vaccine.