Moderna’s RSV Vaccine Approved by FDA

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.