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The FDA approved Arexvy on Wednesday, making it the world’s first respiratory syncytial virus (RSV) vaccine. It will be available to adults 60 and older as soon as this winter, British biopharma company GSK announced this week.
The FDA estimates that RSV contributes to 6,000–10,000 deaths and up to 160,000 hospitalizations of adults 65 and older each year.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement on Wednesday.
The vaccine’s availability is dependent on a recommendation from the CDC’s Advisory Committee on Immunization Practices, which will meet next month. GSK has “millions of doses ready to be shipped,” the company reported in its earnings call last month.
The GSK vaccine reduced the risk of patients developing lower respiratory tract disease in clinical trials, with an 82.6% efficacy rate, according to a study of about 25,000 patients aged 60 and over published earlier this year in the New England Journal of Medicine.
“With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD, asthma, or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV,” American Medical Group Association (AMGA) President and Chief Medical Officer John Kennedy said in a statement Wednesday.
While Arexvy is the first FDA-approved RSV vaccine for older adults, it may not be the last. The FDA is expected to approve Pfizer’s RSV vaccine for adults 60 and over this month. Moderna is also finishing the Phase 3 Trial of its mRNA vaccine for RSV in older adults, the company announced in January.