The Food and Drug Administration has approved the first-ever vaccine for protection against respiratory syncytial virus (RSV). Arexvy, made by GSK, is indicated for adults aged 60 years and older, the agency announced Wednesday.
Like flu, RSV is highly contagious and causes seasonal outbreaks. Infections typically lead to mild symptoms, but can be deadly in vulnerable populations. In a clinical trial, Arexvy proved 82.6% effective against the development of lower respiratory tract disease caused by the virus in adults aged 60 years and older.
The vaccine also reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1%, researchers found. In addition, efficacy was 94.6% in participants who had one or more underlying medical conditions, GSK reported.
Common side effects found in a subset of trial participants were injection site pain, fatigue, muscle pain, headache and joint stiffness and/or pain.
Expected availability
The Centers for Disease Control and Prevention must also sign off on the vaccine before it can head to market. Its advisers are scheduled to discuss Arexvy in June, and GSK said that it expects the vaccine to be available this fall, ahead of the 2023/2024 RSV season.
Arexvy’s approval is a public health achievement, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a Wednesday statement.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” he said.
In the United States, RSV leads to approximately 60,000 to 120,000 hospitalizations and up to 10,000 deaths each year among adults 65 years of age and older, the FDA reported.
High demand projected
GSK expects demand for the vaccine to be high. It has projected “Shingrix-like” sales, in reference to the standard-of-care FDA-approved vaccine that protects older adults against shingles, FiercePharma reported.
But competition may soon follow. Other RSV drugs are in the approval pipeline, including one from Pfizer that received a recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee in February.
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