Arexvy Vaccine Provides Significant Protection For Long-Term Care Facilities

The Food and Drug Administration (FDA) has approved the first-ever vaccine to protect people from respiratory syncytial virus (RSV). Arexvy, produced by GSK, has been indicated for use in adults aged 60 years and above.

RSV is a highly contagious virus that leads to seasonal outbreaks, and while it usually causes mild symptoms, it can be deadly for some vulnerable populations.

The Arexvy vaccine was shown to be 82.6% effective in clinical trials against lower respiratory tract disease caused by the virus in adults aged 60 years and above.

Researchers also found that the vaccine reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1%. The vaccine was 94.6% effective in participants with one or more underlying medical conditions.

The vaccine’s most commonly reported side effects among participants in the clinical trial were injection site pain, fatigue, muscle pain, headache, and joint stiffness and pain.

The vaccine now requires approval from the Centers for Disease Control and Prevention before it can be brought to market. Its advisers are expected to discuss Arexvy in June, and GSK anticipates that the vaccine will be available before the 2023/2024 RSV season this fall.

The FDA estimates RSV leads to about 60,000 and 120,000 hospitalizations in the United States and up to 10,000 deaths yearly among adults aged 65 and over.

Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, called Arexvy’s approval a public health achievement, particularly for older adults and those with underlying health conditions that put them at high risk of severe disease caused by RSV.

GSK expects the vaccine to be in high demand and has projected sales similar to those seen with Shingrix, the FDA-approved vaccine that protects older adults against shingles.

However, competition may be forthcoming, as other RSV drugs, including one from Pfizer that received a recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee in February, are in the approval pipeline.

“Outbreaks of respiratory viruses like RSV in long-term care facilities can have devastating consequences. The approval of Arexvy represents a significant step forward in protecting these facilities and reducing the risk of severe illness and death from this highly contagious virus,” – Saba Ansari, VP of Clinical Services.