FDA Grants Approval to GlaxoSmithKline Biologicals
By Annette Pinder
The U.S. Food and Drug Administration (FDA) has approved Arexvy, the first respiratory syncytial virus (RSV) vaccine for use in the United States. The vaccine has been shown to prevent lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the vaccine’s approval is especially important for older adults, and especially for older adults who have underlying health conditions, such as heart or lung disease, or weakened immune systems.
The FDA explains that RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. The virus typically starts during the fall and peaks during winter. A common cause of lower respiratory tract disease (LRTD), RSV affects the lungs, and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention (CDC), RSV is responsible for approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths each year among adults ages 65 years and older.
The main clinical study that was conducted of Arexvy determined its safety and effectiveness as a single dose administered to individuals 60 years of age and older. Those who participated will remain in the study through three RSV seasons to help determine the effects of repeat vaccinations. The 12,500 participants who received the vaccine showed a reduced risk of developing RSV by 82.6% and severe RSV by 94.1%. Common side effects that were reported included injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain.
The vaccines will soon be available. Learn more at https://arexvy.com.
