FDA Approves World's First RSV Vaccine for Older Adults: Arexvy by GlaxoSmithKline

Sixty years after initial failed trials, a vaccine for respiratory syncytial virus (RSV) has been approved by the U.S. Food and Drug Administration (FDA).

Arexvy, the world’s first approved vaccine for RSV, was greenlit by the FDA on Wednesday for the prevention of lower respiratory tract disease caused by RSV in people aged 60 and above. The vaccine is manufactured by GlaxoSmithKline Biologicals.

“Today’s approval of the first RSV vaccine is an important public health achievement”, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. The vaccine prevents “a disease which can be life-threatening,” he continued, saying that the approval “reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

The highly contagious virus circulates seasonally, usually beginning in the cooler months and peaking in winter. Dr. Marks noted that “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.” It causes infections of the lungs and breathing passages, according to the FDA, and is a common cause of lower respiratory tract disease (LRTD) in older adults. LRTD can lead to pneumonia and swelling of the bronchioles – the small airways in the lungs. In the U.S. the Centres for Disease Control and Prevention (CDC) estimates that RSV kills up to 10,000 adults 65 and older each year.

The FDA says the main clinical study of Arexvy included 25,000 participants, half of whom received the vaccine with the other half receiving a placebo. The vaccine cohort was found to have approximately 94% less risk of developing severe RSV-associated LRTD, and over 82% less risk of developing any RSV-associated LRTD. Two other studies were conducted with people age 60 and older, in which approximately 2500 participants received the Arexvy vaccine.