FDA approves nation's first RSV vaccine for people 60 and older

Older woman getting vaccinated

US Air National Guard, David Kujawa / Flickr cc

Today, the US Food and Drug Administration (FDA) announced its approval of the nation's first respiratory syncytial virus (RSV) vaccine for use in people aged 60 years and older.

RSV is a highly contagious virus that infects the lungs and airways of people of all age-groups. RSV usually begins circulating in fall, peaking in winter. RSV is a common cause of lower respiratory tract disease (LRTD), which can cause life-threatening pneumonia and swelling of the small airways.

94.1% reduction in risk of severe illness

The vaccine, made by GlaxoSmithKline and sold under the brand name Arexvy, was approved on the basis of data from an ongoing randomized, controlled trial conducted among this age-group in in the United States and abroad showing its efficacy and safety. The approval follows the March 1 recommendation from the FDA's vaccine advisory group, which has also recommended Pfizer's RSV vaccine for the same age-group.

So far in the study, about 12,500 participants have received Arexvy, and 12,500 have received a placebo. Among all participants, the vaccine reduced the risk of RSV-related LRTD by 82.6% and lowered the risk of severe LRTD by 94.1%, the announcement said. The most common adverse effects among Arexvy recipients were injection-site pain, fatigue, muscle pain, headache, and joint stiffness and pain.

In another study, which involved concomitant administration of Arexvy and an FDA-approved flu vaccine, two participants developed acute disseminated encephalomyelitis, a rare type of inflammation of the brain and spinal cord, and one died. In a separate study, one participant developed Guillain-Barré syndrome (a rare disorder in which the body’s immune system damages nerve cells) 9 days after receiving Arexvy.

An 'important public health achievement'

"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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the announcement.

Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening

Peter Marks, MD, PhD

Each year, RSV leads to about 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 and older in the United States, according to the Centers for Disease Control and Prevention (CDC).

On May 18, the FDA's vaccine advisors will meet to discuss a recommendation for the use of Pfizer's vaccine for preventing RSV in infants as old as 6 months by immunizing pregnant women.

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