First Vaccine for RSV Approved for Adults 60 and Older

The U.S. Food and Drug Administration (FDA) has approved Arexvy, the first vaccine for RSV (respiratory syncytial virus), for adults ages 60 and older.

RSV is a common respiratory virus that in most people causes coldlike symptoms. In young children and older adults, however, an infection can turn dangerous, even deadly. RSV can lead to pneumonia and bronchiolitis (an inflammation of the small airways in the lung). It can also worsen other chronic health conditions common among the older population, such as asthma and chronic obstructive pulmonary disease (COPD).

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"We've learned so much more about RSV, and now it's quite evident that it really is as important as influenza, particularly for older adults, and even more so for those with underlying conditions,” says William Schaffner, M.D., professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine and medical director of the National Foundation for Infectious Diseases.

Between 60,000 and 160,000 adults 65 and older are hospitalized with RSV each year, and 6,000 to 10,000 older adults die from it annually, according to figures from the Centers for Disease Control and Prevention (CDC). By comparison, during the 2021-2022 flu season, preliminary estimates show that 51,686 adults 65 and older were hospitalized with influenza, and 3,818 died. 

Two vials of Arexvy, developed from manufacturer GlaxoSmithKline (GSK), the world's first RSV vaccine for 60-plus adults.

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“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,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Clinical trial data reviewed by the FDA and published in the New England Journal of Medicine found that Arexvy, from manufacturer GlaxoSmithKline (GSK), reduced the risk of symptomatic illness from an RSV infection in adults 60 and older by nearly 83 percent; the risk of severe disease was cut by about 94 percent in the older adult population. Some side effects were reported, the most common of which include injection site pain, fatigue, muscle pain, headache and joint stiffness/pain. The FDA notes that atrial fibrillation, an irregular heart rate, was reported within 30 days of vaccination in 10 of the roughly 12,500 participants who received Arexvy and four of the roughly 12,500 participants who received the placebo. GSK will conduct a study to assess this risk, along with other rare events, the FDA said.

A long wait

Scientists have been working to develop an RSV vaccine for decades, but the very nature of the virus and how it infects our cells has made it difficult, Schaffner explains. Researchers cracked the code, however, and now several RSV candidates are in the pipeline.

Len Friedland, M.D., vice president and director of scientific affairs and public health at GSK, told AARP that the new GSK vaccine is also being studied in adults 50 to 59, since individuals in this age group with underlying health conditions are at high risk for severe illness from RSV. Results from this research should be available soon, Friedland said.