The Food and Drug Administration has approved a second vaccine to treat respiratory syncytial virus in older adults.
The new shot, Abrysvo, is indicated for use in adults aged 60 years and older, drugmaker Pfizer disclosed Wednesday. The news comes a month after the FDA greenlit GSK’s Arexvy for treating older adults, the first RSV vaccine approved in the United States.
Abrysvo was found to be 67% effective in preventing confirmed RSV cases with two symptoms, and 86% effective in preventing disease with three or more symptoms, according to clinical trial data published in April. Fewer than 10% of the more than 37,000 clinical trial participants had typical side effects associated with vaccination, such as pain at the injection site, fatigue, headache and muscle pain, Pfizer noted.
The FDA’s vaccine advisers in February voted 7 to 4 in favor of recommending Abrysvo’s approval. Those who voted against approval pointed to safety concerns and a perception that the vote was rushed, the Center for Infectious Disease Research & Policy at the University of Minnesota reported at the time. In contrast, the advisers gave GSK’s Arexvy a 10-to-2 nod for safety, and a unanimous thumbs-up for efficacy.
Pfizer anticipates that Abrysvo will be available in time for RSV season in the fall.
“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century,” Annaliesa Anderson, PhD, senior VP, chief scientific officer-vaccine research and development at Pfizer, said in a statement. “Abrysvo will address a need to help protect older adults against the potentially serious consequences of RSV disease.”
RSV can cause severe respiratory illness in vulnerable older adults and children. It is estimated to infect up to 10% of nursing home residents per year, and leads to death in 2% to 5% of cases, studies have found. Long-term care facilities are vulnerable to seasonal outbreaks of the disease.
Between 60,000 and 160,000 older adults are hospitalized and up to 10,000 die each year from RSV infection, according to the Centers for Disease Control and Prevention.
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