The Food and Drug Administration on Wednesday approved the first vaccine to fight the severe respiratory syncytial virus, or RSV.
Arexvy, the new vaccine, developed by GlaxoSmithKline, is approved for adults 60 and older and is 82% effective in preventing lower respiratory tract disease caused by RSV, according to test data. It is also 94% effective in those with at least one underlying medical condition.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a potentially life-threatening disease and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Respiratory syncytial virus infects almost everyone by age 2 and usually causes cold symptoms. But it is also the leading cause of hospitalizations among newborns and younger children. Among children under 5 years of age, the Centers for Disease Control and Prevention reports between 58,000 and 80,000 hospitalizations a year.
RSV also strikes late in life, causing more than 177,000 hospitalizations and 14,000 deaths in adults each year.
At an FDA advisory panel meeting in FebruaryGSK researchers have reported several cases of neurological disorders after vaccination, including a case of Guillain-Barré in a 78-year-old woman in Japan about nine days after receiving the shot.
However, panel members voted to recommend the vaccine, saying it is still safe and effective for adults.
Guillain-Barré syndrome, or GBS, is a rare neurological disorder in which the body’s immune system destroys nerve cells, causing muscle weakness and sometimes paralysis, according to the CDC. About 70% of people diagnosed with GBS make a full recovery, according to the National Institute of Neurological Disorders and Stroke. Symptoms can last for years, but experts say most people recover within a few months.
RSV vaccines Shots for babies and adults are on the way. Here’s what the CDC says about them.
Other RSV vaccines in development
GSK’s vaccine is one of several RSV vaccines and treatments being reviewed by regulatory agencies. Others include:
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Sanofi’s monoclonal antibody for infants and young children: A monoclonal antibody from Sanofi and AstraZeneca, called nirsevimab, helps prevent RSV lower respiratory tract disease in newborns and infants entering or in their first RSV season. If approved, it would be the second monoclonal antibody on the market for infants.
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Pfizer’s RSV vaccine for pregnant women: The FDA said it has agreed to review Pfizer’s vaccine candidate, RSVpreF, for approval and set an action date for August 2023. If approved, the vaccine would be for pregnant women to help protect against in severe RSV disease in infants from birth to 6 months.
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Pfizer’s vaccine for adults: This vaccine candidate goes under the same name as the mother vaccine, RSVpreF. Pfizer’s data found that its vaccine was more than 85% effective in preventing RSV-related lower respiratory tract disease in adults.
Contributor: Karen Weintraub, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
USA TODAY’s patient health and safety coverage is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation provides no editorial input.
This article originally appeared in USA TODAY: The FDA has approved the world’s first RSV vaccine for adults
