FDA approves first RSV vaccine for adults 60 and older
Brady Knox
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The Food and Drug Administration has approved the first-ever vaccine for respiratory syncytial virus, better known as RSV.
The vaccine, Arexvy, made by the company GSK, is designed to be administered by a single shot to adults 60 and over. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet in June to decide whether to give an official recommendation. If the recommendation is given, the vaccine will be available for seniors as early as October.
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RSV is a highly contagious virus that often leads to other, more severe diseases, such as lower respiratory tract disease. An estimated 6,000-10,000 U.S. citizens aged 65 and over die from RSV annually, out of 60,000-120,000 of those hospitalized, according to the FDA.
“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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
“RSV certainly is an important disease in the elderly. In some years, the burden of RSV disease comes close to the burden of flu in the elderly. And this is really a wonderful development,” Dr. Ruth Karron, a professor of international health at Johns Hopkins Bloomberg School of Public Health, told CNN.
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The FDA study featured 25,000 patients, with half receiving the vaccine and half a placebo. The vaccine was found to significantly reduce RSV-associated lower respiratory tract disease (LRTD) by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.
In one of two other studies featuring Arexvy administered concomitantly with an FDA-approved influenza vaccine, two participants developed acute disseminated encephalomyelitis (ADEM), one of whom died.