WASHINGTON — The U.S. approved the first vaccine for RSV on Wednesday, shots to protect older adults against a respiratory virus that’s most notorious for attacking babies but endangers their grandparents, too.
The Food and Drug Administration decision makes GSK’s shot, called Arexvy, the first of several potential vaccines in the pipeline for RSV to be licensed anywhere.
The move sets the stage for adults 60 and older to get vaccinated this fall — but first, the Centers for Disease Control and Prevention must decide if every senior really needs RSV protection or only those considered at high risk from the respiratory syncytial virus. CDC’s advisers will debate that question in June.
After decades of failure in the quest for an RSV vaccine, doctors are anxious to finally have something to offer — especially after a virus surge that strained hospitals last fall.
“This is a great first step … to protect older persons from serious RSV disease,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, who wasn’t involved with its development. Next, “we’re going to be working our way down the age ladder” for what’s expected to be a string of new protections.
The FDA is considering competitor Pfizer’s similar vaccine for older adults. Pfizer also is seeking approval to vaccinate pregnant women, so their babies are born with some of mom’s protection.
There isn’t a vaccine for kids yet but high-risk infants often get monthly doses of a protective drug during RSV season — and European regulators recently approved the first one-dose option. The FDA also is considering whether to approve Sanofi and AstraZeneca’s one-shot medicine.
“This is a very exciting time with multiple potential RSV solutions coming out after years of really nothing,” said Dr. Phil Dormitzer, chief of vaccine research and development for GSK, formerly known as GlaxoSmithKline.
RSV is a cold-like nuisance for most people but it can be life-threatening for the very young, the elderly and people with certain high-risk health problems. It can impede babies’ breathing by inflaming their tiny airways, or creep deep into seniors’ lungs to cause pneumonia.
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die. Among older adults, as many as 177,000 are hospitalized with RSV and up to 14,000 die annually.
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