Following a surge cases in the fall of 2022 that crowded hospitals and intensive care units around the country with sick infants and older adults, a vaccine against respiratory syncytial virus or RSV, could be available for use soon.
After decades of research, the first vaccine of its kind against RSV has been approved by the Food and Drug Administration and could be given to vulnerable adults over 60 this fall.
Arexvy, made by GSK, will be available in a single-shot dose for older adults, who are at risk for severe infection and possibly death from the common respiratory virus. Also at risk for severe illness and deaths from RSV are infants and young children.
The Centers for Disease Control and Prevention says 60,000-120,000 older adults in the U.S. are hospitalized each year and 6,000-10,000 die from RSV infection. In addition to those over 65, adults at highest risk include those with chronic heart or lung disease and those with weakened immune systems.
The FDA approval 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 virus. CDC’s advisers will debate that question in June.
After decades of failure in the quest for a RSV vaccine, doctors are anxious to finally have something to offer — especially after the virus surge last fall that strained hospitals, in addition to seasonal influenza and COVID-19.
“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 of a vaccine for pregnant women, so that 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 single-shot formulation.
In an international study of about 25,000 people 60 and older, one dose of the vaccine was nearly 83% effective at preventing RSV lung infections, and reduced the risk of severe infections by 94%.
To see how long protection lasts, GSK is tracking study participants for three years, comparing some who get just one vaccination during that time and others who get a yearly booster. GSK reported that shot reactions during trials were typical of vaccinations, such as muscle pain and fatigue.
There was a hint of a rare but serious risk — one case of Guillain-Barre syndrome, which usually causes temporary paralysis, and two cases of brain and spinal-cord inflammation. The FDA said it was requiring the company to continue studying if there is any link to the vaccine.
If the CDC ultimately recommends the vaccination for some or even all seniors, it will add another shot for the fall along with their yearly flu vaccine – and maybe another COVID-19 booster.
Dr. Barney Graham, a clinical trials physician, immunologist and virologist — now a professor and administrator at Morehouse School of Medicine — worked for years at the National Institutes of Health on developing vaccines for RSV and other viruses.
“It’s amazing, exciting and gratifying,” said Graham, who was not involved in the development of the GSK vaccine. “All those things you can imagine after spending a life working on this.”
The Associated Press contributed to this article.
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