WASHINGTON (AP) — 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.

Why has it taken so long to come up with a vaccine? The field suffered a major setback in the 1960s when an experimental shot worsened infections in children. Scientists finally figured out a better way to develop these vaccines — although modern candidates still were first tested with adults.

GSK’s new vaccine for older adults trains the immune system to recognize a protein on RSV’s surface, and contains an ingredient called an adjuvant to further rev up that immune reaction.

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 given a yearly booster.

Shot reactions 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 can cause usually temporary paralysis, and two cases of a type of brain and spinal cord inflammation. The FDA said it was requiring the company to continue studying if there really is a 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.

“We’ll have to educate the population that this virus that not everyone has heard about is actually an important threat to their health in the wintertime,” said Schaffner, an infectious disease expert at Vanderbilt University. ___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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Children’s hospitals in parts of the U.S. are seeing a surge in a common respiratory illness that can cause severe breathing problems for babies.

RSV cases fell dramatically two years ago as the pandemic shut down schools, day cares and businesses. With restrictions easing in the summer of 2021, doctors saw an alarming increase in what is normally a fall and winter virus.

Now, it’s back again. And doctors are bracing for the possibility that RSV, flu and COVID-19 could combine to stress hospitals.

“I’m calling it an emergency,” said Dr. Juan Salazar of Connecticut Children’s Hospital, where RSV has caused a shuffling of patients into playrooms and other spaces not normally used for beds. The institution explored using a National Guard field hospital, but has set aside that option for now.

A look at RSV and what the recent surge may mean:

WHAT IS RSV?

It stands for respiratory syncytial virus, a common cause of mild cold-like symptoms such as runny nose, cough and fever. Nearly all U.S. children normally catch an RSV infection by age 2.

People infected are usually contagious for three to eight days. Babies and people with weakened immune systems can spread RSV for up to four weeks. There is no vaccine for it, though several candidates are in testing.

WHO DOES IT AFFECT?

Everyone can get RSV. But it causes the most threat to infants, older adults and other vulnerable people, who can get serious airway and lung infections.

Among U.S. kids under age 5, RSV typically leads to 58,000 hospitalizations and up to 500 deaths in a year.

For adults 65 and older, RSV causes 177,000 hospitalizations and 14,000 deaths yearly.

For babies, the struggle to breathe can interfere with eating. “And that’s really when we start to worry,” said Dr. Melanie Kitagawa of Texas Children’s Hospital in Houston, where more than 40 children have RSV.

“They’re breathing fast, breathing deep. We see them using muscles in their chest to help them breathe,” Kitagawa said. “These are kids who are having difficulty taking a bottle because their breathing is being impacted and they can’t coordinate both at once.”

WHY IS THERE AN INCREASE NOW?

The virus is encountering a highly vulnerable population of babies and children who were sheltered from common bugs during the pandemic lockdowns.

Immune systems might not be as prepared to fight the virus after more than two years of masking, which offered protection, according to Dr. Elizabeth Mack of Medical University of South Carolina.

“South Carolina is drowning in RSV,” Mack said in a news release. The surge arrived earlier this year than normal, she said.

For babies, their mothers may not have been infected with RSV during pregnancy, which could have given the children some immunity.

U.S. health officials have noted a rise this month in national reports of respiratory illnesses, which they say is at least partly due to the early spread of flu in much of the South.

Last week, more than 7,000 tests came back positive for RSV, according to CDC figures. That’s more than in previous surges.

IS THERE A TREATMENT?

There’s no specific treatment, so it’s a matter of managing symptoms and letting the virus run its course. Doctors may prescribe oral steroids or an inhaler to make breathing easier.

In serious cases, patients in the hospital may get oxygen, a breathing tube or a ventilator.

WHAT DO DOCTORS RECOMMEND?

Prevent the spread of viruses by washing hands thoroughly and staying home when you’re sick.

During RSV season, an injection of an antibody-based medicine is sometimes prescribed to protect premature infants and other very vulnerable babies.

If you’re worried your child is having a severe breathing problem, “do not hesitate” to go to an emergency department or call 911, said Dr. Russell Migita of Seattle Children’s Hospital, where RSV is on the rise.

For less severe medical problems, Migita said, call your regular health care provider for advice, use telehealth or go to urgent care.

In Chicago on Saturday, Dr. Juanita Mora saw a family of five kids all with RSV, ranging from a 3-year-old to a teenager. Fearing what’s ahead this winter, she’s telling everyone to get a flu shot and a COVID-19 booster.

“We don’t want a triple whammy, a triple pandemic,” Mora said.

___

Associated Press/Report for America reporter James Pollard contributed from Columbia, South Carolina. AP Medical Writer Mike Stobbe contributed.

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