"This is very exciting," says one infectious disease doctor. The new RSV vaccines were approved in 2023—and today’s research shows just how effective they are in protecting those at risk.
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Highlights
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Is the RSV vaccine necessary? Respiratory syncytial virus, or RSV, is a common respiratory virus that typically causes mild, cold-like symptoms—but it can lead to serious complications for certain groups. That’s why the recently developed RSV vaccine has been hailed as a historic medical advancement. While it’s not recommended for everyone, research now shows it offers powerful protection for those considered most at-risk.
According to the U.S. Centers for Disease Control and Prevention (CDC), most people who catch RSV recover in a week or two; however, the virus can be severely dangerous for babies and seniors. It is the leading cause of bronchiolitis and pneumonia in infants 1 year old and younger. The Cleveland Clinic reports that prior to the RSV vaccine’s development, the virus led to 80,000 hospitalizations of children under 5 and 160,000 hospitalizations of seniors annually.
What is the RSV vaccine?
In 2023, the U.S. Food and Drug Administration (FDA) approved the first vaccine against RSV. Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement that the “approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening.”
This original RSV vaccine was developed for older adults—and since then, new formulations have been approved to expand protection to other at-risk groups. Here’s what’s available today:
Adults
- Ages 60 and over: Three RSV vaccines are now FDA-approved—Arexvy, Abrysvo, and mResvia.
- Ages 50 to 59: Arexvy is approved for those at an increased risk of RSV complications due to health conditions, such as a chronic disease.
- Ages 18 to 59: Abrysvo and mResvia are approved for those at an increased risk of severe illness.
- Pregnant women: Abrysvo is approved for use in pregnant women to protect their newborns (vaccination during weeks 32 to 36 of pregnancy).
Infants
While not a vaccination, Nirsevimab (Beyfortus) is an antibody injection approved in 2023 to protect babies from serious RSV complications.
“This is very exciting,” says Kathryn S. Moffett, MD, a professor and division chief of pediatric infectious diseases at West Virginia University School of Medicine. “Until recently, we only had one RSV shot for babies [considered only for] preemies born early and at extremely low birth weights with underlying diseases.”
Who needs the RSV vaccine?
The RSV vaccine is currently only available for people at risk of developing severe complications from the virus. The CDC guidelines also note that the RSV shot isn’t currently an annual vaccine—its protection lasts longer than one year. More research is needed to determine exactly how long immunity lasts, but for now, a single dose is recommended for eligible groups.
Older adults
The CDC recommends that all adults age 75 and older get a dose of any FDA-approved RSV vaccine. Adults over age 50 with an increased risk of severe RSV are also advised to get vaccinated. These risk factors can include:
- Chronic heart or lung disease.
- A weakened immune system.
- Underlying health conditions, such as diabetes.
- Living in a nursing home or long-term care facility.
Pregnant women
To help protect newborns from RSV, the maternal RSV vaccine Abrysvo is approved for use at 32 through 36 weeks of the expectant parent’s pregnancy. Currently, the CDC recommends maternal RSV vaccination from September through January specifically.
Administered as a single shot into the muscle, pregnant people would receive immunity from the RSV vaccine during pregnancy and pass that along to their baby before birth.
“Babies born at term who have no risks for serious RSV infection can still become very ill,” Dr. Moffett says. “This is why vaccinating mothers is really important. There is evidence that moms of term babies who get really sick with RSV have limited to no memory of having RSV, so their baby was wide open and not protected at all.”
Infants
All infants under 8 months of age should get one dose of Beyfortus (a brand name for nirsevimab), a long-acting monoclonal antibody shot that can protect against severe RSV, the CDC states. Some infants aged 8 to 19 months can get a second dose of nirsevimab to help them through their second RSV season if they have underlying health issues.
A traditional vaccine causes your body to build up antibodies that protect you against a virus like RSV. By contrast, monoclonal antibody shots give you antibodies so you have them ready to go when exposed to RSV.
This new RSV treatment is a game-changer, Dr. Moffett says. “The current available shot for at-risk newborns must be given monthly for five months and does not seem to confer the same amount of protection as the newer shot.”
How effective is the RSV vaccine?
Data from the first seasons following the rollout of the new RSV vaccines shows they offer serious protection for both older adults and infants.
Here’s what we know so far:
- A December 2024 study published in JAMA Network Open shows that the vaccine is 89% effective in preventing RSV-related hospitalization for adults 60 years and older, including those with heightened risk factors.
- A September 2025 study from The Lancet found that the maternal RSV vaccine is 72% effective at preventing hospitalization in infants (when administered to the mother more than 14 days before birth).
- According to July 2025 research published in Pediatrics, the nirsevimab antibody injection is 87.2% effective in preventing RSV in infants—and 98% effective in preventing hospitalization.
Are there any risks to the RSV vaccine?
In February 2023, the FDA held an advisory panel meeting with researchers from GSK (formerly known as GlaxoSmithKline)—the manufacturer of Arexvy, the first approved RSV vaccine.
During clinical trials, the researchers reported a few neurological events among vaccine recipients, including a case of Guillain-Barré Syndrome (GBS). A 2025 study published in JAMA Network Open analyzed data from the 2023-2024 RSV season and found a small increase in GBS risk—about 11 cases per one million vaccine doses.
To put that risk in perspective, past research published in The Lancet found that getting the flu carries an even higher risk of GBS, with about 17 cases per one million flu infections. The CDC emphasizes “it is more likely that a person will get GBS after getting the flu than after vaccination.” Likewise, the CDC maintains that the benefits of RSV vaccination outweigh the potential risks.
In addition, there were some early concerns about whether the maternal RSV vaccine raised the risk of preterm birth. However, follow-up studies—summarized by the American College of Obstetricians & Gynecologists—have found no link between the RSV vaccine and preterm delivery.
The bottom line
“Vaccines save lives, and when you are exposed to this virus, even if it gets in your system, you have been building up immunity to fight off infection and temper that reaction,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, a professor and the inaugural chair of family medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. “Without the vaccine, you can have complications and could end up hospitalized or even die from RSV.”
Dr. Iroku-Malize recommends talking with your healthcare provider about whether the benefits outweigh the risks for you and your family members.
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