Key takeaways:
Three vaccines are FDA approved to decrease the risk of lower respiratory tract disease (LRTD) from respiratory syncytial virus (RSV): Arexvy, Abrysvo, and mRESVIA. All three vaccines are given as a single, intramuscular shot
All three vaccines are FDA approved for adults 60 years of age and older. Abrysvo is also approved for adults 18 to 59 years old at high risk of LRTD from RSV, and in pregnant women between 32 and 36 weeks of pregnancy. Arexvy is also approved for adults age 50 to 59 who are at high risk of LRTD from RSV.
As of January 2025, the CDC recommends the RSV vaccine in all adults age 75 and older, adults age 60 to 74 who are at increased risk of severe RSV, and pregnant mothers during weeks 32 through 36 of pregnancy (Abrysvo only).
Mild RSV vaccine side effects may include pain at the injection site, tiredness, and headache. Severe risks, like a serious allergic reaction, can happen but are rare.
Respiratory syncytial virus (RSV) is a common cause of illness, especially in children under 2 years old. Most of the time, RSV symptoms are mild. They include a runny nose, coughing, and fever. But for some people, an RSV infection results in severe illness. Premature infants, adults older than 65, and anyone with a weakened immune system are more at risk for complications from RSV.
If you or your child have ever had RSV, you might be wondering if there’s a vaccine for it. Here, we’ll cover which RSV vaccines are FDA approved, and which are currently being studied.
Three adult RSV vaccines are FDA approved as of January 2025. These are intramuscular (IM) shots that are given as a single dose:
Arexvy and Abrysvo were approved in 2023. mRESVIA was approved in 2024. mRESVIA is the only RSV vaccine that comes as a prefilled syringe.
Additionally, two monoclonal antibody treatments — Beyfortus (nirsevimab-alip) and Synagis (palivizumab) — are approved to prevent RSV in some infants. Beyfortus and Synagis block RSV from entering and infecting cells. They provide “passive immunity” against RSV. But they aren’t vaccines. Beyfortus and Synagis help your child’s immune system recognize and fight RSV if it enters the body. Your child might still get RSV, but they’re less likely to get seriously ill from it.
All three vaccines are approved for people who are 60 years of age and older. Additionally, Abrysvo is approved as a one-time dose in pregnant women during weeks 32 to 36 of pregnancy. This may help prevent your baby from experiencing serious illness from RSV in their first 6 months.
The CDC recommends the RSV vaccine for the following groups of people:
All adults age 75 and older
Adults age 60 to 74 who are at increased risk of severe RSV
Pregnant mothers during weeks 32 through 36 of pregnancy and during the months of September to January (Abrysvo only).
Several situations put people at increased risk of severe RSV. Some examples include having:
Chronic heart or lung disease
Weakened immune system, such as after an organ transplant
Chronic liver disease
Severe obesity (body mass index ≥40 kg/m2)
Comparing RSV vaccines: Two vaccines, Abrysvo and Arexvy, are FDA approved to treat RSV in adults. While they have some things in common, there are also several differences between them.
Managing RSV vaccine side effects: What side effects can you expect from Arexvy and Abrysvo? Knowing what to watch for, and how to manage them, can help you minimize discomfort and risks.
Managing RSV: If you’ve come down with RSV, there are several treatment options. It’s also important to know when to contact your healthcare professional about RSV.
At this time, the RSV vaccine isn’t an immunization you receive yearly. Currently, the CDC recommends receiving an RSV vaccine dose only one time. This includes receiving Abrysvo during one pregnancy but not other pregnancies that happen after that. In this case, the infant should receive Beyfortus one time after birth during the months of October to March.
Besides Arexvy, Abrysvo, and mRESVIA there are many RSV vaccines being studied. Examples include:
MV-012-968 (from Meissa), an intranasal vaccine for infants
CodaVax-RSV (from Codagenix), an intranasal vaccine for infants and young children
BLB201 (from Blue Lake Biotechnology), an intranasal vaccine for infants, young children, and older adults
In the past few years, there’s been exciting research on RSV vaccines. This has led to three FDA-approved RSV vaccines, which we’ll cover below.
Arexvy is FDA approved for adults who are:
60 years of age and older
50 through 59 years of age who are at high risk for lower respiratory tract disease (LRTD) from RSV
The research leading to these FDA approvals is discussed below.
Study name: AReSVi-006
Who: About 25,000 adults aged 60 years or older
Study results:
The effects of a single dose of Arexvy covered two RSV seasons. One dose of Arexvy was about 83% effective at preventing RSV-LRTD, and about 94% effective at preventing severe RSV, during the first season.
During a second RSV season, Arexvy was about 77% effective at preventing RSV-LRTD, and about 85% effective at preventing severe RSV.
Study No. 2: NCT05590403
Who: About 1,600 participants aged 50 to 59 years old
Study results: Compared to adults aged 60 years and older in the AReSVi-006 study, Arexvy provided a comparable immune response in adults aged 50 to 59 years old.
CDC recommendations: At this time, the CDC doesn’t have recommendations for RSV vaccines in adults younger than 60. As of June 2024, they believe more information is needed to determine the best use of RSV vaccines in this population. However, it’s important to remember that Arexvy is FDA approved for some adults age 50 to 59. So talk to your primary care provider about whether Arexvy is right for you if you are part of this age group.
Study No. 3 and 4: NCT06389487 and NCT05921903
Who: About 400 participants age 18 to 49 years old at high risk of LRTD from RSV due to certain chronic conditions (receiving one dose), and about 130 participants age 18 and older who are immunocompromised (receiving two doses).
Study results: Preliminary results show that adults age 18 to 49 years at high risk of LRTD from RSV had a similar immune response to Arexvy compared to adults aged 60 years and older. The same was true when comparing immunocompromised adults age 18 to 49 to adults aged 50 and older.
CDC recommendations: Arexvy isn’t FDA approved in people younger than 50, so there are no CDC recommendations at this time for the use of Arexvy in this population.
Abrysvo is FDA approved as a single dose for:
Adults who are 60 years of age and older
Adults between 18 to 59 years of age who are at high risk for LRTD from RSV
Pregnant mothers at 32 to 36 weeks of pregnancy
The research leading to these FDA approvals is discussed below.
Study No. 1: RENOIR
Who: Over 34,000 adults aged 60 and older
Results: Abrysvo was about 67% effective at preventing RSV-LRTD, and about 86% effective at preventing severe RSV in study participants. As of October 2023, Pfizer is still studying whether one dose of Abrysvo stays effective through a second RSV season.
CDC recommendations: The CDC recommendations for Arexvy and Abrysvo in adults 60 years of age or older are the same. Talk to your HCP about the risks versus benefits of receiving the RSV vaccine based on your current health status and personal preferences.
Study No. 2: MATISSE
Who: Over 7,000 pregnant women
Results:
Abrysvo was about 82% effective at 3 months and about 70% effective at 6 months at preventing hospitalizations for severe RSV in infants born to pregnant women who got the vaccine.
More people receiving Abrysvo had preeclampsia (1.4% versus 1.8%) and preterm births (4.7% versus 5.7%) compared to those who did not receive Abrysvo. It’s unclear whether these outcomes are directly related to Abrysvo. The FDA is requiring that Pfizer further study whether there is a true association between Abrysvo and an increased risk of preeclampsia or preterm birth.
CDC recommendations: To prevent severe RSV-related hospitalizations in infants, pregnant people should receive one dose of Abrysvo during weeks 32 through 36 of pregnancy.
Study No. 3: MONeT
Who: About 700 participants aged 18 to 59 years old at high risk of LRTD from RSV due to certain chronic conditions (receiving one dose), and about 200 participants aged 18 and older who are immunocompromised (receiving two doses)
Study results: Compared to the people in the RENOIR study discussed above (who were 60 years and older), Abrysvo provided a comparable immune response (in the participants aged 18 to 59 years old who were at high risk of RSV disease) in the MONeT study.
CDC recommendations: As of January 2025, the CDC hasn’t put out recommendations for RSV vaccines in adults younger than 60. They believe more information is needed to determine the best use of RSV vaccines in this population. However, Abrysvo is FDA approved for some adults 18 and older. So talk to your primary care provider about whether Abrysvo is right for you.
The mRESVIA vaccine is FDA approved as a single dose for adults who are 60 years of age and older. The research leading to this FDA approval is discussed below.
Study: ConquerRSV
Who: 37,000 adults aged 60 years or older
Results: mRESVIA was 84% effective at preventing RSV-LRTD in study participants. It was also about 83% effective at preventing severe RSV in study participants. But ConquerRSV also showed that as time goes on, this level of effectiveness drops. By 9 months after receiving mRESVIA, effectiveness dropped to about 63% for preventing RSV-LRTD (including severe RSV).
Recently, researchers made a discovery about a specific protein — called the F protein — in RSV’s structure. The F protein is how RSV infects cells.
The RSV vaccines being studied use different methods to deliver a specific form of the F protein (called preF) to the body. The preF protein is viewed by your body as harmful, so your immune system makes antibodies against it. If you’re later exposed to RSV, your body will already have antibodies that recognize the preF protein. This can help your immune system fight off the infection.
Abrysvo and Arexvy contain protein subunits. Protein subunit vaccines contain a version of the preF protein itself. Arexvy also contains an adjuvant, which is a substance that helps your immune system respond to a vaccine better.
mRESVIA uses mRNA technology in their RSV vaccine. mRNA vaccines instruct cells in the body to make the preF protein. This might sound familiar because it’s the same technology used in Moderna’s COVID-19 vaccine.
The nasal spray RSV vaccines in earlier phases of clinical trials contain a live, weakened virus — either of RSV or a different virus carrying the F protein.
In studies of the RSV vaccines, the most common side effects included:
Pain at the injection site
Fatigue
Headache
Muscle and joint pain
These vaccines were found to be safe in studies, and these side effects are similar to the side effects seen with most vaccines. Serious side effects — such as a severe allergic reaction — from vaccines are rare.
As mentioned above, there was an increase in the number of preeclampsia cases and preterm births in pregnant women receiving Abrysvo compared to those who didn’t receive the vaccine. But we don’t know if these outcomes are due to Abrysvo itself. Pfizer is studying whether there is a true association between Abrysvo and an increased risk of preeclampsia or preterm birth.
No vaccine can prevent 100% of infections. But you’re much less likely to have serious complications (such as hospitalization or death) from an infection if you’ve been vaccinated against the germ that causes it.
An RSV vaccine is no different — it won’t be 100% effective at preventing someone from getting RSV. Still, it’s an important tool for protecting people from RSV-associated health risks. This is especially true for people who are more likely to have serious disease, such as older adults.
RSV can cause serious health issues, especially for older adults and infants. Currently, three RSV vaccines are FDA approved in the U.S. to lower the risk of lower respiratory tract disease (LRTD) and hospitalization due to RSV: Arexvy, Abrysvo, and mRESVIA.
All three RSV vaccines are currently approved for adults who are 60 years of age or older. Arexvy is also approved in adults 50 to 59 years old at high risk of LRTD from RSV. Abrysvo is also approved for use in adults age 18 to 59 who are at high risk of LRTD from RSV, and in pregnant women during 32 to 36 weeks of pregnancy. This lowers the risk of serious illness from RSV in infants born to people who received Abrysvo.
Talk to your healthcare professional about whether you qualify for Arexvy, Abrysvo, or mRESVIA. The decision to get an RSV vaccine depends on your medical history, age, and personal preferences.
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