Respiratory Syncytial Virus (RSV) Vaccine Safety

Key points

RSV, is a common respiratory virus. You can protect against RSV with vaccination.

Overview

Respiratory Syncytial Virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can cause severe illness.

Available vaccines & manufacturer package inserts

Fact‎

RSV vaccines may be given at the same time as other routine vaccines for older adults, pregnant people, young children and infants.

For older adults

  • The FDA approved ABRYSVO in 2023. Pfizer RSV vaccine (ABRYSVO) is approved for individuals aged 60 years and older to prevent lower respiratory tract disease (LRTD) caused by RSV.
  • The FDA approved AREXVY in 2023. GSK RSV vaccine (AREXVY) is approved for individuals aged 60 years and older and adults ages 50 to 59 who are at increased risk to prevent LRTD caused by RSV.
  • The FDA approved mRESVIA in 2024. Moderna RSV vaccine (mRESVIA) is only approved for individuals aged 60 years and older to prevent LRTD caused by RSV.

All adults aged 75 years and older and adults aged 60-74 years who are at increased risk for severe RSV disease should receive a single dose of RSV vaccine.1

For infants and certain young children

  • The FDA approved Nirsevimab (Beyfortus), an injectable monoclonal antibody, to prevent RSV LRTD.
  • Nirsevimab is a passive immunization and is approved for infants born or entering their first RSV season and for some young children who are at increased risk for severe RSV disease and entering their second RSV season.

For pregnant people (maternal RSV vaccine)

  • The FDA approved ABRYSVO in 2023. Pfizer RSV vaccine (ABRYSVO) is approved for pregnant people at 32 through 36 weeks gestational age to protect their babies from LRTD and severe LRTD caused by RSV.
    • ABRYSVO is the only RSV vaccine approved and recommended for use in pregnant people. AREXVY is not recommended for pregnant people.
Keep Reading: Vaccine Information Statements

Who should & should not get the vaccine

Common side effects

ABRYSVO

  • Pain where the shot is given.
  • Fatigue (feeling tired).
  • Headache.
  • Muscle pain.
  • Nausea.

For pregnant people

  • Pain where the shot is given.
  • Headache.
  • Muscle pain.
  • Nausea.

AREXVY

  • Pain where the shot is given.
  • Fatigue (feeling tired).
  • Muscle and joint pain.
  • Headache.

mRESVIA

  • Pain where the shot is given.
  • Fatigue (feeling tired).
  • Muscle and joint pain.
  • Headache.

Nirsevimab

  • Pain, redness, hardness or swelling where shot is given.
  • Rash.

When to call 911‎

Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

Vaccines and monoclonal antibody products, like any medicine, can have side effects. Most common side effects after RSV vaccination are usually mild or moderate.

Report possible adverse events to VAERS‎
‎

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.
Submitting a Vaccine Adverse Event Reporting System (VAERS) Report and Using VAERS Data

A closer look at the safety data

Fact‎

All three RSV vaccines and the monoclonal antibody passive immunization (nirsevimab) have been shown to be safe and effective in clinical trials when used according to the approved indications and recommendations. 23456CDC and FDA continue to monitor the safety of the RSV vaccines and the passive immunization and will share findings with the public as they become available.

For older adults

In clinical trials assessing the safety of RSV vaccines in adults aged 60 years and older, the frequency of serious adverse events (SAEs) was similar in the vaccine and placebo groups.

In the clinical trials in adults aged 60 years and older for GSK (Arexvy) and Pfizer (Abrysvo), a small number of people developed serious neurologic conditions, such as Guillain-Barré syndrome (GBS) within 42 days after RSV vaccination. Given the small number, it was unclear whether the vaccine caused these events, or whether they occurred due to chance. In clinical trials, there were no reported cases of GBS after vaccination using mRESVIA, Abrysvo, nor Arexvy vaccine within 42 days after vaccination.7

CDC and FDA are conducting population-based surveillance to assess risks for GBS and other adverse events.

For infants and young children

No safety concerns were observed during the clinical trials for infants and young children who received the nirsevimab passive immunization. The incidence of serious adverse events was not increased in infants receiving nirsevimab compared with those receiving placebo.

For pregnant people

The Pfizer RSV vaccine (ABRYSVO) was studied in clinical trials in pregnant people at 24 through 36 weeks' gestation. SAEs in pregnant people and infants were balanced between the vaccine and placebo group. Clinical trials in pregnant people who received the Pfizer RSV vaccine (ABRYSVO) vaccinated at 24 through 36 weeks' gestation identified a small increase in the number of preterm births in vaccinated pregnant people after receipt of the Pfizer RSV vaccine. When the rate of preterm birth was assessed during the approved dosing interval (32–36 weeks' gestation), 4.2% of infants were born preterm in the Pfizer RSV vaccine group (68 participants) versus 3.7% in the placebo group (59 participants). It is not clear if this is a true safety problem related to RSV vaccine or if this occurred for reasons unrelated to vaccination. Also, 1.8% of vaccinated pregnant people in the clinical trials developed a dangerous high blood pressure condition called pre-eclampsia (compared to 1.4% of pregnant people who received a placebo) during 24 through 36 weeks' gestation. Additional studies are being conducted to look more closely at the potential risk for preterm birth and pregnancy-related high blood pressure issues in mothers, including pre-eclampsia.

Fact‎

ACIP judged the benefits of maternal Pfizer RSV (ABRYSVO) vaccination at 32–36 weeks' gestation to outweigh the potential risks for preterm birth and hypertensive disorders of pregnancy.6

How CDC monitors vaccine safety

CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Keep Reading: About CDC's Vaccine Safety Monitoring Program

Resources

Respiratory Syncytial Virus (RSV) Immunizations
Learn about Respiratory Syncytial Virus (RSV) Immunizations Recs
Who Should NOT Get Vaccinated with these Vaccines?
Who should NOT Get Vaccinated?
RSV ACIP Vaccine Recommendations
ACIP Recommendations on RSV and other MMWR articles. Advisory Committee on Immunization Practices (A...
Vaccine & Immunization Information for Health Care Providers
CDC vaccine and vaccination information for U.S. health care providers.
Immunization Schedules
Stay up-to-date on getting recommended vaccines. Here are immunization schedules for people of all a...
Contraindications and Precautions
Contraindications and Precautions: General Best Practice Guidelines for Immunization. Advisory Commi...
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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  1. Britton A, Roper LE, Kotton CN, et al. Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2024. MMWR Morb Mortal Wkly Rep. ePub: 6 August 2024. DOI: http://dx.doi.org/10.15585/mmwr.mm7332e1
  2. Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus–Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1115–1122. DOI: http://dx.doi.org/10.15585/mmwr.mm7241e1
  3. Fleming-Dutra KE, Jones JM, Roper LE, Prill MM, Ortega-Sanchez IR, Moulia DL, Wallace M, Godfrey M, Broder KR, Tepper NK, Brooks O, Sánchez PJ, Kotton CN, Mahon BE, Long SS, McMorrow ML. Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices – United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Oct 13;72(41);1115-1122.
  4. Jones JM, Fleming-Dutra KE, Prill MM, Roper LE, Brooks O, Sánchez PJ, Kotton CN, Mahon BE, Meyer S, Long SS, McMorrow ML. Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices – United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72(34);920-925.
  5. Melgar M, Britton A, Roper LE, Talbot HK, Long SS, Kotton CN, Havers FP. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices – United States, 2023.MMWR Morb Mortal Wkly Rep. 2023 Jul 21;72(29);793-801.
  6. Advisory Committee on Immunization Practices (ACIP). ACIP Presentation Slides: September 22, 2023 Meeting. https://www.cdc.gov/vaccines/acip/meetings/slides-2023-09-22.html
  7. https://www.fda.gov/media/179005/download