Frequently Asked Questions About RSV Vaccine for Adults

RSV is a common cause of respiratory illness in infants and young children, as well as older adults. Each season, RSV causes substantial morbidity and mortality in older adults, including lower respiratory tract disease, hospitalization, and death. There are an estimated 60,000–160,000 hospitalizations and 6,000–10,000 deaths annually due to RSV among adults ages 65 years and older.

There are two RSV vaccines approved for adults ages 60 years and older: GSK Arexvy and Pfizer Abrysvo. Both vaccines are recombinant protein vaccines that cause the immune system to produce RSV antibodies. Both are currently approved as a single dose and were shown in clinical trials to protect against symptomatic lower respiratory tract disease caused by RSV in adults ages 60 and older, with more than 80% percent efficacy in the first RSV season after vaccination. GSK’s vaccine includes an adjuvant (the same adjuvant used in GSK’s recombinant zoster vaccine [Shingrix]), which is a component that is intended to enhance the immune response to vaccination. Pfizer’s vaccine does not contain an adjuvant. CDC does not have a preferential recommendation for either vaccine. Patients who are 60 years and older may receive whichever vaccine is available.

CDC recommends that older adults ages 60 years and older may receive a single dose of RSV vaccine using SCDM. A SCDM recommendation differs from routine age-based and risk-based vaccine recommendations for which the default decision is to vaccinate all persons in a specified age group or risk group. With a SCDM recommendation, there is no group in which the vaccine is universally recommended. Rather, the decision to vaccinate a patient is based on individual health characteristics and informed by discussions between the patient and health care provider (anyone who provides or administers vaccines, including primary care physicians, specialists, physician assistants, nurse practitioners, registered nurses, and pharmacists). Health care providers may consider multiple factors when discussing RSV vaccination with patients, including whether the patient has any risk factors for severe RSV disease, the safety profile of the RSV vaccine products, a patient’s preferences for RSV vaccination, and the clinical discretion of the health care provider in that patient’s case.

Healthcare providers are encouraged to discuss RSV vaccination with persons aged 60 years and older to determine if it is appropriate for the specific patient and when it may be most beneficial to administer. Adults at increased risk of severe RSV disease are most likely to benefit from vaccination (see below), and benefits are maximized when RSV vaccine is given in the late summer or early fall, just prior to the onset of the RSV season (see below).

To learn more about SCDM vaccination recommendations, see the ACIP background on the topic. For additional guidance on the SCDM recommendation for RSV vaccination, and which patients are most likely to benefit from RSV vaccination, see CDC’s provider job aid and the MMWR report on use of RSV vaccines in adults ages 60 years and older.

Although RSV infection generally causes mild upper respiratory disease in healthy adults, RSV can cause serious illness in adults with certain underlying medical conditions or other risk factors. Adults ages 60 years and older who are at higher risk for severe RSV disease include:

• those with chronic medical conditions such as:
  • lung diseases (e.g., chronic obstructive pulmonary disease, asthma)
  • cardiovascular diseases (e.g., congestive heart failure, coronary artery disease)
  • neurologic or neuromuscular conditions
  • kidney disorders
  • liver disorders
  • hematologic disorders
  • diabetes mellitus
  • moderate or severe immune compromise (either attributable to a medical condition or receipt of immunosuppressive medications or treatment)
• those who are frail
• those of advanced age*
• those who reside in nursing homes or other long-term care facilities
• those with other underlying medical conditions or factors that a health care provider determines might increase the risk of severe respiratory disease

*The risk of severe RSV among adults increases with age, with the highest rates of hospitalization among those aged 75 years and older. Although age may be considered in determining an older adult patient’s risk for severe RSV-associated disease, there is no specific age threshold at which RSV vaccination is universally recommended within the age group of adults ages 60 years and older.

For examples of medical conditions or treatments that may cause people to become  moderate to severely immunocompromised, visit CDC’s page, People Who Are Immunocompromised.

For additional guidance on the SCDM recommendation for RSV vaccination, and which patients are most likely to benefit from RSV vaccination, see CDC’s provider job aid and the MMWR report on use of RSV vaccines in adults 60 years and older.

For patients who have not already received an RSV vaccine and decide to get one, CDC encourages healthcare providers to maximize the benefit of RSV vaccination by giving them their RSV vaccine in late summer or early fall.  The 2023-2024 RSV season more closely resembled pre-pandemic RSV seasonal trends, therefore the benefit of RSV vaccines can be maximized if administered just before the RSV season usually begins.

RSV vaccine is not currently an annual vaccine, meaning older adults do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older, using shared clinical decision-making. Studies are ongoing to determine whether older adults would benefit from receiving additional RSV vaccine doses in the future.

The most common side effects after RSV vaccination reported from clinical trials included pain, redness, and swelling where the shot is given, fatigue, fever, headache, nausea, diarrhea, and muscle or joint pain. These side effects were usually mild.

Serious neurologic events, including Guillain-Barré syndrome (GBS) and other inflammatory neurologic events, were reported after RSV vaccination in clinical trials.  Preliminary safety surveillance data from the Vaccine Adverse Event Reporting System (VAERS) (co-managed by CDC and FDA) and the Vaccine Safety Datalink (VSD), as well as from a partnership between FDA and the Centers for Medicaid and Medicare Services (CMS), suggest a potential increased risk of GBS after vaccination in older adults. Due to uncertainties and limitations, these analyses cannot establish if there is an increased risk for GBS after RSV vaccination. CDC and FDA are conducting population-based active surveillance to monitor for GBS following RSV vaccination. Additional analyses using these surveillance data are underway and will provide more information about whether there is an association between RSV vaccines and GBS.

Until additional evidence is available to clarify the risk of inflammatory neurologic events after vaccination, RSV vaccination in older adults should be directed to those who are at highest risk for severe RSV disease and therefore most likely to benefit from vaccination, including those with chronic medical conditions, those who are elderly or frail, or those who live in nursing homes. As for all FDA-approved vaccines, CDC will conduct post-marketing safety surveillance to further inform RSV vaccine recommendations. For more information, see CDC’s vaccine safety surveillance webpages.

You should administer either Arexvy (GSK adjuvanted RSV vaccine) or Abrysvo (Pfizer RSV vaccine) intramuscularly in the deltoid region of the upper arm with a 1- to 1.5-inch needle. For additional information on vaccine administration, see job aid on giving intramuscular vaccines to adults.

Yes. Guidance below summarizes the preparation for both Arexvy (GSK adjuvanted RSV vaccine) or Abrysvo (Pfizer RSV vaccine). After reconstitution, both vaccines should be discarded if not used within 4 hours.

• Arexvy (GSK)
  • Prepare by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid). The reconstituted vaccine should be an iridescent, colorless to pale brownish liquid. Either administer Arexvy immediately or store protected from light in the refrigerator (36°F to 46°F [2°C to 8°C]) or at room temperature up to 77°F (25°C) and use within 4 hours. Do not freeze reconstituted vaccine. Package Insert – AREXVY (fda.gov)

• Abrysvo (Pfizer)
  • Prepare by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying prefilled syringe containing sterile water diluent component. Either administer Abrysvo immediately or store at room temperature at 59°F to 86°F (15°C to 30°C) and use within 4 hours. Do not freeze reconstituted vaccine; do not store reconstituted vaccine under refrigerated conditions (36°F to 46°F [2°C to 8°C]). Use within 4 hours. Package Insert – ABRYSVO (fda.gov)

Storage for Arexvy (GSK adjuvanted RSV vaccine) and Abrysvo (Pfizer RSV vaccine) is as follows:

• Arexvy
  • Arexvy adjuvant suspension component vial and lyophilized antigen component vials must be refrigerated in the original package at temperature of 36°F to 46°F (2°C to 8°C). Protect vials from light. Do not freeze. Discard if the adjuvant suspension component or antigen component has been frozen. Package Insert – AREXVY (fda.gov)

• Abrysvo
  • Abrysvo kit (vial of lyophilized antigen component [a sterile white powder] and prefilled syringe containing sterile water and diluent component) must be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton. Do not freeze. Discard if any component has been frozen. Package Insert – ABRYSVO (fda.gov)

Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older using shared clinical decision-making. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.  Additional surveillance and evaluation activities are planned to assess how long the vaccines protect against RSV and whether additional doses will be needed.

Administration of RSV vaccine on the same day with other adult vaccines is acceptable. However, according to results of coadministration studies of RSV vaccines with influenza vaccines, common side effects, such as fever and soreness at the injection site, may be increased when these two vaccines are administered on the same day. Some studies also suggest it’s possible that the RSV and flu vaccines may not produce as strong of an immune response if they’re given on the same day, but the clinical significance of this is unknown. Additional research is ongoing to further inform guidance on same-day administration of the RSV vaccine and other adult vaccines, including the COVID-19 vaccine.

CDC expects little RSV transmission during the summer, so waiting until late summer and early fall to vaccinate patients provides them the best protection when RSV begins circulating again. However, providers recommending RSV vaccine based on SCDM can continue offering vaccination to eligible adults who remain unvaccinated at any time.

One dose of RSV vaccine may provide protection against RSV disease in adults ages 60 years and older for at least two winter seasons, when RSV normally circulates.

RSV vaccine recommendations can be found here:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm