Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over

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Vaccine recommendations

There are two RSV vaccines licensed for use in adults aged 60 years and older in the United States: GSK Arexvy and Pfizer Abrysvo. For additional details on the recommendations of the Advisory Committee on Immunization Practices (ACIP) for RSV vaccination, see Adult RSV ACIP Vaccine Recommendations.

 Adults aged 60 years and older:

CDC recommends that adults 60 years of age and older may receive a single dose of RSV vaccine using shared clinical decision-making (SCDM). This means that health care providers and their patients should have a conversation to determine if RSV vaccination will be beneficial. This 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. Under SCDM, there is no default. Rather, the decision whether to vaccinate a patient is individually based 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).

The decision may be informed by a patient’s health status, their risk of severe RSV disease (see Risk Factors for Severe RSV disease below), the health care provider’s clinical judgment, the patient’s preferences, the safety profile of the RSV vaccine products (see Vaccine Safety section below) and other factors. The SCDM recommendation for RSV vaccination is intended to allow providers and patients flexibility based on what is best for each individual patient.

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).

Risk factors for severe RSV disease

Epidemiologic evidence indicates that persons aged 60 years and older who are at highest risk for severe RSV disease and who might be most likely to benefit from vaccination include those with chronic medical conditions such as:

  • Cardiopulmonary disease,
  • Kidney disorders,
  • Liver disorders,
  • Neurologic or neuromuscular conditions,
  • Hematologic disorders,
  • Diabetes mellitus, and
  • Moderate or severe immune compromise (either attributable to a medical condition or receipt of immunosuppressive medications or treatment);

as well as:

  • Persons who are frail*;
  • persons of advanced age†;
  • persons who reside in nursing homes or other long-term care facilities; and
  • persons with other underlying conditions or factors that the provider determines might increase the risk for severe respiratory disease.

*Frailty is a multidimensional geriatric syndrome and reflects a state of increased vulnerability to adverse health outcomes. Although there is no consensus definition, one frequently used tool is the Fried frailty phenotype in which frailty is defined as a clinical syndrome with three or more of the following symptoms present: unintentional weight loss (10 lbs [4.5 kg] in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity.

†The risk of 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.

To learn more about SCDM vaccination recommendations, see ACIP’s webpage 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 60 or older.

Timing of RSV vaccination and number of doses

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. Although typical RSV seasonality was disrupted by the COVID-19 pandemic, the 2023-2024 RSV season more closely resembled pre-pandemic RSV seasonal trends, so RSV seasonality is likely to be more predictable in the future. The benefit of vaccines can be maximized if administered just before the RSV season usually begins.

The RSV vaccine is not currently an annual vaccine, meaning people 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. Additional surveillance and evaluation activities are ongoing to determine whether older adults might benefit from receiving additional RSV vaccines in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.

Contraindications and precautions:

GSK Arexvy should not be administered to a person with a history of severe allergic rection, such as anaphylaxis, to any component of this vaccine. Information about GSK Arexvy can be found in the manufacturer’s package insert.

Pfizer Abrysvo should not be administered to a person with a history of severe allergic reaction, such as anaphylaxis, to any component of this vaccine. Information about Pfizer Abrysvo can be found in the manufacturer’s package insert.

Adults with a minor acute illness, such as a cold, can receive RSV vaccination. Moderate or severe acute illness, with or without fever, is a precaution to vaccination; vaccination should generally be deferred until the patient recovers.

To learn more, see ACIP Contraindications Guidelines for Immunization, General Best Practice Guidelines for Immunization.

Types and composition of RSV vaccines

In May 2023, the Food and Drug Administration (FDA) licensed two RSV vaccines for use in U.S. adults ages 60 years and older:

GSK Arexvy consists of a recombinant RSV F protein antigen (based on the RSV-A subtype), stabilized in the prefusion conformation (preF), and AS01E adjuvant. The AS01 adjuvant system is the same used in GSK’s recombinant zoster vaccine (RZV, Shingrix), but at a lower dose. The vaccine is supplied as a single-dose vial of 120 μg of lyophilized preF antigen component to be reconstituted with the accompanying vial of AS01E adjuvant suspension component. A single dose after reconstitution is 0.5 mL. Consult the package insert for proper storage and handling details, shelf life, and reconstitution instructions: Package Insert – AREXVY (fda.gov).

Pfizer Abrysvo consists of a recombinant RSV F protein antigen (based on both the RSV-A and RSV-B subtypes), stabilized in the prefusion conformation (preF). The vaccine is supplied as a single-dose vial of 120 μg of lyophilized preF antigen component (60 μg from RSV-A, 60 μg from RSV-B) to be reconstituted with the accompanying vial of sterile water diluent component. A single dose after reconstitution is approximately 0.5 mL. Consult the package insert for proper storage and handling details, shelf life, and reconstitution instructions: Package Insert – ABRYSVO (fda.gov).

Vaccine efficacy

GSK Arexvy

Vaccine efficacy data are available from one large phase 3 randomized, blinded, placebo-controlled clinical trial in participants aged 60 years and older (1–3). In this trial, a single dose of the GSK RSV vaccine reduced symptomatic RSV lower respiratory tract disease (LRTD) by 82.6% during the first RSV season after vaccination compared to a placebo, and by 56.1% during the second RSV season. Statistically significant efficacy against RSV LRTD was demonstrated in participant subgroups including those aged 70 years and older, those with and without at least one chronic medical condition, those classified as fit, and those classified as pre-frail. Due to insufficient participant enrollment among certain subgroups, the trial was underpowered to demonstrate efficacy against RSV LRTD in adults 80 years and older and those classified as frail.

Efficacy against medically attended RSV LRTD, inclusive of inpatient and outpatient medical attention, was similar to efficacy against all RSV LRTD. The trial was underpowered to demonstrate efficacy against RSV-associated hospitalization and RSV-associated death.

The duration of vaccine efficacy beyond two RSV seasons after vaccination is unknown.

Pfizer Abrysvo

Vaccine efficacy data are available from one large phase 3 randomized, blinded, placebo-controlled clinical trial in participants aged 60 years and older (2–4). In this trial, a single dose of the Pfizer RSV vaccine reduced RSV lower respiratory tract illness (LRTI) with 3 or more lower respiratory signs and symptoms by 88.9% during the first RSV season after vaccination compared to a placebo, and by 78.6% during a partial second RSV season (interim estimate; the second season efficacy will be updated upon study completion). Statistically significant efficacy against 3-symptom RSV LRTI was demonstrated in participant subgroups including those aged 70 years and older, and those with and without at least one chronic medical condition. Due to insufficient enrollment of participants aged 80 years and older, the trial was underpowered to demonstrate efficacy against RSV LRTI in this age group. Participant frailty was not assessed in this clinical trial.

Efficacy against medically attended RSV LRTI, inclusive of inpatient and outpatient medical attention, was similar to efficacy against all RSV LRTI. The trial was underpowered to demonstrate efficacy against RSV-associated hospitalization and RSV-associated death.

The duration of vaccine efficacy beyond two RSV seasons after vaccination is unknown.

Vaccine safety

GSK Arexvy

In clinical trials, most adults aged 60 years and older who received the GSK RSV vaccine experienced vaccine-related reactions. The most common reactions in the large phase 3 clinical trial were pain at the injection site (61%), fatigue (34%), myalgia (29%), and headache (27%) (1). Grade 3 reactions (severe enough to prevent normal daily activities) occurred in 4% of vaccine recipients.

Across all clinical trials in adults aged 60 years and older, inflammatory neurologic events were reported in three of 17,922 participants within 42 days after receipt of the GSK RSV vaccine (2). All three events occurred in trials without a placebo arm. The reported cases included one case of Guillain-Barré syndrome (GBS) with symptom onset 9 days postvaccination in an open-label phase 3 clinical trial and two cases of acute disseminated encephalomyelitis (ADEM) among participants in a randomized phase 3 coadministration study. The two ADEM cases were reported in participants after concomitant receipt of the GSK RSV vaccine and standard dose seasonal influenza vaccine; symptom onset occurred 7 and 22 days postvaccination, and one case was fatal. In both ADEM cases, the diagnosis was based on symptoms and clinical findings only; diagnostic testing (including brain imaging, cerebrospinal fluid testing, and nerve conduction studies) was not performed, leading to uncertainty in the diagnoses. Both ADEM cases were reported from the same study site. The site investigator later revised the diagnosis from ADEM to hypoglycemia and dementia in the fatal case, and from ADEM to stroke in the non-fatal case.

In the large phase 3 clinical trial, a higher number of participants who received the GSK RSV vaccine than those who received placebo reported atrial fibrillation within 30 days after injection (10 vs. 4 participants) (2). However, due to the small number of these events, it is not known at this time whether they occurred due to chance, or whether RSV vaccination increases the risk of atrial fibrillation.

Pfizer Abrysvo

In clinical trials among adults aged 60 years and older, vaccine-related reactions were common among participants who received the Pfizer RSV vaccine. The most common reactions in the large phase 3 clinical trial were fatigue (16%), headache (13%), and pain at the injection site (11%) (4). Grade 3 reactions (severe enough to prevent normal daily activities) occurred in approximately 1% of vaccine recipients.

Across all clinical trials in adults aged 60 years and older, inflammatory neurologic events were reported in three of 20,255 participants within 42 days after receipt of the Pfizer RSV vaccine (2). The events included one case of GBS with symptom onset 14 days postvaccination, one case of Miller Fisher syndrome (a GBS variant) with symptom onset 10 days postvaccination; and one case of undifferentiated motor-sensory axonal polyneuropathy with worsening of preexisting symptoms 21 days postvaccination.

In the large phase 3 clinical trial, a higher number of participants who received the Pfizer RSV vaccine than those who received placebo reported atrial fibrillation within the 30 days after injection (10 vs. 4 participants) (2). However, due to the small number of these events, it is not known at this time whether they occurred due to chance, or whether RSV vaccination increases the risk of atrial fibrillation.

Ongoing Studies and Surveillance

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 Medicare and Medicaid 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. If a risk if present, these analyses may also be able to determine its magnitude.

Due to the small number of inflammatory neurologic events in the clinical trials and the preliminary nature of the post-licensure safety surveillance results regarding GBS, it is not known at this time whether RSV vaccination is associated with increased risk of GBS or other neurologic adverse events. According to FDA post-marketing requirements and commitments, both manufacturers will conduct safety studies to evaluate the risk of neurologic adverse events and atrial fibrillation following RSV vaccination. CDC will continue to monitor adverse events following RSV vaccination through its vaccine safety surveillance systems. This information will be updated with results from post-marketing safety studies and from vaccine safety surveillance, as they become available.

For more information on vaccine safety, see Vaccine Information and Safety Studies | Vaccine Safety | CDC.

Adverse events after RSV vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear that the vaccine caused the adverse event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.html or by telephone at 1-800-822-7967.

References

  1. Papi A, Ison MG, Langley JM, et al.; AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med 2023;388:595–608. https://www.nejm.org/doi/10.1056/NEJMoa2209604. PMID:36791160.
  2. Melgar M, Britton A, Roper LE, et al. 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;72:793–801. DOI: http://dx.doi.org/10.15585/mmwr.mm7229a4.
  3. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/06-RSV-Adults-Melgar-508.pdf
  4. Walsh EE, Pérez Marc G, Zareba AM, et al.; RENOIR Clinical Trial Group. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med 2023;388:1465–77. https://www.nejm.org/doi/10.1056/NEJMoa2213836. PMID:37018468.

Storage and handling for RSV vaccines

Proper vaccine storage and handling practices play an important role in protecting individuals and communities from vaccine-preventable diseases. For general recommendations and guidance, see Vaccine Storage and Handling. Provided below is guidance specific to RSV vaccines.

GSK Arexvy:

GSK’s vaccine is supplied in two vials that must be reconstituted prior to administration. One vial is a lyophilized antigen component and the second is a liquid diluent adjuvant suspension. You MUST use the diluent provided by the manufacturer. Refer to the manufacturer’s package insert for specific instructions on reconstituting the vaccine: Package Insert – AREXVY (fda.gov).

Before reconstitution:

  • Store vaccine and diluent refrigerated between 2°C and 8°C (36°F and 46°F).
    • Store these in their original package and keep them together in the refrigerator to optimize organization.
  • Never freeze the vaccine or diluent.
  • Protect the vial from light.

After reconstitution:

  • Immediately administer the vaccine; you should prepare the vaccine only when ready for use.
  • If you do not immediately administer the vaccine, there are some minor differences in storage:
    • Store the reconstituted refrigerated between 2°C and 8°C (36°F and 46°F) OR at room temperature [up to 25°C (77°F)]. The difference is due to the allowance of storage at room temperature.
    • Never freeze the reconstituted vaccine, and
    • Protect it from light.
  • Once you’ve reconstituted the vaccine, you begin a 4-hour beyond-use date clock. This means that you must use the reconstituted vaccine within 4 hours; otherwise discard it.

Pfizer Abrysvo:

Pfizer’s vaccine is supplied in a kit with three components: a vial of Lyophilized Antigen Component (a sterile white powder), a prefilled syringe containing Sterile Water Diluent Component, and a vial adapter. Refer to the manufacturer’s package insert for specific instructions on reconstituting the vaccine: Package Insert – ABRYSVO (fda.gov).

Before reconstitution:

  • Store vaccine and diluent refrigerated between 2°C and 8°C (36°F and 46°F).
    • Store these components in their original package and keep them together in the refrigerator to optimize organization.
  • Never freeze the vaccine or diluent.

After reconstitution:

  • Immediately administer the vaccine; you should prepare the vaccine only when ready for use. If you do not immediately administer the vaccine, there are some minor differences in storage:
    • Store the reconstituted vaccine ONLY at room temperature [15⁰C to 30⁰C (59⁰F to 86⁰F)].
    • Do NOT refrigerate. This is very different than other reconstituted vaccines. Typically, storage after reconstitution is refrigerated storage only or refrigerated or room temperature storage. For this vaccine, do NOT put it back in the refrigerator.
    • Never freeze the vaccine or diluent.
  • Once you’ve reconstituted the vaccine, you begin a 4-hour beyond-use date clock. This means that you must use the reconstituted vaccine within 4 hours; otherwise discard it.

Administering RSV vaccines

This page provides a summary of guidance for administering FDA-licensed RSV vaccines for use in U.S. adults aged 60 years and older RSV vaccines, including route, number of doses, and co-administration with other vaccines.

Do not use any RSV vaccine beyond the expiration date printed on the label.

Route

Administer RSV vaccine intramuscularly. The preferred site of administration is the deltoid region of the upper arm. Do not administer RSV vaccine intravenously, intradermally, or subcutaneously.

Administration with other vaccines

Coadministration of RSV vaccines with other adult vaccines during the same visit is acceptable. Available data on immunogenicity of coadministration of RSV vaccines and other vaccines are currently limited. Coadministration of RSV and seasonal influenza vaccines met noninferiority criteria for immunogenicity with the exception of the FluA/Darwin H3N2 strain when the GSK RSV vaccine was coadministered with adjuvanted quadrivalent inactivated influenza vaccine. RSV and influenza antibody titers were somewhat lower with coadministration; however, the clinical significance of this is unknown.

Administering RSV vaccine with one or more other vaccines at the same visit might increase local or systemic reactogenicity. Data are only available for coadministration of RSV and influenza vaccines, and evidence is mixed regarding increased reactogenicity. Data are lacking on the safety of coadministration with other vaccines that might be recommended for persons in this age group, such as COVID-19 vaccines; pneumococcal vaccines; adult tetanus, diphtheria, and pertussis vaccines; and the recombinant zoster vaccine (the recombinant zoster vaccine and GSK’s RSV vaccine contains the same adjuvant). When deciding whether to coadminister other vaccines with an RSV vaccine, providers should consider whether the patient is up to date with currently recommended vaccines, the feasibility of the patient returning for additional vaccine doses, risk for acquiring vaccine-preventable disease, vaccine reactogenicity profiles, and patient preferences. Post-licensure efficacy and safety monitoring of coadministered RSV vaccines with other vaccines will further direct guidance.

Resources

Recommendations for RSV Vaccination

Clinician Education

Materials for Patients

References and Resources

  • Melgar M, Britton A, Roper LE, et al. 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;72:793–801. DOI: http://dx.doi.org/10.15585/mmwr.mm7229a4.
  • Hamid S, Winn A, Parikh R, et al. Seasonality of Respiratory Syncytial Virus – United States, 2017-2023. MMWR Morb Mortal Wkly Rep. 2023 Apr 7;72(14):355-361. doi: 10.15585/mmwr.mm7214a1
  • CDC RSV Surveillance & Research