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

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Vaccine recommendations

There are three RSV vaccines licensed for use in adults ages 60 years and older in the United States: GSK’s AREXVY, Moderna’s mRESVIA, and Pfizer’s ABRYSVO. For additional details on the recommendations of the Advisory Committee on Immunization Practices (ACIP) for RSV vaccination, see Adult RSV ACIP Vaccine Recommendations.

CDC recommends a single dose of RSV vaccines for:

All adults ages 75 and older
Adults ages 60-74 who are at increased risk of severe RSV disease

Risk factors for severe RSV disease

Epidemiologic evidence indicates that all adults ages 75 or older and adults ages 60-74 with certain risk factors are at increased risk of severe RSV. The following conditions increase the risk of severe RSV:

Cardiovascular disease (e.g., heart failure; coronary artery disease; congenital heart disease, excluding isolated hypertension),
Lung disease (e.g., chronic obstructive pulmonary disease [COPD], emphysema, asthma, interstitial lung disease, cystic fibrosis),
Advanced chronic kidney disease (e.g., stages 4–5, dependence on hemodialysis or other renal replacement therapy),
Diabetes mellitus with end-organ damage (e.g., diabetic nephropathy, neuropathy, retinopathy, or cardiovascular disease),
Severe obesity (body mass index ≥40 kg/m²),
Liver disorders (e.g., cirrhosis),
Neurologic or neuromuscular conditions (e.g., neuromuscular conditions causing impaired airway clearance or respiratory muscle weakness, excluding history of stroke without impaired airway clearance),
Hematologic disorders (e.g., sickle cell disease, thalassemia), and
Moderate or severe immune compromise (either attributable to a medical condition or receipt of immunosuppressive medications or treatment);

As well as:

People who are frail*;
People who reside in nursing homes or other long-term care facilities providing assistance with activities of daily living;^† and
People with other chronic medical conditions or risk factors that a healthcare provider determines might increase the risk of severe disease due to respiratory infection.

^*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.

^†Retirement communities and independent living communities for seniors are not considered long-term care facilities. Adults 60-74 living in these facilities may still be recommended to receive RSV vaccination if they have certain medical conditions listed above.

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.

The RSV vaccine is not currently an annual vaccine, meaning eligible adults do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for all adults ages 75 and older and adults ages 60-74 with increased risk of severe RSV disease. Additional surveillance and evaluation activities are ongoing to determine whether adults might benefit from receiving additional RSV vaccine doses in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.

Contraindications and precautions:

GSK’s AREXVY 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 GSK’s AREXVY can be found in the manufacturer’s package insert.

Pfizer’s 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’s ABRYSVO can be found in the manufacturer’s package insert.

Moderna’s mRESVIA 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 Moderna’s mRESVIA can be found in the manufacturer’s package insert.

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

Types and composition of RSV vaccines

There are three RSV vaccines licensed by the Food and Drug Administration (FDA) for use in U.S. adults ages 60 and older:

GSK’s AREXVY consists of a recombinant RSV F protein antigen (based on the RSV-A subtype), stabilized in the prefusion conformation (preF), and AS01_E 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 AS01_E 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).

In June 2024, FDA licensed AREXVY for use in people ages 50–59 who are at increased risk of RSV lower respiratory tract disease. ACIP did not hold a vote to recommend AREXVY for people ages 50–59. At this time, ACIP concluded more information is needed to determine the best policy option for the use of RSV vaccines in people ages 50–59. CDC will continue to monitor the effectiveness and safety of these vaccines in people ages 60 and older and is committed to re-evaluating potential RSV vaccine recommendations for people ages 50–59 when additional information becomes available.

Pfizer’s 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).

Moderna’s mRESVIA consists of a single 0.5 mL-dose vial containing 50 μg of nucleoside modified mRNA encoding the RSV F glycoprotein (monovalent, based on the RSV-A subtype), stabilized in the prefusion conformation (pre-F protein). Consult the package insert for proper storage and handling details, shelf life, and more: Package Insert – MRESVIA (fda.gov).

Vaccine effectiveness

Protein Subunit Vaccines (GSK’s AREXVY and Pfizer’s ABRYSVO)

During clinical trials, RSV vaccines for people ages 60 and older reduced the risk of symptomatic lower respiratory tract disease by 80%-90% in the first season after RSV vaccination. While the protection provided by RSV vaccines wanes over time, they still offer significant protection against serious RSV illness for at least 2 years.

CDC data from the first season of use showed that RSV vaccine provided protection against hospitalization, critical illness (ICU admission and death), and emergency department visits among people ages 60 and older.

During 2023-2024:

AREXVY was approximately 77% to 83% effective in preventing RSV-associated hospitalization or emergency department encounters in adults 60 and older.
ABRYSVO was approximately 73% to 79% effective in preventing RSV-associated hospitalization or emergency department encounters in adults 60 and older.

Ongoing monitoring is needed to assess RSV vaccine effectiveness beyond the first season after vaccine receipt and in different risk groups as RSV vaccine coverage increases.

Vaccine efficacy

mRNA Vaccine (Moderna’s mRESVIA)

A summary of Moderna’s large phase 2/3 randomized, blinded placebo-controlled clinical trial in participants ages 60 and older can be found in the manufacturer’s package insert.

Vaccine safety

GSK’s AREXVY

In clinical trials, most adults ages 60 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 ages 60 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’s ABRYSVO

In clinical trials among adults ages 60 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 ages 60 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.

During the June 2024 ACIP meeting, CDC and FDA presented new data from ongoing safety monitoring which continue to suggest a potential increased risk of GBS after RSV vaccination with the two protein subunit vaccines (AREXVY by GSK and ABRYSVO by Pfizer). However, at this time, more data are needed to determine if there is an increased risk of Guillain-Barré Syndrome after 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.

Moderna’s mRESVIA

In clinical trials among adults ages 60 and older, vaccine-related reactions were common among participants who received mRESVIA. The most common reactions in the large phase 3 clinical trial were pain at the injection site (56%), fatigue (31%), headache (27%), and myalgia (26%), arthralgia (22%), axillary (underarm) swelling or tenderness (15%), and chills (12%). See the manufacturer’s package insert for more safety information about mRESVIA.

As with all vaccines, CDC and FDA will conduct routine post-licensure safety surveillance for adverse events following vaccination with mRESVIA.

References

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.
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.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/06-RSV-Adults-Melgar-508.pdf
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’s 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’s 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.

Moderna’s mRESVIA:

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Refer to the manufacturer’s package insert for specific instructions on storage and thawing: Package Insert – mRESVIA (fda.gov).

Frozen Storage

Store frozen between -40°C to -15°C (-40°F to 5°F).

Storage after Thawing

Storage at 2°C to 8°C (36°F to 46°F):

Pre-filled plastic syringes may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to use.

Storage at 8°C to 25°C (46°F to 77°F):

Pre-filled plastic syringes may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours after removal from refrigerated conditions. Discard the pre-filled syringe if not used within this time. Syringes should not be returned to the refrigerator after being thawed at room temperature.
Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.
Do not refreeze once thawed. Do not shake.

Administering RSV vaccines

This page provides a summary of guidance for administering FDA-licensed RSV vaccines for use in U.S. adults ages 60 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

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