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

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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 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).

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).

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

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.

Number of doses

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 for adults ages 60–74 with increased risk of severe RSV disease.

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