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CDC recommendation

CAPVAXIVE is a single-dose PCV recommended by the CDC for1-3:

  • Adults 65+:
  • Vaccine-naïve or vaccination history is unknown
  • Previously vaccinated with PCV13 only or PPSV23 only, ≥1 year prior
  • As a supplemental dose for those previously vaccinated with PCV13 and PPSV23*
  • Adults 19-64:
  • With certain chronic medical conditions or other risk factors who are vaccine-naïve or vaccination history is unknown
    • Diabetes, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma, smoking, alcoholism
  • Previously vaccinated but have not completed a recommended seriesa

*Routine if PCV13 was administered at any age and PPSV23 was administered before age 65 with the last pneumococcal vaccine being at least 5 years prior. Shared clinical decision-making if PCV13 was administered at any age and PPSV23 was administered at or after the age of 65 and the last pneumococcal vaccine was at least 5 years prior.1,3

aPatients are eligible to receive CAPVAXIVE if they only received PCV13 or PPSV23 ≥1 year ago or if last dose of PPSV23 was completed ≥5 years ago where PCV13 and PPSV23 were both received.1,3

Share with health care professionals

CDC, Centers for Disease Control and Prevention; IPD, invasive pneumococcal disease; PCV, pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine.

References:

  1. Kobayashi M. Summary of work group interpretations of EtR and policy option on PCV21 use in adults. Slide deck presented at: Advisory Committee on Immunization Practices Meeting; June 26-28, 2024; virtual.
  2. ACIP recommendations. Centers for Disease Control and Prevention. Last reviewed June 28, 2024. Accessed June 28, 2024. https://www.cdc.gov/vaccines/acip/recommendations.html
  3. Kobayashi M, Pilishvili T, Farrar JL, et al. Pneumococcal vaccine for adults aged ≥19 years: recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR Recomm Rep. 2023;72(3):1-39. doi:10.15585/mmwr.rr7203a1
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Indications

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
  • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Select Safety Information

Do not administer CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.
 
Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.
 
The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).
 
The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).
 
Vaccination with CAPVAXIVE may not protect all vaccine recipients.

Before administering CAPVAXIVE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
  • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A,

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A,

Select Safety Information

Do not administer CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.
 
Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.
 
The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).
 
The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).
 
Vaccination with CAPVAXIVE may not protect all vaccine recipients.

Before administering CAPVAXIVE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer CAPVAXIVE to individuals with a history of a severe

Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.