About Pneumococcal Vaccines
The Food and Drug Administration (FDA) licensed 4 pneumococcal vaccines for use in the United States. Learn about the types, composition, immunogenicity, and efficacy of these vaccines, as well as view package inserts, below.
Types and Composition of Pneumococcal Vaccines
The FDA licensed 3 conjugate and 1 polysaccharide vaccines for protection against pneumococcal disease.
Pneumococcal Conjugate Vaccines
Pneumococcal conjugate vaccines (PCVs) are differentiated by the number of serotypes they provide protection against — PCV13, PCV15, and PCV20.
PCV13 (Prevnar13®) includes purified capsular polysaccharide of 13 serotypes of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F) conjugated to a nontoxic variant of diphtheria toxin known as CRM197. A 0.5 milliliter (mL) PCV13 dose contains approximately 2.2 micrograms (µg) of polysaccharide from each of 12 serotypes and approximately 4.4 µg of polysaccharide from serotype 6B; the total concentration of CRM197 is approximately 34 μg. The vaccine contains 0.02% polysorbate 80, 0.125 milligrams of aluminum as aluminum phosphate adjuvant, and 5 mL of succinate buffer.
PCV15 (Vaxneuvance®) is a sterile suspension of purified capsular polysaccharides from 15 serotypes of S. pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) individually conjugated to a nontoxic variant of diphtheria toxin known as CRM197. A 0.5 mL PCV15 dose contains 2.0 µg of polysaccharide from each of 14 serotypes and 4.0 µg of polysaccharide from serotype 6B, 30 µg of CRM197 carrier protein, 1.55 mg L-histidine, 1 mg of polysorbate 20, 4.50 mg sodium chloride, and 125 µg of aluminum as aluminum phosphate adjuvant. The vaccine does not contain any preservatives.
PCV20 (Prevnar20®) is a sterile suspension of saccharides from 20 serotypes of S. pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) individually linked to a nontoxic variant of diphtheria toxin known as CRM197. A 0.5 mL dose contains approximately 2.2 μg of saccharides from each of 19 serotypes, approximately 4.4 μg of saccharides from serotype 6B, 51 μg CRM197 carrier protein, 100 μg polysorbate 80, 295 μg succinate buffer, 4.4 mg sodium chloride, and 125 μg aluminum as aluminum phosphate adjuvant.
Pneumococcal Polysaccharide Vaccine
Pneumococcal polysaccharide vaccine or PPSV23 (Pneumovax 23®) includes purified preparations of pneumococcal capsular polysaccharide. PPSV23 contains polysaccharide antigen from 23 types of pneumococcal bacteria. It contains 25 µg of each antigen per dose and contains 0.25% phenol as a preservative.
- Conjugate: A type of vaccine that joins a protein to an antigen in order to improve the protection the vaccine provides
- Polysaccharide: A type of vaccine that is composed of long chains of sugar molecules that resemble the surface of certain types of bacteria in order to help the immune system mount a response
Immunogenicity and Vaccine Efficacy
PCVs
FDA licensed the first pneumococcal conjugate vaccine (PCV7) in 2000. A large clinical trial showed PCV7 reduced invasive disease caused by vaccine serotypes by 97%. Compared to unvaccinated children, children who received PCV7:
- Had 20% fewer episodes of chest X-ray confirmed pneumonia
- Had 7% fewer episodes of acute otitis media
- Underwent 20% fewer tympanostomy tube placements
PCV7 also reduced nasopharyngeal carriage, among children, of pneumococcal serotypes in the vaccine.
FDA licensed PCV13 in 2010 based on studies comparing the serologic response of children who received PCV13 to those who received PCV7. These studies showed PCV13 induced antibody levels comparable to those induced by PCV7 and shown to be protective against invasive disease.
In another study, children aged 7 through 71 months received up to 3 PCV13 doses according to age-appropriate immunization schedules. None of the children had previously received a pneumococcal conjugate vaccine. The antibody responses were comparable to those achieved after the 3-dose infant PCV13 series in the U.S. immunogenicity trial with the exception of serotype 1. The IgG geometric mean concentration was lower for serotype 1 among children aged 24 through 71 months.
Researchers conducted a randomized placebo-controlled trial (CAPiTA trial) in the Netherlands among approximately 85,000 adults 65 years or older from 2008 through 2013. This trial evaluated the clinical benefit of PCV13 in the prevention of pneumococcal pneumonia. The results of the CAPiTA trial demonstrated:
- 46% efficacy against vaccine-type pneumococcal pneumonia
- 45% efficacy against vaccine-type non-bacteremic pneumococcal pneumonia
- 75% efficacy against vaccine-type invasive pneumococcal disease (IPD)
Substantial evidence demonstrates routine infant PCV7 and PCV13 vaccination reduced carriage and transmission of vaccine serotypes. This resulted in lower IPD incidence among unvaccinated persons of all ages, including infants too young to receive the vaccine.
FDA licensed PCV15 and PCV20 in 2021 for use in adults based on studies comparing the serologic response of adults who received either PCV15 or PCV20 to those who received PCV13. These studies showed PCV15 and PCV20 induced antibody levels comparable to those induced by PCV13. The studies also showed PCV15 and PCV20 were safe compared with PCV13. FDA licensed PCV15 in 2022 for use in children 6 weeks through 17 years of age. This was based on clinical trial data showing PCV15 induced antibody levels comparable to those induced by PCV13 and that PCV15 was safe.
PPSV23
More than 80% of healthy adults who receive PPSV23 develop antibodies against the serotypes contained in the vaccine. This immune response usually occurs within 2 to 3 weeks after vaccination. Older adults and persons with some chronic illnesses or immunodeficiency may not respond as well. Elevated antibody levels persist for at least 5 years in healthy adults but decline more quickly in persons with certain underlying illnesses. Children younger than 2 years of age generally have a poor antibody response to PPSV23.
PPSV23 vaccine efficacy studies have resulted in various estimates of clinical effectiveness. Overall, the vaccine is 60% to 70% effective in preventing invasive disease caused by serotypes in the vaccine. PPSV23 shows reduced effectiveness among immunocompromised persons; however, because of their increased risk of IPD, CDC recommends PPSV23 for people in these groups who receive PCV15. There is no consensus regarding the ability of PPSV23 to prevent non-bacteremic pneumococcal pneumonia.
Studies comparing patterns of asymptomatic pneumococcal carriage before and after PPSV23 vaccination have not shown decreases in carrier rates among those vaccinated.
Package Inserts
Consult the following package inserts for proper storage and handing details, shelf life, and reconstitution instructions:
- Adamkiewicz TV, Silk BJ, Howgate J, et al. Effectiveness of the 7-valent pneumococcal conjugate vaccine in children with sickle cell disease in the first decade of life. Pediatrics. 2008;121(3):562–9.
- Andrews NJ, Waight PA, George RC, Slack MPE, Miller E. Impact and effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive pneumococcal disease in the elderly in England and Wales. Vaccine. 2012;30(48):6802–8.
- Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Ped Infect Dis J. 2000;19(3):187–95.
- Black S, Shinefield H, Ling S, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Ped Infect Dis J. 2002;21(9):810–5.
- Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372(12):1114–25.
- Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA, PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010;125(5):866–75.
- Djennad A, Ramsay ME, Pebody R, et al. Effectiveness of 23-valent polysaccharide pneumococcal vaccine and changes in invasive pneumococcal disease incidence from 2000 to 2017 in those aged 65 and over in England and Wales. EClinicalMedicine. 2019;6:42–50.
- Dominguez A, Salleras L, Fedson DS, et al. Effectiveness of pneumococcal vaccination for elderly people in Catalonia, Spain: a case-control study. Clin Infect Dis. 2005;40(9):1250–7.
- Gutierrez Rodriguez MA, Ordobas Gavin MA, Garcia-Comas L, et al. Effectiveness of 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and over in the region of Madrid, Spain, 2008–2011. Euro Surveill. 2014;19(40):20922.
- Kim JH, Chun BC, Song JY, et al. Direct effectiveness of pneumococcal polysaccharide vaccine against invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia in elderly population in the era of pneumococcal conjugate vaccine: A case-control study. 2019;37(21):2797–804.
- Moore MR, Link-Gelles R, Schaffner W, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine for prevention of invasive pneumococcal disease in children in the USA: A matched case-control study. Lancet Respir Med. 2016;4(5):399–406.
- Pilishvili T, Bennett NM. Pneumococcal disease prevention among adults: Strategies for the use of pneumococcal vaccines. Vaccine. 2015;33(4):D60–5.
- Rudnick W, Liu Z, Shigayeva A, et al. Pneumococcal vaccination programs and the burden of invasive pneumococcal disease in Ontario, Canada, 1995–2011. 2013;31(49):5863–71.
- Shimbashi R, Suzuki M, Chang B, et al. Effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive pneumococcal disease in adults, Japan, 2013–2017. Emerg Infect Dis. 2020;26(10):2378–86.
- Su W, Chuang P, Chang L, et al. Application of the screening and indirect cohort methods to evaluate the effectiveness of pneumococcal vaccination program in adults 75 years and older in Taiwan. BMC Infect Dis. 2021;21(1):45.
- Vila-Corcoles A, Salsench E, Rodriguez-Blanco T, et al. Clinical effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumonia in middle-aged and older adults: a matched case-control study. Vaccine. 2009;27(10):1504–10.
- Yeh SH, Gurtman A, Hurley DC, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126(3):e493–505.
- Pneumococcal Vaccine Information Statements
- PCV (English / Other Languages)
- PPSV23 (English / Other Languages)
- Pink Book’s Chapter on Pneumococcal Disease
Epidemiology & Prevention of Vaccine-Preventable Diseases