About Pneumococcal Vaccines

There are 2 pneumococcal vaccines licensed for use in the United States by the Food and Drug Administration (FDA). Learn about the types, composition, immunogenicity, and efficacy of these vaccines, as well as view package inserts, below.

Types and Composition of Pneumococcal Vaccines

There is one conjugate and one polysaccharide vaccine for protection against pneumococcal disease licensed by FDA.

Pneumococcal Conjugate Vaccine

Pneumococcal conjugate vaccine (PCV13 or 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 (P80), 0.125 milligrams (mg) of aluminum as aluminum phosphate (AlPO4) adjuvant, and 5 mL of succinate buffer.  The vaccine does not contain thimerosal preservative.

Pneumococcal Polysaccharide Vaccine

Pneumococcal polysaccharide vaccine (PPSV23 or Pneumovax23^®) is composed of 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.

Immunogenicity and Vaccine Efficacy

Pneumococcal Conjugate Vaccine

In a large clinical trial, PCV7 (the first pneumococcal conjugate vaccine that was licensed in the United States in 2000) was shown to reduce invasive disease caused by vaccine serotypes by 97%. Children who received PCV7 had 20% fewer episodes of chest X-ray confirmed pneumonia, 7% fewer episodes of acute otitis media and underwent 20% fewer tympanostomy tube placements than did unvaccinated children. PCV7 also reduces nasopharyngeal carriage, among children, of pneumococcal serotypes included in the vaccine.

PCV13 was licensed in the United States based upon studies that compared the serologic response of children who received PCV13 to those who received PCV7. These studies showed that PCV13 induced levels of antibodies that were comparable to those induced by PCV7 and shown to be protective against invasive disease.

In another study of PCV13, children 7 through 11 months, 12 through 23 months, and 24 through 71 months of age who had not received pneumococcal conjugate vaccine doses previously were administered 1, 2, or 3 doses of PCV13 according to age-appropriate immunization schedules. These schedules resulted in antibody responses to each of the 13 serotypes that were comparable to those achieved after the 3-dose infant PCV13 series in the U.S. immunogenicity trial, except for serotype 1, for which IgG geometric mean concentration (GMC) was lower among children aged 24 through 71 months.

A randomized placebo-controlled trial (CAPiTA trial) was conducted in the Netherlands among approximately 85,000 adults 65 years or older during 2008–2013 to evaluate the clinical benefit of PCV13 in the prevention of pneumococcal pneumonia. The results of the CAPiTA trial demonstrated 45.6% efficacy of PCV13 against vaccine-type pneumococcal pneumonia, 45.0% efficacy against vaccine-type non-bacteremic pneumococcal pneumonia and 75.0% efficacy of PCV13 against vaccine-type invasive pneumococcal disease (IPD).

Substantial evidence has accumulated to demonstrate that routine infant PCV7 and PCV13 vaccination has reduced transmission of vaccine serotypes, resulting in a reduced incidence of invasive pneumococcal disease among unvaccinated persons of all ages, including infants too young to be vaccinated and older adults.

Pneumococcal Polysaccharide Vaccine

More than 80% of healthy adults who receive PPSV23 develop antibodies against the serotypes contained in the vaccine, usually within 2 to 3 weeks after vaccination. Older adults, and persons with some chronic illnesses or immunodeficiency may not respond as well, if at all. In children younger than 2 years of age, antibody response to PPSV23 is generally poor. Elevated antibody levels persist for at least 5 years in healthy adults but decline more quickly in persons with certain underlying illnesses.

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 included in the vaccine. Despite the vaccine’s reduced effectiveness among immunocompromised persons, PPSV23 is still recommended for such persons because they are at increased risk of developing severe disease. There is no consensus regarding the ability of PPSV23 to prevent non-bacteremic pneumococcal pneumonia. For this reason, healthcare professionals should avoid referring to PPSV23 as “pneumonia vaccine”.

Studies comparing patterns of pneumococcal carriage before and after PPSV23 vaccination have not shown clinically significant 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:

• Pneumovax23^® [9 pages]
• Prevnar13^® [42 pages]

 Top of Page

References

• 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.
• 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 Mar 14. [ePub ahead of print]
• Pilishvili T, Bennett NM. Pneumococcal disease prevention among adults: Strategies for the use of pneumococcal vaccines. Vaccine. 2015;33(4):D60–5.
• 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.

Top of Page