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About Pneumococcal Vaccines

One of the Recommended Vaccines by Disease

The Food and Drug Administration (FDA) licensed 2 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 one conjugate and one polysaccharide vaccine for protection against pneumococcal disease.

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, 0.125 milligrams of aluminum as aluminum phosphate adjuvant, and 5 mL of succinate buffer. The vaccine does not contain thimerosal preservative.
Pneumococcal Polysaccharide Vaccine

Pneumococcal polysaccharide vaccine (PPSV23 or Pneumovax23®) 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.

Helpful Terms

  • 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

Pneumococcal Conjugate Vaccine

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 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 during 2008–2013. This trial evaluated 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
  • 75.0% efficacy of PCV13 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.

Pneumococcal Polysaccharide Vaccine

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, CDC recommends PPSV23 for these groups because of their increased risk of invasive pneumococcal disease (IPD). 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:

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