About Pneumococcal Vaccines

There are 4 pneumococcal vaccines recommended for use in the United States. See below to learn about the types, composition, immunogenicity, and efficacy of these vaccines, as well as view package inserts.

Types and Composition of Pneumococcal Vaccines

There are 4 vaccines recommended for protection against pneumococcal disease: 3 conjugate and 1 polysaccharide.

Pneumococcal Conjugate Vaccines

Pneumococcal conjugate vaccines (PCVs) are differentiated by the number of serotypes they protect against.

PCV21 (CAPVAXIVE™) is a sterile solution of purified capsular polysaccharides from Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B (de-O-acetylated prior to conjugation), 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B individually conjugated to CRM197 carrier protein. A 0.5 mL PCV21 dose contains a total of 84 mcg of pneumococcal polysaccharide antigen (4 mcg each of polysaccharide serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B (deOAc 15B), 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) conjugated to approximately 65 mcg of CRM197 carrier protein, 1.55 mg L-histidine, 0.50 mg of polysorbate 20, 4.49 mg sodium chloride, and water for injection. The vaccine doesn’t 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.

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 doesn’t contain any preservatives.

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.

Immunogenicity, Vaccine Efficacy, Safety

PCV21

The Food and Drug Administration (FDA) licensed PCV21 in 2024 for use in individuals 18 years of age and older. Studies showed that PCV21 induced antibody levels comparable to PCV15, PCV20, or PPSV23 for the shared serotypes in adults 50 years of age and older. Studies have shown the safety of PCV21 to be comparable to PCV15, PCV20, and PPSV23.

PCV15 and PCV20

FDA licensed PCV15 and PCV20 in 2021 for use in adults. Studies showed they induced antibody levels comparable to those induced by PCV13 or PPSV23. The studies also showed PCV15 and PCV20 were safe compared with PCV13 with or without PPSV23.

FDA approved PCV15 in 2022 and PCV20 in 2023 for use in children 6 weeks through 17 years of age. This was based on clinical trial data showing they induced antibody levels comparable to those induced by PCV13. The studies also showed that safety of PCV15 and PCV20 were comparable to that of PCV13.

PCV7 and PCV13 in Children

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. Studies showed PCV13 induced antibody levels comparable to those induced by PCV7 and shown to be protective against invasive disease.

Substantial evidence demonstrates routine infant PCV7 and PCV13 vaccination reduced pneumococcal carriage and transmission of vaccine serotypes. This resulted in lower invasive pneumococcal disease (IPD) incidence among unvaccinated persons of all ages, including infants too young to receive the vaccine.

PCV13 in Adults

From 2008 through 2013, researchers conducted a randomized, placebo-controlled trial (CAPiTA trial) in the Netherlands among approximately 85,000 adults 65 years or older. It demonstrated:

• 46% efficacy against vaccine-type pneumococcal pneumonia
• 45% efficacy against vaccine-type non-bacteremic pneumococcal pneumonia
• 75% efficacy against vaccine-type IPD

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.

Multiple studies have resulted in various estimates of the clinical effectiveness of PPSV23. Overall, the vaccine is 60% to 70% effective in preventing IPD 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 who also receive PCV15 because of the broader serotype protection that PPSV23 provides. 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 haven’t shown decreases in carriage rates among those vaccinated.

Package Inserts

Consult the following package inserts for proper storage and handing details, shelf life, and reconstitution instructions:

• CAPVAXIVE™
• Prevnar20^®
• Vaxneuvance^®
• Pneumovax 23^®