What is the Pneumococcal Conjugate Vaccine 13 (PCV 13) regimen?

From the Guidelines

The PCV13 regimen consists of a 4-dose series at ages 2,4,6, and 12–15 months for infants and children who have not received any previous PCV7 or PCV13 doses. This recommendation is based on the Advisory Committee on Immunization Practices (ACIP) guidelines, as outlined in the study published in MMWR Recommendations and Reports 1. The vaccine protects against 13 strains of Streptococcus pneumoniae bacteria that can cause serious infections, including pneumonia, meningitis, and bloodstream infections.

Key Points

• The PCV13 regimen is recommended for all children aged 2–59 months, with a 4-dose series at ages 2,4,6, and 12–15 months 1.
• For children who have received ≥1 dose of PCV7, the series should be completed with PCV13, and a supplemental dose of PCV13 is recommended for all children aged 14–59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule 1.
• The vaccine is generally well-tolerated, with potential side effects including injection site reactions, fever, decreased appetite, irritability, and fatigue, which are typically mild and resolve within a few days.

Special Considerations

• For children with underlying medical conditions, a supplemental PCV13 dose is recommended through age 71 months 1.
• Children aged 2–18 years with underlying medical conditions should also receive PPSV23 after completing all recommended doses of PCV13 1.
• The schedule for administering PCV13 doses to children aged <24 months is outlined in Table 9 of the study published in MMWR Recommendations and Reports 1, which provides guidance on the recommended PCV13 regimen based on age and vaccination history.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Pneumococcal Conjugate Vaccine 13 (PCV13) Regimen

• The PCV13 regimen is designed to protect against 13 serotypes of Streptococcus pneumoniae, a common cause of otitis media, sinusitis, and pneumonia in children 2.
• The vaccine is recommended for all infants and children under 24 months of age, with a routine schedule of 2,4, and 6 months, and a fourth dose at 12 to 15 months of age 2.
• The PCV13 regimen has been shown to be effective in preventing invasive pneumococcal disease, as well as pneumonia and otitis media, in healthy children 2.
• The vaccine has also been recommended for children 24 to 59 months of age who are at high risk for pneumococcal infection 2.

Dosage Schedules

• Different dosage schedules for PCV13 have been considered, including a 3-dose primary series without a booster, or a 2-dose primary series with a booster dose 3.
• The choice of schedule depends on various factors, including disease epidemiology, vaccine efficacy, and practical considerations such as existing vaccine schedules and program performance 3.
• A schedule that provides PCV doses early in life may be preferred in low-income countries where pneumococcal disease peaks early in life 3.

Immunogenicity and Efficacy

• PCV13 has been shown to induce a strong immune response, with higher titers and more durable antibody responses compared to the 23-valent pneumococcal polysaccharide vaccine (PPSV23) 4.
• The vaccine has been effective in preventing nasopharyngeal carriage and noninvasive pneumonia, and has shown consistent efficacy against invasive pneumococcal disease 5, 6.
• PCV13 has been approved for use in adults, and has been shown to address an unmet medical need for non-bacteremic pneumococcal pneumonia 6.