Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]

(Prevnar 13®)

Prevnar 13®

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Drug updated on 4/17/2024

Dosage FormInjection (intramuscular; 0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children 6 weeks through 5 years of age (prior to the 6th birthday).
  • Indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children 6 weeks through 5 years of age (prior to the 6th birthday). No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
  • Indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children 6 years through 17 years of age (prior to the 18th birthday),.
  • Indicated for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults 18 years of age and older.

Summary
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  • Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein] (Prevnar 13) is indicated for active immunization against invasive disease and otitis media caused by various Streptococcus pneumoniae serotypes in children aged between 6 weeks to under 18 years, as well as prevention of pneumonia and invasive disease in adults aged over 18.
  • A review of fifteen systematic reviews/meta-analyses focused on the safety, effectiveness, and comparison with other pneumococcal vaccines such as PCV10, PCV15, PCV20, and PPSV23 along with considerations for specific population subgroups.
  • Prevnar 13 demonstrates superior efficacy compared to PPSV23 in preventing vaccine-type invasive pneumococcal disease (VT IPD) and pneumonia among adults. It also shows better immunogenicity than PCV10 for certain serotypes among young children.
  • Both Prevnar 13 and the ten-valent pneumoconjugate vaccine show significant reductions in outcomes related to Otitis Media. However, further comparisons are needed due to some data suggesting that the latter might offer better protection against certain outcomes related to this condition.
  • Vaccine failure rates are low, indicating high overall effectiveness, but continued surveillance is required due to its association with breakthroughs involving serotypes like 19A, 3, and 19F, which may necessitate the inclusion of more serotypes into future vaccines.
  • The evidence regarding co-administration safety when using multiple vaccines alongside Prevnar remains inconclusive; while some studies report increased adverse events, others indicate fewer occurrences, highlighting the complexity involved in the assessment process.
  • The implementation of Prevnar has contributed towards controlling outbreaks by reducing antimicrobial-resistant diseases including nasopharyngeal carriage, invasive pneumonic illness, and otitis media, depending on the outbreak's associated serotype.
  • The introduction of this vaccine within childhood vaccination programs has led to a reduction in invasive pneumococcal disease rates among adults, particularly for vaccine-type serotypes. However, an increase in non-vaccine type IPDs has been observed, especially among individuals over 65 years of age.

Product Monograph / Prescribing Information

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systematic review and meta-analysis of the efficacy and effectiveness of pneumococcal vaccines in adults.2023Pathogens
Immunogenicity and seroefficacy of 10-valent and 13-valent pneumococcal conjugate vaccines: a systematic review and network meta-analysis of individual participant data.2023EclinicalMedicine
Systematic review of the efficacy, effectiveness and impact of high-valency pneumococcal conjugate vaccines on otitis media.2023Human Vaccines and Immunotherapeutics
Effectiveness of pneumococcal vaccines on otitis media in children: a systematic review.2023Value in Health
A systematic review of invasive pneumococcal disease vaccine failures and breakthrough with higher-valency pneumococcal conjugate vaccines in children.2022Expert Review of Vaccines
Current situation and need for prevention of invasive pneumococcal disease and pneumococcal pneumonia in 6- to 64-year-olds in Japan.2021Journal of Infection and Chemotherapy
Efficacy and effectiveness of the PCV-10 and PCV-13 vaccines against invasive pneumococcal disease.2020Pediatrics
Interchangeability between pneumococcal conjugate vaccines for pediatric use: a systematic literature review.2020Expert Review of Vaccines
Safety of co-administration versus separate administration of the same vaccines in children: a systematic literature review.2019Vaccines
Outbreaks of severe pneumococcal disease in closed settings in the conjugate vaccines era, 2010-2018: a systematic review to inform national guidance in the UK.2019Journal of Infection
The impact of routine childhood immunization with higher-valent pneumococcal conjugate vaccines on antimicrobial-resistant pneumococcal diseases and carriage: a systematic literature review.2019Expert Review of Vaccines
Pneumococcal conjugate vaccine against serotype 3 pneumococcal pneumonia in adults: a systematic review and pooled analysis.2019Vaccine
A systematic literature review and network meta-analysis feasibility study to assess the comparative efficacy and comparative effectiveness of pneumococcal conjugate vaccines.2019Human Vaccines & Immunotherapeutics
Impact of the 13-Valent pneumococcal conjugate vaccine among adults: a systematic review and meta-analysis.2019Clinical Infectious Diseases
Serotype distribution of disease-causing Streptococcus pneumoniae in Thailand: a systematic review.2019Vaccine
Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to 23-valent pneumococcal polysaccharide in immunocompetent adults: a systematic review and meta-analysis.2019Vaccine

Clinical Practice Guidelines