Drug updated on 4/17/2024
| Dosage Form | Injection (intramuscular; 0.5 mL) |
| Drug Class | Vaccines |
| 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
- 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
| Document Title | Year | Source |
|---|---|---|
| Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) Prescribing Information. | 2017 | Pfizer Inc., Philadelphia, PA |