Drug updated on 9/5/2024
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.
Latest News
Summary
- Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria crm197 protein]) is 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); and 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) with no otitis media efficacy data available for serotypes 1, 3, 5, 6A, 7F, and 19A. Additionally, it is indicated 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); and 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.
- This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
- Invasive Pneumococcal Disease (IPD): PCV13 showed 75% efficacy against PCV13-type IPD in one RCT, with effectiveness in observational studies ranging from 47% to 68%. PPSV23 had a pooled effectiveness of 45% against PPSV23-type IPD across nine studies.
- Pneumococcal Pneumonia (PP): PCV13 demonstrated 45% efficacy against PCV13-type PP, with observational study effectiveness ranging from 38% to 68%. PPSV23's pooled effectiveness against PPSV23-type PP was 18% across five studies.
- Otitis Media (OM) in Children Under 24 Months: Effectiveness varied among PCVs, with PCV13 showing a reduction of 2.2% to 68%, PCV10 showing 5.6% to 84%, and PCV7 showing 8% to 42.7%.
- Acute Otitis Media (AOM): PCV13 had a vaccine effectiveness (VE) of 86% against AOM, while PCV10 showed effectiveness of 26.9% against clinically defined AOM and 43.3% against bacteriologically confirmed AOM.
- Co-administration studies of PCV13 indicated mixed results, with some studies reporting more adverse events following immunization (AEFI) and others reporting fewer, compared to separate administrations.
- PCV13 and PPV23 exhibited similar overall safety profiles, but PCV13 was associated with significantly more local reactions in pneumococcal-naïve individuals.
- No significant safety concerns were identified for mixed schedules involving PHiD-CV/PCV13 or during outbreaks, where PPV23 was commonly preferred.
- Young children (<2 years and <5 years) were predominantly studied for effectiveness against OM and AOM, while adults aged ≥65 years were the primary focus for effectiveness of PCV13 against CAP and IPD; studies also included assessments of vaccine failures and breakthrough cases in children without comorbidities, with additional emphasis on geographic regions such as Japan and the USA, and on populations with comorbid conditions who demonstrated a higher burden of IPD and PP.
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 |