Infants, Children and Adolescents (6 Weeks Through 17 Years of Age)
PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is indicated for active immunization of infants, children and adolescents from 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Adults (18 Years of Age and Older)
PREVNAR 20 is indicated for active immunization of adults 18 years of age and older for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Clinical efficacy for the prevention of pneumonia was studied with PREVNAR 13 for the shared serotypes (see 14 CLINICAL TRIALS), but not for the additional serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F.
PREVNAR 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.
Based on the data submitted to and reviewed by Health Canada, the safety and efficacy of PREVNAR 20 in pediatric patients (6 weeks to <18 years of age) have been established. Therefore, Health Canada has authorized an indication for pediatric use in individuals 6 weeks through 17 years of age (prior to the 18th birthday). See 1 INDICATIONS, 8.2.1 Clinical Trial Adverse Reactions – Pediatrics and 14 CLNICAL TRIALS.
PREVNAR 20 has been studied in the geriatric population (see 7.1 Special Populations and 14 CLINICAL TRIALS).
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