Prevnar 13
STN#: 125324
Proper Name: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Tradename: Prevnar 13
Manufacturer: Wyeth Pharmaceuticals, Inc
Indications:
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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).
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Active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A In children 6 weeks through 5 years of age (prior to the 6th birthday).
- 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).
- 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.
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Limitations: Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.
Product Information
Supporting Documents
- August 22, 2017 Approval Letter - Prevnar 13
To include changes to the package insert regarding temporary temperature excursions. - March 24, 2017 Summary Basis for Regulatory Action - Prevnar 13
- March 24, 2017 Approval Letter - Prevnar 13
To include results from a trial to evaluate Prevnar 13 when administered concomitantly with seasonal inactivated influenza vaccine in adults 50 years and older, who received 1 or more doses of 23-valent Pneumococcal Polysaccharide Vaccine - Approval History, Letters, Reviews, and Related Documents - Prevnar 13
- Supporting Documents older than three years - Prevnar 13