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In this section: Vaccines
 * Vaccines
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 1. Home
 2. Vaccines, Blood & Biologics
 3. Vaccines
 4. PREVNAR 20

 1. Vaccines


PREVNAR 20

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STN: 125731
Proper Name: Pneumococcal 20-valent Conjugate Vaccine
Tradename: PREVNAR 20
Manufacturer: Wyeth Pharmaceuticals LLC
Indication:

 * Active immunization for the prevention of invasive disease 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 in individuals 6 weeks of age
   and older.
 * Active immunization for the prevention of otitis media caused by S.
   pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks
   through 5 years of age.
 * Active immunization for the prevention of pneumonia caused by S. pneumoniae
   serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A,
   19F, 22F, 23F, and 33F in individuals 18 years of age and older.


PRODUCT INFORMATION

 * Package Insert - PREVNAR 20
 * Demographic Subgroup Information - PREVNAR 20 (Pneumococcal 20-valent
   Conjugate Vaccine)
   Refer to Section 1.1 of the Clinical Review Memo for information about
   participation in the clinical trials and any analysis of demographic subgroup
   outcomes that is notable.


SUPPORTING DOCUMENTS

 * April 27, 2023 Approval Letter - PREVNAR 20
 * September 30, 2022 Approval Letter - PREVNAR 20
 * June 10, 2021 Approval Letter - PREVNAR 20
 * June 8, 2021 Summary Basis for Regulatory Action - PREVNAR 20
 * Approval History, Letters, Reviews and Related Documents - PREVNAR 20


   CONTENT CURRENT AS OF:
   
   04/28/2023


 * REGULATED PRODUCT(S)
   
    * Biologics

 * Vaccines
    * Emergency Use Authorization for Vaccines Explained
    * Approved Vaccine Products
    * Questions about Vaccines
   
   




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