Proper Name: Pneumococcal 15-valent Conjugate Vaccine
Manufacturer: Merck Sharp & Dohme Corp.
Indication: 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, 22F, 23F and 33F in adults 18 years of age and older.
- Package Insert - VAXNEUVANCE
- Patient Information - VAXNEUVANCE
- Demographic Subgroup Information – Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE)
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.
- July 16, 2021 Approval Letter - VAXNEUVANCE
- July 16, 2021 Summary Basis for Regulatory Action - VAXNEUVANCE
- Approval History, Letters, Reviews, and Related Documents - VAXNEUVANCE