STN: 125690
Proper Name: Ebola Zaire Vaccine, Live
Tradename: ERVEBO
Manufacturer: Merck Sharp & Dohme Corp.
Indication:

• Indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.

Product Information

• Package Insert - ERVEBO
• Patient Information - ERVEBO
• Demographic Subgroup Information – ERVEBO (Ebola Zaire Vaccine, Live)
  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

• December 19, 2019 Approval Letter - ERVEBO
• December 19, 2019 Summary Basis for Regulatory Action - ERVEBO
• Statistical Review - ERVEBO
• Approval History, Letters, Reviews, and Related Documents - ERVEBO

Related Information

• First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response