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                Vaccines, Blood & Biologics

Vaccines, Blood & Biologics

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          ERVEBOVaccines, Blood & Biologics ERVEBO
  
  	
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    Print**STN:**125690**Proper Name:** Ebola Zaire Vaccine, Live**Tradename:** ERVEBO**Manufacturer:** Merck Sharp & Dohme LLC**Indication:**

ERVEBO is a vaccine indicated for For the prevention of disease caused by Zaire ebolavirus in individuals 12 months 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

July 27, 2023 Approval Letter - ERVEBO
	July 27, 2023 Clinical Review Memo - ERVEBO
	Statistical Review and Evaluation - ERVEBO
	September 16, 2022 Approval Letter - ERVEBO
	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 - ERVEBORelated Information

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

                                                                                  Content current as of:
      08/09/2023Vaccines, Blood & Biologics

          
                        Infectious Disease Tests


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          Xenotransplantation
 
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