Overview
Ebola virus vaccine is a vaccine used to prevent Ebola virus disease caused by Zaire ebolavirus in adults, prevent outbreaks, and reduce the extent of the virus spreading in case of outbreaks. Ebola virus disease, formerly known as Ebola hemorrhagic fever, is a rare but severe and often deadly disease. It is highly contagious: human to human transmission occurs from contact with body fluids from infected patients. It is characterized by fever, headache, myalgia, and gastrointestinal symptoms. These may be accompanied by hypotension and respiratory, kidney and liver failure, as well as internal and external bleeding. In the Filoviridae family, there are five unique Ebolavirus species that are each named after the geographical region where it was first identified. The mortality rate of the Zaire species is about 80%. Confirmed outbreaks of Ebola virus disease have been documented since the 1970s, mostly in Sub-Saharan Africa, where Ebola first appeared in 1976 near the Ebola River in Zaire (presently referred to as the Democratic Republic of the Congo) and Sudan. Between 2014 and 2016, Ebola outbreaks occurred in West Africa, leading to more than 11,310 total deaths during this time in Guinea, Liberia, and Sierra Leone. In 2016, this epidemic was exhausted after these countries were declared Ebola-free by 2016, and the World Health Organization (WHO) lifted the Public Health Emergency of International Concern (PHEIC) status on the West Africa Ebola outbreak. The first live, attenuated Ebola virus vaccine was developed by a team of Canadian researchers at Canada’s National Microbiology Laboratory and was later patented by the Canadian government. In non-human primate clinical trials, the vaccine was effective in inducing an immune response against the Ebola viruses. This vaccine was later sold to NewLink Genetics, a biotech company that held the license to the vaccine from 2010 to 2014, although the vaccine was not marketed. In 2014, Merck Inc. signed a licensing agreement with NewLink for further development and marketing. Ervebo, the marketed Ebola virus vaccine by Merck, was first approved by the European Commission in November 2019 after the European Medicines Agency recommended it be licensed. In December 2019, Ervebo was approved by the FDA in the United States. Ervebo consists of an envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain) fused into a vesicular stomatitis virus (VSV) backbone. By introducing the relatively inactive viral protein to the patient, the patient’s immune system learns to recognize and attack the virus if he or she is exposed to it in the future.
Background
Ebola virus vaccine is a vaccine used to prevent Ebola virus disease caused by Zaire ebolavirus in adults, prevent outbreaks, and reduce the extent of the virus spreading in case of outbreaks. Ebola virus disease, formerly known as Ebola hemorrhagic fever, is a rare but severe and often deadly disease. It is highly contagious: human to human transmission occurs from contact with body fluids from infected patients. It is characterized by fever, headache, myalgia, and gastrointestinal symptoms. These may be accompanied by hypotension and respiratory, kidney and liver failure, as well as internal and external bleeding. In the Filoviridae family, there are five unique Ebolavirus species that are each named after the geographical region where it was first identified. The mortality rate of the Zaire species is about 80%. Confirmed outbreaks of Ebola virus disease have been documented since the 1970s, mostly in Sub-Saharan Africa, where Ebola first appeared in 1976 near the Ebola River in Zaire (presently referred to as the Democratic Republic of the Congo) and Sudan. Between 2014 and 2016, Ebola outbreaks occurred in West Africa, leading to more than 11,310 total deaths during this time in Guinea, Liberia, and Sierra Leone. In 2016, this epidemic was exhausted after these countries were declared Ebola-free by 2016, and the World Health Organization (WHO) lifted the Public Health Emergency of International Concern (PHEIC) status on the West Africa Ebola outbreak. The first live, attenuated Ebola virus vaccine was developed by a team of Canadian researchers at Canada’s National Microbiology Laboratory and was later patented by the Canadian government. In non-human primate clinical trials, the vaccine was effective in inducing an immune response against the Ebola viruses. This vaccine was later sold to NewLink Genetics, a biotech company that held the license to the vaccine from 2010 to 2014, although the vaccine was not marketed. In 2014, Merck Inc. signed a licensing agreement with NewLink for further development and marketing. Ervebo, the marketed Ebola virus vaccine by Merck, was first approved by the European Commission in November 2019 after the European Medicines Agency recommended it be licensed. In December 2019, Ervebo was approved by the FDA in the United States. Ervebo consists of an envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain) fused into a vesicular stomatitis virus (VSV) backbone. By introducing the relatively inactive viral protein to the patient, the patient’s immune system learns to recognize and attack the virus if he or she is exposed to it in the future.
Indication
Ebola Zaire vaccine is indicated for active immunization of individuals 12 months of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebolavirus.
Associated Conditions
- Ebola Virus Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2023/11/13 | Phase 3 | Recruiting | Institute of Tropical Medicine, Belgium |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |