Ervebo FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 7, 2023.
FDA Approved: Yes (First approved December 19, 2019)
Brand name: Ervebo
Generic name: ebola zaire vaccine, live
Dosage form: Injection
Company: Merck
Treatment for: Ebola Zaire Disease Prophylaxis
Ervebo (ebola zaire vaccine, live) is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.
- Ebola virus disease is a rapidly progressive, severe, potentially fatal and transmissible hemorrhagic illness caused by infection with one of the Ebola virus species. While there are six identified Ebola virus species, the Zaire ebolavirus strain has been the leading cause of outbreaks over the last 20 years.
- Ervebo is a live recombinant viral vaccine consisting of a vesicular stomatitis virus (VSV) backbone deleted for the VSV envelope glycoprotein and substituted with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain). Immunization with Ervebo results in an immune response and protection from disease caused by Zaire ebolavirus.
- Ervebo is administered as a single dose by intramuscular injection.
- Warnings and precautions associated with Ervebo include anaphylaxis, and appropriate medical treatment and supervision must be available in case of an anaphylactic event. Ervebo may not protect all vaccinated individuals. Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission. Vaccine virus RNA has been detected in blood, saliva, urine, and fluid from skin vesicles of vaccinated individuals for up to 14 days after vaccination, and transmission of vaccine virus is a theoretical possibility.
- The most commonly reported local and systemic adverse events in clinical trials were:
- Individuals 18 years of age and older: injection-site pain (70%); headache (55%); feverishness (39%); muscle pain (33%); somnolence, reduced activity, fatigue (26%); joint pain, arthralgia (19%); chills (17%); injection-site swelling (17%); decreased appetite (15%); abdominal pain (13%); injection-site redness (12%); nausea (10%); arthritis (5%); vomiting (4%), rash (4%); abnormal sweating (3%) and mouth ulceration (2%).
- Individuals 12 years through 17 years of age: headache (59%); injection-site pain (52%); feverishness (48%); myalgia (30%); somnolence, reduced activity, fatigue (28%); decreased appetite (21%); chills (19%); dizziness (17%); abdominal pain (16%); arthralgia (16%); nausea (8%); abnormal sweating (5%); diarrhea (4%); vomiting (4%); injection-site pruritus (3%); injection-site swelling (3%) and mouth ulceration (2%).
- Individuals 3 years through 11 years of age: feverishness (65%); headache (50%); injection-site pain (40%); decreased appetite (24%); somnolence, reduced activity, fatigue (22%); abdominal pain (21%); chills (14%); myalgia (12%); vomiting (11%);dizziness (8%); nausea (8%); injection-site pruritus (7%); crying (3%); arthralgia (3%); diarrhea (3%); injection-site swelling (3%); abnormal sweating (1%); mouth ulceration (2%) and irritability (1%).
- Individuals 12 months through 2 years of age: feverishness (83%); crying (31%); decreased appetite (27%); injection-site pain (26%); somnolence, reduced activity, fatigue (20%); diarrhea (19%); vomiting (17%); irritability (11%); screaming (10%); mouth ulceration (6%); chills (5%); injection-site swelling (5%); headache (4%); abdominal pain (2%); abnormal sweating (2%) and injection-site erythema (1%).
Development timeline for Ervebo
Further information
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