Immunization with ERVEBO results in an immune response and protection from disease caused by Zaire ebolavirus. The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire ebolavirus are unknown.

ERVEBO® is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.

ERVEBO is a suspension for injection supplied as a 1 mL dose in single-dose vials.

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%). (6.1)
• 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%). (6.1)
• 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%). (6.1)
• 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%). (6.1)

Severe allergic reaction (e.g., anaphylaxis) to any component of ERVEBO.

• Anaphylaxis has been observed following administration of ERVEBO. Appropriate medical treatment and supervision must be available in case of anaphylactic event following the administration of ERVEBO. (5.1)
• Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission. (5.2)
• Vaccine virus RNA has been detected in blood, saliva, urine, and fluid from skin vesicles of vaccinated individuals; transmission of vaccine virus is a theoretical possibility. (5.4)