ERVEBO (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification - Seite 2

Selected Safety Information for ERVEBO

CONTRAINDICATIONS

Do not administer ERVEBO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein.

WARNINGS AND PRECAUTIONS

Management of Acute Allergic Reactions

Among 15,399 subjects vaccinated with ERVEBO, there were two reports of anaphylaxis. Monitor individuals for signs and symptoms of hypersensitivity reactions following vaccination with ERVEBO. Appropriate medical treatment and supervision must be available in case of an anaphylactic event following the administration of ERVEBO.

Limitations of Vaccine Effectiveness

Vaccination with ERVEBO may not protect all individuals. Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission.

Immunocompromised Individuals

The safety and effectiveness of ERVEBO have not been assessed in immunocompromised individuals. The effectiveness of ERVEBO in immunocompromised individuals may be diminished. The risk of vaccination with ERVEBO, a live virus vaccine, in immunocompromised individuals should be weighed against the risk of disease due to Zaire ebolavirus.

Transmission

Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults. Transmission of vaccine virus is a theoretical possibility.

ADVERSE REACTIONS

The clinical development program for ERVEBO included clinical studies conducted in North America, Europe and Africa, in which a total of 15,399 adults received a dose of ERVEBO. The total number of subjects vaccinated with ERVEBO in double-blind, placebo-controlled trials was 1,712 and in open label trials was 13,687.

The most common injection-site adverse reactions reported by subjects taking ERVEBO in Study 1 (N=500) were injection-site pain (34.0%) and redness/swelling (2%). The most common injection-site adverse reactions reported by subjects taking ERVEBO in Study 2 (N=1051) were injection-site pain (70.0%), swelling (17%), and redness (12%).

The most common systemic adverse reactions reported following vaccination with ERVEBO in Study 1 (N=498) were headache (37%), feverishness (34%), muscle pain (33%), fatigue (19%), nausea (8%), joint pain/tenderness (7%), rash (4%), and abnormal sweating (3%). The most common systemic adverse reactions reported following vaccination with ERVEBO in Study 2 (N=1051) were joint pain (18%), arthritis (5%), rash (4%), and vesicular lesions (2%).