Adverse events following yellow fever preventive vaccination campaigns in eight African countries from 2007 to 2010

作者：Breugelmans J G^*; Lewis R F; Agbenu E; Veit O; Jackson D; Domingo C; Boethe M; Perea W; Niedrig M; Gessner B D; Yactayo S

来源：Vaccine, 2013, 31(14): 1819-1829.

DOI：10.1016/j.vaccine.2013.01.054

• Adverse event
• Adverse event following immunization
• Unified database
• Vaccine safety
• Yellow fever
• Yellow fever vaccine safety
• Yellow Fever Initiative
• Yellow fever vaccine
• Yellow fever vaccine associated neurologic disease
• Yellow fever vaccine associated viscerotropic disease

Background: Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown.
Methods: From 2007 to 2010, eight African countries Benin, Cameroon, Guinea, Liberia, Mali, Senegal, Sierra Leone, and Togo- implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded.
Results: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11(50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YEL-AND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience.
Conclusions: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventive mass vaccination campaigns in YF endemic areas.

• 出版日期2013-4-3