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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines
Vaccine, Volume 31, No. 35, Year 2013
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Description
With the advent of new vaccines targeted to highly endemic diseases in low- and middle-income countries (LMIC) and with the expansion of vaccine manufacturing globally, there is an urgent need to establish an infrastructure to evaluate the benefit-risk profiles of vaccines in LMIC. Fortunately the usual decade(s)-long time gap between introduction of new vaccines in high and low income countries is being significantly reduced or eliminated due to initiatives such as the Global Alliance for Vaccines and Immunizations (GAVI) and the Decade of Vaccines for the implementation of the Global Vaccine Action Plan. While hoping for more rapid disease control, this time shift may potentially add risk, unless appropriate capacity for reliable and timely evaluation of vaccine benefit-risk profiles in some LMIC's are developed with external assistance from regional or global level. An ideal vaccine safety and effectiveness monitoring system should be flexible and sustainable, able to quickly detect possible vaccine-associated events, distinguish them from programmatic errors, reliably and quickly evaluate the suspected event and its association with vaccination and, if associated, determine the benefit-risk of vaccines to inform appropriate action. Based upon the demonstrated feasibility of active surveillance in LMIC as shown by the Burkina Faso assessment of meningococcal A conjugate vaccine or that of rotavirus vaccine in Mexico and Brazil, and upon the proof of concept international GBS study, we suggest a sustainable, flexible, affordable and timely international collaborative vaccine safety monitoring approach for vaccines being newly introduced. While this paper discusses only the vaccine component, the same system could also be eventually used for monitoring drug effectiveness (including the use of substandard drugs) and drug safety. © 2013.
Authors & Co-Authors
Izurieta, Héctor S.
United States, Silver Spring
Food and Drug Administration
Zuber, Patrick Louis F.
Switzerland, Geneva
Organisation Mondiale de la Santé
Bonhoeffer, Jan
Switzerland, Basel
Brighton Collaboration Foundation
Switzerland, Basel
Universitäts-kinderspital Beider Basel
Chen, Robert T. T.
United States, Atlanta
Centers for Disease Control and Prevention
Sankohg, Osman
Ghana, Accra
Indepth Network
South Africa, Johannesburg
Wits School of Public Health
Viet Nam, Hanoi
Hanoi Medical University
Laserson, Kayla F.
South Korea, Seoul
International Vaccine Institute, Seoul
Sturkenboom, M.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Loucq, Christian
Kenya, Kisumu
Kemri/cdc Research and Public Health Collaboration
Weibel, D. M.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Dodd, Caitlin N.
Netherlands, Rotterdam
Erasmus Mc
Black, Steven B.
Netherlands, Rotterdam
Erasmus Mc
Statistics
Citations: 26
Authors: 11
Affiliations: 12
Identifiers
Doi:
10.1016/j.vaccine.2013.05.027
ISSN:
0264410X
e-ISSN:
18732518
Study Locations
Burkina Faso