Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines
Food and Drug Administration (FDA), MD, United States; World Health Organization, Geneva, Switzerland; Brighton Collaboration Foundation, Basel, Switzerland; University Children's Hospital Basel, University of Basel, Basel, Switzerland; Centers for Disease Control and Prevention (CDC), Atlanta, GA, United States; INDEPTH Network, Accra, Ghana; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa; Hanoi Medical School, Hanoi, Viet Nam; KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya; Erasmus University Medical Center, Rotterdam, Netherlands; International Vaccine Institute, Seoul, South Korea; University of Children's hospital, University of Cincinnati, OH, United States
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.
Rotavirus vaccine; vaccine; article; Brazil; clinical evaluation; communicable disease; demography; disease control; drug efficacy; drug monitoring; drug safety; drug surveillance program; endemic disease; epidemiological monitoring; health care personnel; hospitalization; human; international cooperation; lowest income group; mass immunization; Mexico; priority journal; risk benefit analysis; therapy effect; vaccination; vaccine failure; Adverse events; Benefit-risk; Effectiveness; Safety; Vaccine; Communicable Disease Control; Communicable Diseases; Epidemiological Monitoring; Humans; Risk Assessment; Vaccination; Vaccines