title: Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines.
abstract: 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.
authors.affiliation: Food and Drug Administration (FDA), MD, United States. hector.izurieta@fda.hhs.gov
authors.forename: Hector S
authors.initials: HS
authors.lastname: Izurieta
authors.forename: Patrick
authors.initials: P
authors.lastname: Zuber
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.forename: Robert T
authors.initials: RT
authors.lastname: Chen
authors.forename: Osman
authors.initials: O
authors.lastname: Sankohg
authors.forename: Kayla F
authors.initials: KF
authors.lastname: Laserson
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
authors.forename: Christian
authors.initials: C
authors.lastname: Loucq
authors.forename: Daniel
authors.initials: D
authors.lastname: Weibel
authors.forename: Caitlin
authors.initials: C
authors.lastname: Dodd
authors.forename: Steve
authors.initials: S
authors.lastname: Black
mesh_terms: D003140:Communicable Disease Control; D003141:Communicable Diseases / Q000276:immunology*; D062665:Epidemiological Monitoring; D006801:Humans; D018570:Risk Assessment; D014611:Vaccination; D014612:Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use
chemical_list: D014612:Vaccines
keywords: Adverse events; Benefit-risk; Effectiveness; Safety; Vaccine