title: Enhancing Vaccine Safety Capacity Globally: A Lifecycle Perspective.
abstract: Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a "lifecycle" approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle-income countries.
authors.affiliation: Office of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: bchen@cdc.gov.
authors.forename: Robert T
authors.initials: RT
authors.lastname: Chen
authors.affiliation: Office of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Tom T
authors.initials: TT
authors.lastname: Shimabukuro
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
authors.forename: David B
authors.initials: DB
authors.lastname: Martin
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Patrick L F
authors.initials: PL
authors.lastname: Zuber
authors.affiliation: Erasmus University Medical Center, Rotterdam, Netherlands.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Weibel
authors.affiliation: Erasmus University Medical Center, Rotterdam, Netherlands.
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D019049:Developed Countries; D003906:Developing Countries; D004335:Drug and Narcotic Control; D014943:Global Health; D006801:Humans; D017589:Immunization Programs; D007115:Immunization Schedule; D057285:Precision Medicine; D037841:Pregnant People; D011358:Product Surveillance, Postmarketing / Q000379:methods; D012107:Research Design; D018570:Risk Assessment; D012449:Safety; D049490:Systems Biology; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines