title: Evidence based vaccinology.
abstract: Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.
authors.affiliation: Merck Vaccine Division, Merck and Company, P.O. Box 4, WP97A-343, West Point, PA 19486-0004, USA. david_nalin@merck.com
authors.forename: David R
authors.initials: DR
authors.lastname: Nalin
mesh_terms: D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D017277:Drug Approval; D004345:Drug Industry; D019317:Evidence-Based Medicine; D006801:Humans; D014612:Vaccines / Q000191:economics / Q000302:isolation & purification* / Q000494:pharmacology / Q000592:standards
chemical_list: D014612:Vaccines