title: Against vaccine assay secrecy.
abstract: Increasing the transparency of the evidence base behind health interventions such as pharmaceuticals, biologics, and medical devices, has become a major point of critique, conflict, and policy focus in recent years. Yet the lack of publicly available information regarding the immunogenicity assays upon which many important, widely used vaccines are based has received no attention to date. In this paper we draw attention to this critical public health problem by reporting on our efforts to secure vaccine assay information in respect of 10 vaccines through Canada's access to information law. We argue, under Canadian law, that the public health interest in having access to the methods for these laboratory procedures should override claims by vaccine manufacturers and regulators that this information is proprietary; and, we call upon several actors to take steps to ensure greater transparency with respect to vaccine assays, including regulators, private firms, researchers, research institutions, research funders, and journal editors.
authors.affiliation: a Faculties of Medicine and Law; Health Law Institute ; Dalhousie University ; Halifax , Nova Scotia , Canada.
authors.forename: Matthew
authors.initials: M
authors.lastname: Herder
authors.forename: Todd F
authors.initials: TF
authors.lastname: Hatchette
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Langley
mesh_terms: D022126:Access to Information; D002170:Canada; D003219:Confidentiality; D006801:Humans; D014612:Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D014612:Vaccines
keywords: access to information law; intellectual property; transparency; vaccine assays
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