Abstract

Background: The gaps in clinical trial evidence about vaccination in pregnancy have serious implications for health care worker and public misunderstandings. Contradictions between National Immunization Technical Advisory Group (NITAG) recommendations and regulatory product labeling information contribute to misinformation about vaccine safety and effectiveness.
Methods: A mixed methods approach that included a stakeholder consensus decision-making workshop and a national survey of Canadian health care providers (HCPs).
Results: We identified knowledge gaps and serious limitations concerning the information in vaccine product labels. Stakeholders were troubled that some HCPs rely on regulatory product labels to inform their decisions without knowing their limitations in content. Our survey showed that HCPs were uncertain about the purpose of product labels and the evidence contained in them. Over a third of respondents incorrectly thought that product labels and NITAG recommendations are based on the same evidence and that the information they contain is regularly updated.
Conclusions: Applying social risk theories, we show how such gaps in information defer responsibility for decisions about disease risk and vaccine safety from regulatory agencies and vaccine manufacturers onto HCPs and their clients. This may be especially relevant for COVID-19 and other emerging vaccines that are initially authorized for conditional or emergency use, and especially in understudied populations such as pregnant people. More frequent updating and alignment of robust, unbiased, and independently reviewed clinical trial and postmarket safety and effectiveness evidence with NITAG recommendations would allay HCP and public misunderstandings.

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Information & Authors

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Published In

cover image Journal of Women's Health
Journal of Women's Health
Volume 31Issue Number 8August 2022
Pages: 1103 - 1112
PubMed: 35730988

History

Published online: 17 August 2022
Published in print: August 2022
Published ahead of print: 22 June 2022

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Authors

Affiliations

Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Canadian Center for Vaccinology, IWK Health Centre, Halifax, Canada.
Technoscience & Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Canada.
Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Canadian Center for Vaccinology, IWK Health Centre, Halifax, Canada.
Kirsten Weagle
Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Department of Pediatrics (Infectious Diseases), Dalhousie University, Halifax, Canada.
Canadian Center for Vaccinology, IWK Health Centre, Halifax, Canada.
Technoscience & Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Canada.

Notes

Address correspondence to: Janice E. Graham, PhD, Department of Pediatrics (Infectious Diseases), Dalhousie University, 5849 University Avenue, C-302, P.O. Box 15000, Halifax, Nova Scotia B3H 4H7, Canada [email protected]

Authors' Contributions

T.A.M., K.A.T., and J.E.G. conceived of the idea, drafted, and revised the article. K.W. assisted with data analysis, interpretation, and writing of results.

Author Disclosure Statement

All authors report no conflicts of interest.

Funding Information

This study was supported by grants from the Department of Pediatrics, Dalhousie University and IWK Health, the Canadian Institutes of Health Research (PJT-148908), and by a contract with the Public Health Agency of Canada in collaboration with the SOGC. K.W. was supported by a Dalhousie Medical Research Foundation summer studentship.

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