Diagnostic Testing for Vaccinomics: Is the Regulatory Approval Framework Adequate? A Comparison of Canada, the United States, and Europe

OMICS: A Journal of Integrative Biology, 2011 September;15(9):597-605, doi: 10.1089/omi.2010.0135

10 Pages Posted: 18 Jan 2013

See all articles by Yann Joly

Yann Joly

McGill University - Centre for Genomics and Policy

Georgia Koutrikas

McGill University - Centre for Genomics and Policy

Emma Ramos-Paque

McGill University - Centre for Genomics and Policy

Ma'n H. Zawati

McGill University - Centre of Genomics and Policy

Jennifer Gardy

University of British Columbia (UBC)

Michael Hayden

University of British Columbia (UBC)

Bruce Carleton

University of British Columbia (UBC)

Date Written: 2011

Abstract

Vaccinomics aims to integrate variability information from multiple levels of the biological hierarchy from genome to proteome to metabolome, and ways in which these biological parts interact with each other and the environment. Vaccinomics holds significant promise as a new public health tool in designing safer and more effective vaccines for both developed and developing countries. Vaccinomics tests that are envisioned to be used in tandem with vaccine-based health interventions could permit an informed forecast of individual and subpopulation variations in immune responses to vaccines, reduce adverse effects, and contribute to a foundation for rational and directed use of vaccines. A proactive, multidisciplinary engagement with vaccinomics is now timely and much needed in order to develop regulations that best ensure the protection of the public and promote the transition of vaccinomics innovations from discovery to real-life public health applications. This article examines and compares the regulatory oversight of vaccinomics tests in Canada, the United States, and Europe. Recent trends in these jurisdictions suggest that regulatory agencies view personalized genomics/omics medicine, such as vaccinomics, as a desirable goal. At the same time, proposals to increase oversight could impact progress in the field and affect the availability of vaccinomics tests in public health practice and the diagnostic test market. The comparative analysis of vaccinomics in three jurisdictions presented in this article highlights both the convergence and divergence of regulatory oversight. In a rapidly emerging field such as vaccinomics that is pivotal for global public health, achieving better harmonization of policies may be an advantageous target, while ensuring that symmetry exists between the goals of public safety and promoting public health innovation. We suggest it is now timely to proactively initiate a constructive dialogue among all stakeholders (publics, policymakers, researchers, private sector, governments) to foster the development of appropriately targeted regulatory policies in this field.

Suggested Citation

Joly, Yann and Koutrikas, Georgia and Ramos-Paque, Emma and Zawati, Ma'n H. and Gardy, Jennifer and Hayden, Michael and Carleton, Bruce, Diagnostic Testing for Vaccinomics: Is the Regulatory Approval Framework Adequate? A Comparison of Canada, the United States, and Europe (2011). OMICS: A Journal of Integrative Biology, 2011 September;15(9):597-605, doi: 10.1089/omi.2010.0135, Available at SSRN: https://ssrn.com/abstract=2202315

Yann Joly (Contact Author)

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Georgia Koutrikas

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Emma Ramos-Paque

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Ma'n H. Zawati

McGill University - Centre of Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Jennifer Gardy

University of British Columbia (UBC) ( email )

2329 West Mall
Vancouver, British Columbia BC V6T 1Z4
Canada

Michael Hayden

University of British Columbia (UBC) ( email )

2329 West Mall
Vancouver, British Columbia BC V6T 1Z4
Canada

Bruce Carleton

University of British Columbia (UBC) ( email )

2329 West Mall
Vancouver, British Columbia BC V6T 1Z4
Canada

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