An open letter to:
International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The International Coalition of Medicines Regulatory Authorities
European Medicines Agency
European Directorate for the Quality of Medicines and Healthcare
European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
Home Office
Department of Health and Social Care
Department for Business, Energy & Industrial Strategy
Medicines & Healthcare products Regulatory Agency
National Institute for Health and Care Excellence (NICE)
We are calling for a change of mindset and a clear timetable for regulatory change to enable accelerated development of medicines which are likely to be safer, more effective and cheaper, without the use of animals. Investment in human relevant science offers a golden opportunity to revitalise medical research, save money, create wealth and improve public health.
We find ourselves in a time of global health emergency, one that will challenge our healthcare, social fabric and economy for years to come. Hard choices today have been borne out of great and immediate need. Yet there are patterns emerging in the scientific response that will have far reaching consequences for how we progress medical science in the future.
In March 2020, Moderna Therapeutics, one of the first companies to begin research into COVID-19, trialled a vaccine in humans in parallel to animals(1) – a break from the linear process requiring animal trials before clinical trials. The University of Oxford also subsequently trialled COVID-19 vaccines in humans without the usual preceding animal trials(2).
Given the urgency of the crisis and that both vaccines contain components known to be safe to use in people, the opportunity to fast-track trials straight into humans was approved in order to save lives. Moderna Therapeutics Chief Medical Officer Tal Zaks stated, “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial.”(3)
The International Coalition of Medicines Regulatory Authorities (ICMRA) agreed that “it is not required to demonstrate the efficacy of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding to [first in human] FIH clinical trials.”(4)
The European Medicines Agency and European Commission have expressed their commitment to advancing animal free new approach methodologies for drug development and safety assessment in the context of COVID-19.(5)
Prioritising human relevant approaches in the search for a COVID-19 vaccine sets a powerful precedent. The emergency has forced an appraisal of what is truly necessary to deliver safe and effective medicines as quickly as possible. Traditional animal-based tests are too slow and unreliable to meet the ambitious goal of a vaccine or treatment within a year(6). As Dr Francois Busquet and colleagues from the Center for Alternatives to Animal Testing-Europe state, human relevant approaches offer crucial advantages of speed and “much more robust and exacting data than any animal experiment could deliver.”(7)
Myriad human relevant technologies are currently available and increasingly used within basic and clinical research, such as 3D human ‘lungs-on-a-chip’ that more accurately reflect human biology and enable study of the disease in real human tissue(8). There has never been a more pertinent moment to embrace these new approach methodologies and to step up investment in advancing technologies which are representative of the whole human system. This is how we will save precious time, replace invasive animal experiments and avoid the unreliability inherent in extrapolating from species with very different immune systems.
We now need the vision to adopt this approach for all human disease and illness – from COVID-19 to cancer, dementia to diabetes – as outlined in the Alliance for Human Relevant Science White Paper, ‘Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom’(8). Something good can come from the COVID-19 emergency.
Aysha Akhtar, MD, MPH, President and CEO, Center for Contemporary Sciences
Professor Alberto Alemanno, Founder and Director of The Good Lobby
Kathy Archibald, Chair, Safer Medicines Trust
Dr Jarrod Bailey, Director of Science and Technology, Center for Contemporary Sciences
Marc Bekoff, Ph.D., Professor emeritus Ecology and Evolutionary Biology, University of Colorado, Boulder
Dr Adrian Biddle, Queen Mary University of London
Dr Charlotte Blattner, Senior Lecturer and Researcher, University of Berne
Dr Simon Brooman, Senior Lecturer Law, Liverpool John Moores University
Dr Kit Byatt, Retired Consultant Geriatrician
Dr Eleanor Burt, citizen
Dr Martin Clift, Associate Professor, Biomedical Sciences, Swansea University
Professor Michael D. Coleman, Professor of Toxicology, Aston University
Professor Mark Cunningham, Trinity College Dublin, Ireland
Prof Matthew Dalby, Director of the lifETIME Centre for Doctoral Training in Engineered Tissues
Dr Lori Leigh Davis, Lecturer in Responsible Enterprise
Tamara Drake, Director of Research and Regulatory Policy, Center for Responsible Science
Dr Christina Dodkin, Lord Dowding Fund
Dr Stephen Dunne, University of Sunderland
Professor Amanda Ellison, Durham University
Dr Luis Falcon, President, GNU Solidario
Professor Sebastien Farnaud, Faculty of Health & Life Sciences, Coventry University
Professor Robert Garner, School of History, Politics and International Relations, University of Leicester
Professor Lorna Harries, Professor of Molecular Genetics, University of Exeter
Robyn Hederman, Fellow, Oxford Centre for Animal Ethics
Revd Professor Martin Henig, Wolfson College Oxford
Dr. Carolina Herrera, PhD, Imperial College London
Professor Jon Heylings, Dermal Technology Laboratory Ltd and Professor of Toxicology, Keele University
Dr Ewelina Hoffman, Principal Lead Scientist, Immuone
Prof. Dr. Kai Horsthemke, Associate Professor, KU Eichstätt-ingolstadt, Germany
Dr Kimberley Jayne, Lord Dowding Fund
Dr Nicola Jeffery PhD, University of Exeter Medical School
Rebecca Jenkins LL.B, LL.M, Associate Fellow, Oxford Centre for Animal Ethics
Linda Johnson, Ph.D, Visiting Professor, University of Michigan-Flint
Dr Shireen Kassam, Consultant Haematologist and Lifestyle Medicine Physician
Dr Gerry Kenna, Pharmaceutical Director, Safer Medicines Trust
Andrew Knight, Professor of Animal Welfare and Ethics, & Founding Director, Centre for Animal Welfare, University of Winchester
Dr Tomasz Kostrzewski, Director, Biology, CN Bio Innovations Limited
Dr Laura Leslie, Biomedical Engineer, Aston University
The Revd Professor Andrew Linzey, PhD, DD, HonDD, Director of the Oxford Centre for Animal Ethics
Dr Clair Linzey, PhD, Professor of Animal Theology, Graduate Theological Foundation
Dr Zaynah Maherally, Research Fellow, Neuro-Oncology Research Group, School of Pharmacy and Biomedical Sciences, University of Portsmouth.
Michael Mansfield QC
Dr Hayley McMillan, Queens University, Belfast
Dr Monika Merkes PhD (public health), Honorary Associate, La Trobe University
Dr Les Mitchell, Research Fellow, University of Fort Hare Hunterstoun
Dr Dania Movia, Trinity College Dublin
Dr Sam Murray, Senior Research Fellow, University of Portsmouth
Leonid Nikitenko PhD DSc SFHEA FRSB, Lecturer in Biomedical Sciences, University of Hull
Dr Alpesh Patel, Animal Free Research UK
Professor Mike Philpott, Professor of Cutaneous Biology, Queen Mary University London
Professor Geoff Pilkington, Emeritus Professor of Neuro-oncology, University of Portsmouth
Dr Muhammad Rahman, Blizard Institute, Queen Mary University
Dr Ruman Rahman, Associate Professor of Molecular Neuro-Oncology, University of Nottingham
Rebecca Ram, Scientific Consultant, Safer Medicines Trust
Professor Manuel Salmeron-Sanchez FRSE, Chair of Biomedical Engineering, University of Glasgow
Joan Schaffner, Associate Professor of Law, The George Washington University Law School
Jeff Sebo, Clinical Assistant Professor of Environmental Studies, Affiliated Professor of Bioethics, Medical Ethics, and Philosophy, New York University
Dr Hannah Short, General Practitioner, Oakfield Surgery, Newmarket
Dr Claire Smith, UCL Great Ormond St Institute of Child Health
Dr Rebecca Rose Stanton, Associate Fellow at the Oxford Center for Animal Ethics
Dr Katy Taylor, Director of Science and Regulatory Affairs, Cruelty Free International
Dr Katya Tsaioun, Director, Evidence-based Toxicology Collaboration, Johns Hopkins Bloomberg School of Public Health
Dr Jan Turner, Director, Safer Medicines Trust
Dr Mark C Turner, Research Fellow in Endocrinology and Metabolism, Coventry University
Dr Richard Twine, Co-Director, Centre for Human-Animal Studies (CfHAS), Edge Hill University
Alliance for Human Relevant Science
Animal Free Research UK
Certara
CN Bio Innovations Limited
Cruelty Free International
Cyprotex
Dermal Technology Laboratory (DTL Ltd).
Institute of Bio-Sensing Technology
Kirkstall Ltd
Lord Dowding Fund
Safer Medicines Trust
UPM Biomedicals
*The open letter illustrates the view and opinion of the signatories but not necessarily of their associated organisations.
References
1 https://endpts.com/breaking-moderna-posts-a-promising-snapshot-of-human-data-for-a-leading-covid-19-vaccine (Accessed 28/05/2020); https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins (Accessed 07/04/2020)
2 https://covid19vaccinetrial.co.uk/blog-how-long-will-it-take-get-oxford-vaccine-deployment (Accessed 01/06/2020)
3 https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/(Accessed 28/05/2020)
4 http://www.icmra.info/drupal/sites/default/files/2020-03/First%20regulatory%20COVID-19%20workshop%20-%20meeting%20report_March%202020.pdf (Accessed 28/05/2020)
5 https://www.uni-konstanz.de/en/university/news-and-media/current-announcements/news-in-detail/how-nam-can-speed-up-covid-19-drug-discovery/ (Accessed 16/06/2020)
6 https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/(Accessed 28/05/2020)
7 Busquet F, Hartung T, Pallocca G, Rovida C, Leist1 M. Harnessing the power of novel animal‑free test methods for the development of COVID‑19 drugs and vaccines. Archives of Toxicology, 2020; https://doi.org/10.1007/s00204-020-02787-2
