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Rethinking Vaccine Development as an Integral Part of Preparedness in the European Health Union

Published online by Cambridge University Press:  12 November 2020

Marco RIZZI*
Affiliation:
Senior Lecturer, University of Western Australia Law School, Perth, WA, Australia; email: marco.rizzi@uwa.edu.au.

Abstract

This opinion piece puts forward a critique of the policy and regulatory frameworks governing vaccines, understood as tools to confront pandemic and epidemic diseases (PEDs). Vaccines being the universally recognised prime method of prevention, immunisation campaigns and vaccine research and development (R&D) could reasonably be expected to feature prominently in any policy and/or strategic document addressing emerging health threats. Yet, vaccination occupies a relatively subsidiary role, with a prevalent focus on risk management mechanisms. This piece outlines the main characteristics of preparedness frameworks and looks at vaccine development in the course of PED outbreaks in the recent past, concluding that the COVID-19 pandemic calls for a paradigm shift in vaccine R&D, which should become integral to public health preparedness.

Type
Articles
Copyright
© The Author(s), 2020. Published by Cambridge University Press

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Footnotes

I wish to thank the anonymous reviewers for their helpful comments and Gatwiri M’mbijiwe for her excellent research assistance. All mistakes remain my own.

References

1 The Lancet, “Public-Health Preparedness Requires More than Surveillance” (2004) 364 The Lancet 1639.

2 ibid.

3 ibid.

4 Updated figures are retrievable from: Johns Hopkins University of Medicine, “COVID-19 Dashboard by the Centre for Systems Science and Engineering at John Hopkins University of Medicine” (Coronavirus Resource Center) <https://coronavirus.jhu.edu/map.html> (last accessed 20 July 2020).

5 TT Le et al, “The COVID-19 vaccine development landscape” (2020) 19 Nature Reviews Drug Discovery 305–06 <https://www.nature.com/articles/d41573-020-00073-5> (last accessed 2 October 2020). An experimental vaccine from Oxford is showing promising signs: see PM Folegatti et al, “Safety and immunogenicity of the ChAd0x1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of Phase 1/2, single-blind, randomised controlled trial” (2020) The Lancet <https://doi.org/10.1016/S0140-6736(20)31604-4> (last accessed 2 October 2020).

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8 Decision No 1082/2013/EU of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 2119/98/EC (Health Threats Decision) [2013] OJ L 293.

9 The key issue is that the main drivers of R&D investment are the probability of success of a new vaccine coupled with the potential extent of demand. See A Lo, KW Siah and CH Wong, “Estimating Probabilities of Success of Vaccine and Other Anti-Infective Therapeutic Development Programs” (2020) 1 Harvard Data Science Review <https://doi.org/10.1162/99608f92.e0c150e8> (last accessed 2 October 2020). On the impact of estimated demand, see the discussion below regarding the R&D process for the Ebola, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) vaccines.

10 As highlighted in numerous recent industry reports: see, for example, S Ugalmugle and R Swain, “Global Vaccines Market Size by Age Group (Pediatric, Adult), by Technology (Conjugate, Attenuated, Inactivated, Recombinant, Toxoid), by Disease (Cancer, Hepatitis, Pneumococcal Disease, DTP, Dengue, Influenza, Human Papilloma Virus, Meningococcal Disease, Polio, Rotavirus), Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2019–2025” (2019) Global Market Insights <https://www.gminsights.com/industry-analysis/vaccines-market> (last accessed 2 October 2020).

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16 Broberg, supra, note 15.

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25 The Lancet, supra, note 1.

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27 Health Threats Decision, supra, note 8, Art 5 on Joint procurement of medical countermeasures.

28 Gostin and Katz, supra, note 15, 286.

29 Gostin et al, supra, note 15.

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34 Anderson, supra, note 32, 782.

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36 Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating medicinal products for human use (Medicines Directive) [2001] OJ L 311.

37 Lurie et al, supra, note 7.

38 ibid.

39 EMA, “EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines” (4 May 2020) EMA/213341/2020.

40 EMA, “International regulators align positions on phase 3 COVID-19 vaccine trials” (9 July 2020) EMA/367602/2020.

41 D Fairgrieve et al, “Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19” (2020) 11 European Journal of Risk Regulation 565; Rizzi, supra, note 35.

42 (2005) 42 USC§247d-6d.

43 Fairgrieve et al, supra, note 41, 35–36.

44 WHO, “Emergency Use Assessment and Licensing Procedure (EUAL) for candidate vaccines for use in the context of a public health emergency” (7 July 2015) <https://www.who.int/medicines/news/EUAL-vaccines_7July2015_MS_(Updated_notes-disclaimers_21Aug2018).pdf?ua=1> (last accessed 3 October 2020).

45 M Rizzi, “Vaccines for Pandemic and Epidemic Diseases: Towards Defining the Space of EU Public Health between Security Policy and a Transnational Market” (2017) 8 European Journal of Risk Regulation 686, 694.

46 ibid, 695; S Nagai, “Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan” (2019) 20 International Journal of Molecular Sciences 3801. Emergency procedures also include seriously debilitating or life-threatening diseases.

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60 S Berkley, “Share the Risks of Ebola Vaccine Development: Ebola Vaccines Have Little in the Way of Commercial Markets, so the Risks Should Be Shared Between Governments and Industry” (2015) 519 Nature 263.

61 Renda and Castro, supra, note 17, 276.

62 R Roper and K Rehm, “SARS Vaccines: Where Are We?” (2009) 8 Expert Review of Vaccines 887; S Perlman and R Vijay, “Middle East Respiratory Syndrome Vaccines” (2016) 47 International Journal of Infectious Diseases 23; E Riedmann, “MERS Vaccine Is Technically Feasible, but Is It Commercially Feasible?” (2014) 10 Human Vaccines & Immunotherapeutics 1429.

63 L Mannix, “We should have had vaccine already: Australian expert who cracked virus code” (The Sydney Morning Herald, 28 March 2020) <https://www.smh.com.au/national/we-should-have-had-vaccine-already-australian-expert-who-cracked-virus-code-20200327-p54elr.html> (last accessed 3 October 2020).

64 See European Union, “The pillars of Next Generation EU” (European Commission, 10 June 2020) <https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/recovery-plan-europe/pillars-next-generation-eu_en> (last accessed 3 October 2020). The Health Programme features under Pillar 3: Learning the lessons from the crisis.

65 M Mazzucato, The Entrepreneurial State – Debunking Public vs Private Sector Myths (London, Penguin 2018).

66 European Commission, “Coronavirus: EU supports vaccine research with additional €100 million” (NEWS, 22 July 2020) <https://ec.europa.eu/info/news/coronavirus-eu-supports-vaccine-research-additional-eu100-million-2020-jul-22_en> (last accessed 3 October 2020).

67 European Union, “EU research and innovation in action against the coronavirus: funding, results and impact” (European Commission, September 2020) <https://ec.europa.eu/info/sites/info/files/research_and_innovation/research_by_area/documents/ec_rtd_coronavirus-research-projects-overview.pdf> (last accessed 3 October 2020).