European Journal of Health Law 28 (2021) 165–183 brill.com/ejhl Pigs Don’t Fly and You Cannot Expect Absolutely Safe COVID-19 Vaccines (But You Should Expect a Fair Compensation) Vera Lúcia Raposo | ORCID: 0000-0001-7895-2181 Faculty of Law, University of Macau, Macau, China [email protected], [email protected] Abstract This paper focuses on the COVID-19 vaccines authorised for use in the European Union, and explores the mechanisms in place to control vaccine safety and to com- pensate injured patients, mainly in the context of European law. Based on these con- siderations, the paper concludes that the refusal by some potential vaccinees to take the vaccine based on safety concerns is ungrounded and an indication of unrealistic expectations, but that in order to build public trust proper compensation mechanisms should be in place. Keywords COVID-19 – compensation – drug safety – drug approval – pharmacovigilance – vaccines. 1 Introduction Whether it comes as a surprise or not, many people do not want to get vaccinated against COVID-19 with the available vaccines1 (this paper uses ‘COVID-19 vaccines’ to refer to the various vaccines approved or under devel- opment to protect against the disease caused by the SARS-Cov-2 virus). 1 R. Tucker, ‘Approximately a Fifth of People Across the World Would Refuse a COVID-19 Vaccine’, Hospital Healthcare Europe (14 December 2020), available online at https://hospi talhealthcare.com/covid-19/approximately-a-fifth-of-people-across-the-world-would -refuse-a-covid-19-vaccine/ (retrieved 20 January 2021). © Koninklijke Brill NV, Leiden, 2021 | doi:10.1163/15718093-bja10042Downloaded from Brill.com09/26/2021 08:06:31PM via free access 166 Raposo Vaccination is essential to build herd immunity to control the pandemic, espe- cially considering that 80% of infected individuals are asymptomatic,2 and a significant number of infections (between 40% to 50%) occur before the onset of the first symptoms. Mandatory vaccination3 against COVID-19 has been gen- erally rejected by Governments,4 although it will probably be required in some situations, such as international travel. There are many reasons for refusing to be vaccinated,5 including religious objections,6 political – legal ‘my body, my choice’ objections,7 safety concerns regarding vaccines in general8 and concerns about the safety of COVID-19 vaccines in particular.9 This paper addresses objections based on the safety (or lack thereof) of COVID-19 vaccines and of vaccines in general, the lack of consistency of such critics and the possible mechanisms to address suspicions and criticism (pharmacovigilance, compensation). This paper begins by comparing the development and approval of COVID-19 vaccines to those of other vaccines in Europe, as the accelerated process is the basis of some wariness on the part of potential vaccinees. It next explores how adverse reactions to the vaccine are monitored (and potentially prevented) as well as the mechanisms in place to compensate patients who suffer from adverse effects, mainly in the context of European law. The paper concludes with the finding that COVID-19 vaccines are as safe as drugs can be and should 2 C. Heneghan, J. Brassey and T. Jefferson, ‘COVID-19: What Proportion Are Asymptomatic?’, Centre for Evidence-Based Medicine (6 April 2020), available online at https://www.cebm .net/covid-19/covid-19-what-proportion-are-asymptomatic/ (retrieved 2 January 2021). 3 In a recent paper, Julian Savulescu (J. Savulescu, ‘Good Reasons to Vaccinate: Mandatory or Payment for Risk?’ Journal of Medical Ethics 47 (2021) 78–85) advocated for mandatory vac- cination, carrying a penalty for noncompliance in the form of a payment (in cash or in kind). 4 M. Rodriguez Martinez, ‘Will any Countries in Europe Make the COVID Vaccine Compulsory?’, Euronews (7 December 2020), available online at https://www.euronews.com/2020/12/07/ will-any-countries-in-europe-make-the-covid-vaccine-compulsory (retrieved 15 February 2021). 5 A. Kitta and D.S. Goldberg, ‘The Significance of Folklore for Vaccine Policy: Discarding the Deficit Model’, Critical Public Health 27(4) (2017) 506–514, doi: 10.1080/09581596.2016.1235259. 6 G. Pelčić, S. Karačić, G.L. Mikirtichan, O.I. Kubar, F.J. Leavitt, M. Cheng-Tek Tai, N. Morishita, S. Vuletić and L. Tomašević, ‘Religious Exception for Vaccination or Religious Excuses for Avoiding Vaccination’ Croatian Medical Journal 57(5) (2016) 516–521, doi: 10.3325/ cmj.2016.57.516. 7 J.A. Reich, ‘Neoliberal Mothering and Vaccine Refusal: Imagined Gated Communities and the Privilege of Choice’, Gender and Society 28(5) (2014) 679–704. 8 N.E. MacDonald, ‘Vaccine Hesitancy: Definition, Scope and Determinants’, Vaccine 33 (2015) 4161–4164. 9 N.M. Pace and L. Dixon, ‘COVID-19 Vaccinations (Liability and Compensation Considerations Critical for a Successful Campaign)’, Rand Corporation (September 2020), available online at https://www.rand.org/pubs/perspectives/PEA761-1.html (retrieved 20 February 2021). European Journal of HealthDownloaded Law 28from (2021) Brill.com09/26/2021 165–183 08:06:31PM via free access Pigs Don’t Fly and You Cannot Expect 167 not be refused due to their expedited production and approval. This paper aims to demonstrate that COVID-19 vaccines, despite some unavoidable risks, are our best hope to fight the pandemic. 2 Risks Posed by Drugs Are Lower than Those Posed by Alternatives The first concern people have with vaccines relates to their general safety.10 Many consider vaccines to be more dangerous than the diseases they aim to prevent. In the vast majority of cases, drugs successfully treat disease, relieve pain and even save lives; however, very rarely, they can have dangerous, even fatal effects.11 This is true for all pharmaceuticals, vaccines included.12 Safety, in the context of pharmaceutical products, cannot be described as the total absence of risk. Rather, a drug is considered safe when its risks are tolerable, as concluded based on an analysis of those risks, the drug’s expected benefits and the existing therapeutic alternatives.13 Therefore, before a new vaccine is released onto the market, its possible hazards and expected benefits are considered in a risk assessment.14 This assessment procedure is quite strict, and only a positive assessment will result in approval of the drug for use; how- ever, no drug is without risks,15 as past research has shown.16 Adverse effects are rare17 but unavoidable.18 10 MacDonald, supra note 8. 11 V.L. Raposo, ‘Safe Drugs Versus Innovative Drugs (Can We Have Both?)’, Advanced Pharmaceutical Bulletin 10(3) (2020) 334–337. Doi:10.34172/apb.2020.041. 12 F. Destefano, P.A. Offit and A. Fisher, ‘Vaccine Safety’, Plotkin’s Vaccines (2018) 1584–1600. https://doi.org/10.1016/B978-0-323–35761-6.00082-1. 13 V.L. Raposo, Danos Causados por Medicamentos – Enquadramento Jurídico à Luz do Ordenamento Europeu (Coimbra: Almedina, 2018). 14 H. Arlegui, K. Bollaerts, F. Salvo, V. Bauchau, G. Nachbaur, B. Bégaud and N. Praet, ‘Benefit – Risk Assessment of Vaccines. Part I: A Systematic Review to Identify and Describe Studies About Quantitative Benefit – Risk Models Applied to Vaccines’, Drug Safety 43 (2020) 1089–1104, doi: 10.1007/s40264–020–00984–7. 15 R. Kwok, ‘Vaccines: The Real Issues in Vaccine Safety’, Nature 473 (2011) 436–438, doi: 10.1038/473436a. 16 S. Bhattacharyya, A. Vutha and C.T. Bauch, ‘The Impact of Rare But Severe Vaccine Adverse Events on Behaviour-Disease Dynamics: A Network Model’, Science Reports 9 (2019) 7164, doi: 10.1038/s41598–019–43596–7. 17 Ibid. 18 E. Wertheimer, ‘Unavoidably Unsafe Products: A Modest Proposal’, Chicago-Kent Law Review 71 (1996) 189–217. See also G. Millward, A Disability Act? The Vaccine Damage Payments Act 1979 and the British Government’s Response to the Pertussis Vaccine Scare, Social History of Medicine 30(2) (2017) 429–447, doi: 10.1093/shm/hkv140, about adverse events involving vaccines. European Journal of Health Law 28 (2021) 165–183Downloaded from Brill.com09/26/2021 08:06:31PM via free access 168 Raposo Myths exist in popular culture – promoted by fake news19 – regarding the adverse effects of vaccines, including allegations that they cause autism, ham- per the immune system and lead to myriad life-threatening secondary effects. None of these allegations have scientific support. The best source of informa- tion regarding medicine is science,20 not pseudo-science,21 and certainly not fabricated information available on social media,22 where these myths are fre- quently propagated. According with scientific experts, those that are not vaccinated are more prone to get infected and, if that happens, they are most likely to get severely ill.23 Vaccines not only prevent the vaccinated from becoming infected but also protect the general population by leading to herd immunity24 and, eventually, to the eradication of the disease. Conversely, according to the WHO, the refusal to vaccinate is one of the greatest health threats of our time.25 Experts also demonstrated that in COVID-19 pandemic herd immunity cannot be achieved through natural infection,26 therefore, the vaccine is our best shot to fight the pandemic. 19 N.A. Atehortua and S. Patino, ‘COVID-19, a Tale of Two Pandemics: Novel Coronavirus and Fake News Messaging’, Health Promotion International (2020), doi: 10.1093/heapro/ daaa140. 20 S. Geoghegan, K.P. O’Callaghan and P.A. Offit, ‘Vaccine Safety: Myths and Misinformation’ Frontiers in Microbiology 11 (2020) 372, doi: 10.3389/fmicb.2020.00372; J.P. Goullé and L. Grangeot-Keros, ‘Aluminum and Vaccines: Current State of Knowledge’, Médicine et Maladies Infectueuses 50(1) (2020) 16–21; V. Vetter, G. Denizer, L.R. Friedland, J. Krishnan and M. Shapiro, ‘Understanding Modern-Day Vaccines: What You Need to Know’ Annals of Medicine 50(2) (2018) 110–120, doi: 10.1080/07853890.2017.1407035.