Mass vaccination against covid-19: the result of individual, free and informed consent?

Echoing the analyses of more and more scientists who question politicians and citizens about the risks linked to the new anti-covid 19 vaccines, despite the media vindictiveness they are subjected to on a daily basis, this article summarizes the grey areas around these vaccines and draws the necessary conclusions: citizens’ demands, including the right to information and vaccine freedom, but not only…

While mass vaccination has begun in our country (and a few weeks after the first vaccines were inoculated in Great Britain), there are still many grey areas around vaccines. Regarding the Pfizer vaccine: « With approximately 19,000 participants followed for an average of 2 months, infrequent adverse events may have gone undetected. Also, vaccine efficacy against asymptomatic Covid-19 disease has not yet been reported. Finally, the question of vaccine efficacy in children, adolescents, pregnant women, and immunocompromised individuals was not addressed in this trial. New studies are planned to investigate the benefit-risk ratio of vaccination in these populations. (…) However, important questions remain unanswered to this day. What about the possibility of new side effects once millions of people have been vaccinated and over a longer period of time? What will happen if a large number of people do not receive a second injection? How long does this vaccination work? Can this vaccine prevent asymptomatic disease and limit transmission of the virus? »⁽¹⁾

It is therefore not yet known whether it will allow the vaccinated to not transmit the virus: « At this stage, Phase 3 trials will not answer the question of vaccine action against virus infection/transmission (…) In monkeys, it has been shown that for some of the vaccines studied, protection at the of the upper airways (where the virus replicates the most) was sometimes partial, with a possible risk of transmission after vaccination »⁽²⁾. Some even fear that the vaccinated could become « super-contaminators « ⁽³⁾. When in doubt, the WHO recently stated that despite vaccination, the wearing of masks, social distancing and all sanitary measures should be continued.

Furthermore, although the available data are insufficient for the time being, some vaccines seem to confer a short immunity. Regular or even multiple vaccinations (several different vaccines) aretherefore being considered⁽⁴⁾. Finally, the virus mutates, which could quickly render obsolete the vaccines developed:  » The infectious disease specialist believes that the problem is now virological, with the risk of the emergence of new SARS-CoV2 viral strains, which may well be insensitive to the immune response induced by the vaccines currently being tested. SARS-COV‑2 mutates 10 times less than the influenza virus and between 10 and 100 times less than HIV. In addition, its recombination capacity is less than that of the influenza virus. That said, the risk of mutation is real. With SARS-CoV2, there are already seven virus families, which include a very large number of variants. This is quite worrying « ⁽⁵⁾. In response to this possibility, some producers are considering adapting their vaccine as mutations occur and making vaccination periodic⁽⁶⁾. Is this multiple and repeated vaccination in a context where each of the new vaccines still poses many questions about safety and many unknowns about efficacy a reasonable strategy?

A duty to inform the patient

Moving from testing vaccines on tens of thousands of people to vaccinating millions of people means that there is a risk of undetected side effects. After only two days of vaccination in Great Britain, such effects have already appeared, and it is now recommended that people with a history of significant allergic reactions not be vaccinated⁽⁷⁾. The side effects of the candidate vaccines were only taken into account over a few months. The people most at risk, for whom the risks are, we are told,  » more acceptable from the point of view of risk-benefit balance « , will therefore act as experimental subjects for the study of the effects of vaccines in the longer term⁽⁸⁾: they must be informed. Assuming that vaccination of young people is preferred⁽⁹⁾This would pose an unacceptable risk to young people, since the risks associated with the side effects of vaccines (unknown) must be weighed against the risks they run from covid-19 (low): young people and those responsible for them must therefore also be informed. Vaccinating young people would not even be of interest to those at risk if it turns out that vaccines do not prevent the spread of the virus.

Several challenging policy initiatives have already been brought to the attention of the public. Regulation 2020/1043 adopted this summer by the EU allows producers of vaccines and anti-covid19 treatments containing GMOs to dispense with the need to produce an environmental impact assessment and biosafety study before starting clinical trials. Published on July 17, the text was adopted in the European Parliament under an emergency procedure, without amendments or debate⁽¹⁰⁾. The European Medicines Agency, on the other hand, considered that a conditional market authorization was the most appropriate regulatory mechanism to deal with the emergency created by the current pandemic :  » Given the urgency of the health situation, derogatory marketing authorizations could be granted to the vaccine, which is obtaining good results while phase 3 is still underway… Leaving many questions about the virus still unanswered . »⁽¹¹⁾. For its part, the European Commission wants to step up the fight against what it considers to be misinformation, particularly on the issue of vaccines⁽¹²⁾. The combination of these different initiatives sounds like an attempt (in the process of being crowned with success) to force the issue.

Cautious scientists versus propaganda

Scientists who are not « anti-vaccine » and who have written or are working on vaccines⁽¹³⁾, share some of the concerns about these new vaccines. These are inspired by knowledge of their subject and not by irrationality. Faced with considerations such as those set out in the expert note on the assessment of the health and environmental risks associated with certain vaccines produced in September 2020 by Dr. Velot, molecular geneticist and chairman of the scientific council of the Committee for Research and Independent Information on Genetic Engineering (a very clear expert note, written especially for the general public, and accessible via the link in the footnote below⁽¹⁴⁾), it seemed necessary for Belgium (as for other countries) to set up a « persuasive » task force including a  » cell in charge of rationalizing and coordinating scientific and public communication  » to convince the reluctant population to be vaccinated. Most media, many of which have lost their independence⁽¹⁵⁾The media have followed in their footsteps with a daily barrage of pro-vaccine articles and broadcasts that look like propaganda and that immediately disqualify (like any propaganda speech) any critical or questioning remarks coming from the scientific and citizen spheres.

However, the objections raised are not systematically from movements that are a priori hostile to all forms of vaccination: many people believe that some vaccinations are useful under certain conditions, while others are not. In this case, as Dr. Velot’s arguments show, the conditions do not seem to be met at this time in the case of the proposed vaccines. These objections are not the result of a generalized distrust of science or medicine since they are also made by doctors and scientists. They stem from the objective limits of the vaccines currently offered, from a justified mistrust of certain irregular practices⁽¹⁶⁾ well-documented by pharmaceutical companies, as P. Lannoye usefully reminds us in an article⁽¹⁷⁾This is a healthy distrust of the univocal scientific expertise taken into account by politicians and of the political power itself, both of which have managed to generate a global crisis from a « simple« They are not willing to adopt, in their management of this crisis, a global and multidisciplinary vision and democratic procedures.

Vaccine freedom and right to information

If nothing should prevent someone who wishes to be vaccinated from doing so, nothing should prevent an individual from freely making a decision, without any pressure presented as moral, and regardless of his or her level of scientific expertise, concerning his or her body and health, which are his or her primary individual responsibility. Whatever liberal (not totalitarian) philosophical conception of the body one subscribes to, any treatment of my individual body should be subject to my free and informed consent: by virtue of human dignity, the principle on which fundamental human rights are based, neither the power nor the collectivity has the right to consider my body as a means to their end.

Of course, this is not the prevailing view in our country (and even less so in other developed countries). On the basis of the principle of individual autonomy, the freedom not to be vaccinated is certainly defensible from an ethical point of view when the person who decides not to be vaccinated will bear the consequences alone (e.g. tetanus vaccine), notes the Belgian Bioethics Advisory Committee: this freedom has moreover been given a legal basis through the law on patients’ rights. But when the purpose of vaccination is to protect others, the political justifications for compulsory vaccination are based on considerations presented as ethical. Although only polio vaccination is mandatory in Belgium, the jurisprudence already contains all the arguments that would allow other vaccines to be made mandatory, even if these vaccines caused (in rare cases) serious side effects⁽¹⁸⁾. Of course, the analysis should take into account the assessment of the risk associated with the vaccination in relation to the risk inherent in the development of the disease itself, and the seriousness of the danger of the disease to the population. Furthermore, these measures should be provided for by law and cannot be left to an implementing authority. They should be reviewed periodically according to epidemiological and scientific data in order to adequately address public health protection. Finally, the public authority should ensure that immunization is free from commercial influence.

The Belgian Bioethics Advisory Committee recognizes that it is  » more difficult to decide  » on cases of diseases for which « the vaccination should ideally cover all individuals to achieve population-wide immunity, but do not pose a significant threat to a proportion of those vaccinated who therefore have no substantial benefit from being vaccinated « (e.g., vaccination of boys against rubella or HPV infection and vaccination of girls against mumps). But he concludes that a Nuffield Council report states that,  » from an ethical perspective, there is a case for encouraging individuals to participate in immunization programs when there is little or no personal benefit, but that they represent a significant advantage for others  » because  » if everyone was based on self-interest, prevention would have little or no chance of success.⁽¹⁹⁾. We must be aware that this argument would justify a large number of vaccines! But what is this Nuffield Council to which the Bioethics Advisory Committee gives its opinion, leaves the last word and finally abandons the task of determining what will or will not be considered « ethical » for the Belgian population?

The Nuffield Council, founded in 1991 in the United Kingdom, is a foundation that examines and explores the ethical issues raised by recent advances in biological and medical research. It is funded by the Nuffield Foundation, the Medical Research Council and the Wellcome Trust. The latter is a London-based research association created in 1936 with the legacy of pharmaceutical magnate Henry Wellcome to fund research to improve human and animal health. The Wellcome Trust is one of the world’s richest charitable foundations, one of the world’s largest providers of funding for biomedical research, which  » supports the public understanding of science  » (i.e. the social acceptance of scientific advances). It supports the development of new vaccines and the wider use of existing vaccines where (in developing countries)  » politicians may not be able to decide which vaccines are most useful or lack the expertise to organize their deployment. It also funds covid-19 vaccine development through CEPI, founded in 2017. As a reminder, this CEPI scheme funds independent research projects to develop vaccines against epidemics caused by emerging infectious agents, including coronavirus. In other words, the Nuffield Council, which ultimately dictates to the Belgian Bioethics Advisory Committee what ethics is, is funded by the Wellcome Trust, which itself funds vaccine research and the CEPI scheme (also funded by the Bill and Melinda Gates Foundation).

Nothing should oblige the population to accept without debate the idea that vaccination is justified by the argument of altruism, civic-mindedness, responsibility or solidarity. This idea can of course be shared by anyone who wishes to do so, but this should not hide the fact that vaccination involves such economic stakes that some of its promoters have been exerting cultural influence for decades to the point of shaping our conception of bioethics. But what ethical principle can justify the state forcing an individual (and in many cases generations of babies and children who are our most precious commodities) to take a life-threatening risk to protect one or more others? Because we are talking about a vital risk here, and even more so in the case of GMO or RNA vaccines for which, in addition to the classic medical risks, we cannot exclude genetic effects that can be transmitted to descendants and environmental risks. Drawing a parallel between this argument and the libertarian argument of those who do not want to pay the taxes necessary to set up public services and social security is not relevant because in the case of taxes, it is a monetary contribution; in the case of vaccination, it is a (potentially risky) attack on individual physical integrity. Are unborn babies now destined to be welcomed into a society that disposes of their bodies from birth in the (decreed) interest of the collective?

Of course, this ethical debate would be less important if vaccines did not pose any risk. But 1) there is no such thing as zero risk in vaccination 2) the risk raises the question of the control exercised by society over these vaccines to guarantee their safety, a control that is currently insufficient since it is essentially based on the information that vaccine producers agree to provide⁽²⁰⁾. Only the option of free and informed individual consent therefore seems to be truly justified by the ethics of fundamental rights. And in order to be able to express a truly informed consent, the citizen is entitled to expect from the public authorities that they give and allow him access to transparent, complete, honest, critical and contradictory information, since we are talking about medicine, that is to say not an exact science, but a knowledge under construction, in addition to being a discipline linked to economic and political stakes. More broadly, it is through free, serious, honest and plural reflection and information, and not through censorship and propaganda, that the fight against misinformation, the construction of a critical spirit in the population and the restoration of a greater confidence of citizens in politics and science will be achieved.

Mass vaccination: consequences and alternatives

In substance: is it really necessary to vaccinate the entire population or almost all of it, when the median infection fatality rate linked to covid-19 is currently estimated by the WHO at a maximum of 0.23%?⁽²¹⁾, some scientists wonder. ?⁽²²⁾ Nothing forces the population to accept the blackmail of an adventurous collective vaccination in exchange for the promise of a return to normal life. Indeed, vaccination is not the only alternative available to us. Vaccines are not the only way to treat or prevent diseases: other therapeutic options exist. On the one hand, strengthening the immune system is one of the scientifically recognized means of fighting infections; on the other hand, a multitude of molecules are already available⁽²³⁾ or in the public domain, even if our research models, based on intellectual property, often lead to neglecting the latter, or even rejecting them out of hand; but we invest much less in prevention or in the development of valid serologies than in vaccines⁽²⁴⁾. These three avenues are alternatives to vaccines whose emergency development does not seem to offer sufficient guarantees in terms of safety, efficacy and usefulness. Citizens, and particularly people at risk, therefore expect the public authorities to take these alternatives into account and develop them.

Accepting that mass vaccination is the imposed solution for a return to normal life is tantamount to consenting to therapeutic choices being made by the private sector according to its revenue prospects, i.e. to renouncing the independence of science. This is tantamount to accepting that political and societal choices are made according to these private interests, in other words, to renouncing democracy. This means that billions of public money will be poured into the private sector, once to finance private research, and again to buy vaccines whose patents will be held by the companies, who will be able to set the prices. Finally, it means exposing ourselves to the risk that these billions of dollars will no longer be available for other social policies (health, education, social security, etc.), in other words, we will be giving up the resources that would allow us to build the future. This is done in an opaque context, since contracts with pharmaceutical companies are not public⁽²⁵⁾, and one of the European negotiators has been identified as the former director general of a major pharmaceutical lobby⁽²⁶⁾ (the European Federation of Pharmaceutical Industries and Associations (EFPIA). A context where a journalist cannot, without incurring censorship, question the power in place on the democratic legitimacy of such decisions when some of the members who lead to their adoption are or have been linked during their career to multinationals or the world of finance⁽²⁷⁾.

Citizens’ demands for vaccination against covid-19

Therefore:

• As citizens, we expect from public authorities that at no time the vaccination against covid-19 is made compulsory, not even indirectly by making access to certain spheres (nurseries, schools, public places, private places…) or activities (travel, leisure…) conditional to the vaccination status. A democratic public debate must take place on vaccination.
• We expect the government to exclude people with conflicts of interest from the decision-making process.
• We expect that the arguments of the cautious scientists regarding the new vaccines against covid-19 will be heard and taken into account at the level of decision-making procedures, decision-making procedures that must urgently restore and increase the democratic process.
• We expect governments and physicians to inform patients who are candidates for covid-19 vaccination of the uncertainties that remain about these vaccines. In addition, vaccine package inserts (which should not be marketing inserts) should be made available to the public and especially to patients prior to vaccination.
• People at risk and the general population expect public authorities to take into account existing alternatives to vaccination (prevention, treatment) and to invest in public research on alternatives to vaccination based on the study of molecules in the public domain, rather than favouring the therapeutic repositioning of molecules or treatments protected by intellectual property rights.
• We remind the public authorities of the irresponsible nature of the European Regulation 2020/1043 on GMO vaccines against bovine spongiform encephalopathy of 15/07/20, for which 6 associations have lodged an appeal for annulment with the Court of Justice of the European Union, in terms of health and the environment, both with regard to present generations and future generations And we alert the reader to the precedent-setting effect that this regulation could have on the issue of GMOs in general.