Update, July 15 and 19, 2021
I am following the debate around the world on implicit or explicit mandatory vaccination with increasing concerns. There are two possible models of how the vaccines function out there. The one says that the side-effects from the novel mRNA and vector based vaccines are short-lived, rare and that the vaccines or highly effective (the conventional view). The other postulates that there will be a tremendous increase in diseases and deaths caused by the vaccines, that already the observed side-effects are not rare and severe and that the vaccines are not as effective as we are made to believe (the unconventional view). We do not know which model is the truth ‑ a classical form of model uncertainty. Is it therefore not irresponsible from an ethical perspective by policy makers and public health officials to even think about implicit or explicit mandatory vaccination? Could it be that policy makers and public health officials, who favor mandatory vaccination, will one day, i.e., 10 to 15 years down the road, be responsible for substantial health damage and deaths of those citizens whom they now force to participate in the current vaccination experiment on human beings? Months ago, I would have thought that such pressure will never arise. I was wrong.
- Laura Blackburn of University of Cambridge published in 2018 (!!!) an introduction to RNA based vaccines, see https://www.phgfoundation.org/briefing/rna-vaccines, reaching the following conclusion: “There is still a lot of work to be done before mRNA vaccines can become standard treatments, in the meantime, we need a better understanding of their potential side effects, and more evidence of their long term efficacy”.
- Robert Malone, who was involved in the invention of the mRNA based technology, warns now publicly – and for many months warned the FDA – that the spike protein is biologically active and may thus circulate causing health damages. His wife, Jill Malone, writes a fantastic blog, https://www.rwmalonemd.com/news, which also discusses (i) the societal problems we are facing because of censorship and (ii) the bio-ethical perspectives on the current vaccination experiment. I should add that Mr. Malone’s webpage had been taken off the English Wiki for reasons discussed in detail here. On the German wiki page one still finds a discussion on how other scientists contradict Mr. Malone.
- For the German audience, the group around the microbiologist Sucharit Bhakdi continues to issue warnings – also in a public letter to medical doctors, see https://www.mwgfd.de/2021/07/wissenschaftliche-mitteilung-an-die-aerzteschaft ‑ about the dangers of the vaccines, including the insight that the spike protein circulates in the blood of vaccinated patients and of adverse immunological reactions. Likewise, does the related international group of Doctors for Covid Ethics, see https://doctors4covidethics.org/about/.
I am not an expert, so as I emphasized before, whatever I write reflects a purely subjective judgement on the resolution of a risk-uncertainty trade-off. With that in mind, let me reemphasize once more that, in my view, the risk-uncertainty trade-off of the vaccines is resolved against the vaccines for the healthy population of age 60 and younger. Medical treatments have improved. So there exist good substitutes in case individuals in this group get severly sick (which is a low probability event). Any discussion on implicit or explicit mandatory vaccination must stop immediately.
Update, May 1, 2021
Since I have written the first version of this blog, several studies have been published that document the high efficacy of the novel vaccinations. These findings are based on matching studies, which are inferior to randomized controlled trials, but given the available empirical evidence so far, it seems that some of my concerns on the efficacy of the vaccines are washed out. We also learned about short-run negative side effects. In this update, I want to shift the main emphasis on neither of those aspects. My main emphasis here is on the following question: Are the documented negative short-run effects only the peak of the iceberg? Could it therefore be rather irresponsible to recommend vaccination to the entire population and to put so much (implicit or explicit) pressure on the non-vaccinated? Would an intermediate path of recommending vaccination to the above 50 year old and to persons at risk potentially be better?
Tautologically, we still do not have any data on the long-run risks of the novel vaccines (irrespective of type, in particular, irrespective of the production technology), because they are too young. Thus, to me the key trade-off is between risk and uncertainty. By risk I mean a situation in which probabilities are (more or less) known. Uncertainty, in contrast, is Knightean uncertainty, i.e., probabilities are not known. On the one hand, the risk to die or to get severely sick from a corona infection is by now broadly known, but the uncertainty around potential negative long-run side effects of the vaccines is large. (Of course, the public media makes us believe that the new variants are particularly harmful and that long covid is a serious thread but these are exaggerations: the unconditional risks for the young and healthy are very low.) On the other hand, the potential exists that at one point in time we will reach the conclusion that it was all wrong to do such a vaccination experiment with the (as intended or factually done) the facto entire population. Clemens Arvay has written an excellent book on the topic, with numerous counterarguments against his statements all of which can be found on the web.
I am not a natural scientist and thus I can ultimately not judge the arguments put forward in these publications, but I do strongly believe in a statement that a medical scientist once made in a conversation with me, which is not directly related to Covid-19: “The human body is so complex, we do understand very little of it.” I think that there is a deep truth to this general statement. I therefore also think that no serious scientist can deny that there exists the potential that the novel vaccines may turn out to be harmful in some years down the road, simply because we do not know what processes will be going in the bodies of vaccinated people. In particular, if these bodies are (very) young. A serious debate can thus only be about whether this potential is large or small.
Against this backdrop, is it not rather irresponsible by many politicians and governments around the world to put that much pressure on citizens to get vaccinated? Is this experiment with the population at large justified? As I argued before, in my view, a much better strategy than achieving herd immunity at such an unknown price would be to tame the pandemic. With age, the risk-uncertainty trade-off of the vaccinations is probably resolved in favor of vaccination, whereas for the young and healthy this is not the case. For sure – and I hereby restate what many critical voices said or wrote before me – in light of this uncertainty it should be an individual decision without any moral or legal pressure whether to get vaccinated or not.
When I drop such statements in conversations with my colleagues they often argue that there is an externality involved here, which arises if too many citizens would remain non-vaccinated. In my view, this aspect should not receive a large decision weight, because many of the elderly and vulnerable (and many more) will eventually be vaccinated and thus will to a large degree be protected. I therefore do not see any reason why we should not proceed with the Covid-19 vaccination programs as we do with the flue vaccination. In particular, because the externality argument has to be weighted against the “internality” argument on the unknown long-run risks of the vaccines made above. This argument must receive the higher decision weight the younger the bodies are that are given the vaccines.
Finally, to add to this argument, in terms of an international sharing of risks, it would in my view be a much more responsible strategy to role out the vaccines to populations at risk in developing countries ‑ again to the old and vulnerable ‑ rather than to vaccinate the young and healthy in the rich world.
My proposal is as follows:
- No legal or moral pressure on the non-vaccinated, which will of course also mean not to grant extra rights to those who are vaccinated. It is an individual decision.
- No recommendation of vaccinations to the young (and for sure not to children) because the risks from Covid-19 are relatively low to this group of the population and the human body is still in a very active development process. Therefore, the risk-uncertainty trade-off is resolved against vaccination for this group of the population. Of course, it is an individual decision after all.
- If according to long-run studies on the vaccines in some years down the road it should turn out that such concerns are not justified, then one could expand the vaccination programs, maybe attempting to even wipe out the corona virus. However, maybe, this will then not be needed at all, because by then treatment technologies and medication will have improved to an extent that vaccination continues to be recommended to groups in the population that are at high risk, just as for the flue vaccination.
Update, February 08, 2021: In response to feedback from policy makers I trace out three policy implications from my blog below, two of which are explicit from the text, the third is a compromise between my suggestions and the status quo:
- Independent expert committee: Take serious the warnings about potential long-run negative health consequences from adverse immunological reactions and form an independent expert committee to investigate these warnings.
- Change objective: Modify the goal from achieving herd immunity from the vaccination to taming the epidemic by proceeding with the covid-19 vaccinations as with the regular flu vaccination (which does not mean that covid-19 is a regular flu). Accordingly, if policy makers conclude on the basis of existing data that vaccinating the elderly (and the frail) can be done without health concerns, then recommend vaccination only to people above age 50 or age 60. The younger can, of course, also receive the vaccination but only if accompanied by appropriate education on risks and benefits. Under no circumstances should there be any pressure to get vaccinated – neither of a legal nor of a moral form.
- Statistical data analysis: As a compromise of my suggestion to interrupt the vaccination program to collect data in controlled trials and of the status quo, one alternative is to proceed in parallel, i.e., conduct controlled trials while the vaccines are already in the field. Another – inferior – alternative is to form an expert group of biometricians, statisticians, and econometricians to accompany the current field experiments with data analyses using sophisticated empirical methods. Collect data on socioeconomic characteristics from the treated, and, if feasible, also from control groups who do not receive the vaccination. It is indispensable to learn about the true effectiveness of the vaccines, in particular among the elderly and frail, in order to accompany the vaccination programs with additional measures to protect this group in the population. Notice that I have in mind measures along the lines of the recommendations of the German virologist Hendrik Streeck, and not measures in the spirit of extended lockdowns, see my blog “Zero-Covid and No-Covid: A Critical Comment”. Also notice that the incoming raw data from Israel cannot be directly explored to extract the needed information on the effectiveness of the vaccines, because there is no control group. Thus, also for this data, sophisticated data analysis is called for using matching methods.
I should stress that I do not have any vested interests in writing this blog, also not in regard of item 3 of my above suggestions, because I am not a micro-econometrician, and I would therefore not be part of such a group of data experts.
Blog, February 02, 2021
In my view, we do not have a sufficiently deep discussion on the risk-benefit trade-off of the novel vaccines. Could it be that governments expose their citizens to too large of a risk? Do the risks outweigh the benefits? On the one hand, there exists the possibility that the vaccines are particularly dangerous in the longer run for those who need them the most, namely the elderly and vulnerable. On the other hand, too little is known regarding the effectiveness of the vaccines for that group. Furthermore, the young and healthy – who face a very low risk from the virus, but who do face an unknown risk from the vaccination – may still pass on the virus, and thus there may be no positive externality from the vaccinated in this group of the population to others. So, could it be that for this group the individual risks of the vaccination outweigh the social benefits?
Neither am I a biologist nor do I have any medical experience. However, as a scientist committed to the truth, I am concerned, hereby speak up and urge government officials, in particular in Germany, to interrupt the vaccination program in order to collect more data in controlled trials and to form an independent expert committee to investigate recent warnings on potentially serious adverse effects from the vaccines.
My concerns began when I first heard of the test results and of the finding that the high and truly amazing 95% effectiveness of the Biontech/Pfizer vaccination would not vary by age. I could simply not believe that samples were large enough to conclude with such statements. This concern was confirmed from Table 8 of the RKI bulletin, which shows that confidence bands for the effectiveness for the 75 and older range from -13% to 100%. In this group, there were only some 780 test persons, out of which only 5 were infected in the placebo – the control – and zero in the test – the treatment – group. In addition to this huge uncertainty regarding the effectiveness, if samples are so small, how can we have sufficient knowledge on potential (short-run) negative side effects? Of course, we know even less about potentially harmful long-run side effects of the new types of vaccines, because the horizons of the test phases are simply too short, but there is reasons to be concerned, see below.
One can also read from that table that there were only 4 cases of severe illness in the control group and 1 in the treatment group. Point estimate of 75% effectiveness but huge confidence bands. What can we learn from a handful of observations on the effectiveness of the vaccination against a serious disease? Very little.
Next, came the information from a commentary by Peter Doshi in the British Medical Journal which basically states that, in the Biontech/Pfizer trials, suspected but not confirmed covid-19 cases had been excluded. Peter Doshi presents a calculation that including these cases would reduce the relative effectiveness to at most 30%, way below the 50% threshold for authorization of the vaccine on the market. The study also concludes that we need more data, a statement I can only underscore.
Finally, I learned about cell biologists, hermatologists, imunologists and neurologists raising their concerns about high long run risks from the vaccines. Among those warnings are that serious illnesses and deaths will occur as a direct consequence of taking the COVID-19 vaccines because of adverse immunological reactions. For instance, the immunologist Hooman Noorchashm warns in a public letter sent to the US FDA dated January 26 of the immunological dangers of the novel Pfizer vaccine, most especially to those who are elderly, frail or have significant cardiovascular risk factors. Despite this, Mr. Noorchashm states that “I do believe that it is the patriotic duty of every American who can reasonably and safely be vaccinated, to do so – in order that we save our nation from this pandemic peril that is threatening our very existence.”
I reach a different conclusion. Neither the data uncertainty nor these warnings must be ignored. I urge government officials – and the German government in particular – to interrupt the vaccination program and to instead conduct extended controlled trials. We need more data, and we need independent expert committees who investigate the aforementioned possibility of adverse immunological reactions. Of course, tracking the current field experiments on the population is in the hands of the European EMA, and in Germany of the STIKO, but I am convinced that we need a break in order to buy time to investigate more in controlled trials and not to continue with this field experiment on the population.
In its recent update of January 29 the STIKO states that, in contrast to the Biontech/Pfizer and Moderna mRNA based vaccines, the vector based AstraZeneca vaccine shall only be offered to persons of age 18-64, whereas the mRNA based vaccines can also be offered to people above age 65. From my reading of the above mentioned RKI bulletin, I do not understand why the STIKO concludes that, in the case of the Biontech/Pfizer vaccines, there are instead enough observations for the elderly? The STIKO also recommends that formerly recovered should receive a vaccination no earlier than six months after their recovery in order to avoid excessive side effects. In light of potential risks of the vaccines and since a partial immunity is already achieved through an infection and since an existing study on influenza viruses concludes that “vaccines incorporating variants of pandemic viruses seem to provide little benefit to those previously immune”, does the recommendation to vaccinate the formerly infected really reflect an appropriate resolution of the trade-offs between risks and benefits?
It is my understanding that, since the novel vaccines are developed by a very different technology than conventional vaccines are, people who received the vaccination – or, the treatment – may still pass on the virus. In fact, as of now, there is not any evidence that this would not be the case. This is why vaccinated people still have to wear masks. Thus, positive externalities from vaccination – that the non-vaccinated are partially protected by the vaccinated – are far from clear, and the so-called sterile immunity may be out of reach. Why would then a caring government expose the young and healthy part of its population – who face a low risk of dying from the corona virus conditional on being infected – to unknown long-run risks from the vaccination, if the social benefits are so unclear? Would that not require first a controlled trial – see below – before carrying out such a huge experiment with the, as intended, entire population? On the other side, regarding the elderly population, it seems that we simply do not yet have enough data, and for the vulnerable, risks from side-effects and adverse immunological reactions later might be too high. Is it not then that a caring government should conclude that the risks potentially outweigh the benefits and thus this vaccination experiment on the population at large should not be carried out until we have more data from controlled trials? The most recent development is the intention to also vaccinate children. In light of the above arguments: Why? In sum, conditional on establishing effectiveness among the elderly and conditional on finding that long-run risks are not a concern, would it not be better to proceed as with the flu vaccination and to only recommend the vaccination above age 60 (or age 50, where the conditional mortality risk from corona in Germany exceeds one percent)?
What would additional controlled trials have to achieve? If the goal is taming the pandemic – which I personally regard as sufficient –, then the trials need to recruit those at high risk (such as the frail and elderly) and be powered to detect reduction in hospitalization, ICU use and death. Given the hypothesis of a 95% efficacy, it would not take large trials to confirm this benefit in that population, if it exists. If the goal is herd immunity, then the trials need to study prevention of infection and onward transmission, which is way more difficult to investigate.
Interrupting vaccination programs now to conduct at least the first type of controlled trial does not imply that we need to go into a prolonged lockdown – the current lockdown in Germany is anyway inappropriate. We have other means to contain the virus and to protect the elderly and vulnerable, e.g., through widespread use of rapid testing and improved treatment. Of course, following such a path requires chutzpa by politicians and may imply – in case the matter is resolved against the vaccination – that a large chunk of taxpayers’ money is lost. In case it will be, this will, however, be just a classical example of sunk costs. At a minimum, the vaccination programs must be accompanied by a better education about risks involved. For sure, there should be no pressure to get vaccinated, neither of a legal nor of a moral form.
I therefore regard the slow start of the vaccination programs in continental Europe as a virtue. In my view, governments should further slow it down to collect and to analyze more data in controlled trials.
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