The failure of applied solutions :
Massive vaccination
3 countries that had brutal massive vaccination campaigns witnessed their worst epidemic mortality peak and their longest deadliest phase (figures 1, 2, 3, 4 and 5) in conjunction with vaccination campaign initiation.
In 2 of these cases, their covid mortality exceeded that for all the preceding 10 months of the epidemic. These countries are Israel, United Arab Emirates (UAE) and United Kingdom (UK). Israel used mRNA Pfizer, UK used mRNA Pfizer, Moderna and Astrazeneca, UAE used mRNA Pfizer, Sputnik and Sinopharm.
It is interesting to note that this deadly episode coinciding with vaccination happened in Israel and the UK under strict lockdown including non essential business closure and stay home mandates.
It is also troubling to see that Israel’s mortality peak only follows its cases peak by 8 days instead of the usual 14 to 21 days or the 17 days observed in previous peak thus possibly hinting to a deadlier more striking infection or frailest population dying more than in prior epidemic peak.
New mortality peaks seem to appear in Israel in ages 15-44 and 65+ after epidemic and after vaccination (figure 4). A similar situation appears in Belgium who had been spared since beginning 2021 coincinding with vaccination acceleration and its extension to 45-64 years old group with comorbidities. (figure 4)
Kuwait, Bahrain, Uruguay, Seychelles, Hungary, Monaco, Mongolia and to a lesser extent Chile are also facing a very high mortality coinciding again with massive vaccination 28 . More recently, India started a fast massive vaccination campaign late March 2021 coinciding once more with a severe rise in mortality as shown in figure 2, worse than all prior episodes combined
Italy, France and Estonia are observing an excess all cause mortality precisely in the age groups 75 to 84 that have been vaccinated mostly by mRNA Pfizer and Moderna and to some extent Astrazeneca (Figure 5).
Death coinciding with vaccination repeatedly does not establish causality but calls for fair complete independent investigations as suspicion is raised and numbers are alarming particularly that this failure adds to prior ones.
Reproducing the experiment, with a risk of reproducing results illustrated in (figures 1,2,3,4,5).
Israel, Emirates, UK, Kuwait, Bahrain, India, Uruguay, Seychelles and Chile chose to vaccinate massively, including in some cases, populations at low risk of severe disease 29 sometimes without prior control as to pre-existing on going covid infection or pre-existing covid natural cellular immunity 30 31 .
This was done in disregard of a clear risk, benefit analysis for each individual, wasting vaccines that could have been made available to populations at risk in other parts of the world thus raising ethical, medical and scientific questions.
Requested investigation should explore how these vaccination campaigns failed to prevent this terrible outcome and if they contributed to it. All hypothesis should be explored including non-mutually exclusive hypothesis such as Antibodies Dependency Enhancement (ADE) 32 33 , Enhanced Respiratory Disease (ERD) 34 35 , vaccines side effects, vaccinated population being more infectious, vaccination places being clustering places, counter productive effect on already naturally immunized population or over-inflated vaccine efficacy on some populations, pressure-selection ... Hospitalizations, appearances or increases of syndromes must all be documented...Deaths had to occur before aknowledging thrombosis risks, is it necessary to wait for all the rest?
Benefit/risk was ignored when low risk young and healthy populations were exposed, pressured, tempted to vaccinate with very limited benefit, some short-term risks and unknown long-term risks 36 37 38 39 .
Excess mortality and possible hospitalizations coinciding with vaccinated groups in several countries calls for exact investigations of short term overlooked or ignored issues in addition to longer term side effects that are yet to be discovered.
Any treatment must come with counter-indications and a clear risk benefit analysis for every group and for the community. There have been attempts to explain such failure and outcome by variants in UK, south America, and now India. Such variants did not have the same effect in other countries that were not massively vaccinating. It remains unclear if pressure – selection resulting from massive vaccination leads to selection of variants that elude vaccinal immunity, tests and possibly other measures. Such hypothesis give current observations must be considered carefully. If it is not the case then, careful attention must be paid to vaccine side effects on some sub-categories as the cause of such surges in mortality. Suspicion will remain until is explained in each of such cases causes of increased mortality. Vaccination maybe a tool that may help with such a pandemic, but an accurate risk benefit analysis must be done for each category, each vaccine and efficacy on circulating variants based on sufficient data. Massive vaccination independent of such analysis has shown to be a failure to avoid a significant mortality rise in many cases and calls urgently for a nuanced approach.
Reckless behavior of massive inconsiderate vaccination becomes more serious when vaccinating those who already contracted covid 19 as this population had been excluded from Pfizer and Moderna trials. Any population that has been excluded from the trial can only be vaccinated within a trial. If they are healthy their benefit from vaccination was already low. If they recovered there is hardly any theoretical benefit and no demonstrated benefit. Risks are present on the short and long term.
By vaccinating covid recovered individuals, in addition to putting them at risk, outside of any trial, a negative alteration of cellular immunity cannot be excluded which would be counterproductive for all.
While data accumulated to demonstrate diversity, efficacy, and higher performance in prevention of variant-related infections of naturally-acquired immunity, with demonstrated importance of Lymphocytes qualitative response and mucosal immunity role, while no strong evidence of correlates with serological antibody measures, avoiding or delaying such natural immunity to develop within lower risk population may result in increased or continued risks for all 40 41 42 43 .
Changes to protocols, changing duration between shots as suggested in some cases or adding a third shot as suggested in others must be done within same standards of evidence requirements consistently and in many cases under a controlled trial approach measuring risks and benefits.
Any population for whom efficacy is not demonstrated can only be vaccinated within a proper clinical trial.
At the very least, this demonstrates that massive vaccination failed to show a visible effect at times when virus is circulating. High levels of mortality calls for an investigation to identify if it has not been counter-productive possibly making things worse and exposing individuals with little benefit to short and long term side effects.
By vaccinating massively including those with low benefit, in addition to exposing them to unnecessary risks from first vaccination and from eventually multiplication of vaccinations if new strains emerge requiring new vaccinations. This happening with multiple vaccines calls for caution with the process and for more adequate attention concerning each vaccine as well as vaccination multiplication with the same vaccine or a different one. Independent clinical trials would need to be done for such a serious matter to be handled upon extrapolations without sufficient data.
This massive vaccination was done disregarding individual risk/benefit sometimes in some countries without proper informed consent, possibly pressuring or tricking some to vaccinate exposing them to short term risks and unknown long-term risks without sufficient scientific and ethical basis. It was done disregarding solidarity between nations by vaccinating individuals who do not need it and for whom risks exceed benefits and it was done without careful control to minimize risks of pressure selection. The final outcome is that above mentioned countries had a terrible mortality wave and in the case of Israel high mortality episodes after the epidemic wave in groups 15-44 and 65+ and in Belgium excess mortality reappeared after several months of normality.
In 2 of these cases, their covid mortality exceeded that for all the preceding 10 months of the epidemic. These countries are Israel, United Arab Emirates (UAE) and United Kingdom (UK). Israel used mRNA Pfizer, UK used mRNA Pfizer, Moderna and Astrazeneca, UAE used mRNA Pfizer, Sputnik and Sinopharm.
It is interesting to note that this deadly episode coinciding with vaccination happened in Israel and the UK under strict lockdown including non essential business closure and stay home mandates.
It is also troubling to see that Israel’s mortality peak only follows its cases peak by 8 days instead of the usual 14 to 21 days or the 17 days observed in previous peak thus possibly hinting to a deadlier more striking infection or frailest population dying more than in prior epidemic peak.
New mortality peaks seem to appear in Israel in ages 15-44 and 65+ after epidemic and after vaccination (figure 4). A similar situation appears in Belgium who had been spared since beginning 2021 coincinding with vaccination acceleration and its extension to 45-64 years old group with comorbidities. (figure 4)
Kuwait, Bahrain, Uruguay, Seychelles, Hungary, Monaco, Mongolia and to a lesser extent Chile are also facing a very high mortality coinciding again with massive vaccination 28 . More recently, India started a fast massive vaccination campaign late March 2021 coinciding once more with a severe rise in mortality as shown in figure 2, worse than all prior episodes combined
Italy, France and Estonia are observing an excess all cause mortality precisely in the age groups 75 to 84 that have been vaccinated mostly by mRNA Pfizer and Moderna and to some extent Astrazeneca (Figure 5).
Death coinciding with vaccination repeatedly does not establish causality but calls for fair complete independent investigations as suspicion is raised and numbers are alarming particularly that this failure adds to prior ones.
Reproducing the experiment, with a risk of reproducing results illustrated in (figures 1,2,3,4,5).
Israel, Emirates, UK, Kuwait, Bahrain, India, Uruguay, Seychelles and Chile chose to vaccinate massively, including in some cases, populations at low risk of severe disease 29 sometimes without prior control as to pre-existing on going covid infection or pre-existing covid natural cellular immunity 30 31 .
This was done in disregard of a clear risk, benefit analysis for each individual, wasting vaccines that could have been made available to populations at risk in other parts of the world thus raising ethical, medical and scientific questions.
Requested investigation should explore how these vaccination campaigns failed to prevent this terrible outcome and if they contributed to it. All hypothesis should be explored including non-mutually exclusive hypothesis such as Antibodies Dependency Enhancement (ADE) 32 33 , Enhanced Respiratory Disease (ERD) 34 35 , vaccines side effects, vaccinated population being more infectious, vaccination places being clustering places, counter productive effect on already naturally immunized population or over-inflated vaccine efficacy on some populations, pressure-selection ... Hospitalizations, appearances or increases of syndromes must all be documented...Deaths had to occur before aknowledging thrombosis risks, is it necessary to wait for all the rest?
Benefit/risk was ignored when low risk young and healthy populations were exposed, pressured, tempted to vaccinate with very limited benefit, some short-term risks and unknown long-term risks 36 37 38 39 .
Excess mortality and possible hospitalizations coinciding with vaccinated groups in several countries calls for exact investigations of short term overlooked or ignored issues in addition to longer term side effects that are yet to be discovered.
Any treatment must come with counter-indications and a clear risk benefit analysis for every group and for the community. There have been attempts to explain such failure and outcome by variants in UK, south America, and now India. Such variants did not have the same effect in other countries that were not massively vaccinating. It remains unclear if pressure – selection resulting from massive vaccination leads to selection of variants that elude vaccinal immunity, tests and possibly other measures. Such hypothesis give current observations must be considered carefully. If it is not the case then, careful attention must be paid to vaccine side effects on some sub-categories as the cause of such surges in mortality. Suspicion will remain until is explained in each of such cases causes of increased mortality. Vaccination maybe a tool that may help with such a pandemic, but an accurate risk benefit analysis must be done for each category, each vaccine and efficacy on circulating variants based on sufficient data. Massive vaccination independent of such analysis has shown to be a failure to avoid a significant mortality rise in many cases and calls urgently for a nuanced approach.
Reckless behavior of massive inconsiderate vaccination becomes more serious when vaccinating those who already contracted covid 19 as this population had been excluded from Pfizer and Moderna trials. Any population that has been excluded from the trial can only be vaccinated within a trial. If they are healthy their benefit from vaccination was already low. If they recovered there is hardly any theoretical benefit and no demonstrated benefit. Risks are present on the short and long term.
By vaccinating covid recovered individuals, in addition to putting them at risk, outside of any trial, a negative alteration of cellular immunity cannot be excluded which would be counterproductive for all.
While data accumulated to demonstrate diversity, efficacy, and higher performance in prevention of variant-related infections of naturally-acquired immunity, with demonstrated importance of Lymphocytes qualitative response and mucosal immunity role, while no strong evidence of correlates with serological antibody measures, avoiding or delaying such natural immunity to develop within lower risk population may result in increased or continued risks for all 40 41 42 43 .
Changes to protocols, changing duration between shots as suggested in some cases or adding a third shot as suggested in others must be done within same standards of evidence requirements consistently and in many cases under a controlled trial approach measuring risks and benefits.
Any population for whom efficacy is not demonstrated can only be vaccinated within a proper clinical trial.
At the very least, this demonstrates that massive vaccination failed to show a visible effect at times when virus is circulating. High levels of mortality calls for an investigation to identify if it has not been counter-productive possibly making things worse and exposing individuals with little benefit to short and long term side effects.
By vaccinating massively including those with low benefit, in addition to exposing them to unnecessary risks from first vaccination and from eventually multiplication of vaccinations if new strains emerge requiring new vaccinations. This happening with multiple vaccines calls for caution with the process and for more adequate attention concerning each vaccine as well as vaccination multiplication with the same vaccine or a different one. Independent clinical trials would need to be done for such a serious matter to be handled upon extrapolations without sufficient data.
This massive vaccination was done disregarding individual risk/benefit sometimes in some countries without proper informed consent, possibly pressuring or tricking some to vaccinate exposing them to short term risks and unknown long-term risks without sufficient scientific and ethical basis. It was done disregarding solidarity between nations by vaccinating individuals who do not need it and for whom risks exceed benefits and it was done without careful control to minimize risks of pressure selection. The final outcome is that above mentioned countries had a terrible mortality wave and in the case of Israel high mortality episodes after the epidemic wave in groups 15-44 and 65+ and in Belgium excess mortality reappeared after several months of normality.
Figure 1 – Israel, Emirates, UK massively vaccinating
Figure 2 – Worst Covid phase in India, Kuwait and Bahrain coinciding with massive vaccination
Figure 3 - Uruguay, Hongrie, Seychelles
Figure 4 – Israel mortality rise after wave in young and elederly after vaccination and Belgium 45-64
Figure 5 – France and Italy excess mortality in mRNA vaccinated groups
The failure of applied solutions :
Vaccine efficacy and safety evidence
Emergency authorization was given to be used wisely. Past experiences showed us that clinical trials, safety assessments are here for a reason and in some cases are not sufficient [ ][ ][ ].
This Vaccination is based on limited understaning of short term risks since clinical trials have had short durations for evaluating short term safety (28 days to 4 months), and relatively small samples (12,000 to 25,000 compared to hundreds of millions). Risks of bias are high due to limited studies all done by manufacturers. Lack of critical interpretation of side effects observed during trials, weak pharmacovigilance in most countries in the absence of control groups adds to the problem. In addition to that, many countries stepped out of protocols mainly for logistics reasons or side effects making extrapolations and adding risk to risk.
Clinical trials phase 3 for proper observation were due for most vaccines early 2023. Until, we have sufficient long-term understanding, fully informed consent is medically, scientifically and ethically needed without pressure or temptation of any kind for everyone's benefit.
This is even more true for mRNA vaccines who rely on a novel technology with unknown positive and negative consequences. Efficacy and safety must be reassessed with new trials for vaccine updates and mutations that may alter behavior. Efficacy and safety must be reassessed with trials before use outside of clinical trial protocols that led to emergency authorization or before considering new shots. Efficacy and safety must be reassessed with trials before mixing vaccines or accumulating different versions of vaccines. Safety and efficacy reports and studies from the initial trial must be shared with the population as to continued efficacy and safety.
Observation of efficacy in protecting recipients of vaccines from manufacturers' published studies has its limitations
Observation of short-term safety also calls some questioning
Observation on long term safety
A preliminary study from Denmark suggests some efficacy 64% in infection reduction 7 days after Pfizer second dose for Care Home Residents and very limited protection before. This is promising if it translates into severe course and mortality reduction as it would indicate that one of the niches who need vaccination and are at relatively low risk of long-term side effects would get benefit.[ ] Such niche or benefit could be confirmed after above mentioned all causes mortality have been fully investigated and explained. It would validate vaccination for a large portion of those at risk.
In addition to previously stated limitations related to sampling, partial unblinding, exclusions[ ],,exclusion criteria, efficacy by group, Efficacy demonstrated for those with least benefits and highest risk of side effects, short term perspective... Analysis for several vaccines including Pfizer and Moderna was done exclusively on Relative Risk Reduction and did not include Absolute Risk Reduction and Numbers Needed to Treat.[ ] This is a way to present information on its best facet but all these criteria are needed when it is time to make a decision.
For example, in the Pfizer study, if we look at severe disease outcome. There were 9 cases in Placebo group out of 21728 and 1 in the vaccine group out of 21720. That is respectively 0,041 % and 0,005 %. That tells that over study period vaccination has reduced risk of severe Covid from 0.041 % to 0.005 %= risk reduction of 0.36 %. It also tells that to reduce 1 case of severe Covid one needs to vaccinate 2715 individuals who will be at risk of short- and long-term side effects if massive vaccination is performed.
On the other hand, for Pfizer trial, there were 4484 related adverse side effects in the vaccine group and 1095 for placebo. This means a Relative Increased Risk (RIR) of 61 % and an Absolute Increased Risk (AIR) of 15 % which is high particularly that adverse events are more common in the younger population who most often have a mild course of disease. Severe adverse events were in 240 in the vaccine group and 139 in Placebo group equivalent to an RIR of 27 % and an AIR of 0.46 %. This means to avoid 1 severe Covid case 733 will suffer from side effects and 13 would suffer from severe side effects.
This calls for targeted vaccination towards those with benefit and low risk of such adverse events. The young and healthy are also those at highest risk of long-term side effects of this novel technology. It goes without saying that those recovered cannot be vaccinated outside of a new clinical trial as they were excluded from the trial, their benefit unknown likely low and risks unknown thus should be assumed high.
Looking at the NNT for Moderna to prevent severe covid, 30 placebo group members had severe Covid and 185 had covid in the placebo group and 11 in the vaccine group. This corresponds in the context of the trial described by the authors as an environment of « appreciable risk », to vaccinating 15210 individuals. In that context NNT is around 507 (15210/(30-0)) to prevent severe Covid and around 87 to prevent mild or moderate Covid 19 (15210/(185-11)) . The rough result would mean on the short-term vaccinating 15210 individuals results in sparing 173 mild or moderate symptoms, 30 Hospitalization on the one side.
On the other hand grade 3+ events occurred in 15.8 % that would mean in trial context 2403 individuals had a serious non-life threatening adverse event that may require hospitalization. Adverse events were more common in the younger whom had least benefit from vaccine protection.[ ][ ] It also means that in context of clinical trial, to avoid 1 case of serious Covid 19, 80 individuals would suffer from grade 3 adverse side effect. This is high and again as the young get least benefit and are at highest risk of such adverse events, it calls for targeted vaccination towards those with benefit and low risk of such adverse events. There have also been imbalances in some severe side effects which should have been explored in greater details before proceeding to recommend intervention massively. The young and healthy are those at highest risk for long term side effects of this novel technology. It goes without saying that those recovered cannot be vaccinated outside of a new clinical trial as they were excluded from the trial, their benefit unknown likely low and risks unknown thus should be assumed high.
Janssen’s vaccine had been approved in Europe and the USA many months before any studies were published . Press releases were marketing it as a product promising 85 % efficacy, authorities in Europe and the US gave an emergency authorization for this vaccine and never contested such publicity outside of any scientific publication or even pre-print. As the publication came out a few months later, it turns out efficacy as per the study of the manufacturer is 66.9 % in preventing Covid 19 that is 18 % lower. However, it seems to have as good or better RRR for older population who need it most. For Severe Covid there were 19 individuals in the vaccine group and 80 in the placebo group indicating an efficacy of around 80 % on what is ultimately a small sample. The vaccine group was 19630 and placebo group was 19 691. That would give us for an absolute risk for severe Covid of in the context of the trial of 0.09 % for the vaccine group and of 0.4 % for the placebo group corresponding to an ARR of 0.31 %. It would also mean that to avoid one severe covid the NNT value would be around 323.
Janssen’s study reports sufficient sample sizes for obesity, hypertensions and type 2 diabetes. Thromboembolic events occurred in 11 cases in the vaccine group and 3 in the placebo group corresponding to a Relative Increased Risk of 78 % and an Absolute Increased Risk (AIR) of 0.04 % which remains high and should have triggered more attention and more exploration particularly that one such case was grade 4. RIR of 80 % and AIR of 0,016 % of was observed for Seizures. 6 cases of Tinitus, 1 cerebral hemorrhage and 1 case of the Guillain–Barré were observed. AIR of systemic event would be 1.7 % in the young and 0.4 % in those above 60. In context of this trial, for 1 severe case avoided, 5 would have a systemic reaction and 0.33 would have a serious side effect. This is a high number, strongly urging for targeted vaccination towards those with a clear identified benefit particularly that long term side effects remain unknown and efficacy towards new variants remains unknown. However, late publication, arrival of such publication after suspension in the US because of thromboembolic events occurring in real population, disclosure of such known risk and others by the study after-market authorization, inconsistencies between the text of the NEJM study and tables S6-S9 of the appendices, all call for caution. This preliminary analysis relies on the text of the NEJM study rather than the appendices.
This only accounts for the short-term risks and further urges towards vaccinating those have a significant possible benefit. Those with limited benefit are at higher risk of short-term adverse events and long-term ones as we have no knowledge of long-term efficacy or side effects. If needed be, this further stresses importance of targeted vaccination towards those at risk to avoid unwarranted serious side effects and long term consequences on those with low risk in addition to wasting vaccine doses and preventing others whom may have a benefit from gaining access in less developed countries.
There are exclusions whose outcome has not been published, high rates of significant or severe side effects identified by studies particularly in young healthy individuals, there are even inconsistencies in the case of Janssen between the study and its appendices.
We request that the raw data be made public so that at least data can be analyzed short term, and that ongoing collected data comparing vaccine group and placebo continue be made public as follow up data for safety.
Economic analysis also favors that course. Above example for Pfizer implies several costs, Vaccinating 2715 individuals to prevent 1 serious disease comes with a cost of around $95 000 paid to the manufacturer to which must be added:
From which must be deducted:
Targeted wise vaccination would be beneficial for health of vaccinated population, their economy and solidarity between nations.
Multiple reports indicate that vaccinated individuals can still be infected in large proportions, can also be infectious and including turn out to be super spreaders.
As variants are emerging concomitantly with vaccination campaigns using different vaccines, special caution must be taken towards pressure selection further leading to mutations that escape vaccinal immunity. This risk is highest as many vaccines, particularly the ones above mentioned target only the spike protein. Efficacy of vaccines must be determined against circulating variants from real life data as preliminary reports indicate significant reduced efficacy on some variants at least for Pfizer.[ ]
Targeted vaccination is needed as new mutations are happening and current vaccines may become obsolete fast, vaccination accumulation comes with risks benefits that will need to be assessed. We cannot just target an accumulation of failures and add risk to risk into unchartered territories.
Targetted vaccination is warranted as large portions of population in many countries are already immunized naturally against the full virus and may better resist mutations. Their benefit from vaccination is minimal if any and their risks depend on vaccines. For that matter, Pfizer and Moderna assumed past infection as being an exclusion criteria.
Efficacy, cost and safety would be completely different in case of a targeted vaccination towards those at risk provided efficacy and safety are demonstrated. From a public health perspective RRR, ARR and NNT can lead to very different decisions as to sampling and choosing. A community may be mislead and vaccinate excessively the wrong population with avoidable side effects and long-term consequences.
Many theoretical risks may be feared particularly from mRNA vaccines. We don’t know if multiple vaccinations may lead to unforeseen outcomes nor do we know bodies’ reaction after meeting a mutant or another coronavirus. The truth is we don’t know enough and should not add risks to risks. We do not know efficacy agaisnt some emerging strains.
An emergency authorization was granted to Jansen's vaccine in the US and Europe before publication of clinical trial results. Its use has been suspended since then in the US further indicating that we are in unchartered territories independently of future analysis. Astrazeneca vaccine was also suspended in several countries after harm was suspected on young healthy individuals who were at low risk of severe covid or covid death. Some of them may have been at negligible risk, had they recovered already from Covid or had they developed cellular immunity with light symptoms.
It has been suggested that manufacturers would adapt their vaccines to new variants. Each adaptation would require a clinical trial and special safety tests associated to vaccine accumulation covering similar targets in a short time span.
It has been suggested to skip all protocols and give some people a third injection or even mix vaccines outside of any trials.
An additional concern arises from Pfizer's and possibly other manufacturers' proposal to vaccinate control groups thus making it harder to identify imbalances and possible long term side effects. This additional step away from evidence based science combined with requests to limit manufacturers' liablities is most worrying.
The absence of carcinogenicity studies also raises questions, as the injected components are lipidic but lead to the production of an unusual free protein whose long-term effects are unknown. The question of cancers can therefore be raised.
There is potential to mRNA vaccines but it needs to be tested thoroughly as we always did.
Hypotheses need to be tested as often they turn out to be false.
As indicated in previous section, from mortality data, the data of the big picture paints an image of failure of one size fits all massive vaccination in spite of media trying to present things otherwise and social media trying to control the debate.
There seem to be an imbalance in the analysis of above mentioned studies exploring in length benefits to the detriment of a short less extensive analysis of side effects, their consequences and by definition long term side effects. Post vaccination vigilance is weak in most countries and little is done for comparisons with control groups.
The evidence for healthy individuals is probably moderate to strong. The benefit for these individuals is weak as they are at low risk of covid mortality. The risk of side effects is high based on known side effects but also given that we have no knowledge of long term impacts particularly for mRNA vaccines.
The evidence for the elderly whom have not had covid was weak to moderate and has improved slightly with above mentioned Danish study. The risk of long-term side effects is to be assessed based on their life expectancy. Ultimately, it should be their decision without pressure or temptation.
Evidence for vaccinating the elderly was not provided by the study but rather by data collected by real life use on populations. We should be careful with experimentations as data could go one way or another. The elderly were included in the Pfizer trial even if in insufficient numbers. Efficacy was not demonstrated but they could have hoped for a benefit. Maybe they did and maybe we will be reassured after excess mortality in above mentioned countries is fully explained.
The evidence for those who have recovered from Covid is absent. Their benefits are negligible [ ][ ] and risks are high. It must also be taken into account, current knowledge as to long lasting memory immunity protective effect [ ][ ]. Looking merely at antibodies is insufficient as cellular immunity plays a major role possibly more significant than that of antibodies.
The evidence for those under immunosuppressive treatment and those immunocompromised is unknown.
No one can responsibly make a claim as to the long term safety of these new vaccines.Vaccines have a niche, people should be fully informed without pressure or temptation but current marketing to magnify advantages and minimize risks is not compatible with science or medicine nor does it benefit humanity.
A nuanced approach is needed. Tables 1, 2, 3, 4 provide a risk benefit analysis for 3 vaccines, and different vaccination approaches.
This Vaccination is based on limited understaning of short term risks since clinical trials have had short durations for evaluating short term safety (28 days to 4 months), and relatively small samples (12,000 to 25,000 compared to hundreds of millions). Risks of bias are high due to limited studies all done by manufacturers. Lack of critical interpretation of side effects observed during trials, weak pharmacovigilance in most countries in the absence of control groups adds to the problem. In addition to that, many countries stepped out of protocols mainly for logistics reasons or side effects making extrapolations and adding risk to risk.
Clinical trials phase 3 for proper observation were due for most vaccines early 2023. Until, we have sufficient long-term understanding, fully informed consent is medically, scientifically and ethically needed without pressure or temptation of any kind for everyone's benefit.
This is even more true for mRNA vaccines who rely on a novel technology with unknown positive and negative consequences. Efficacy and safety must be reassessed with new trials for vaccine updates and mutations that may alter behavior. Efficacy and safety must be reassessed with trials before use outside of clinical trial protocols that led to emergency authorization or before considering new shots. Efficacy and safety must be reassessed with trials before mixing vaccines or accumulating different versions of vaccines. Safety and efficacy reports and studies from the initial trial must be shared with the population as to continued efficacy and safety.
Observation of efficacy in protecting recipients of vaccines from manufacturers' published studies has its limitations
- It relies on a few hundred people for example the Pfizer study relies on 650 people in total 550 in the control group and 100 on the intervention group for the entire vaccination period and only 171 individuals if we assess efficacy 7 days after second injection. Moderna and Astrazeneca have similar or smaller samples. The results are statistically valid and even strong for the population tested but cannot be extrapolated beyond to show levels of efficacy on subgroups in particular those with comorbidities, combination of comorbidities or for the elderly.
- Efficacy as to severe Covid relies on 10 people for Pfizer.
- There was no covid mortality in either group further indicating that the context was one of either low risk epidemic or low risk sample. It is difficult to establish a reduction of mortality from such a sample particularly for those who need it most that is the elderly, and those with comorbidities.
- In Pfizer's case, there are questions as to 3410 people excluded with « suspected covid » 1594 in the vaccine group and 1816 in the control group which would alter efficacy [ ] In Jansen's case, efficacy seems to be from its recently published study at 66.9% much lower than claimed 90+%. It seems slightly more effective on 60+ on that category. [ ][ ]
- Decision to vaccinate massive populations relies on 1 trial funded and controlled by the manufacturer inducing a bias risk.
- In the case of Pfizer and Moderna, those with history of Covid were excluded making benefit/risk for those already infected impossible to evaluate. Such population is probably large in much of Europe and the US. Most of them may have been already at low risk of severe covid or death and after recovering, their severe covid risk is likely negligible. As they have been explicitly excluded, as their benefit cannot be determined, as their vaccination risk since unknown, must be assumed high, as they are less likely to spread than naive populations and possibly vaccinated, vaccination should be avoided or at least they must be warned.
- Given suspected large numbers of asymptomatic or lightly symptomatic populations whom may not know they had covid, they must at least be offered cellular reactivity tests before making a free informed decision.
- Efficacy relies on small numbers, is demonstrated for populations with limited benefit from vaccination and unknown thus high long-term risks. It is less clear for those at high risk and is not demonstrated on mortality.
Observation of short-term safety also calls some questioning
- In Pfizer's case, there are 371 individuals who have been excluded from the statistical analysis on or prior to 7 days after second injection. No reports have been given about disease course for these individuals. Instead of excluding them, this would have given insight as to ADE risks and risks before vaccine effect is fully active
- The imbalance in these 371 excluded individuals 311 in the vaccine group and 60 in the placebo group calls for further questioning. This questionning becomes all more pressing as reports seem to indicate that such unexplained imbalance with higher levels of infections immediately after vaccination. This imbalance should have been investigated to ensure absence of an increased susceptibility risk after vaccination.
- Excluded populations such as those with history of covid, immunocompromised, those with immunosuppressive therapies leaves us without clinical trial to validate responsibly benefit/risk
- There is no data as to risks to if and when immunity starts to weaken in presence or absence of virus encounter
- Significant adverse effects (fever in 16% of the young) comparable to those of the disease itself in younger healthy individuals have been observed. Yet outcome of those excluded must be made public before conclusions for Pfizer. Israel mortality analysis including that of age 15-44 needs to be made public to understand better. Jansen's safety analysis relies on a relatively small sample 3356 individuals.
Observation on long term safety
- mRNA vaccines are a new technology-, mid- and long-term side effects are unknown.
- Precautionary principle and responsibility calls for assuming that such risk maybe significant
- Other non mRNA vaccines do not yet have enough observation time and their risks are unknown
- Better midterm understanding would be available early 2023 when comparing conditions of the intervention group with the control group if we are to have a scientific protective approach
- Phase 3 raw data, if released progressively may give more insight
- Phase 4 should adapt to compensate for this quasi experimentation by having active monitoring of all vaccinated individuals and releasing such data
- For consistency data related to hospitalizations and mortality within 45 days after vaccination should be reported to identify those dead with vaccine just like we identified those dead with covid and monitor for any unusual numbers
A preliminary study from Denmark suggests some efficacy 64% in infection reduction 7 days after Pfizer second dose for Care Home Residents and very limited protection before. This is promising if it translates into severe course and mortality reduction as it would indicate that one of the niches who need vaccination and are at relatively low risk of long-term side effects would get benefit.[ ] Such niche or benefit could be confirmed after above mentioned all causes mortality have been fully investigated and explained. It would validate vaccination for a large portion of those at risk.
In addition to previously stated limitations related to sampling, partial unblinding, exclusions[ ],,exclusion criteria, efficacy by group, Efficacy demonstrated for those with least benefits and highest risk of side effects, short term perspective... Analysis for several vaccines including Pfizer and Moderna was done exclusively on Relative Risk Reduction and did not include Absolute Risk Reduction and Numbers Needed to Treat.[ ] This is a way to present information on its best facet but all these criteria are needed when it is time to make a decision.
For example, in the Pfizer study, if we look at severe disease outcome. There were 9 cases in Placebo group out of 21728 and 1 in the vaccine group out of 21720. That is respectively 0,041 % and 0,005 %. That tells that over study period vaccination has reduced risk of severe Covid from 0.041 % to 0.005 %= risk reduction of 0.36 %. It also tells that to reduce 1 case of severe Covid one needs to vaccinate 2715 individuals who will be at risk of short- and long-term side effects if massive vaccination is performed.
On the other hand, for Pfizer trial, there were 4484 related adverse side effects in the vaccine group and 1095 for placebo. This means a Relative Increased Risk (RIR) of 61 % and an Absolute Increased Risk (AIR) of 15 % which is high particularly that adverse events are more common in the younger population who most often have a mild course of disease. Severe adverse events were in 240 in the vaccine group and 139 in Placebo group equivalent to an RIR of 27 % and an AIR of 0.46 %. This means to avoid 1 severe Covid case 733 will suffer from side effects and 13 would suffer from severe side effects.
This calls for targeted vaccination towards those with benefit and low risk of such adverse events. The young and healthy are also those at highest risk of long-term side effects of this novel technology. It goes without saying that those recovered cannot be vaccinated outside of a new clinical trial as they were excluded from the trial, their benefit unknown likely low and risks unknown thus should be assumed high.
Looking at the NNT for Moderna to prevent severe covid, 30 placebo group members had severe Covid and 185 had covid in the placebo group and 11 in the vaccine group. This corresponds in the context of the trial described by the authors as an environment of « appreciable risk », to vaccinating 15210 individuals. In that context NNT is around 507 (15210/(30-0)) to prevent severe Covid and around 87 to prevent mild or moderate Covid 19 (15210/(185-11)) . The rough result would mean on the short-term vaccinating 15210 individuals results in sparing 173 mild or moderate symptoms, 30 Hospitalization on the one side.
On the other hand grade 3+ events occurred in 15.8 % that would mean in trial context 2403 individuals had a serious non-life threatening adverse event that may require hospitalization. Adverse events were more common in the younger whom had least benefit from vaccine protection.[ ][ ] It also means that in context of clinical trial, to avoid 1 case of serious Covid 19, 80 individuals would suffer from grade 3 adverse side effect. This is high and again as the young get least benefit and are at highest risk of such adverse events, it calls for targeted vaccination towards those with benefit and low risk of such adverse events. There have also been imbalances in some severe side effects which should have been explored in greater details before proceeding to recommend intervention massively. The young and healthy are those at highest risk for long term side effects of this novel technology. It goes without saying that those recovered cannot be vaccinated outside of a new clinical trial as they were excluded from the trial, their benefit unknown likely low and risks unknown thus should be assumed high.
Janssen’s vaccine had been approved in Europe and the USA many months before any studies were published . Press releases were marketing it as a product promising 85 % efficacy, authorities in Europe and the US gave an emergency authorization for this vaccine and never contested such publicity outside of any scientific publication or even pre-print. As the publication came out a few months later, it turns out efficacy as per the study of the manufacturer is 66.9 % in preventing Covid 19 that is 18 % lower. However, it seems to have as good or better RRR for older population who need it most. For Severe Covid there were 19 individuals in the vaccine group and 80 in the placebo group indicating an efficacy of around 80 % on what is ultimately a small sample. The vaccine group was 19630 and placebo group was 19 691. That would give us for an absolute risk for severe Covid of in the context of the trial of 0.09 % for the vaccine group and of 0.4 % for the placebo group corresponding to an ARR of 0.31 %. It would also mean that to avoid one severe covid the NNT value would be around 323.
Janssen’s study reports sufficient sample sizes for obesity, hypertensions and type 2 diabetes. Thromboembolic events occurred in 11 cases in the vaccine group and 3 in the placebo group corresponding to a Relative Increased Risk of 78 % and an Absolute Increased Risk (AIR) of 0.04 % which remains high and should have triggered more attention and more exploration particularly that one such case was grade 4. RIR of 80 % and AIR of 0,016 % of was observed for Seizures. 6 cases of Tinitus, 1 cerebral hemorrhage and 1 case of the Guillain–Barré were observed. AIR of systemic event would be 1.7 % in the young and 0.4 % in those above 60. In context of this trial, for 1 severe case avoided, 5 would have a systemic reaction and 0.33 would have a serious side effect. This is a high number, strongly urging for targeted vaccination towards those with a clear identified benefit particularly that long term side effects remain unknown and efficacy towards new variants remains unknown. However, late publication, arrival of such publication after suspension in the US because of thromboembolic events occurring in real population, disclosure of such known risk and others by the study after-market authorization, inconsistencies between the text of the NEJM study and tables S6-S9 of the appendices, all call for caution. This preliminary analysis relies on the text of the NEJM study rather than the appendices.
This only accounts for the short-term risks and further urges towards vaccinating those have a significant possible benefit. Those with limited benefit are at higher risk of short-term adverse events and long-term ones as we have no knowledge of long-term efficacy or side effects. If needed be, this further stresses importance of targeted vaccination towards those at risk to avoid unwarranted serious side effects and long term consequences on those with low risk in addition to wasting vaccine doses and preventing others whom may have a benefit from gaining access in less developed countries.
There are exclusions whose outcome has not been published, high rates of significant or severe side effects identified by studies particularly in young healthy individuals, there are even inconsistencies in the case of Janssen between the study and its appendices.
We request that the raw data be made public so that at least data can be analyzed short term, and that ongoing collected data comparing vaccine group and placebo continue be made public as follow up data for safety.
Economic analysis also favors that course. Above example for Pfizer implies several costs, Vaccinating 2715 individuals to prevent 1 serious disease comes with a cost of around $95 000 paid to the manufacturer to which must be added:
- cost of vaccination act.
- cost of treatments and possibly hospitalizations of grade 3 adverse events caused by vaccines.
- cost of work stopping.
From which must be deducted:
- cost of treatment of that 1 serious case and that of mild cases.
Targeted wise vaccination would be beneficial for health of vaccinated population, their economy and solidarity between nations.
Multiple reports indicate that vaccinated individuals can still be infected in large proportions, can also be infectious and including turn out to be super spreaders.
As variants are emerging concomitantly with vaccination campaigns using different vaccines, special caution must be taken towards pressure selection further leading to mutations that escape vaccinal immunity. This risk is highest as many vaccines, particularly the ones above mentioned target only the spike protein. Efficacy of vaccines must be determined against circulating variants from real life data as preliminary reports indicate significant reduced efficacy on some variants at least for Pfizer.[ ]
Targeted vaccination is needed as new mutations are happening and current vaccines may become obsolete fast, vaccination accumulation comes with risks benefits that will need to be assessed. We cannot just target an accumulation of failures and add risk to risk into unchartered territories.
Targetted vaccination is warranted as large portions of population in many countries are already immunized naturally against the full virus and may better resist mutations. Their benefit from vaccination is minimal if any and their risks depend on vaccines. For that matter, Pfizer and Moderna assumed past infection as being an exclusion criteria.
Efficacy, cost and safety would be completely different in case of a targeted vaccination towards those at risk provided efficacy and safety are demonstrated. From a public health perspective RRR, ARR and NNT can lead to very different decisions as to sampling and choosing. A community may be mislead and vaccinate excessively the wrong population with avoidable side effects and long-term consequences.
Many theoretical risks may be feared particularly from mRNA vaccines. We don’t know if multiple vaccinations may lead to unforeseen outcomes nor do we know bodies’ reaction after meeting a mutant or another coronavirus. The truth is we don’t know enough and should not add risks to risks. We do not know efficacy agaisnt some emerging strains.
An emergency authorization was granted to Jansen's vaccine in the US and Europe before publication of clinical trial results. Its use has been suspended since then in the US further indicating that we are in unchartered territories independently of future analysis. Astrazeneca vaccine was also suspended in several countries after harm was suspected on young healthy individuals who were at low risk of severe covid or covid death. Some of them may have been at negligible risk, had they recovered already from Covid or had they developed cellular immunity with light symptoms.
It has been suggested that manufacturers would adapt their vaccines to new variants. Each adaptation would require a clinical trial and special safety tests associated to vaccine accumulation covering similar targets in a short time span.
It has been suggested to skip all protocols and give some people a third injection or even mix vaccines outside of any trials.
An additional concern arises from Pfizer's and possibly other manufacturers' proposal to vaccinate control groups thus making it harder to identify imbalances and possible long term side effects. This additional step away from evidence based science combined with requests to limit manufacturers' liablities is most worrying.
The absence of carcinogenicity studies also raises questions, as the injected components are lipidic but lead to the production of an unusual free protein whose long-term effects are unknown. The question of cancers can therefore be raised.
There is potential to mRNA vaccines but it needs to be tested thoroughly as we always did.
Hypotheses need to be tested as often they turn out to be false.
As indicated in previous section, from mortality data, the data of the big picture paints an image of failure of one size fits all massive vaccination in spite of media trying to present things otherwise and social media trying to control the debate.
There seem to be an imbalance in the analysis of above mentioned studies exploring in length benefits to the detriment of a short less extensive analysis of side effects, their consequences and by definition long term side effects. Post vaccination vigilance is weak in most countries and little is done for comparisons with control groups.
The evidence for healthy individuals is probably moderate to strong. The benefit for these individuals is weak as they are at low risk of covid mortality. The risk of side effects is high based on known side effects but also given that we have no knowledge of long term impacts particularly for mRNA vaccines.
The evidence for the elderly whom have not had covid was weak to moderate and has improved slightly with above mentioned Danish study. The risk of long-term side effects is to be assessed based on their life expectancy. Ultimately, it should be their decision without pressure or temptation.
Evidence for vaccinating the elderly was not provided by the study but rather by data collected by real life use on populations. We should be careful with experimentations as data could go one way or another. The elderly were included in the Pfizer trial even if in insufficient numbers. Efficacy was not demonstrated but they could have hoped for a benefit. Maybe they did and maybe we will be reassured after excess mortality in above mentioned countries is fully explained.
The evidence for those who have recovered from Covid is absent. Their benefits are negligible [ ][ ] and risks are high. It must also be taken into account, current knowledge as to long lasting memory immunity protective effect [ ][ ]. Looking merely at antibodies is insufficient as cellular immunity plays a major role possibly more significant than that of antibodies.
The evidence for those under immunosuppressive treatment and those immunocompromised is unknown.
No one can responsibly make a claim as to the long term safety of these new vaccines.Vaccines have a niche, people should be fully informed without pressure or temptation but current marketing to magnify advantages and minimize risks is not compatible with science or medicine nor does it benefit humanity.
A nuanced approach is needed. Tables 1, 2, 3, 4 provide a risk benefit analysis for 3 vaccines, and different vaccination approaches.
Table 1 – Analyse de l'étude suivant l'essai clinique d'un seul fabricant menant à l'approbation d'urgence
Table 2 – Approche ciblée en cas de besoin vs. Approche randomisée massive
Table 3 – Rapport bénéfices/risques par groupe
Table 4 – Autres
The failure of applied solutions :
Vaccinal passport or any similar document paper or electronic that confers undue advantage or pressures someone to vaccinate
In addition to being morally, ethically, and legally questionable from a scientific standpoint such passports is not justified for multiple reasons as explained in previous sections.
From a scientific point of view, a vaccinal passport is not supported and maybe counterproductive possibly harmful on an individual and global level, as the vaccine may reprogram “innate immune system” in unexpected ways and maybe counter productive 63 . This adds to the fact that we still know little about such products and technologies; agencies have granted debatable exemptions, and some manufacturers are suggesting to vaccinate placebo group making it more difficult to spot or track side effects some of which may be as serious as cancer, or altering immune system. There is a very large population recovered or “asymptomatic” that is immune possibly exceeding 2 Billion individuals 64 , in spite of a large efforts, to ignore their existence. They need to be made aware through cellular testing or their clinical history and be informed of their protection and that such protection alters the benefit risk balance at an individual level and collectively. They should also be made aware that current knowledge indicates that cellular immunity is often long-lasting.
Such population may save vaccines for those who have more benefits than risks, it also would bring global protection from unexpected side effects related to possible immunity alterations or other side effects to be discovered after billions have been vaccinated.
Yet people are being pushed, pressured through media, some health agencies and some regulatory bodies to vaccinate in spite of higher risks than benefits.
Testing for existence of cellular immunity prior to vaccination is a needed option and would contribute to informed consent.
For ethical reasons, authors of this paper do not support segregation and feel the situation does not justify vaccinal passeports.
A simulation was performed, dealing with a corona virus pandemic hosted by the GATES foundation, John Hopkins and WEF late October 2019 right before SARSCOV2 was identified. This simulation seems to have served as a roadmap to countries' reactions except that it had assumed a much higher mortality and treatments to be less effective than they turned out to be. Countries dealt with the epidemic in a similar manner to that indicated during that simulation failing to distinguish that actual mortality was lower, and treatments were more widespread and effective than indicated in a simulation that had already targeted vaccines as the solution. They are now failing to recognize natural immunity that has saved humanity through all past epidemics through multiple mileniums.
It is neither right nor scientific to push people to vaccinate by giving them money, depriving them from education, jobs, travel or social life. It is just pressuring them to vaccinate to achieve a goal we fail to understand.
It is not science and its benefit or harm has not been demonstrated. In all cases, excessive mortality happening in countries that massively vaccinated must be explained as to who, when, why, what before undertaking further steps...
If we were to be consistent, we would require all to have either test or a proof of reactivity from cellular immunity to circulating strains whether vaccinated or not. We do not support this idea, but it would at least be consistent and would at least demonstrate some resistance to virus independently of vaccination instead of unjustifiably push those with higher risks than benefits towards vaccination without taking responsibility for mandatory vaccination.
The fact that states have been brave enough to reopen and return to populations their civil liberties demonstrate feasibility of such approach in population.
From a democratic point of view, it would become a tool of segregation, division and possibly submission.
In some countries such a policy is strongly opposed by the population as is demonstrated by a large inquiry done in France on more than 100 000 individuals by a public institution demonstrating that 67% are strongly opposed and 72% are opposed to such a passport or certificate 65 .
It has been suggested to maintain such segregation and civil liberties restrictions until you the WHO declare the end of the pandemic. However, if SARSCOV-2 follows the same pattern as that of HCOV-OC43, continues to circulate as a common cold, it may be a long time before the WHO declares the end of the pandemic. This may be reinforced if we continue to count those mostly dead of comorbidities as COVID deaths. In many countries there were many periods where there was no excess mortality matching reported covid attributed mortality.
Evidence as to vaccinal passport stopping the epidemic is absent, and risks are high. All it does, is promote vaccination for those with a negative risk benefit balance to the benefit of manufacturers and those who would profit from setting up a new control system as to populations’ movements. It adds pressure and temptation to a weakened tired population and exposes a large portion to possibly unknown risks with little benefit to them and unforeseen consequences to the community. Such risks take society into uncharterred territories harming social, mental and physical health.
- They do not guarantee that all vaccinated individuals or even most have sufficient active cellular immunity against circulating strains
- They would push individuals with more risks than benefits to vaccinate
- They may increase risk of pressure selection
- They do not prevent spreading or even super-spreading from happening
- Vaccines are medical interventions that cannot and should not be promoted or pushed as a vulgar product or pushed /pressured without clear counter-indications, precautions and individual risk/benefit understanding
From a scientific point of view, a vaccinal passport is not supported and maybe counterproductive possibly harmful on an individual and global level, as the vaccine may reprogram “innate immune system” in unexpected ways and maybe counter productive 63 . This adds to the fact that we still know little about such products and technologies; agencies have granted debatable exemptions, and some manufacturers are suggesting to vaccinate placebo group making it more difficult to spot or track side effects some of which may be as serious as cancer, or altering immune system. There is a very large population recovered or “asymptomatic” that is immune possibly exceeding 2 Billion individuals 64 , in spite of a large efforts, to ignore their existence. They need to be made aware through cellular testing or their clinical history and be informed of their protection and that such protection alters the benefit risk balance at an individual level and collectively. They should also be made aware that current knowledge indicates that cellular immunity is often long-lasting.
Such population may save vaccines for those who have more benefits than risks, it also would bring global protection from unexpected side effects related to possible immunity alterations or other side effects to be discovered after billions have been vaccinated.
Yet people are being pushed, pressured through media, some health agencies and some regulatory bodies to vaccinate in spite of higher risks than benefits.
Testing for existence of cellular immunity prior to vaccination is a needed option and would contribute to informed consent.
For ethical reasons, authors of this paper do not support segregation and feel the situation does not justify vaccinal passeports.
A simulation was performed, dealing with a corona virus pandemic hosted by the GATES foundation, John Hopkins and WEF late October 2019 right before SARSCOV2 was identified. This simulation seems to have served as a roadmap to countries' reactions except that it had assumed a much higher mortality and treatments to be less effective than they turned out to be. Countries dealt with the epidemic in a similar manner to that indicated during that simulation failing to distinguish that actual mortality was lower, and treatments were more widespread and effective than indicated in a simulation that had already targeted vaccines as the solution. They are now failing to recognize natural immunity that has saved humanity through all past epidemics through multiple mileniums.
It is neither right nor scientific to push people to vaccinate by giving them money, depriving them from education, jobs, travel or social life. It is just pressuring them to vaccinate to achieve a goal we fail to understand.
It is not science and its benefit or harm has not been demonstrated. In all cases, excessive mortality happening in countries that massively vaccinated must be explained as to who, when, why, what before undertaking further steps...
If we were to be consistent, we would require all to have either test or a proof of reactivity from cellular immunity to circulating strains whether vaccinated or not. We do not support this idea, but it would at least be consistent and would at least demonstrate some resistance to virus independently of vaccination instead of unjustifiably push those with higher risks than benefits towards vaccination without taking responsibility for mandatory vaccination.
The fact that states have been brave enough to reopen and return to populations their civil liberties demonstrate feasibility of such approach in population.
From a democratic point of view, it would become a tool of segregation, division and possibly submission.
In some countries such a policy is strongly opposed by the population as is demonstrated by a large inquiry done in France on more than 100 000 individuals by a public institution demonstrating that 67% are strongly opposed and 72% are opposed to such a passport or certificate 65 .
It has been suggested to maintain such segregation and civil liberties restrictions until you the WHO declare the end of the pandemic. However, if SARSCOV-2 follows the same pattern as that of HCOV-OC43, continues to circulate as a common cold, it may be a long time before the WHO declares the end of the pandemic. This may be reinforced if we continue to count those mostly dead of comorbidities as COVID deaths. In many countries there were many periods where there was no excess mortality matching reported covid attributed mortality.
Evidence as to vaccinal passport stopping the epidemic is absent, and risks are high. All it does, is promote vaccination for those with a negative risk benefit balance to the benefit of manufacturers and those who would profit from setting up a new control system as to populations’ movements. It adds pressure and temptation to a weakened tired population and exposes a large portion to possibly unknown risks with little benefit to them and unforeseen consequences to the community. Such risks take society into uncharterred territories harming social, mental and physical health.
The failure of applied solutions :
Masks
One size fits all face covering for many months in open air and public places.
Evidence as to mask efficacy against covid is weak if that. It is even weaker in outdoors settings where risks are minimal
66
67 .
Some Media who have had a large influence in driving the epidemic are starting to relate it. It seems devoid of reason to suggest that vaccination could free people from outdoor masking as this latter is baseless. Data comparing face covering mandates outdoors suggests a possible counterproductive effect
68
69 .
Studies exploring which masks, when, for how long, associated hygiene and feasibility have gone missing.
Mask wearing, is a medical interventions and prolonged wearing comes with unknown risks for adults and children as no population have had to wear masks daily for multiple hours for such prolonged time indoors and outdoors. There is even less data as to prolonged mask wearing for children.
The only setting in which the mask seems to have an efficacy is within hospitals where symptomatic patients (pulmonary clinical presentations) are more numerous, or eventually when worn by symptomatic persons in crowded indoors places in period of high virus circulation, thus the air transmission risk is higher. FFP2 masks were the type of masks with the higher rate of lowering the risk. Under such conditions, mask hygiene can be respected thus showing efficacy and minimizing risks linked to prolonged use.
Prior to this epidemic, evidence indicated that face covering and cloths masks were associated to populations developing asthma, being more subject to infections, developing nasal resistance in addition to headaches possibly leading to increased consumption of anti-inflammatory drugs. We know this from studies done where populations are mandated to cover their faces for religious regions
70
71
72
73
74 .
Besides its sanitary effect, attention should be given to mechanical effect of “resistance to breathing” induced from long-term mask wearing. It has long been demonstrated that an increased pulmonary effort can cause stress and damages. Still more especially for children in development, long-term mask wearing may be deleterious and cause cascade of long-lasting pathologies
75
76 .
Breathing pesticides from cotton, detergent, solvents and other chemicals from masks for a prolonged time may also come with its share of future risks. Nobody can responsibly claim to know what the long term side effects are of such constant prolonged wearing of masks on adults or growing children.
Evidence is weak, it is absent outdoors, benefits are limited, some risks are known, others have been hypothesized and others may still be discovered. Yet masks are enforced in many countries including outdoors and on children. Authorities imporsing such brutal interventions did not accompany it by any monitoring instruments to at least measure efficacy benefits and risks on the short and long term.
The failure of applied solutions :
Fear propagation
Fear has been a tool used by some governments, some media and some members of the medical body to control populations.
Many scientists forgot that chronic stress is harmful may cause deadly and chronic diseases, have a physiological impact and a psychological one. It may weaken the immune system to the extent of increasing epidemic severity in all senses
77
78
79 .
Those propagating fear successfully, made people afraid of each other, nourishing hatred and guilt based on little or no evidence. They were claiming that healthy people are dangerous, that everyone is potentially dangerous and that our mere existence becomes a threat.
Fear and pressure extended to healthcare providers in some democratic countries. In addition, to co-signatories of the letter, others have expressed support but feared retaliation in their carreers or supplies if they contradicted authorities' view.
This adds to harmfull psychological, social, side effects associated to anxiety possibly leading to depression eating disorders, addictions and violence.
“Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” as defined by the WHO. In addition to physical issues addressed by this letter, following fear propagation, oppression, pressure, absence of debate, mental and social health must become a priority as matter of urgency and the WHO must urge to stop experimenting and contribute to bringing back a free, peaceful, calm society.
Conclusion