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Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Request to the WORLD HEALTH ORGANIZATION (WHO) P

urpose: We call for a debate on choices, investigations into grey areas, dialogue on inconsistencies and a transparent model built with citizens for free and informed choices about their health. We call onto the WHO and medical bodies of member countries under the article 1 and article 2 points a, f, g, h, m, p, s of the WHO constitution which are : [1] Article 1 : « The objective of the World Health Organization(hereinafter called theOrganization)shall be the attainment by all peoples of the highest possiblelevel of health » Article 2 : « In order to achieve its objective, the functions of the Organization shall be : - (a) to act as the directing and co-ordinating authority on internationalhealth work - (f) to establish and maintain such administrative and technical services asmay be required, including epidemiological and statistical services - (g)to stimulate and advance work to eradicate epidemic, endemic andother disease - (h) to promote, in cooperation with other specialized agencies where necessary, the prevention of accidental injuries - (m) to foster activities in the field of mental health, especially those affecting the harmony of human relations - (p) to study and report on, in cooperation with other specialized agencieswhere necessary, administrative and social techniques affecting publichealth and medical care from preventive and curative points of view,including hospital services and social security - (s)to establish and revise as necessary international nomenclatures of dis-eases, of causes of death and of public health practices; - (…) » It would appear that these principles have not been respected as demonstrated hereafter.

1) Introduction/Facts............................................................................................................................2

2) Analysis of interventions neglected.................................................................................................3

Aeration and encouraging activity in open air settings..............................................................3

Obesity, sports and nutrition......................................................................................................4

Neutraceticals and Vitamin D levels correction........................................................................5

Multidrug therapy .....................................................................................................................6

3) The failure of applied solutions........................................................................................................8

Massive vaccination..................................................................................................................8

Vaccine efficacy and safety evidence.......................................................................................11

Vaccinal passport or any similar document paper or electronic that confers undue advantage or pressures someone to vaccinate................................................................................................17

Fear propagation......................................................................................................................20

3) Conclusion .....................................................................................................................................20

1 [Accessed 26/03/2021] May 2021 Page 1 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 1) Introduction/Facts On January 30th, 2020, the World Health Organization declared an international health emergency, for the 6th time since 1964. The SARS COV 2 was, at that time, already present on several continents, at that time it had alreafy affected most countries. To cope with a situation of unprecedented magnitude in recent history, a number of States have implemented solutions, most of which were dictated by urgency, without carefull discernement weighing between benefits and risks. As a result of that, and since then, legions of different generalized containment measures have been adopted. In less than a year, in most states, the police has become the rule and freedom the exception! Authors of this referral, all of which are scientists, or renowned doctors, whom distinguished themselves in the care of patients with COVID 19, fully understand the need to prioritize public health when necessary to the detriment, undoubtedly, of some freedoms. In addition to the search for strict proportionality, they intend to argue that the measures thus enacted have, for many, no scientific basis, no health legitimacy as their benefit has never been demonstrated, whereas their risks have been clearly identified, and are estimated colossal individually and collectively. On an individual level, and as will be explained, the generalized wearing of a mask, confinement measures, forced isolation, mass vaccination, have certain consequences, and the signatories of this letter are astonished that such consequences are denied or minimized, while the literature abounds as to them. However, the benefit of these decisions is notoriously insufficient to be able to imagine curbing their very real risks. This lack of scientific basis for the measures thus enacted and generalized, tend to worry the community of international jurists, who will soon submit a demonstrative request to the UN Human Rights Committee in order to question whether the pandemic just did not serve as a pretext for some States to establish the New bases of a social contract, which, unbalanced, would allow the restriction of public freedoms, and the force of opposition represented by their implementation. Without being afraid of words, it is up to the Signatory Doctors and scientists to question the World Health Organization on what it intends to implement so that the covid19 epidemic is not followed by a political and social collapse. , economic of States, while they cannot accept that an infectious disease with limited and manageable medical consequences, can serve as a pretext for calling into question the foundations of democratic civilization, and that thus, despite themselves, they can be assimilated to promoters of a new political equilibrium. It is up to your prestigious authority to denounce, following the UN, the political, economic, or philosophical recoveries of the pandemic, recalling the warning of Antonio GUTERRES, on February 22: “Using the pandemic as a pretext, authorities in some countries have deployed heavy-handed security responses May 2021 Page 2 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version and emergency measures to crush dissent, criminalize basic freedoms, silence independent reporting and curtail the activities of non-governmental organisations.”2 The signatories of this request are scientists, and science is their only guidance: a science based on evidence, a science which evolves, and which cannot be the object of political use, while their word cannot serve as a basis for justifying restrictions on public freedoms. Some restrictions were for other purposes, they remind us that science cannot accept approximations, especially when these have consequences as serious as those we are witnessing at the moment. They deplore that measures of doubtful and insufficiently proven effectiveness have been implemented, while others, yet with a level of proof, benefit and low risks have not been favored or implemented. The question is all the more pressing because with more than 3 million deaths attributed to Covid-19, we can only see a failure in Europe, America and parts of the Middle East. These regions are in a worse situation than the 1889 railroad flu, which may have been caused by the emergence of another Coronavirus, HCOV-OC43. This failure occurred despite the fact that this pandemic was predictable and had very low risks for the vast majority of the healthy population, as shown by the WHO's own publications.3 With the support of these scientists and physicians, a comparative risk/benefit analysis is proposed (see Tables 5 and 6). 2) Analysis of interventions neglected Aeration and encouraging activity in open air settings Data has accumulated to show that risk of contamination in outdoor settings is very rare independently of any other factors. It has been estimated to be 18.7 times lower than indoors. [4][5] Evidence also suggests that good aeration reduces infection risks significantly as per your own WHO recommendations [6] . This is consistent with prior knowledge indicating that proper ventilation greatly reduces risk of infection. It had even been suggested that for influenza it could be as efficient as having 50 % to 60 % of the population vaccinated.[7] This is true for Covid 19 and many other respiratory diseases. It would been easy to encourage people to increase activity outdoors and encourage businesses to invest into good aeration. 2 Accessed 2nd of May 2021 3 Infection fatality rate of COVID-19 inferred from seroprevalence data John P A Ioannidis Bulletin of the World Health Organization; Type: Research Article ID: BLT.20.265892 4 Tommaso Celeste Bulfone, Mohsen Malekinejad, George W Rutherford, Nooshin Razani, Outdoor Transmission of SARS-CoV-2 and Other Respiratory Viruses: A Systematic Review, The Journal of Infectious Diseases, Volume 223, Issue 4, 15 February 2021, Pages 550–561, 5 Hua Qian et al. Indoor transmission of SARS‐CoV‐2 indoor air october 2020 6 World Health Organization (WHO) Roadmap to improve and ensure good indoor ventilation in the context of COVID-19 Accessed April 22nd 7 Smieszek, T., Lazzari, G. & Salathé, M. Assessing the Dynamics and Control of Droplet- and Aerosol-Transmitted Influenza Using an Indoor Positioning System. Sci Rep 9, 2185 (2019). May 2021 Page 3 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Businesses with good aeration could even be encouraged to remain open. This would increase population livelihood, would help the economy, would reduce underground activities and would help with this epidemic and possibly the next prophesized one. Instead businesses are closed, outdoor gatherings are controlled in many countries. Once again measures that strengthen population with likely efficacy are disregarded in favor of measures that weaken populations in spite of low evidence of efficacy. Benefits for encouraging outdoor time and promoting investments into good aeration in shops, businesses, and public places are high whereas risks are low. Yet shops are closed and populations are restricted and pushed indoors through curfew mandates and other oppressive restrictions. Obesity, sports and nutrition Obesity and poor health have been identified as probably one of the highest risk factors associated with severe disease. This has been known since April 2020 and largely confirmed since then.[8][9][10][11] 12 months have passed and no active campaigns for encouraging sport, better diet, have been conducted in most countries. Instead population was pushed to stay home, stock on unhealthy foods and pushed onto fast food which stayed open in many countries when sports activities were kept closed and outdoors restaurants and cafes were closed. Encouraging people to stay active, healthy, facilitating nutritious foods and providing nutritionists support for those who need it, is feasible, its cost is minimal compared to cost of other measures. Such interventions make population stronger against this disease and probably many others. Yet it is disregarded by most countries. Obesity reduction may have saved lives and should have been facilitated to population to have that choice, engaging in exercise following a healthier diet may have led to results as studies show within 6 months before second epidemic phase. 12 Instead, conditions were created to increase obesity possibly increasing deaths in addition to other psychological and health side effects. Active actions to reduce obesity and improve nutrition come with little risks and high benefits including for 8 Lighter, J., Phillips, M., Hochman, S., Sterling, S., Johnson, D., Francois, F., & Stachel, A. (2020). Obesity in Patients Younger Than 60 Years Is a Risk Factor for COVID-19 Hospital Admission. Clinical Infectious Diseases, 71(15), 896–897. doi:10.1093/cid/ciaa415 9 Sean Wei Xiang et al. Association of Higher Body Mass Index With Severe Coronavirus Disease 2019 (COVID-19) in Younger Patients Clinical Infectious Diseases November 2020 10 Mehl-Madrona et al. Understanding SARSCOV-2 propagation, impacting factors to derive possible scenarios and simulations medRxiv 2020.09.07.20190066; doi: 11 Liu, M., Deng, C., Yuan, P., Ma, J., Yu, P., Chen, J., Zhao, Y. and Liu, X. (2020), Is there an exposure–effect relationship between body mass index and invasive mechanical ventilation, severity, and death in patients with COVID‐19? Evidence from an updated meta‐analysis. Obesity Reviews, 21: e13149. 12Johnston, Bradley C et al. Comparison of Weight Loss Among Named Diet Programs in Overweight and Obese Adults A Meta-analysis jama.2014 May 2021 Page 4 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version reducing severity of Covid19. Neutraceticals and Vitamin D levels correction It has been identified that a large portion of the population in many countries is vitamin D deficient. It has also been accepted that higher levels of vitamin D is helpful with most respiratory diseases. Studies have confirmed this association for COVID as early as April and it has largely been confirmed since then.[13][14] A recent meta-analysis comprising a little less than one million people shows that vitamin D deficiency is associated to susceptibility, severity and mortality.[15] Experimental trials have shown efficacy including on the elderly, reducing significantly mortality.[16][17] This further validates what has been known for years associating good vitamin D levels to improved outcome for respiratory diseases.[18] Campaigns to help correct vitamin D levels were not conducted in most countries in spite of its benefits for covid and beyond. Instead, lockdowns and masking may have led to further vitamin D deprivation causing harm in adults and children. If we are searching for best options, it would be easy with vaccination campaigns happening to propose to those who refuse vaccination a vitamin D correction plan. It could also be proposed to those who accept vaccination, such correction and compare all causes mortality for all 4 groups during ongoing vaccination phases 3 and 4. Evidence as to benefit is significant for covid and much more, risks associated to reaching optimum vitamin d levels are low with high short- and long-term benefits. In addition to vitamin d, other neutraceticals, commonly used, safe and well understood provide sufficient evidence to be used such as Quercetin, Vitamin C, Zinc Sulfate, Artemesia tea... Trials with Nigella Sativa have shown very satisfactory results reducing by 4 mortality rate, duration of 13 Daneshkhah, A. et al.The Possible Role of Vitamin D in Suppressing Cytokine Storm and Associated Mortality in COVID-19 Patients. medRxiv, 2020.2004.2008.20058578. April 2020 doi:10.1101/2020.04.08.20058578 14 Ebadi, M., & Montano-Loza, A. J. (2020). Perspective: improving vitamin D status in the management of COVID-19. European Journal of Clinical Nutrition, 74(6), 856–859. May 2020 doi:10.1038/s41430-020-0661-0 15 Akbar Mohammad Rizki, Wibowo Arief, Pranata Raymond, Setiabudiawan Budi Low Serum 25-hydroxyvitamin D (Vitamin D) Level Is Associated With Susceptibility to COVID-19, Severity, and Mortality: A Systematic Review and Meta-Analysis Frontiers in Nutrition March 2021 DOI 10.3389/fnut.2021.660420 16 Vitamin D Supplementation Associated to Better Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID QuasiExperimental Study Gaëlle Annweiler Mathieu Corvaisier, Jennifer Gautier, Vincent Dubée, Erick Legrand, Guillaume Sacco, Cédric Annweiler Nutrients November 2020 17 MartaEntrenas Castillo et al. Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study Sciencedirect October 2020 18 Rhaiza Aponte, Cristina Palacios, Vitamin D for prevention of respiratory tract infections (eLENA) June 2017 May 2021 Page 5 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version hospitalization for severe cases and recovery time for moderate cases19 20 In parts of the world Neutraceticals have been used within safe ranges with evidence of efficacy. Some parts of Asia and Africa, used neutraceticals and faired better than Europe and much of America where in some cases, offical position was to deny any possibility of efficacy and recommend people to move away from all neutraceticals failing to further explore benefits. For that matter, from an aethical point of view, a safe neutracetical with possible benefits would have to be considered and proposed to a patient at risk. Not doing it maybe objectionable. Multidrug therapy Ivermectin is safe drug that has been known for decades, used thoroughly and its effects well documented. As a treatment, it is by definition safer since only given to those who need it, who are already sick and doesn't put at risk other healthy individuals. In terms of safety, it is safer than any of the vaccines who have undergone a short safety assessment and would have to be administered to healthy individuals with some known side effects and others to be discovered in the short and long term. Multiple independent RCT trials have been conducted involving more than 2 282 patients. Almost all show indecently efficacy on different categories of populations with great significance. There may be a 75% reduction in mortality with a confidence interval of 95%[21][22] . Sample sizes of these trials taken together largely exceed those used for any of the validated vaccines whom all had efficacy samples below 1 000 and most had even lower efficacy samples. Many such trials were independent and free of conflicts of interests. In addition to RCT results, multiple observations in slaughter houses, nursing homes and doctors' experience have led many doctors to largely use it in multiple countries and their experience seems to confirm trial results mentioned. Ivermectin is a cheap public domain molecule that would interfere with major interests and all new studies must be involve individuals beyond any suspicion of conflicts of interests. The fact that independent researchers confirm a same trend provides even stronger evidence. Treating successfully sick people is safer than injecting healthy individuals with products that are yet to be understood on the short and long term. Looking at the big picture, South Africa’s curve reverted after doctors massively decided to start using ivermectin in spite of agencies advising otherwise. They may have saved lives. The government, under such pressure decided to privilege Ivermectin’s use followed by a sharp fast improvement. 19 Koshak A E et al. Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT) OSF preprints August 2020 DOI:10.31219/ 20 Ashraf S et al. Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multi-center placebo-controlled randomized clinical trial Medrxiv November 2020 doi: 21 Andrew Hill et al. Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection Research Square January 2021 DOI: 10.21203/ 22 Yagisawa M et al. Global trends in clinical studies of ivermectin in COVID-19 Japanese Journal of Antibiotics March 2021 May 2021 Page 6 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Based on known safety and evidence showing it was likely effective, some states have embraced Ivermectin and many doctors in other countries where doctors still have freedom of prescription have used it base on evidence and ethics. In other states, some governments have restricted doctors from performing their duty of helping patients with best available science through pressure or even blocking supply thus depriving patients from a chance of a better outcome. At this stage, further fair independent studies can be conducted to establish extent of efficacy but until then the evidence for risk/benefit is largely favorable and likely more convincing than that of any vaccine. Early multi drug treatment sequenced and dosed as per clinical directions combined with some neutraceticals has shown positive results for many patients to the extent that when doctors can exercise their duties, it has become de facto standard of care by doctors using best available data to best help their patients.23 24 25 26 27 This is happening at a time where many health agencies are dismissing or delaying such solutions using different evaluation standards and not paying sufficient attention to long-term side effects of new molecules. Such agencies failed to contribute to improving on use of such emerging solutions and focused their attention on dismissing all solutions and recommend waiting for vaccines and treatments provided by private organizations with limited challenges of their studies or replication requirements. Given that multi-drug therapy sequenced and dosed as per clinical directions has become de-facto standard of care in most world areas, all new interventions whether for treatment or for prophylaxis should be compared to multi-drug therapy and not to a placebo in terms of evidence, niches, benefits and risks both short and longterm. Early outpatient treatment with low doses Hydroxychloroquine combined with a Macrolide for patients without heart conditions has been ousted without a real scientific conclusion Hydroxychloroquine and Macrolides are known treatments. Their safety and counter indications are well established both short and long term which is not the case for vaccines whom benefit of conditional emergency authorization with short and long side effects under discovery. There have been several outpatient early treatment studies both RCT and observational showing efficacy. There have been a few studies indicating no benefit. Some of the few latter studies have been criticized for bias due to conflicts of interests. The Lancet gate was a demonstration of manipulation to prove a ridiculous claim as to hydroxychloroquine being dangerous. The lancet study was retracted. Based on one fallacious study that needs to be investigated, the discovery clinical trial had its hydroxychloroquine/Macrolide early outpatient arm interrupted leaving people in doubt. This calls for further questioning. Other large studies involved patients in late stage, did not 23 Procter B C, McCullough P A et al. Early Ambulatory Multidrug Therapy Reduces Hospitalization and Death in High-Risk Patients with SARSCoV-2 (COVID-19) ijirms March 2021 24 Derwand A et al. COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study Science direct October 2020 25 Chodhurry A T M M et al. A Comparative Study on Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin Therapy on COVID-19 Patients EJMO 2021 DOI: 10.14744/ejmo.2021.16263 26 McCullough, Alexander P, Armstron R, Arvinte C et al. Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19) IMR press December 2020 DOI:10.31083/j.rcm.2020.04.264 27 Accessed May 10th 2021 May 2021 Page 7 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version use above mentioned proposed by therapy nor did they use suggested dosage proposed by successful studies. Failing to demonstrate absence of efficacy or efficacy, contradicting studies, studies being stopped before a clear conclusion, stopping doctors or even hospitals from continuing studies proves further failure of many institutions. Investigations are warranted. 3) 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 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 pre28 day+rolling+average&Relative+to+Population=true&Align+outbreaks=false&country=JPN~ISR~TUR [Accessed 26/03/2021 and 26/04/2021] 29 O’Driscoll, M., Ribeiro Dos Santos, G., Wang, L. et al. Age-specific mortality and immunity patterns of SARS-CoV-2. Nature 590, 140–145 (2021). May 2021 Page 8 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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 30 Wegene Borena, Zoltán Bánki, Katie Bates, Hannes Winner, Lydia Riepler, Annika Rössler, Lisa Pipperger, Igor Theurl, Barbara Falkensammer, Hanno Ulmer, Andreas Walser, Daniel Pichler, Matthias Baumgartner, Sebastian Schönherr, Lukas Forer, Ludwig Knabl, Reinhard Würzner, Dorothee von Laer, Jörg Paetzold, Janine Kimpel Follow-up study in the ski-resort Ischgl: Antibody and T cell responses to SARS-CoV-2 persisted for up to 8 months after infection and transmission of virus was low even during the second infection wave in Austria Medrxiv February 2021 31 Alison Tarke, et al. Negligible impact of SARS-CoV-2 variants on CD4+ and CD8+ T cell reactivity in COVID-19 exposed donors and vaccinees BioRxiv March 2021 doi: 32 Lee, W.S., Wheatley, A.K., Kent, S.J. et al. Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nat Microbiol 5,1185– 1191 (2020) 33 Arvin, A.M., Fink, K., Schmid, al. A perspective on potential antibody-dependent enhancement of SARS-CoV-2. Nature 584, 353–363 (2020). 34 Flor M. Munoz, Jakob P. Cramer, Cornelia L. Dekker, Matthew Z. Dudley, Barney S. Graham, Marc Gurwith, Barbara Law, Stanley Perlman, Fernando P. Polack, Jonathan M. Spergel, Eva Van Braeckel, Brian J. Ward, Arnaud M. Didierlaurent, Paul Henri Lambert, Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data, Vaccine January 2021, 35 Patricio L. Acosta, Mauricio T. Caballero, Fernando P. Polack Brief History and Characterization of Enhanced Respiratory Syncytial Virus Disease Clinical and vaccine immunology March 2016 DOI: 10.1128/CVI.00609-15 36 Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Fernando P. Polack, M.D., Stephen J. Thomas, M.D., Nicholas Kitchin, M.D., Judith Absalon, M.D., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., John L. Perez, M.D., Gonzalo Pérez Marc, M.D., Edson D. Moreira, M.D., Cristiano Zerbini, M.D., Ruth Bailey, B.Sc., Kena A. Swanson, Ph.D., et al. December 31, 2020 N Engl J Med 2020; 383:2603-2615 DOI: 10.1056/NEJMoa2034577 37 38 39 May 2021 Page 9 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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 variantrelated 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 40 SARS-CoV-2 genome-wide T cell epitope mapping reveals immunodominance and substantial CD8+ T cell activation in COVID-19 patients Science Immunology Apr 2021 DOI: 10.1126/sciimmunol.abf7550 41 Hall V J et al. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN) The Lancet April 2021 DOI: 42 Jagannathan P et al. Immunity after SARS-CoV-2 infections Nat Immunol April 2021 43 Dan J M et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection Science Feb 2021 DOI: 10.1126/science.abf4063 May 2021 Page 10 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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. 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 [44][45][46] . 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 1) 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. 2) Efficacy as to severe Covid relies on 10 people for Pfizer. 3) 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. 4) 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 [47] 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. [48][49] 44 [Accessed 26/03/2021] 45 [Accessed 26/03/2021] 46 Hallberg, P et al. Pandemrix-induced narcolepsy is associated with genes related to immunity and neuronal survival EBio Medicine February 2019 DOI: 47 [Accessed 26/03/2021] 48 Sadof J et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 New Egland Journal of Medicine April 2021 DOI: 10.1056/NEJMoa2101544 49 Logunov D et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia Lancet Feb 2021 DOI : 10.1016/S0140-6736(21)00234-8 May 2021 Page 11 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 5) Decision to vaccinate massive populations relies on 1 trial funded and controlled by the manufacturer inducing a bias risk. 6) 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 negligeable. 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. 7) 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. 8) 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 1) 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 2) 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.50 51 3) Excluded populations such as those with history of covid, immunocompromised, those with immunosuppressive therapies leaves us without clinical trial to validate responsibly benefit/risk 4) There is no data as to risks to if and when immunity starts to weaken in presence or absence of virus encounter 5) 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 1) mRNA vaccines are a new technology-, mid- and long-term side effects are unknown. 2) Precautionary principle and responsibility calls for assuming that such risk maybe significant 3) Other non mRNA vaccines do not yet have enough observation time and their risks are unknown 4) 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 5) Phase 3 raw data, if released progressively may give more insight 6) Phase 4 should adapt to compensate for this quasi experimentation by having active monitoring of all vaccinated individuals and releasing such data 7) 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 50 [Accessed May 12th 2021] 51 [Accessed May 12th 2021] May 2021 Page 12 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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.[52] 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[53],,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.[54] 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 52 Rask Mountsen-Helms,I et al. Vaccine effectiveness after 1st and 2nd dose of the BNT162b2 mRNA Covid-19 Vaccine in long-term care facility residents and healthcare workers – a Danish cohort study Medrxiv March 2021 53 54 Ronald B. Brown Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials Medicina February 2021 May 2021 Page 13 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version in the younger whom had least benefit from vaccine protection.[55][56] 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 published57 . 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 55 Baden Lindsey R et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine New England Journal of Medicine February 2021 DOI: 10.1056/NEJMoa2035389 56 FDA’s Clinical Investigator Course Accessed April 24th 2021 57 Accessed April 24th 2021 May 2021 Page 14 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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: o cost of vaccination act. o cost of treatments and possibly hospitalizations of grade 3 adverse events caused by vaccines. o cost of work stopping. From which must be deducted: o 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.[58] 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 58 Kustin T et al. Evidence for increased breakthrough rates of SARS-CoV-2 variants of concern in BNT162b2 mRNA vaccinated individuals Medrxiv April 2021 doi: May 2021 Page 15 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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 negligeable 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. May 2021 Page 16 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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 negligeable [59][60] and risks are high. It must also be taken into account, current knowledge as to long lasting memory immunity protective effect [61][62] . 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. 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. 1) They do not guarantee that all vaccinated individuals or even most have sufficient active cellular immunity against circulating strains 2) They would push individuals with more risks than benefits to vaccinate 3) They may increase risk of pressure selection 4) They do not prevent spreading or even super-spreading from happening 5) 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 59 Holm Hansen C et al. Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study The Lancet Macrh 2021 DOI: 60 Abu-Raddad LJ et al. SARS-CoV-2 reinfection in a cohort of 43,000 antibody-positive individuals followed for up to 35 weeks. medRxiv. January 2021 61 Dan M J et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection Science Feb 2021 DOI: 10.1126/science.abf4063 62 Borena W et al. Follow-up study in the ski-resort Ischgl: Antibody and T cell responses to SARS-CoV-2 persisted for up to 8 months after infection and transmission of virus was low even during the second infection wave in Austria Medrxiv February 2021 May 2021 Page 17 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Some states, never closed, some reopened without a rebound or prophesized surge of cases following such reopening. One may state Russia, Texas, Florida, Tajikistan and Sweden whom never closed, where as other countries saw terrible surges with restrictions in place such as Portugal, or Slovenia. Others saw terrible surges faith restrictions and vaccination such as Israel, the UK and now India. From a scientific point of view, a vaccinal passport is not supported and maybe counterproductive possibly harmful on an individual and global level. 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.[63] 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. 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. A. 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.[64][65] 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. [66][67] 63 [Accessed 26/04/2021] 64 Jefferson T et al. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No.: CD006207. DOI: 10.1002/14651858.CD006207.pub5. 65 MacIntyre, C. R., Seale, H., Dung, T. C., Hien, N. T., Nga, P. T., Chughtai, A. A., … Wang, Q. (2015). A cluster randomised trial of cloth masks compared with medical masks in healthcare workers. BMJ Open, 5. doi:doi:10.1136/bmjopen-2014-006577 66 Mehl-Madrona et al. Understanding SARSCOV-2 propagation, impacting factors to derive possible scenarios and simulations medRxiv 2020.09.07.20190066; doi: 67 Accessed April 22nd 2021 May 2021 Page 18 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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.[68][69][70][71][72] 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.[73][74] 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. 68 Marija G. Matic et al. Does Occupational Exposure to Solvents and Pesticides in Association with Glutathione S-Transferase A1, M1, P1, and T1 Polymorphisms Increase the Risk of Bladder Cancer? The Belgrade Case-Control Study PLOS One June 2014 69 Ahmad, E., Mohammed, M., Rayes, A., Qahtani, A., Elzubier, A., & Suliman, F. (2001). The Effect of Wearing the Veil by Saudi Ladies on the Occurrence of Respiratory Diseases. The Journal of asthma: official journal of the Association for the Care of Asthma, 38, 423–426. doi:10.1081/JAS100001497 70 Alghadir, A., Aly, F., & Zafar, H. (2012). Effect of face veil on ventilator function among Saudi adult females. PAKISTAN JOURNAL OF MEDICAL SCIENCES, 28, 71–74 71 Mallah, E. M., Hamad, M. F., Elmanaseer, M. A., Qinna, N. A., Idkaidek, N. M., Arafat, T. A., & Matalka, K. Z. (2011). Plasma concentrations of 25-hydroxyvitamin D among Jordanians: Effect of biological and habitual factors on vitamin D status. BMC Clin Pathol, 11, 8. doi:10.1186/1472- 6890-11-8 72 Zhu, J. H., Lee, S. J., Wang, D. Y., & Lee, H. P. (2014). Effects of long-duration wearing of N95 respirator and surgical facemask: a pilot study. Journal of Lung, Pulmonary & Respiratory Research, 1(4), 97–100 73 Akoumianaki E et al. The Injurious Effects of Elevated or Nonelevated Respiratory Rate during Mechanical Ventilation American Journal of Respiratory and Critical Care Medicine April 2018 74 Dekerlegand R. L. et al. Work of Breathing Science Direct 2007 May 2021 Page 19 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 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.[75][76][77] This adds to harmfull psychological, social, side effects associated to anxiety possibly leading to depression eating disorders, addictions and violence. 3) Conclusion The time has come, to drive decisions on science, real data and evidence instead of hypothesis. Benefits and risks of each intervention must be measurable. Just like for covid vaccines, to this date, we do not have independent quality studies indicating risks/benefits of masks use: which masks, where, when, how, when to change them, for whom......Scientifically, we are almost at the same point we were at in 1918. o Testing medical interventions outside of trials boundaries is taking us 7 decades ago o Masks took us back a century ago. o Lockdowns took us back to the middle ages o Denying treatment to patients and compromising on safety of new technologies maybe taking us to times before civilization and Hippocrates. To this date, re-allocation of cheap molecules whose risks are known were denied support and were demonized. Even when safety was known, compiled trials brought evidence, such drugs were denied emergency use authorization and were being subjected to different standards of evidence or safety than those applied to vaccines. When results were promising, further studies were never performed, keeping science in doubt. It is time to evaluate all tools under the same consistent, pragmatic risk/benefit analysis criteria and choose those that prove efficacy, minimize risk, protect freedom, peoples' livelihood physical and mental health. As natural immunity has progressed in much of the world, as humanity has acquired much understanding, vaccines alongside treatments, population strengthening, protection of the frailest, used wisely may provide us very soon with a favorable outcome. The following measures are urgently required 75 Yaribeygi H, et al. The impact of stress on body function: A review Excli journal 2017 doi: 10.17179/excli2017-480 76 Schneiderman N et al. STRESS AND HEALTH: Psychological, Behavioral, and Biological Determinants Annu Rev Clin Psychol. 2005 doi: 10.1146/annurev.clinpsy.1.102803.144141 77 Segerstrom SC et al. Psychological Stress and the Human Immune System: A Meta-Analytic Study of 30 Years of Inquiry Psychol Bull. 2004 Jul doi: 10.1037/0033-2909.130.4.601 May 2021 Page 20 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 1) Immediate study in cooperation with above mentioned country authorities to learn where and why outcome is so disappointing to help choice for whom, when, which risks and which benefits 2) Recommendation to test for ongoing infection before vaccinating 3) Obligation to verify that the individual has healed from Covid either through interviewing him or through cellular immunity testing. 4) Warn against vaccinating those who have had covid already and require that for mRNA vaccines, this be done within a clinical trial boundaries. 5) Recommend emergency use authorization for Ivermectin as evidence for its safety is higher than that of vaccines and it probably shows efficacy. 6) Warn against a vaccinal passport or any similar discriminatory tool reminding that vaccinated may spread just as well and only those with reactive cellular immunity might spread less.78 79 7) Make a recommendation against constant masking of adults particularly outdoors 8) Make a recommendation against masking children 9) Make a recommendation to countries to promote good, diet, sports and make sure all their decisions help their population become healthier and stronger 10) Make a recommendation to countries to conduct nationwide active indicatives to correct vitamin D deficiencies and make sure interventions contribute to that effect 11) Make a recommendation to countries to conduct nationwide active initiatives to improve aeration in public places and businesses 12) Call for an immediate investigation of all suspect actors related to the “lancet gate” 80 and consequences such as interrupted trials that did not resume possibly resulting in preventing lives from being saved. 13) Require from countries to actively monitor all vaccinating individuals for the 8 years following vaccination and report daily publicly all data related to mortality, hospitalizations, disability, autoimmune diseases, blood diseases, respiratory diseases, cancers, idiopathic diseases, in comparison with a control of non vaccinated individuals. 14) Call for an enquiry in cooperation with local authorities of each country as to the reason for excess mortality in each of the countries where excess mortality coincided with vaccination. This is much needed in those countries where vaccination coincided with their worst phase after 14 months. 15) Require ethical sharing of vaccines across nations to protect those who have a benefit instead of harming those with a very limited benefit 16) Make risk/benefit evidence-based decisions in a fair society debate for accepted choices that profit the group and protect minorities and freedom 17) Contribute to the scientific debate open by this letter and this first benefit/risks comparison grid using consistent criteria. Remind that when assessing risks/ benefits there are several dimensions, strength of evidence, short term benefits, long term benefits, short term risk and long term risks. 18) Issue recommendations when there is benefit beyond covid until covid preliminary benefit evidence becomes stronger (aeration, vitamin d correction, nutrition and obesity) and only restrict liberties in proportion, for a short time, under democratic control with sufficient evidence of efficacy and never based on hypothesis. 19) Conduct poll analysis as to proportions of populations in different areas who have reactive cellular immunity to better understand needed vaccination level in each area in addition to whom to vaccinate. 78 Sewell et al. Cellular immune responses to covid-19 BMJ 2020;370:m3018 July 2020 79 Kristen W. Cohen et al. Longitudinal analysis shows durable and broad immune memory after SARS-CoV-2 infection with persisting antibody responses and memory B and T cells Medrxiv April 2021 80 Mehra M et al. Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis Lancet June 2020 May 2021 Page 21 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version 20) As a result of above requested investigations, communicate transparently as to possibly discovered vaccines risks, suspected ones, from such investigations and clearly aknowledge that long term side effects and risks are not known. Recommend to countries to require a fair informed consent from each vaccinated without pressure or temptation. 21) Require an investigation of all bodies and individuals decision makers with conflicts of interests. 22) Stop all private funding for all bodies and individuals making decisions This request is also made public as an open letter so that humanity can inform itself, study and read the literature, look at the data, and weigh in on the decisions. . May 2021 Page 22 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Figure 1 – Israel, Emirates, UK massively vaccinating May 2021 Page 23 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Figure 2 – Worst Covid phase in India, Kuwait and Bahrain coinciding with massive vaccination May 2021 Page 24 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Figure 3 – Uruguay, Hungary, Seychelles May 2021 Page 25 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Figure 4 – Israel mortality rise after wave in young and elederly after vaccination and Belgium 45-64 May 2021 Page 26 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Figure 5– France and Italy excess mortality in mRNA vaccinated groups May 2021 Page 27 Request to the WHO : Grouping of scientists, doctors and lawyers - Project English Version Table 1 - Analysis from study following the single manufacturer clinical trial leading to emergency approval Pfizer Moderna Janssen Under Clinical trial ecosystem Main Exclusion criteria 1) Those recovered from Covid 2) Pregnant of breastfeeding 3)Previous vaccination with a Coronavirus vaccine 4)Immuno compromised 5) Treated with immunosuppressants 6) Below 18 7) Allergies, Uticaria possibly to vaccines 1) Below 18 2) Pregnant or breastfeedin 3) Recovered from Covid 4) Allergies, Uticaria possibly to vaccines 5) Bleeding disordesr Phlebotomy 6) Treated with immunosuppressants 7) ImmunoCompromised 1) Below 18 2) Pregnant Total Severe Covid sample used for stats analysis 10 30 99 Relative Reduction Risk from severe Covid 90,00 % 100,00 % 80,00 % Absolute Reduction Risk from severe Covid 0,36 % 0,20 % 0,31 % Relative Reduction Risk from new emerging strains South Africa, Brazil2, India Unknown 70 and 5 countries) Nom Pays Law firms (Initial objective >3 and 3 countries) Nom Pays May 2021 Page 34