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2024-12-01 08:31:35

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by Frédéric Stalder

Dear Pr. Ioannidis,

I read your article «Global estimates of lives and life-years saved by COVID-19 vaccination during 2020-2024» https://www.medrxiv.org/content/10.11012024.11.03.24316673v1 with interest.

First of all, I would like to thank you for your scientific work regarding the covid crisis and non- pharmaceutical interventions. You have tried to remind the scientific community that the role of science is to provide robust data that will be useful for policies instead of promoting harmful policies without any robust evidence of effectiveness. During the crisis, I was shocked to see how some academics imposed their ideology instead of focusing on their role of studying the facts. That’s a bit surprising to read your new preprint in which you make the same mistake of doing science upside down. The impact on mortality from mass vaccination is a very interesting scientific topic. It’s also a highly controversial one, with estimates ranging from 20 million lives saved in 2021 [1] to 17 million people killed [2] by covid vaccines.

Let’s look at the data.

• Randomized control trials: unfortunately, no independant from industry trial has been conducted [3]. covid vaccine RCTs were not designed to provide evidence that vaccines will save lives [4]. mRNA covid vaccines (which are the most commonly covid vaccines used) RCTs did not show any effect on mortality [5,6]. A Cochrane review [7] stated that «The evidence is uncertain for an effect of BNT162b2 and mRNA-1273 on all-cause mortality compared to placebo due to very serious imprecision (risk ratio (RR) 1.07, 95% CI 0.52 to 2.22 ; RR 1.06, 95% CI 0.54 to 2.10 resp.)». A re-analysis of RCTs data showed that incidence of serious adverse events of special interest following mRNA COVID-19 vaccination was higher than incidence of covid-19 hospitalizations [8], calling into question the claim that the benefit/risk ratio of these products is positive for the entire population. It’s a little odd that you cite this article without questioning your assumption that these vaccines save lives across all age groups. Your assumption that the effect of these products is homogeneous across all age groups is contradicted by in vitro and in vivo data [9]. An analysis of raw data of BNT162b2 trial found evidence of an over 3.7-fold increase in number of deaths due to cardiovascular events in BNT162b2 vaccinated subjects compared to Placebo controls [10]. Moreover, BNT162b2 vaccine used on worldwide population was not the same as the one used in clinical trial [11].

• Vaccine effectiveness : Your estimation of covid vaccines effectiveness is based on highly biased observational studies [12, 13, 14].

• Long term effect : Studies have repeatedly shown that after a short period during which covid vaccines protect against infection, the effect is reversed and vaccinated people are more likely to be infected [15, 16, 17, 18]. This negative effect is cumulative depending on the number of doses received. You also co-authored an article analyzing austrian data showing that during the first half of 2023, unvaccinated people were less likely to be reinfected than vaccinated people (HR vs 3 vaccine doses 0.33 [0.33; 0.34] )[19]. Since 2022, vaccination coverage is positively correlated with higher excess deaths, in European Countries [20], in Germany States [21] and in Austrian States [22]. Countries with fewer than 15 % vaccinated had no new COVID outbreaks from 2022 onwards [23]. Any strong assumption that covid vaccines saved lives in the omicron era is not supported by strong evidence. It is highly plausible that mass vaccination led to increase mortality since 2022.

• Viral evolution: mass vaccination probably impacted viral evolution [24, 25], leading outbreaks with transmissible variants in highly vaccinated population.

• Harmful effects: There is increasing evidence of harms caused by covid vaccines. Your methodology, more precisely the claim: «we do not consider deaths and other consequences from adverse effects of SARS-CoV-2 vaccines» is inappropriate if your aim is to estimate the impact of these products on mortality. There is evidence of immune tolerance caused by mRNA vaccines [26], potentially leading to a series of harmful effect, from auto-immune diseases to rapid cancer progression and higher susceptibility to infections, including with SARS-COV-2. Pharmacology of mRNA covid vaccines was poorly understood when they received emergency use autorisation. It is clear now that Spike protein from vaccine persists in the body for a long time after vaccination, and the high immunogenicity of these products comes with a high cost of potentially harmful effects [27, 28]. Evidence of unwanted pharmacologic effect has been provided [29], without any kind of evaluation of effects on health.

Considering all these data, it seems very inappropriate to make strong claim that covid vaccines saved millions of lives. Once again, the role of scientists is to provide robust data, not to make estimations with poor ones. It’s a shame that no randomized controled trial was conducted on high- risk population with relevant clinical primary outcome and appropriate follow-up. Trying to estimate number of lives saved by these products with garbage data and assumptions can only lead to misleading claims. It is plausible that these products saved lives and killed (directly and indirectly) others. Estimation is very premature given the paucity of rubst data, but the policy consisting of vaccinating the entire world with these products was never supported by evidence. It is highly likely that we could have save more lives by using less vaccines. It is time now to come back to good old evidence-based medicine: to use pharma products on individual basis considering high quality relevant scientific data, clinician experience and patient values. I hope you agree that the arrogance of preventive medicine [30] should be fought by scientists.

Best regards, Frédéric Stalder

References: 1/ https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00320-6/fulltext 2/ https://correlation-canada.org/wp-content/uploads/2023/09/2023-09-17-Correlation-Covid- vaccine-mortality-Southern-Hemisphere-cor.pdf 3/ https://www.cochranelibrary.com/cdsr/doi/10.100214651858.MR000033.pub3/full 4/ https://www.bmj.com/content/371/bmj.m4037 5/ https://www.nejm.org/doi/full/10.1056/NEJMoa2110345 6/ https://www.nejm.org/doi/full/10.1056/NEJMoa2113017 7/ https://www.cochranelibrary.com/cdsr/doi/10.100214651858.CD015477/full 8/ https://www.sciencedirect.com/science/article/pii/S0264410X2201028 9/ https://www.cell.com/iscience/fulltext/S2589-0042(24)02280-6 10/ https://ijvtpr.com/index.php/IJVTPR/article/view/86 11/ https://www.bmj.com/content/378/bmj.o1731/rr-2 12/ https://onlinelibrary.wiley.com/doi/10.1111/jep.13839 13/ https://www.ijidonline.com/article/S1201-9712(24)00046-8/fulltext 14/ https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1474045/full 15/ https://academic.oup.com/ofid/article/10/6/ofad209/7131292 16/ https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0293449 17/ https://academic.oup.com/cid/article-abstract/79/2/405/7625220 18/ https://www.medrxiv.org/content/10.11012024.04.27.24306378v1.full.pdf 19/ https://onlinelibrary.wiley.com/doi/10.1111/eci.14136 20/ https://hvlopen.brage.unit.no/hvlopen-xmlui/handle/11250/3062560 21/ https://www.researchgate.net/publication/378124684_Differential_Increases_in_Excess_Mortality_i n_the_German_Federal_States_During_the_COVID-19_Pandemic 22/ https://www.researchgate.net/publication/383498905_Excess_Mortality_in_Austria_during_the_CO VID-19_Pandemic 23/ https://www.sciencedirect.com/science/article/pii/S2405844024107220 24/ https://www.sciencedirect.com/science/article/abs/pii/S0264410X24008132 25/ https://journals.lww.com/idi/fulltext/2024/01000/alterations_of_sars_cov_2_evolutionary_dynamics _by.5.aspx 26/ https://www.mdpi.com/2076-393X/11/5/991 27/ https://www.mdpi.com/2076-393X/12/11/1281 28/ https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1336906/full 29/ https://www.nature.com/articles/s41586-023-06800-3 30/ https://pmc.ncbi.nlm.nih.gov/articles/PMC117852/

—————————————————— Original post by Frédéric Stalder https://x.com/sudokuvariante/status/1859942280045777104 image

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