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The risk/benefit of Covid vaccines is arguably most accurately measured by comparing the all-cause mortality rate of vaccinated against unvaccinated, since it not only avoids most confounders relating to case definition but also fulfils the WHO/CDC definition of "vaccine effectiveness" for mortality. We examine two of the most recent UK ONS vaccine...
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Context 1
... suggests there are no significant excess non-Covid deaths included in the ONS data. In comparing mortality rates by vaccination status, curiously, in the youngest age group the mortality rate is currently around twice as high for those who have received at least one dose of the vaccination compared to those who are unvaccinated, as shown in Figure 4. However, because this group includes such a wide age range it is possible that this potentially extremely disturbing statistic remains strongly confounded by age. ...
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Objective:
To establish the impact of the first 6 months of the COVID-19 outbreak response on gastrointestinal (GI) infection trends in England.
Design:
Retrospective ecological study using routinely collected national and regional surveillance data from seven UK Health Security Agency coordinated laboratory, outbreak and syndromic surveillance...
Citations
... The reliability of the data source should be checked, particularly with regard to the categorization of vaccination status. An independent analysis of a similar database in the United Kingdom, for example, found a major categorization bias (Neil et al., 2022). In any case, the level of safety of vaccination in pregnant women should be related to the level of protection conferred by it according to the principle of respecting the benefit-risk balance to the impacted individual. ...
The objective of this note is to analyse the safety assessment of Comirnaty vaccination of pregnant women in the manufacturer’s risk management plan (RMP) and in the European Medicines Agency (EMA) fact sheet, and to measure the impact on the recommendations that led to the mandatory vaccination of pregnant women caregivers and health-related professionals in France.
The evaluation of this safety was carried out in two phases. In the first phase, which ran from late 2020 to early 2022, the safety profile of the vaccine was not known in pregnant women. In the second phase, which ran from early 2022, the RMP and the EMA report data that were considered reassuring for short-term safety, but were limited. Long-term safety remains still unknown. The RMP is cautious and suggests that intentional injection of pregnant women will remain limited.
The detailed analysis of risk management by the manufacturer, the EMA and the French authorities reveals, to varying degrees, a lack of rigor. The EMA has disregarded certain elements of prudence maintained by the manufacturer, while the manufacturer has allowed the only real clinical trial that might determine any benefit-risk balance to lapse. What is more the only study was restricted to the third trimester of pregnancy. The French authorities recommended mandatory injection of pregnant women caregivers and health-related professionals at a time when the manufacturer and the EMA could provide no guarantees.
... The reliability of the data source should be checked, particularly with regard to the categorisation of vaccination status. Independent analysis of a similar database in the United Kingdom, for example, found a major categorisation bias 25 . † It should be noted that the product was exempted from any pre-clinical genotoxicity study. ...
The objective of this note is to analyse the safety assessment of Comirnaty vaccination of pregnant women in the manufacturer's risk management plan (RMP) and in the European Medicines Agency (EMA) fact sheet, and to measure the impact on the recommendations that led to the mandatory vaccination of pregnant women caregivers and health-related professionals in France.
The evaluation of this safety was carried out in two phases. In the first phase, which runs from late 2020 to early 2022, the safety profile of the vaccine is not known in pregnant women. In the second phase, which runs from early 2022, the RMP and the EMA report data that are considered reassuring for short-term safety, but are limited. Long-term safety is still unknown. The RMP remains cautious and expects that intentional vaccination of pregnant women will remain limited.
The detailed analysis of risk management by the manufacturer, the European Agency and the French authorities reveals, to varying degrees, a lack of rigour. The EMA has disregarded certain elements of prudence maintained by the manufacturer, while the latter has allowed the only real clinical trial capable of determining an individual benefit-risk balance to lapse, which was, moreover, restricted to the third trimester of pregnancy. The French authorities recommended mandatory vaccination of pregnant women caregivers and health-related professionals at a time when the manufacturer and the EMA provided no guarantees.
... 7,8 The effect of this misattribution error on causing grossly overestimated COVID-19 vaccine efficacy has been shown using real-world data from Israel and the UK. 9,10 The data used in the Bagshaw et al study is no longer publicly available from Alberta Health Services, making correction for these errors impossible. ...
We aim to use a recently published research study as an example in order to demonstrate how data can be misinterpreted and result in deriving misleading policy implications. Bagshaw et al wrote that unvaccinated patients with COVID-19 in Alberta, Canada “had substantially greater rates of ICU admissions, ICU bed days, and ICU related costs than vaccinated patients did. This increased resource use would have been potentially avoidable had these unvaccinated patients been vaccinated.” The authors in Bagshaw et al then concluded that their findings “have important implications for discourse on the relative balance of increasingly stringent public health protection (restrictions), including mandatory vaccination policies, and the sustainability and function of health system infrastructure and capacity during the ongoing COVID-19 pandemic.” Here we show the following. First, the effect of vaccination on intensive care admissions were grossly over-estimated. Second, an effect of vaccination on access to acute care and on all-cause excess deaths was grossly over-stated. Third, policy implications were overstated and at best unclear. Overall, the data cannot support what Bagshaw et al called “increasingly stringent public health protection (restrictions), including mandatory vaccination policies”.
... The UK Government has been significantly better than most countries in providing detailed data on Covid cases and deaths indexed by vaccine status. However, despite these efforts we revealed a range of fundamental inconsistencies and flaws in ONS mortality data [1]. Specifically, two of the most recent UK ONS (Office for National Statistics) vaccine mortality surveillance reports [2,3] reveal a range of fundamental inconsistencies and anomalies in the data. ...
... Specifically, two of the most recent UK ONS (Office for National Statistics) vaccine mortality surveillance reports [2,3] reveal a range of fundamental inconsistencies and anomalies in the data. Analysis of these identified the most likely explanations for the observed anomalies are a combination of four possibilities: (1) systemic miscategorisation of deaths between the different categories of unvaccinated and vaccinated; (2) delayed or non-reporting of vaccinations; (3) systemic underestimation of the proportion of unvaccinated; and/or (4) incorrect population selection for Covid deaths. ...
... Likewise, we compared the death counts registered for England in [7] with the ONS dataset and found that 13,593 deaths were missing from the ONS dataset (taking account for the fact that the ONS use only a subset of the population). The mortality rate in the vaccinated and unvaccinated population omitted from the dataset is disproportionately high when compared to historical norms, whilst that reported for the vaccinated are disproportionately low, as previously reported in [1]. ...
The accuracy of any data purporting to show covid 19 vaccine effectiveness or safety is critically dependent on the accuracy of four measurements: (1) people classified as having the disease; (2) vaccination status; (3) reported deaths; and (4) the population of vaccinated and unvaccinated (the so called 'denominators'). Errors in any of these could undermine claims of vaccine effectiveness or safety. We have previously identified anomalies in the UK Government's ONS deaths by vaccination status data (ONS dataset)-specifically that some deaths occurring shortly after vaccination are being wrongly classified as unvaccinated deaths. In this paper we identify a further problem that appears to explain anomalies in the ONS data: the total deaths reported by ONS are significantly lower than we would expect compared to other government datasets, even allowing for the fact that the ONS use only a subset of the population. For both non-covid and covid deaths respectively the number of deaths reported for the within 21 days of first dose vaccination category tally almost perfectly with the number of deaths that would be expected should they have occurred in the third week alone. Thus, for both covid and non-covid deaths, the two weeks of post first vaccination deaths appear to have been omitted from the ONS dataset. This pattern is repeated in all age groups over 60. A variety of factors could have led to deaths in the first 14 days being omitted in the ONS dataset, including miscategorisation, reporting lags and data handling or transcription errors. The dataset is therefore corrupted, making any inferences about vaccine efficacy or safety that are reliant on the data, moot. Accordingly, the ONS should publicly withdraw their dataset and call for the retraction of any claims made by others that are based upon it.
Our understanding of COVID-19 synthetic, modified mRNA (modmRNA) products and their public health impact has evolved substantially since December 2020. Published reports from the original randomized placebo-controlled trials concluded that the modmRNA injections could greatly reduce COVID-19 symptoms. However, the premature termination of both trials obviated any reliable assessment of potential adverse events due to an insufficient timeframe for proper safety evaluation. Following authorization of the modmRNA products for global distribution, problems with the methods and execution of the trials have emerged. The usual safety testing protocols and toxicology requirements were bypassed. Many key trial findings were either misreported or omitted entirely from published trial reports. By implication, the secondary estimates of excess morbidity and mortality in both trials must be deemed underestimates. Rigorous re-analyses of trial data and post-marketing surveillance studies indicate a substantial degree of modmRNA-related harms than was initially reported. Confidential Pfizer documents had revealed 1.6 million adverse events by August 2022. A third were serious injuries to cardiovascular, neurological, thrombotic, immunological, and reproductive systems, along with an alarming increase in cancers. Moreover, well-designed studies have shown that repeated modmRNA injections cause immune dysfunction, thereby potentially contributing to heightened susceptibility to SARS-CoV-2 infections and increased risks of COVID-19. This paper also discusses the insidious influence of the Bio-Pharmaceutical Complex, a closely coordinated collaboration between public health organizations, pharmaceutical companies, and regulatory agencies. We recommend a global moratorium on the modmRNA products until proper safety and toxicological studies are conducted.
There is a vast literature on COVID-19, and this update cannot hope to cover all of what is known about infection in children. Instead, the approach taken is to consider evidence in the light of what I will call ‘myths’ that predominated the pandemic narrative. Now that SARS-CoV-2 is an endemic virus, and much of the panic has subsided, it is important to revisit these myths in order to learn from our mistakes so that we do not repeat the same in the future. I will give evidence to show that SARS-CoV-2 was never a great threat to children, sequelae of infection in children were exaggerated, and vaccine safety and efficacy in children were exaggerated. Nevertheless, the response to the pandemic caused immense predictable and preventable harm to children. Better responses would have considered focused protection of those at high risk from the virus (i.e., older people with severe comorbidities), reducing fear in the population, augmenting surge capacity in healthcare, and cost-benefit analyses of possible responses (i.e., considering the predictable collateral damage acknowledged in previous literature). The Emergency Management process was not followed. This process should now be followed in devising a plan for recovery from the pandemic responses.
Premier volet d'une double publication.
Le second volet est publié ici : https://www.researchgate.net/publication/371946928.
Une sélection de ce travail a donné lieu à une publication vérifiée par les pairs : https://www.researchgate.net/publication/372933264.
Une présentation a été donnée au CSI : https://www.researchgate.net/publication/375690192
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La haute autorité de santé (HAS) a conclu à la légitimité scientifique de l’obligation vaccinale contre le SARS-Cov-2 des soignants à partir du raisonnement selon lequel, la balance bénéfices-risques de la vaccination en général étant favorable, il en allait nécessairement de même pour celle de l’obligation vaccinale. Les justifications de ces deux assertions étaient invalides.
Premièrement, le plateau des bénéfices de la balance de la vaccination quant à la limitation de la diffusion et de la transmission du SARS-Cov-2 était établi à partir d’extrapolations abusives et d’omissions multiples — efficacité vaccinale contre le risque d’infection (symptomatique ou non), biais de classement et probable négativation de l’efficacité vaccinale après la première dose, diminution de l’efficacité vaccinale dans la durée et négativation à distance de la dernière dose — tandis que les efficacités relatives n’étaient jamais traduites en efficacités absolues. Le plateau des risques n’était quant à lui pas du tout établi. La HAS a entre autres recommandé la vaccination obligatoire des soignantes enceintes à une époque où le profil de sécurité du vaccin n’était pas du tout connu chez elles.
Deuxièmement, cette balance bénéfices-risques eût-elle été établie correctement que son inférence vers celle du dispositif de l’obligation vaccinale n’était aucunement documentée. Il aurait notamment fallu recentrer l’analyse sur la population spécifique des soignants, une population jeune et, pour la plupart, déjà mieux protégée par son immunité acquise naturellement face à l’infection. Là encore, les recommandations de la HAS concernant la vaccination des convalescents du Covid avaient été établies à partir d’analyses défectueuses et d’indicateurs décorrélés de la réalité clinique et épidémiologique, qui ne permettaient d’établir ni les bénéfices ni les risques.
Lorsque l’ensemble de ces biais sont corrigés, l’analyse rigoureuse des éléments sur lesquels s’est appuyée la HAS, complétés des références manquantes, fait la preuve scientifique du contraire et invalide l’enjeu de santé publique en faveur de l’obligation vaccinale des soignants.
Given that population COVID-19 vaccination does not appreciably reduce SARS-CoV-2 transmission, instead, the potential to reduce hospitalization has been used to justify coercive vaccine passports. We aim to use a recently published research study as an example in order to demonstrate how data can be misinterpreted and result in deriving misleading ethical and policy implications. Bagshaw et al wrote that unvaccinated patients with COVID-19 in Alberta, Canada “had substantially greater rates of ICU admissions, ICU bed days, and ICU related costs than vaccinated patients did. This increased resource use would have been potentially avoidable had these unvaccinated patients been vaccinated.” The authors in Bagshaw et al then concluded that their findings “have important implications for discourse on the relative balance of increasingly stringent public health protection (restrictions), including mandatory vaccination policies, and the sustainability and function of health system infrastructure and capacity during the ongoing COVID-19 pandemic.” Here we show the following. First, the effect of vaccination on intensive care admissions were grossly over-estimated due to several limitations of this and almost all other vaccine studies. Second, an effect of vaccination on access to acute care and on all-cause excess deaths was grossly over-stated due to several more likely causes being omitted from discussion and from the common narrative. Third, policy implications were overstated and at best unclear due to missing consideration of more relevant aspects required to inform policy. Overall, the data cannot support what Bagshaw et al called “increasingly stringent public health protection (restrictions), including mandatory vaccination policies”.
La présente note a pour objectif d’analyser l’évaluation de la sécurité de la vaccination par le Comirnaty des femmes enceintes dans le plan de gestion des risques (PGR) du fabricant et dans la fiche de l’Agence Européenne du Médicament (AEM), et d’en mesurer l’incidence sur les recommandations qui ont conduit à l’obligation vaccinale des femmes enceintes soignantes et assimilées en France.
L’évaluation de cette sécurité a connu deux phases. Dans la première, qui s’étend de fin 2020 à début 2022, le profil de sécurité du vaccin n’est pas connu chez les femmes enceintes. Dans la seconde, qui court depuis début 2022, le PGR et l’AEM font état de données qui sont jugées rassurantes quant à la sécurité à court terme, mais elles sont limitées. La sécurité à long terme est, elle, toujours inconnue. Le PGR, encore à l’heure actuelle, demeure prudent et s’attend à ce que la vaccination intentionnelle des femmes enceintes reste limitée.
L’analyse détaillée de la gestion du risque par le fabricant, l’agence européenne et les tutelles françaises révèle, à des degrés divers, un manque de rigueur. L’AEM s’est affranchie de certains éléments de prudence maintenus par le fabricant, tandis que ce dernier a laissé péricliter le seul véritable essai clinique à même de déterminer une balance bénéfices-risques individuelle, par ailleurs restreinte au seul troisième trimestre de grossesse. Les tutelles françaises ont recommandé l’obligation vaccinale des femmes enceintes soignantes et assimilées à une époque où le fabricant et l’AEM ne fournissaient aucune garantie.
De nombreux biais statistiques entraînent une surestimation de l'efficacité vaccinale contre le SARS-CoV-2. Cette note, après avoir rappelé le biais qui dissimule une efficacité vaccinale négative dans les deux premières semaines suivant la première dose, en présente trois autres. Le premier est lié à la redéfinition récente de la population de référence à partir de laquelle l'efficacité vaccinale est mesurée : cette population n'est plus celle des individus non-vaccinés mais devient celle des individus vaccinés, à six mois de leur deuxième dose. Ce changement de référentiel non seulement ne permet plus de mesurer l'efficacité vaccinale réelle mais dissimule en outre une possible efficacité vaccinale négative à distance de la deuxième dose-d'autant moins facile à mettre en évidence que la plupart des statistiques privilégient des calculs d'efficacité vaccinale contre le risque d'infection uniquement symptomatique. Le deuxième est l'erreur de catégorisation du statut vaccinal dans certaines statistiques nationales, qui attribuent des décès de vaccinés aux non vaccinés. Ainsi au Royaume-Uni, dont l'analyse corrigée des données montre que l'estimation du bénéfice global de la vaccination en termes de mortalité devient finalement très incertaine, même chez les personnes âgées. Le troisième, qui relève sans doute plus du paralogisme que du biais proprement dit, concerne la succession d'extrapolations erronées à partir desquelles on peut conclure à, et imposer, une efficacité pratique de la vaccination là où il n'y en a peut-être absolument aucune. L'avis de la Haute Autorité de Santé du 21 juillet 2022 en donne une illustration.