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![Figure 1: Covid-19 case rates based on UKHSA data in [3] and reproduced...](profile/Martin-Neil-2/publication/356756711/figure/fig1/AS:1098457473396738@1638904078987/Covid-19-case-rates-based-on-UKHSA-data-in-3-and-reproduced-from-5_Q320.jpg)
This paper has been updated and the new version can be found here:
Official mortality data for England suggest systematic miscategorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination
UPDATED WITH ONS DECEMBER DATA RELEASE & HEALTHY VACCINEE/MORIBUND ANALYSIS
http://dx.doi.org/10.13140/RG.2.2.28055.09124
https://www.re...
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Background
Successive SARS-CoV-2 variants have caused severe disease in long-term care facility (LTCF) residents. Primary vaccination provides strong short-term protection, but data are limited on duration of protection following booster vaccines, particularly against the Omicron variant. We investigated effectiveness of booster vaccination against...
Introduction
COVID-19 Medicine Delivery Units (CMDU) were established in late December 2021 to deliver early antiviral therapy to patients classified as at risk with the aim of preventing hospitalisation.
Methods
We performed a service evaluation at four CMDUs in England. We assessed demographics and triage outcomes of CMDU referral, uptake of ant...
![Figure 1: Covid-19 case rates based on UKHSA data in [3] and reproduced...](profile/Martin-Neil-2/publication/357778435/figure/fig1/AS:1111470788100098@1642006694669/Covid-19-case-rates-based-on-UKHSA-data-in-3-and-reproduced-from-5_Q320.jpg)
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...
Objective
To determine whether household contacts of confirmed cases of COVID-19 have an increased risk of hospitalisation or death.
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Citations
... Unfortunately, despite researchers requesting those data [10], to our knowledge, those are still unavailable everywhere in EU thereby preventing traditional approaches [11]. The only country releasing data around the vaccination status of the deceased has been the UK but unfortunately the provided data might have been prone to miscategorization [27]. For this reason, in a previous work, a causal network has been provided in order to detect a possible connection between excess mortality and anti-covid injection campaigns using data from 18 European countries [24]. ...
The question whether Covid-19 vaccination campaigns could have had an immediate negative impact on excess deaths continues to be debated two years later, in particular in the less than 45 years old. When the age-stratified (anonymized) vaccination status of deceased will be publicly available, the debate should come to an end. In the meantime, this paper provides three new statistical analyses that further shed light on the matter. Two of them connect the temporality of all-cause mortality data with injection data. Another analysis, using internet search trends, investigates possible alternative explanations. We deem that taken together, as it is done in this paper, those three analyses reinforce our previous conclusions suggesting caution when it comes to vaccinating/boosting young European populations.
A preprint is available here:
https://hdl.handle.net/2268/314674
... Work by Fenton et al. showed an unusual spike in mortality in each age group of the unvaccinated population, which coincides with the vaccine roll-out for each age group. 48 The rapid shrinking in the size of this population means a small-time lag could theoretically produce this effect artifactually. Alternative explanations must include the (more likely) possibility that a rise in mortality after vaccination was misattributed to the unvaccinated population: in other words, those counted as 'unvaccinated deaths' would in fact be those who had died within 14 days of being vaccinated (a freedom of information [FOI] request has now confirmed that authorities in Sweden were indeed categorising deaths within 14 days of dosing as unvaccinated, creating a misleading picture of efficacy vs death). ...
Background: In response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several new pharmaceutical agents have been administered to billions of people worldwide, including the young and healthy at little risk from the virus. Considerable leeway has been afforded in terms of the pre-clinical and clinical testing of these agents, despite an entirely novel mechanism of action and concerning biodistribution characteristics.
Aim: To gain a better understanding of the true benefits and potential harms of the messenger ribonucleic acid (mRNA) coronavirus disease (COVID) vaccines.
Methods: A narrative review of the evidence from randomised trials and real world data of the COVID mRNA products with special emphasis on BionTech/Pfizer vaccine.
Results: In the non-elderly population the “number needed to treat” to prevent a single death runs into the thousands. Re-analysis of randomised controlled trials using the messenger ribonucleic acid (mRNA) technology suggests a greater risk of serious adverse events from the vaccines than being hospitalised from COVID-19. Pharmacovigilance systems and real-world safety data, coupled with plausible mechanisms of harm, are deeply concerning, especially in relation to cardiovascular safety. Mirroring a potential signal from the Pfizer Phase 3 trial, a significant rise in cardiac arrest calls to ambulances in England was seen in 2021, with similar data emerging from Israel in the 16–39-year-old age group.
Conclusion: It cannot be said that the consent to receive these agents was fully informed, as is required ethically and legally. A pause and reappraisal of global vaccination policies for COVID-19 is long overdue.
Contribution: This article highlights the importance of addressing metabolic health to reduce chronic disease and that insulin resistance is also a major risk factor for poor outcomes from COVID-19.
... December 3, a preprint by Neil et al. analyzed UK vaccination mortality statistics and concluded that inconsistencies in the data suggested systematic miscategorisation of deaths between the different categories of unvaccinated and vaccinated, delayed or non-reporting of vaccinations, systemic underestimation of the proportion of unvaccinated, and/or incorrect population selection for COVID-19 deaths[211]. ...
Fourth part of the timeline covering a period from October 2021 to December 2021 *** Other parts: *** Part 0: https://www.researchgate.net/publication/348077948 *** Part 1: https://doi.org/10.13140/RG.2.2.13705.36966 *** Part 2: https://doi.org/10.13140/RG.2.2.16973.36326 *** Part 3: https://doi.org/10.13140/RG.2.2.23081.72805 *** Part 5: https://doi.org/10.13140/RG.2.2.35015.16807 *** Additional notes (Feb-Apr 2022): https://doi.org/10.13140/RG.2.2.24356.55682 ***
... Please refer to our previous submission on this topic.(9) Moderna, Inc., acknowledged in their 2Q 2020 SEC filing (14) 19 that "Currently, mRNA is considered a gene therapy product by the FDA." ...
... Note that these comments were spoken ol and not on written slide. 19 Moderna's 2Q2020 SEC filing is dated August 6 2020, and states that the phase 1 study began March 16, 2020, with the phase 2 study being fully enrolled by July 8, 2020. Enrollment for the phase 3 study began July 27, 2020, as also reflected in for clinicaltrials.gov. ...
... Further work is continuing using this methodology. (18) Other analyses (19) from the UK, although hampered by poor and inconsistent data, also suggest a detriment of vaccination on all-cause mortality at least in some age bands. ...
Dear ACIP Chairperson Dr. Lee,
We refer to the letter to you from one of us (DW) of November 19, submitted to the docket (once a number had been assigned) and published as on Trial Site News.(1) DW remains in anticipation of the pleasure of your reply to that, and this letter, as to your proposed actions. We welcome an honest discussion of our analyses.
To enhance transparency and informed consent, we use the term "quasi-vaccine" (q-vaccine) to disclose the fact that these drugs meet FDA's definition of gene therapy products, and constitute a novel class distinct from classical vaccines.
Key concerns are summarized here under these main headings, with detail below and attached.
• Contraindications warranted for all q-vaccines to include other events (thrombosis, myocarditis, etc.). Focusing on a small subset of events in one q-vaccine is regulatory misdirection.
• Insufficient guidance on coagulopathies for Janssen and other quasi-vaccines
• COVID-19 q-vaccine in children 5-11 years: contraindication and re-evaluation of use warranted
• ACIP should be discussing ever reduced benefit for greater risk: Attempting to boost our way out of new variants is the immunological equivalent of heroin addiction.
• Full review of the existing EUAs and BLA is warranted due to greater prevalence of AEs as well as death far exceeding the TTS rate for Janssen and the death reports for all three Covid-19 quasi-vaccines.
Transparency Concerns
We extend earlier remarks concerning your concluding comments at the Nov 19 meeting stressing the importance of transparency in ACIP proceedings and the expression of diverse views. Given the circumstances of how Dec 16 meeting was announced, concerns about opacity are deepened. As before, the late notice, the late-publication of a docket number, the failure of email notifications and late posting of presentation slides, require corrective action.
Based on CDC and FDA decisions, millions in America and around the world are subjected to mandates and other harsh measures that could include imprisonment and loss of employment. The opacity displayed by ACIP not only deepens mistrust within the American public but reverberates around the world. You must be cognizant of your responsibility.
Contraindications warranted for all q-vaccines to include other events (thrombosis, myocarditis etc.)
• Why is the contraindication restricted to a small subset (54 cases of CVST) of a much larger set of many hundreds of thrombosis-related reports for all three quasi-vaccines? Surely this is regulatory misdirection.
• Reporting rates for myo/pericarditis for mRNA AND Janssen q-vaccines are as least as high, surely warranting a contraindication. Why is there inadequate guidance regarding myo/pericarditis? The fact sheets instruct patients to tell providers about previous episodes of myocarditis, with no guidance on how to act on this information.
• Can CDC and FDA guarantee no increased risk with subsequent dosing after previous episodes of other AEs?
• An EUA "Provides for a lower level of evidence than the "effectiveness" standard FDA uses for product approvals" 3 The same must surely be true of the level of evidence needed to demonstrate lack of safety. Accordingly, safety signals must be acted upon far sooner, out of an abundance of caution.
• We propose the following contraindication:
"Do not administer COMIRNATY, Pfizer-BioNTech or Moderna COVID-19 quasi-vaccines to patients with a history of myocarditis or pericarditis or thrombosis following any other mRNA COVID-19 quasi-vaccines."
• Full review of the existing EUAs and BLA is warranted due to: • Greater prevalence of AEs for all three q-vaccines than for a rare AE (TTS) for the Janssen q-vaccine. • Deaths per million (37-66) reported for all three quasi-vaccines far exceed (24-44 times) the threshold of comfort (1.5/million) set by ACIP member Dr. Sanchez and by FDA in establishing the TTS-related contraindication. Insufficient guidance on coagulopathies for Janssen and other quasi-vaccines
• The contraindication for use in those with a history of Thrombosis with Thrombocytopenia Syndrome (TTS) AFTER Janssen dosing fails to guide on how to avoid TTS in the first place.
• CDC must estimate sub-clinical risks of TTS and other coagulopathies with Janssen and the mRNA q-vaccines.
• CDC must issue guidelines on tests and treatment of TTS and other q-vaccine-related adverse events.
• Why does the contraindication not consider risks of ALL coagulation events for all mix-and-match combinations?
• Why has it taken FDA this long to act on safety signals we provided at least 8 weeks ago?
• Now that FDA has enabled estimation of VAERS underreporting for myocarditis, can CDC estimate this for TTS?
• How can CDC/ACIP make any recommendations based on data FDA has failed to verify? (Janssen booster, Pfizer children, molnupiravir safety)
• Why is FDA not consulting with VRBPAC on these issues? • Does ACIP understand that according to the founder of BioNTech, DNA-based quasi-vaccines may carry a risk of insertional mutagenesis?
• In reassessing the risk-benefit ratio for all q-vaccines, has reduced effectiveness against omicron been considered? COVID-19 q-vaccine in children 5-11 years: contraindication and re-evaluation of use warranted
• Early CDC figures reveal rates of myocarditis in 5-11 year-olds (5.21/MM 2 nd dose) higher than for TTS (3.8/MM), warranting a contraindication for use after any episode of myocarditis.
• Pfizer's children's' study efficacy data have not been verified by FDA. Where is Pfizer's study on subclinical myocarditis and troponin levels?
• Our analysis of the VAERS data reveals discrepancies (in both directions) with CDC's analysis. There is an alarming number of cases (including one death) of administration of q-vaccine to a subject of inappropriate age.
• This is a gene therapy product with unevaluated long-term risks. • According to the Australian government's "Nonclinical Evaluation Report," the Pfizer quasi-vaccine was not proposed for pediatric use. Had it been, studies in juvenile animals would have been submitted.(2)
• FDA's risk-benefit is flawed by 26 times in the wrong direction: Risk is at least 4x greater than benefit: including:
o Overestimate of cases prevented based on Pfizer's data by 2.25-2.9x
o No accounting for seroprevalence benefit (88%-Merck, 81%-Pfizer), waning immunity.
o Adjusting for preliminary CDC data on myocarditis in 5-11 year-olds still does not yield a benefit of quasi-vaccination, especially when low activity against omicron is considered.
• A changed Pfizer formulation (for adults and children) differs from that used in trials.
o Improved stability may increase effective dosing, worsening safety profile
o Change in surface properties of LNP may alter injection site uptake and distribution, thereby affecting safety and efficacy.
• Use of Pfizer drug in children 5-11 is akin to using a child car seat with poor regulatory oversight. ACIP should be discussing reduced benefit for greater risk: Immunological equivalent of heroin addiction. pCoQS
• Exposing subjects to risks associated with booster q-vaccination without understanding benefits is irresponsible.
• No data on the toxicity of cumulative dosing/boosting and the non-natural nucleosides used in the mRNA drugs.
• Reduced benefit for greater risk: Attempting to boost our way out of new variants is the immunological equivalent of heroin addiction.
• Concerning lag-dependent correlations between vaccine coverage and all-cause mortality, especially in children.
• The range and number of adverse events demands an integrated approach. Accordingly, we have adopted the terms: post Covid Vaccine Syndrome (pCoVS) or post Covid Quasi-Vaccine Syndrome (pCoQS).
In May 2021 The Lancet published a study of the Pfizer covid vaccine on the population of Israel, claiming to show it was 95% effective. On 17 May 2021 we submitted a rapid response 250-word letter explaining why the study was flawed and how the 95% claim was exaggerated. After an initial response saying they would ask the authors for a response to our letter we heard nothing until 20 months later. On 8 January 2023 The Lancet sent an email apologising for never having got back to us about the letter, saying that they had asked the lead author Dr Sharon Alroy-Preis (SA-P) to respond to our letter but, because she did not provide any formal response, they decided not to publish our letter. We tweeted The Lancet's response and published a substack article highlighting that we were now aware of additional problems with the paper relating to SA-P’s relationship with Pfizer. These media posts got 1.5 million reads within 24 hours. On 11 January 2023 we received an email from The Lancet apologising for the ‘sub-standard experience’ and that they were now inviting us to publish the original letter or an update to it, suggesting the update ‘reflect more current experience with the vaccine’. On 12 January 2023 we submitted our updated letter (they stipulated a maximum of 350 words). On 13 January 2023 we got a response from The Lancet saying they had decided against publishing the letter, asserting that any claim questioning the efficacy and safety of the Pfizer vaccine was ‘misinformation’ and that they did not consider the position of SA-P an undeclared conflict of interest or a challenge to the integrity of the data.
U hrvatskim je medijima sve više govora o cijepljenju djece protiv covid-19, unatoč maloj ulozi djece u prijenosu novog koronavirusa i njihovom malom riziku od teških simptoma, postojanju drugih oblika prevencije, činjenici da klinička ispitivanja nisu dovršena, raznih problema u provedenim ispitivanjima i rastućoj zabrinutosti oko sigurnosti cjepiva i mogućih štetnih učinaka. Cilj je ovog kratkog pregleda odabrane znanstvene literature potaknuti kvalitetnu javnu raspravu prije donošenja potencijalno ishitrenih odluka.
