Springer Nature Requested to Retract the Ministry of Health’s Comirnaty Safety Publication that Concealed AESI Harm & Risks (email trail): doi:10.1007/s40264-023-01332-1
On 10th January 2024, the Drug Safety Journal Editor-in-Chief was requested to retract the following New Zealand Ministry of Health (MOH) publication by MOH employees and the Chair of Biostatistics at the University of Auckland (Springer Nature, the official journal of the International Society of Pharmacovigilance). On 16 January 2024, Ministers were informed of their predecessors’ actions and the Journal retraction request.
MOH Published study: Walton M, Pletzer V, Teunissen T, Lumley T, Hanlon T. Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand. Drug Saf. 2023;46(9):867-879. doi:10.1007/s40264-023-01332-1.
My Peer Review Conclusion: The published study conclusion that provided “reassurances around the safety of the vaccine” is not merited by the data when this is compared with the earlier preprint version (“preprint study” PDF) and the officially disclosed Te Whatu Ora data released in February 2023 for the same study population using a 365-day risk period. Compared with the preprint and 365-day risk period data, the published study biasedly concealed a statistically significant number of Comirnaty-related hospitalizing adverse events of special interest (AESI) and at least three AESI risk factors for ill-justified reasons. This published study does not represent reality.
A Detailed Scientific Critique can be downloaded: https://web.archive.org/web/20240109172641/https://grandsolarminimum.com/wp-content/uploads/2024/01/Drug-Safety-Journal-Retraction-Request_Ministry-of-Health_Comirnaty-Safety-Study.pdf
Emails are provided in reverse chronological order.
Begin forwarded message:
From: carlton@grandsolarminimum.com
Subject: Ministry of Health Comirnaty Safety Publication: Request for Retraction Notification (Scientific Fraud Evident): doi:10.1007/s40264-023-01332-1
Date: January 16, 2024 at 1:44:39 PM GMT+13
To: nitin.joshi@springer.com
Cc: S.Reti@ministers.govt.nz
Dear Dr. Joshi
Thank you for your email. I have copied the Minister of Health for important reasons detailed below.
I consent to you sharing my detailed scientific critique (PDF) of the Ministry of Health’s (MOH) August 2023 Comirnaty safety publication with its MOH authors (Retraction Request).
I request you also send this detailed critique (PDF) to your Journal Editor so (s)he may re-examine this study’s publication worthiness (i.e., putative Scientific Fraud).
The accompanying Officially disclosed MOH data renders the study’s conclusions false and collectively may be evidential in relation to the Crimes Act 1961.
This published study may also have supported Comirnaty’s full approval under Section 20 of the Medicines Act in November 2023, which is relevant to the Minister of Health.
Officially disclosed February 2021-2022 data shows 24,506 hospitalizing adverse events of special interest (AESI) associated with Comirnaty were whittled to 6,083 (preprint), and finally, 3,921 and at least three risk factors vanished by publication using ill-justified reasons and biased methods. The MOH data reveals an estimated-prorated 88,000 Comirnaty-related AESI and at least 3.8x more hospitalizing AESI per 100,000 (February 2021–2022) than all COVID-19 hospitalizations in 2022.
This officially disclosed MOH AESI data did not support Comirnaty’s full approval during the Government’s transition.
MOH Published study: Walton M, Pletzer V, Teunissen T, Lumley T, Hanlon T. Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand. Drug Saf. 2023;46(9):867-879. doi:10.1007/s40264-023-01332-1.
Thank you for promptly responding.
Dr. Carlton Brown BVSc (1986, Massey University), MBA (1997, London Business School).
Former founding CEO and co-innovator at Immune Targeting Systems Ltd (UK), “Vaccines for Mutating Viruses.”
https://independent.academia.edu/grandsolarminimum, https://grandsolarminimum.com/articles-emails-activism/, https://www.linkedin.com/in/carlton-brown-13b66232/,
https://orcid.org/0000-0003-4871-7521
On Jan 15, 2024, at 11:03 AM, Nitin Joshi <nitin.joshi@springer.com> wrote:
Dear Dr Brown
Thank you for your email.
I am writing to seek your permission to share your detailed critique (PDF) with the authors for their comments.
Best wishes
Nitin
Nitin Joshi
(he/him/his)
Editor-in-Chief, Drug Safety
Adis Publications
Springer Nature
Level 2, Aon House, Smales Farm, 74 Taharoto Rd, Takapuna, Auckland 0622, NZ
T +64(0)9 477-0749
Springer Nature advances discovery by publishing robust and insightful research, supporting the development of new areas of knowledge and making ideas and information accessible around the world. We provide the best possible service to the whole research community.
From: carlton@grandsolarminimum.com <carlton@grandsolarminimum.com>
Sent: Thursday, January 11, 2024 7:44 AM
To: Nitin Joshi <nitin.joshi@springer.com>
Cc: COVID19VaccineSafetyNZ <covid19vaccinesafetynz@proton.me>; Thangeswari Rajendran <Thangeswari.Rajendran@springer.com>
Subject: Re: Request for Retraction (Drug Safety journal): Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand (based on this peer review)
Dear Dr. Nitin Joshi, Editorial Board, and Drug Safety Journal Editor
Dear Dr. Nitin Joshi, Editorial Board, and Drug Safety Journal Editor
Thank you for your email.
You already received my letter to the editor highlighting a detailed critique (PDF). Please forward that to your editor. The critique starts at line 98 / page 4 of the re-attached. The content pre-line 98 provides the broader Ministry of Health context into which your journal assists (https://web.archive.org/web/20240109172641/https://grandsolarminimum.com/wp-content/uploads/2024/01/Drug-Safety-Journal-Retraction-Request_Ministry-of-Health_Comirnaty-Safety-Study.pdf)
My email was directed at your journal editor, the peer reviewers, and the International Society of Pharmacovigilance for setting standards that permitted this study and its false conclusion to be published. That has nothing to do with the study authors now. I note your attempt to absolve the journal of responsibility for differences between preprint and published versions. You are now informed.
Your journal is being asked to do its job properly and eliminate study bias so the conclusions fit reality rather than helping the Ministry of Health conceal its iatrogenic harm and homicide committed after the MAAC overruled Medsafe to provisionally approve Comirnaty without a positive benefit-risk balance. To help you reassess the study conclusions, I have provided you the preprint and two officially disclosed Ministry of Health and Te Whatu Ora datasets, one directly associated with this published study and one complementary to it, that have been in the public domain since February 2023. You are now informed.
You will find a reference to “avoiding the detection” in relation to Section 168 of the Crimes Act 1961(https://www.legislation.govt.nz/act/public/1961/0043/latest/096be8ed81d369a9.pdf). All of those people entering the hospital as Comirnaty AESI who left via the morgue, and the 42% of acute kidney injuries whose lifespans were shortened by Comirnaty and excluded from the study at day zero of vaccination, and whose risk factor was vanished by bias could become culpable homicides, manslaughter or murder, or grievous bodily harm victims because the detection of harm was avoided.
Your journal permitted New Zealand’s Ministry of Health to take a list of 39 AESI and whittle that down to 12, seven of which accounted for a paltry 1.6% of background AESI, without disclosing its double standard methodology. At least 24,506 AESI were whittled to 6,083, and finally, 3,921 and at least three risk factors vanished using ill-justified reasons. In assessing adverse events, these authors failed to respect coronavirus vaccine mechanisms of pathogenicity and instead relied largely on a list of AESI generated by the SPEAC/Brighton Collaboration, which was funded by CEPI-affiliated scientists and largely determined before vaccine roll-out (described in V2.0 and V1.2 methodologies).
COVID-19 vaccines exacerbate preexisting disease in vital organs resulting from endothelial damage, thrombosis and embolism, and tissue-specific diseases and inflammation affecting the vascular, heart, respiratory, nervous, kidney, gastrointestinal, endocrine, and immuno-inflammatory systems beyond the narrow list of AESI diagnostic codes the authors whittled away. Freely circulating spike proteins bind the same cell entry receptors used by Ebola, Marburg, HIV, Dengue, West Nile, Zika, Venezuelan, and Eastern Equine Encephalitis, Measles, Hepatitis-B and -C, Mouse Hepatitis, Coxsackie, and SARS-CoV-1 giving it receptor-mediated entry into/interaction with all vital organs. Widespread mRNA spike protein manufacture and its persistence further add to this vital organ disease. Thus, eliminating preexisting AESI removed a very important means by which Comirnaty causes adverse events (i.e., “not of special interest”).
Comirnaty vaccination rendered New Zealanders susceptible to Antibody-Dependent Enhancement of infection. The CEPI-affiliated scientists operating under the Brighton Collaboration aegis concealed ADE within their Vaccine-Associated Enhanced Disease case definition (i.e., pathogenicity mechanism 3, Munoz et al.), which Medsafe’s Risk Management Plan specified would not be mitigated. Thus, the editor and peer reviewers failed to pick up on the February 2021 to February 2022 study period, which eliminated the possibility of assessing ADE/VAED once national borders reopened three weeks later.
Mediation/causal analysis of the Ministry of Health’s 2021-2022 national-level data shows COVID-19 vaccine doses caused excess deaths indirectly mediated by COVID-19 infection with a 6-month delay and directly with a nine and 10-month delay (i.e., comorbidity exacerbation, adverse events, AESI). This suggests a 20-day risk period is wholly inadequate for assessing Comirnaty risk. Furthermore, the one, two, and three-dose COVID-19 rates were significantly higher than the unvaccinated rates (2022). The Ministry of Health was informed it had concealed these higher rates with statistical bias by offering HSU2020 as a population total rather than HSU2021/NZStats2021 (Evidentiary Document sent to Prime Minister Ardern, 05 December 2022).
Thus, the International Society of Pharmacovigilance’s Drug Safety Journal permitted the publication of a national-level safety study that concealed harm and risk factors and failed to ensure important AESIs were assessed or specifically ring-fenced outside the study conclusion. This publication is a scientific fraud and provides no reassurance about Comirnaty’s safety.
This issue will be exposed, so make a decision if you wish the International Society of Pharmacovigilance and Nature brands to be tarnished by this issue.
Yours sincerely
Dr. Carlton Brown BVSc (1986, Massey University), MBA (1997, London Business School).
Former CEO and co-innovator at Immune Targeting Systems Ltd (UK), “Vaccines for Mutating Viruses.”
On Jan 10, 2024, at 10:21 AM, Nitin Joshi <nitin.joshi@springer.com> wrote:
Dear Dr Carlton Brown
Thank you for your email. Preprints, being preliminary versions of research papers, lack formal peer review. Consequently, there is a potential disparity between preprints and the final peer-reviewed versions published in scientific journals.
I would like to invite you to write a formal letter to the editor highlighting your concerns. We will give authors the option to reply to the letter. Both letter and the reply will then be published together in the same issue of the journal.
Best wishes
Nitin
Nitin Joshi
(he/him/his)
Editor-in-Chief, Drug Safety
Adis Publication
Springer Nature
Level 2, Aon House, Smales Farm, 74 Taharoto Rd, Takapuna, Auckland 0622, NZ
T +64(0)9 477-0749
Springer Nature advances discovery by publishing robust and insightful research, supporting the development of new areas of knowledge and making ideas and information accessible around the world. We provide the best possible service to the whole research community.
From: carlton@grandsolarminimum.com <carlton@grandsolarminimum.com>
Sent: Wednesday, January 10, 2024 6:21 AM
To: Nitin Joshi <nitin.joshi@springer.com>; Thangeswari Rajendran <Thangeswari.Rajendran@springer.com>
Cc: COVID19VaccineSafetyNZ <covid19vaccinesafetynz@proton.me>
Subject: Request for Retraction (Drug Safety journal): Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand (based on this peer review)
Importance: High
Dear Drs. Nitin Joshi, Thangeswari Rajendran, and Editorial Board
Based on the following peer review, I request the International Society of Pharmacovigilance retract the New Zealand Ministry of Health’s (MOH) Comirnaty safety study from its journal (“published study”).
Published study: Walton M, Pletzer V, Teunissen T, Lumley T, Hanlon T. Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand. Drug Saf. 2023;46(9):867-879. doi:10.1007/s40264-023-01332-1.
Please find my peer review of this published study attached.
The published study conclusion that provided “reassurances around the safety of the vaccine” is not merited by the data when this is compared with the earlier preprint version (“preprint study”) and the officially disclosed Te Whatu Ora data released in February 2023 for the same study population using a 365-day risk period. Compared with the preprint and 365-day risk period data, the published study biasedly concealed a statistically significant number of Comirnaty-related hospitalizing adverse events of special interest (AESI) and at least three AESI risk factors for ill-justified reasons. This published study does not represent reality.
This request and peer review were saved to the Web Archive and will be sent to various Government Ministers and others because of its national importance. Thank you sincerely for publishing this evidence, which I have saved to the Web Archive.[I]
Please withdraw this misleading publication. Thank you.
Yours sincerely
Dr. Carlton Brown BVSc (1986, Massey University), MBA (1997, London Business School).
Former CEO and co-innovator at Immune Targeting Systems Ltd (UK), “Vaccines for Mutating Viruses.”
PEER REVIEW SUMMARY: The preprint study (day 0-21 risk period, 6,083 AESI) contained 1.6x more AESI than the published study (day 1-21 risk period, 3,921 AESI). Removing day zero from the risk period after the first and second doses was the key version difference, with 1,967 of this difference accounted for by acute kidney injury arising within 24 hours of vaccination. This seemingly small and ill-justified change actually eliminated acute kidney injury (AKI), venous thromboembolism, and thrombocytopenia as statistically significant risk factors. The published and preprint versions of the study also underreported the total AESI events among a list of 12 AESI categories by an average of 6.2x and 4.0x, respectively, compared with a longer 365-day risk period for the same study participants (24,506 AESI, officially disclosed data).
This study was designed with statistical expertise, which concealed hospitalizing AESI cases and risk factors. A biased list of 12 AESI categories out of a potential 39 accounted for 27.7% of the 2019 SAFE Project background AESI. Seven of these AESI categories accounted for a paltry 1.6% of the 2019 background AESI for New Zealand. The published study excluded those AESI cases who had died and failed to generate hospital discharge information. The 20-day risk period was not empirically defined and was poorly justified. Removing day zero from the post-vaccination risk period was ill-justified, yet it eliminated 42% of all AKI hospitalizations within the first 24 hours following vaccination. Such a large number of acute kidney injuries were not preexisting medical conditions.
NEW ZEALAND GOVERNMENT OFFICIALLY RELEASED DATA: This peer-review of the MOH published study utilized the following publications and data officially disclosed by the government.
1) MOH publication: Walton M, Pletzer V, Teunissen T, Lumley T, Hanlon T. Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand. Drug Saf. 2023;46(9):867-879. doi:10.1007/s40264-023-01332-1,
2) MOH preprint version: a PDF copy of the preprint study (03 February 2023) can be downloaded from the Web Archive.https://web.archive.org/web/20230709023307/https://grandsolarminimum.com/wp-content/uploads/2023/07/SSRN-id4329970.pdf,
3) Social Science Research Network removal of the preprint (June 2023): “Walton, Muireann and Pletzer, Vadim and Teunissen, Thomas and Lumley, Thomas and Hanlon, Timothy, Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand.https://web.archive.org/web/20230213202331/https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4329970,
4) Te Whatu Ora officially disclosed AESI data: The number of hospital admissions for each AESI following the second dose of BNT162b2 (Comirnaty) in a period of one year between 19 Feb 2021 and 19 Feb 2022 (365-day risk period, n = 24,506), and the 2021 number of public hospital admission for the same diagnostic codes irrespective of their vaccination status (n = 75,249) https://web.archive.org/web/20230324210947/https://fyi.org.nz/request/21710/response/83023/attach/4/HNZ00011430%20OIA%20Reponse.pdf
5) Statistics New Zealand 2021 population data: https://infoshare.stats.govt.nz
6) Global Vaccine Data Network dashboard: 2014-2019 SAFE Project background AESI case data, https://www.globalvaccinedatanetwork.org/ourwork/safe-project-background-rates-adverse-events-special-interest-aesis-covid-19-vaccination,
7) MOH data: https://web.archive.org/web/20220213230159/https://www.health.govt.nz/covid-19-novel-coronavirus/covid-19-data-and-statistics/covid-19-case-demographics,https://web.archive.org/web/20221231045006/https://www.health.govt.nz/covid-19-novel-coronavirus/covid-19-data-and-statistics/covid-19-case-demographics (COVID-19 hospitalizations).
CONFLICT OF INTEREST: The four Ministry of Health (MOH) employees and the Chair of Biostatistics at the University of Auckland, as study authors declared they “have no conflicts of interest to disclose” despite four being employed by the MOH in a study funded by the MOH (i.e., the National Immunization Programme budget from the MOH) using highly selected data provided by the MOH. The MOH’s Vaccine Safety Surveillance and Research Group undertook the study work, and the project was advised and critically reviewed by the National Immunization Programme, the Clinical Risk Management branch within Medsafe, and the COVID-19 Vaccine Independent Safety Monitoring Board. The New Zealand government funds university professors, and those in key positions do not get there by chance. The fact this MOH study’s conclusions were enabled by MOH employees and statistical expertise paid for by the Government means one is justified to question the authors’ conflict of interest disclosures.
STRATEGIC CONTEXT TO AESI CONCEALMENT: In New Zealand, we faced a situation where Medsafe declined to approve Comirnaty on 28 January 2021 (Officially disclosed), “Due to the unresolved concerns and additional quality, safety and efficacy data to be provided at the time of completion of the evaluation, Medsafe is unable to recommend that this product be granted consent” (Document 7)[i] Furthermore, according to the Medsafe Risk Management Plan conclusion for Comirnaty in January 2021 (Document 17), “It is considered that the safety specification for this product is currently inadequate and does not accurately reflect the important known risks, important potential risks or missing information.”[ii]
Medsafe’s 28 January 2021 decision was then overruled by the Minister of Health’s anonymous Medicines Assessment Advisory Committee (MAAC) on 03 February 2021.[iii]Medsafe had requested the MAAC focus on whether the “benefit-risk balance of Comirnaty vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older is positive” (Documents 7 and 13).[iv] The MAAC approval-overrule arose despite Medsafe stating five days previously, “The benefit-risk balance of Comirnaty (COVID-19 mRNA Vaccine) for active immunization to prevent coronavirus disease 2019 (COVID-19) …, is not clear.”[v]
An independent peer-reviewed risk-to-benefit analysis of Comirnaty’s interim Phase III clinical study safety data demonstrated there was an excess risk of serious AESI, which exceeded by4.4x the risk reduction for COVID-19 hospitalization relative to placebo (Fraiman et al., cited in the review). This risk-to-benefit analysis predicted the Ministry of Health’s 365-day risk period AESI data associated with your Journal’s published study. This data yielded 1.1x (12 AESI categories) and 3.8x (prorated, 39 AESI categories) more Comirnaty hospitalizing AESI per 100,000 (19 February 2021 to 2022) than all COVID-19 hospitalizations per 100,000 in 2022 (i.e., 11 February to 25 December 2022). Thus, the use of statistical bias that conceals AESI and risk factors in the face of a negative benefit-to-risk balance in 2020 and associated with this published Drug Safety study, plus the MAAC’s overrule of Medsafe to approve Comirnaty without a positive benefit-risk balance, intensifies the conveyance of an intent to harm while avoiding detection.
[i] Officially released by the New Zealand Government, Document 7, compiled PDF page 76,https://web.archive.org/web/20230703224316/https://www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf
[ii] Officially released by the New Zealand Government, Document 17, compiled PDF page 161,https://web.archive.org/web/20230703224316/https://www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf
[iii] Officially released by the New Zealand Government, Document 15, pg.121, MOH memo from MAAC to Medsafe (Chris James). From MAAC minutes & recommendations from 109th meeting on 2/2/21, Action and Decisions.https://web.archive.org/web/20230703224316/https://www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf
[iv] Officially released by the New Zealand Government, Document 7, pg.76. Document 13, pg.116, Medsafe’s Evaluation – Quality, January 2021, https://web.archive.org/web/20230703224316/https://www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf
[v] Officially released by the New Zealand Government, Document 10, January 2021, Clinical Evaluation, pg.86,https://web.archive.org/web/20230703224316/https://www.health.govt.nz/system/files/documents/information-release/h202106950_-_response.pdf
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