Journal Retraction Request “Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine in Aotearoa New Zealand” (Ministry of Health Study Conceals Harm & Risks)

by | Jan 9, 2024 | 0 comments

Journal of Drug Safety Retraction Request and Peer Review of the New Zealand Ministry of Health’s Affiliated Study (PDF hyperlink): 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 (Click https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442303/)

Drug Safety: The Official Journal of the International Society of Pharmacovigilance [ISoP] https://link.springer.com/journal/40264/editors

Dear Drs. Nitin Joshi, Thangeswari Rajendran, and Editorial Board (Drug Safety)

Based on the following peer review (Drug Safety Journal Retraction Request_Ministry-of-Health_Comirnaty Safety Study), 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.

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.

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)[ii] 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.”[iii]

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.[iv] 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).[v] 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.”[vi]

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 by 4.4x the risk reduction for COVID-19 hospitalization relative to placebo (Fraiman et al., cited below). 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.

 

DOWNLOAD THE PEER REVIEW: Drug Safety Journal Retraction Request_Ministry-of-Health_Comirnaty Safety Study

Drug Safety Journal Retraction Request and Peer Review of the Ministry of Health Study (PDF hyperlink): 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 (Click https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442303/)

[i] 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, PubMed post: https://web.archive.org/web/20230913024319/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442303/, Publication PDF: https://web.archive.org/web/20240109000219/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442303/pdf/40264_2023_Article_1332.pdf, Supplementary data file: https://web.archive.org/web/20240109000644/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442303/bin/40264_2023_1332_MOESM1_ESM.pdf

[ii] 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

[iii] 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

[iv] 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

[v] 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

[vi] 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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