COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals
Background: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.
Methods: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.
Results: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.
Conclusion: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jeffrey C. Kwong reports financial support was provided by Centers for Disease Control and Prevention. Naveed Z. Janjua reports financial support was provided by Centers for Disease Control and Prevention. Anders Hviid reports financial support was provided by Global Vaccine Data Network. Helen Petousis-Harris reports financial support was provided by New Zealand Ministry of Health. Steven Black reports a relationship with GSK that includes: consulting or advisory. Jeffrey C. Kwong reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Jeffrey C. Kwong reports a relationship with Public Health Agency of Canada that includes: funding grants. Naveed Z. Janjua reports a relationship with AbbVie Inc that includes: consulting or advisory and speaking and lecture fees. Naveed Z. Janjua reports a relationship with Gilead Sciences Inc that includes: speaking and lecture fees. Anders Hviid reports a relationship with Independent Research Fund Denmark that includes: funding grants. Anders Hviid reports a relationship with Lundbeck Foundation that includes: funding grants. Anders Hviid reports a relationship with Novo Nordisk Foundation that includes: funding grants. Anders Hviid reports a relationship with VAC4EU that includes: consulting or advisory. Finnish Institute for Health and Welfare (THL) conducts Public-Private Partnership with vaccine manufacturers and has received research funding from Sanofi Inc. Petteri Hovi has been an investigator in these studies, but has received no personal remuneration. Helen Petousis-Harris has served on expert advisory boards and had speaking engagements for Pfizer and GSK. She has also received research funding from GSK. She has not received any personal honoraria. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Vaksin COVID-19 dan kejadian buruk yang menjadi perhatian khusus: Sebuah studi kohort Jaringan Data Vaksin Global (GVDN) multinasional dari 99 juta individu yang divaksinasi
2024
Latar Belakang: Proyek Keamanan Vaksin COVID Global (GCoVS), didirikan pada tahun 2021 di bawah Jaringan Data Vaksin Global™ (GVDN®) multinasional, memfasilitasi penilaian komprehensif terhadap keamanan vaksin. Penelitian ini bertujuan untuk mengevaluasi risiko kejadian buruk yang menarik (AESI) setelah vaksinasi COVID-19 dari 10 lokasi di delapan negara.
Metode: Menggunakan protokol umum, studi kohort observasional ini dibandingkan dengan tingkat yang diharapkan dari 13 AESI yang dipilih di seluruh hasil neurologis, hematologi, dan jantung. Tarif yang diharapkan diperoleh oleh situs yang berpartisipasi menggunakan data perawatan kesehatan pra-vaksinasi COVID-19 yang bertingkat berdasarkan usia dan jenis kelamin. Tingkat yang diamati dilaporkan dari kumpulan data perawatan kesehatan yang sama sejak peluncuran program vaksinasi COVID-19. AESI yang terjadi hingga 42 hari setelah vaksinasi dengan mRNA (BNT162b2 dan mRNA-1273) dan vaksin vektor adenovirus (ChAdOx1) dimasukkan dalam analisis primer. Risiko dinilai menggunakan rasio yang diamati versus diharapkan (OE) dengan interval kepercayaan 95%. Sinyal keamanan potensial yang diprioritaskan adalah yang memiliki batas bawah dari interval kepercayaan 95% (LBCI) lebih besar dari 1,5.
Hasil: Peserta termasuk 99.068.901 individu yang divaksinasi. Secara total, 183.559.462 dosis BNT162b2, 36.178.442 dosis mRNA-1273, dan 23.093.399 dosis ChAdOx1 diberikan di seluruh situs yang berpartisipasi dalam periode penelitian. Periode risiko setelah jadwal vaksinasi homolog berkontribusi 23.168.335 orang-tahun tindak lanjut. Rasio OE dengan LBCI > 1,5 diamati untuk sindrom Guillain-Barré (2,49, 95 % CI: 2,15, 2,87) dan trombosis sinus vena serebral (3,23, 95 % CI: 2,51, 4,09) setelah dosis pertama vaksin ChAdOx1. Ensefalomielitis disebarluaskan akut menunjukkan rasio OE 3,78 (95 % CI: 1,52, 7,78) setelah dosis pertama vaksin mRNA-1273. Rasio OE untuk miokarditis dan perikarditis mengikuti BNT162b2, mRNA-1273, dan ChAdOx1 meningkat secara signifikan dengan LBCI > 1,5.
Kesimpulan: Analisis multi-negara ini mengkonfirmasi sinyal keamanan yang telah ditetapkan sebelumnya untuk miokarditis, perikarditis, sindrom Guillain-Barré, dan trombosis sinus vena serebral. Sinyal keamanan potensial lainnya yang memerlukan penyelidikan lebih lanjut telah diidentifikasi.
Deklarasi kepentingan yang bersaing Penulis menyatakan kepentingan finansial/hubungan pribadi berikut yang dapat dianggap sebagai kepentingan potensial yang bersaing: Jeffrey C. Kwong melaporkan dukungan keuangan disediakan oleh Pusat Pengendalian dan Pencegahan Penyakit. Naveed Z. Janjua melaporkan dukungan keuangan disediakan oleh Pusat Pengendalian dan Pencegahan Penyakit. Anders Hviid melaporkan dukungan keuangan disediakan oleh Jaringan Data Vaksin Global. Helen Petousis-Harris melaporkan dukungan keuangan diberikan oleh Kementerian Kesehatan Selandia Baru. Steven Black melaporkan hubungan dengan GSK yang meliputi: konsultasi atau penasehat. Jeffrey C. Kwong melaporkan hubungan dengan Institut Penelitian Kesehatan Kanada yang meliputi: hibah pendanaan. Jeffrey C. Kwong melaporkan hubungan dengan Badan Kesehatan Masyarakat Kanada yang meliputi: hibah pendanaan. Naveed Z. Janjua melaporkan hubungan dengan AbbVie Inc yang meliputi: konsultasi atau penasehat dan biaya berbicara dan kuliah. Naveed Z. Janjua melaporkan hubungan dengan Gilead Sciences Inc yang meliputi: biaya berbicara dan kuliah. Anders Hviid melaporkan hubungan dengan Dana Penelitian Independen Denmark yang mencakup: hibah pendanaan. Anders Hviid melaporkan hubungan dengan Yayasan Lundbeck yang meliputi: hibah pendanaan. Anders Hviid melaporkan hubungan dengan Yayasan Novo Nordisk yang meliputi: hibah pendanaan. Anders Hviid melaporkan hubungan dengan VAC4EU yang meliputi: konsultasi atau penasehat. Institut Kesehatan dan Kesejahteraan Finlandia (THL) melakukan Kemitraan Publik-Swasta dengan produsen vaksin dan telah menerima dana penelitian dari Sanofi Inc. Petteri Hovi telah menjadi penyelidik dalam penelitian ini, tetapi belum menerima remunerasi pribadi. Helen Petousis-Harris telah bertugas di dewan penasihat ahli dan memiliki keterlibatan berbicara untuk Pfizer dan GSK. Dia juga telah menerima dana penelitian dari GSK. Dia belum menerima honoraria pribadi. Jika ada penulis lain, mereka menyatakan bahwa mereka tidak memiliki kepentingan keuangan yang bersaing atau hubungan pribadi yang dapat mempengaruhi pekerjaan yang dilaporkan dalam makalah ini.
BREAKING: Huge Safety Study Confirms mRNA 'Vaccine' Adverse Events
The largest COVID-19 'vaccine' safety study ever conducted, involving 99 million 'vaccinated' individuals, confirmed that the injections resulted in a dramatically increased risk of the following:
📍Up to a 610% increased risk of myocarditis
📍378% increased risk of acute disseminated encephalomyelitis (ADEM)
📍323% increased risk of cerebral venous sinus thrombosis (CVST)
📍249% increased risk of Guillain-Barré syndrome (GBS)
https://pubmed.ncbi.nlm.nih.gov/38350768/
These injections are causing an iatrogenic health crisis. They are unsafe and ineffective. Stop the shots.
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