PMID- 38274635
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240228
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 16
IP  - 1
DP  - 2024 Jan
TI  - COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global 
      Vaccination Campaign.
PG  - e52876
LID - 10.7759/cureus.52876 [doi]
LID - e52876
AB  - Our understanding of COVID-19 vaccinations and their impact on health and 
      mortality has evolved substantially since the first vaccine rollouts. Published 
      reports from the original randomized phase 3 trials concluded that the COVID-19 
      mRNA vaccines could greatly reduce COVID-19 symptoms. In the interim, problems 
      with the methods, execution, and reporting of these pivotal trials have emerged. 
      Re-analysis of the Pfizer trial data identified statistically significant 
      increases in serious adverse events (SAEs) in the vaccine group. Numerous SAEs 
      were identified following the Emergency Use Authorization (EUA), including death, 
      cancer, cardiac events, and various autoimmune, hematological, reproductive, and 
      neurological disorders. Furthermore, these products never underwent adequate 
      safety and toxicological testing in accordance with previously established 
      scientific standards. Among the other major topics addressed in this narrative 
      review are the published analyses of serious harms to humans, quality control 
      issues and process-related impurities, mechanisms underlying adverse events 
      (AEs), the immunologic basis for vaccine inefficacy, and concerning mortality 
      trends based on the registrational trial data. The risk-benefit imbalance 
      substantiated by the evidence to date contraindicates further booster injections 
      and suggests that, at a minimum, the mRNA injections should be removed from the 
      childhood immunization program until proper safety and toxicological studies are 
      conducted. Federal agency approval of the COVID-19 mRNA vaccines on a 
      blanket-coverage population-wide basis had no support from an honest assessment 
      of all relevant registrational data and commensurate consideration of risks 
      versus benefits. Given the extensive, well-documented SAEs and unacceptably high 
      harm-to-reward ratio, we urge governments to endorse a global moratorium on the 
      modified mRNA products until all relevant questions pertaining to causality, 
      residual DNA, and aberrant protein production are answered.
CI  - Copyright (c) 2024, Mead et al.
FAU - Mead, M Nathaniel
AU  - Mead MN
AD  - Biology and Nutritional Epidemiology, Independent Research, Copper Hill, USA.
FAU - Seneff, Stephanie
AU  - Seneff S
AD  - Computer Science and Artificial Intelligence Laboratory, Massachusetts Institute 
      of Technology, Cambridge, USA.
FAU - Wolfinger, Russ
AU  - Wolfinger R
AD  - Biostatistics and Epidemiology, Independent Research, Research Triangle Park, 
      USA.
FAU - Rose, Jessica
AU  - Rose J
AD  - Immunology and Public Health Research, Independent Research, Ottawa, CAN.
FAU - Denhaerynck, Kris
AU  - Denhaerynck K
AD  - Epidemiology and Biostatistics, Independent Research, Basel, CHE.
FAU - Kirsch, Steve
AU  - Kirsch S
AD  - Data Science, Independent Research, Los Angeles, USA.
FAU - McCullough, Peter A
AU  - McCullough PA
AD  - Cardiology, Epidemiology, and Public Health, McCullough Foundation, Dallas, USA.
AD  - Cardiology, Epidemiology, and Public Health, Truth for Health Foundation, Tucson, 
      USA.
LA  - eng
PT  - Journal Article
PT  - Retracted Publication
PT  - Review
DEP - 20240124
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
RIN - Cureus. 2024 Feb 26;16(2):r137. PMID: 38414517
PMC - PMC10810638
OTO - NOTNLM
OT  - autoimmune
OT  - cardiovascular
OT  - covid-19 mrna vaccines
OT  - gene therapy products
OT  - immunity
OT  - mortality
OT  - registrational trials
OT  - risk-benefit assessment
OT  - sars-cov-2 (severe acute respiratory syndrome coronavirus -2)
OT  - serious adverse events
COIS- Steve Kirsch is the founder of the Vaccine Safety Research Foundation or VSRF 
      (vacsafety.org) but receives no income from this entity
EDAT- 2024/01/26 06:43
MHDA- 2024/01/26 06:44
PMCR- 2024/01/24
CRDT- 2024/01/26 03:57
PHST- 2024/01/24 00:00 [accepted]
PHST- 2024/01/26 06:44 [medline]
PHST- 2024/01/26 06:43 [pubmed]
PHST- 2024/01/26 03:57 [entrez]
PHST- 2024/01/24 00:00 [pmc-release]
AID - 10.7759/cureus.52876 [doi]
PST - epublish
SO  - Cureus. 2024 Jan 24;16(1):e52876. doi: 10.7759/cureus.52876. eCollection 2024 
      Jan.