Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

Abstract

Two mRNA-based COVID vaccines were granted emergency use authorization in both children and adults in 2021 after a drastically accelerated approval process that allowed the manufacturers to essentially fast-track their vaccines. We analyzed data from regulatory surveillance and self-reporting systems like Defense Medical Epidemiology Database(DMED); EudraVigilance; Eurostat; German health insurers; the Israeli Minister of Health; the Natural Cycles app; Public Health Scotland; the United Kingdom’s (UK) Office for National Statistics (ONS); UK’s yellow card reporting system; the vaccine adverse event reporting system (VAERS); and v-safe entries to look for long-term adverse events of these vaccines that cannot be captured in the expedited clinical safety trials. In this observational study, we analyzed non-foreign VAERS data for selected symptoms reported after COVID, influenza, and pertussis vaccines and calculated rates per vaccine dose administered as well as proportion of total reports received. We also looked at DMED data and compared annual incidence rates of selected conditions by taking into account the total number of military personnel for each study year. Our data show, among other trends, increases in adverse event reports if we compare COVID vaccines to influenza and pertussis vaccines and statistically significant higher numbers of hospital encounters in military personnel, as well as increases in incidences of thromboembolic conditions, such as menstrual abnormalities, myocarditis, and cerebrovascular events after the implementation of COVID vaccine mandates, compared to the five years prior. We verified these observations using data from EudraVigilance; the UK’s ONS; German health providers; and Eurostat. Our meta-analysis of both national and international vaccine adverse events emphasizes the importance of re-evaluating public health policies that promote universal mass vaccination and multiple boosters for all demographic groups. In combination with anecdotal evidence, limitations of the safety trials, and the decreased lethality of new strains our research demonstrates that the cost (both monetary and humanitarian) of vaccinating otherwise healthy people, and especially children, may outweigh the benefits.

Assessment of Comirnaty Injections of Pregnant Women in the Manufacturer’s Risk Management Plan and by the European Medicines Agency: Mandatory Injections for Caregivers in France

“…Finally, and not incidentally, all these estimates are about short-term safety. The long-term safety of Comirnaty vaccination during pregnancy is completely unknown (also see Romero et al, 2023) in this journal where they stress the long range impact on development of certain early toxic exposures). It should be noted that the Comirnaty product was exempted from any pre-clinical genotoxicity study.…”

Forensic analysis of the 38 subject deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial

“…The cardiac event signal identified in this report is confirmed by reports carried out after the worldwide rollout of the Pfizer/BioNTech mRNA anti-SARS-CoV-2 vaccine. It is important to note that the evidence for the cardiac event signal reported here comes directly from a placebo-controlled randomized clinical trial and thus has none of the caveats associated with retrospective observational post-rollout studies, as noted by the WHO Committee (WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation, 2021) Romero et al (2023). reported a clear increase in the number of cases of acute myocardial infarction and deaths due to heart attack based on their review of several US and international vaccine safety databases including VAERS, the US Department of Defense DMED, CDC's V-Safe, Office of National Statistics of England and Wales, EuroStat of the European Union, and others.…”