Global mRNA COVID-19 Immunizations, Often Termed Gene Therapy, Faced Analysis From Registered Trials and Globally Enacted Vaccination Programs | Researchers Suggest Worldwide Pause on mRNA Injections
In the wake of the global pandemic, billions of dollars have been allocated towards the development and purchase of COVID-19 mRNA products. According to recent reports, 92% of this $29.2 billion came from US public funds, with $2.2 billion channeled into supporting clinical trials and $108 million for manufacturing and basic research.
However, concerns have been raised about the speed at which these vaccines were brought to market, and the potential impact this has had on the scientific evaluation process. Political and financial incentives may have played a key role in undermining the rigorous testing typically required for vaccine authorisation.
One example of this rapid authorisation process can be seen in the Emergency Use Authorization (EUA) granted to Pfizer by the US Food and Drugs Administration (FDA). The study designs for the pivotal trials that led to this EUA were never intended to determine whether the mRNA inoculations could help prevent severe disease or premature death.
Before the pandemic, US National Institutes of Health, Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defence (DOD) collectively invested over $336 million in mRNA vaccine development. This investment continued during the pandemic, with BARDA and the DOD collaborating closely in the co-development of Moderna's mRNA vaccine, dedicating over $18 billion.
Despite the rapid authorisation process, concerns about the safety of these mRNA vaccines persist. Pfizer's COVID-19 vaccines, for instance, never underwent adequate safety and toxicological testing according to previously established scientific standards. The process-related impurities were absent from the COVID-19 mRNA products used in the registrational trials. Virtually all doses used in those trials originated from 'clinical batches' produced using what is known as Process 1. As a post-authorization emergency supply measure for global distribution, however, a method much more suitable for mass production known as Process 2 was devised, utilizing bacterial plasmid DNA.
More serious biological consequences of rushing the trials became evident after the EUA, with numerous cardiovascular, neurological, reproductive, haematological, malignant, and autoimmune SAEs identified and published in the peer-reviewed medical literature. A re-analysis of Pfizer's COVID-19 vaccine phase 3 trial data found more serious adverse events among those in the vaccine group.
The main concern is that the COVID-19 mRNA products may transform body cells into viral protein factories with no off-switch, leading to chronic, systemic inflammation and immune dysfunction. Given the well-documented serious adverse events and unacceptable harm-to-reward ratio, governments are urged to endorse and enforce a global moratorium on these modified mRNA products until all relevant questions pertaining to causality, residual DNA, and aberrant protein production are answered.
These concerns are not new. The gene therapy products (GTPs) vaccine platform has been studied for over 30 years as an experimental cancer treatment. Despite the rhetoric, no large randomized double-blind placebo-controlled trials have ever demonstrated reductions in SARS-CoV-2 transmission, hospitalization, or death.
The paper, titled 'COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign', was published in Cureus, a journal of medical science. The researchers' findings have raised important questions about the safety and efficacy of COVID-19 mRNA vaccines, and the need for a more rigorous and transparent approach to their development and authorisation.
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