In response to the worldwide-spread of COVID-19, a disease caused by Coronavirus SARS-CoV-2, several pseudo-mRNA “gene therapy”-based products were rapidly developed and deployed as prophylactic vaccines. In contrast to recombinant viral “gene therapy”-based vaccines such as those developed by Janssen (J&J) and Astra-Zeneca, these RNA products employ non-viral self-assembling Lipid NanoParticle (LNP) technology to deliver genetic information coding for a viral protein (SARS-CoV-2 Spike) into the cells of the patient. Each of these complicated combination products, which include both a biological component (the RNA) and a complex new ingredient (the LNP), were brought to market by private pharmaceutical companies in a rapidly assembled government-corporate collaboration, operating at “warp speed.”
New vaccine development has historically involved a decade-long discovery, research, testing, review and approval process. In contrast, the detailed and time-consuming methodology required to ensure vaccine product safety and effectiveness were scuttled and the overall process was condensed to less than one year. Next, globally harmonized and previously sacrosanct regulatory and scientific standards, carefully developed over decades were discarded when it came to the Emergency Use Authorization (EUA) for the completely novel and barely tested mRNA-based injections.
Although intended to prevent viral infection, replication, spread and COVID disease or death, and to enable “herd immunity”, these products were developed at “Warp Speed” and labeled “vaccines” but differed remarkably from all other currently available vaccine products. That haste and the associated regulatory compromises enabled by lax EUA requirements yielded products with high rates of avoidable existing and emerging treatment-associated serious adverse events including hospitalizations, permanent disabilities and deaths, as reported in both VAERS, and the CDC’s now surreptitiously shuttered V-safe reporting system. The abbreviated testing associated with this novel mRNA/LNP combination product should have led to a substantially greater contemplative pause, well-prior to authorizations and federal implementation and vaccine mandates from federal officials within the executive branch of government.
Damn the Torpedoes
It was obvious to those who were familiar with the scientific method and investigational medicine what could – and ultimately did occur. Drug development processes have a very high failure rate, and the number one reason for clinical failure of investigational medicines is drug safety. Despite that, the government discarded established norms for testing and development with these products. This policy has resulted in avoidable damage to both public trust in government and regulatory authority integrity. Policies and practices based on decades of “lessons learned” from prior product development failures were jettisoned with little discussion or justification.
Going forward, a central unresolved issue is whether federal regulatory authorities will accept responsibility for oversight failures during the COVID crisis, and recommit to fulfilling their essential role in ensuring the safety, purity, effectiveness and consistency of drug and biological medicines administered to their citizens.
The terminology used to define and describe this subcategory of non-viral gene (polynucleotide) delivery formulations can seem very intimidating. For this discussion, we will focus on just introducing the components, their general characteristics and biochemistry, and not on the pseudouridine-incorporating “mRNA” payload which these particles deliver into cells. …