This is part 6 in “Promise or Peril: COVID-19 mRNA Vaccine Issues Series”
The pandemic has ended, but the introduction of the COVID-19 vaccines, which use mRNA technology, signifies the start of a new era in modern medicine. The lagging regulatory framework that the FDA cobbled together specifically for mRNA vaccine approval has set the stage for adverse events related to genetic therapies using this new technology. In this series, we reveal emerging concerns about mRNA injections related to the lipid nanoparticles, spike protein, and vaccine contamination as public documents are released.
In Part 6, we consider the ramifications of the “lagging” regulatory framework for COVID-19 vaccines. In June 2020, the U.S. Food and Drug Administration (FDA) set up special emergency guidance for the manufacturers making the COVID-19 vaccines; this special guidance expires on Nov. 7.
The FDA approval process is intended to safeguard human health when introducing new products. As established previously (in Part 1), mRNA is gene therapy yet the FDA has excluded vaccines from the normal testing requirements imposed on gene therapy products. The regulatory framework isn’t just “lagging,” the FDA guidance appears to have been derelict in its duty to properly test these new products.
FDA Negligence or Intentional Bypass?
Although ribonucleic acid (RNA) therapeutics have been in development for a decade, when messenger RNA (mRNA) technology was proposed for COVID-19 vaccines, a new set of regulatory rules were put in place to expedite production. The new rules allowed manufacturers to submit test results on similar products in lieu of submitting tests on the precise vaccine components.
