The mRNA Covid 19 products are not vaccines; they are gene therapy products. The regulators had to do linguistic backflips to fit these products into the vaccine definition. (Maybe people would have been more hesitant getting the shots if they were called ‘gene therapy?)
by Megan Redshaw, JD, at The Epoch Times at zerohedge.com:
Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of covid-19 ‘vaccines’—and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.
According to a paper published in Nature on June 22, covid-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified covid-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.
Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for covid-19 vaccines in the form of a “rolling review.”
A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes available—without the complete data package or specific controls.
This process led to broad and continuous biodistribution of mRNA covid-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process—starting with influenza vaccines.