mRNA Covid Shots Should Be Labeled ‘Gene Therapy Products,’ Peer-Reviewed Study Warns

An explosive peer-reviewed study has warned that mRNA Covid shots are being incorrectly classified in an effort to bypass regulations for public use.

Researchers behind a study published in the renowned International Journal of Molecular Sciences are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccines.

They are calling on federal government agencies to correctly classify messenger RNA (mRNA) shots as gene therapy products (GTPs).

The researchers warn that mRNA shots must be correctly labeled as GTPs to prevent pharmaceutical companies from bypassing regulatory standards.

According to the paper, Covid mRNA shots, by mode and action, are gene therapy products and should adhere to different regulatory standards.

However, U.S. and European regulatory agencies have not classified Covid mRNA vaccines as gene therapy products.

The incorrect classification has allowed the shots to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.

Currently, regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products.

Because of this, 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.

The shots have been rolled out for public use despite yielding tests with non-compliant results regarding purity, quality, and batch homogeneity.