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.
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."
Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process-starting with influenza vaccines.
The U.S. Food and Drug Administration states that gene therapy seeks to "Modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use." Moderna's Q2 2020 filing with the Securities and Exchange Commission acknowledged that mRNA is "Considered a gene therapy product by the FDA." In addition, BioNTech founder Ugur Sahin, in a 2014 article stated, "One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy."
A number of years ago, the FDA decided to exclude vaccines for infectious diseases from its various guidance for unknown reasons, including vaccines made from gene therapy technology.
"Since Pfizer and Moderna COVID-19 vaccines meet the definition of gene therapy, they should be handled according to gene therapy guidelines."
Known results of anti-cancer therapies that use gene therapy technology and mRNA vaccines could lead us to anticipate safety and efficacy problems, she added.
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