BLUF: Researchers are calling for mRNA vaccines to be classified as gene therapy products due to concerns about safety issues and the bypassing of regulatory standards for their rapid approval.
Researchers argue that COVID-19 mRNA vaccines should be classified as gene therapy products rather than vaccines against infectious diseases. This classification would subject these vaccines to more stringent regulatory standards. However, regulatory agencies in the US and Europe have not made this distinction, allowing mRNA vaccines to be regulated as vaccines instead of gene therapy products.
The current definition of a vaccine by the Centers for Disease Control and Prevention (CDC) does not apply to mRNA vaccines. These vaccines do not contain antigens that trigger the body’s immune response. Instead, they use mRNA, the genetic material of the SARS-CoV-2 virus, to provide instructions to the body’s cells to produce spike proteins, which then trigger an immune response. This process is more similar to gene therapy, where the mRNA instructs the body to produce the desired antigen.
The FDA acknowledges that mRNA is considered a gene therapy product, and BioNTech’s founder has also described mRNA drugs as gene therapy. However, neither the FDA nor the European Medicines Agency (EMA) have referenced these qualifications for mRNA COVID-19 vaccines. This raises concerns about the lack of additional controls and essential studies that should have been conducted for gene therapy products.
In conclusion, researchers argue that mRNA vaccines should be classified as gene therapy products and subjected to the appropriate regulatory standards. This would ensure that essential studies and tests are conducted to determine their long-term safety and efficacy. Without these measures, there are concerns about potential risks and the bypassing of regulatory standards in the rapid approval process for mRNA vaccines.