By Mark Edward
The way we define medical technologies shapes public perception and regulatory oversight. For many wondering how mRNA technologies managed to bypass certain safety protocols—the terminology debate deserves attention.
The FDA’s Semantic Sidestep
The FDA’s Long-Term Follow-Up Guidance for Human Gene Therapy (2020) defines gene therapy as interventions that “modify or manipulate the expression of a gene or to alter the biological properties of living cells.” Yet mRNA products—which instruct cells to produce foreign proteins—aren’t classified as gene therapy because they’re “temporary.”
This distinction seems arbitrary. Whether genetic instructions last days or decades, the mechanism remains the same: delivering genetic material to reprogram cellular machinery. The FDA’s own document acknowledges gene therapy includes products that “alter the biological properties of living cells”—precisely what mRNA shots do.
The Regulatory Escape Hatch
Buried in Appendix 3 of the FDA’s guidance:
“Vaccines for infectious disease indications…are excluded from this gene therapy framework.”
Labelling something a “vaccine” sidesteps gene therapy oversight, even when using similar technology. Coincidentally, the definition of “vaccine” was changed by health authorities and dictionaries around 2021, replacing language about “producing immunity” with “stimulating immune response” or “providing protection”—just in time to include mRNA technology under this umbrella. Convenient timing, wouldn’t you say?
Calling It What It Is
If we can’t call them “gene therapy” without triggering technical objections, I suggest alternative but just as straightforward terms that accurately describe what these products actually do:
- Genetic Therapy
- Genetic Treatment
- Genetic Engineering
- Genetic Modification
- Genetic Programming
- Genetic Medicine
These terms acknowledge reality: mRNA products deliver genetic instructions to cells. The industry simply exploits a loophole where “temporary” equals “not gene therapy”—as if renting a car means it’s not actually a vehicle.
Why This Matters
The FDA’s classification shields mRNA products from the stringent 15-year safety monitoring required for gene therapies. Instead of long-term follow-up for potential issues like cancer or autoimmune disorders, mRNA products face far less scrutiny—despite using novel delivery systems (lipid nanoparticles) that distribute throughout the body.
Temporary Doesn’t Mean Risk-Free
Even “temporary” genetic instructions may cause lasting effects. The FDA acknowledges that even non-integrating vectors can require extended monitoring. Yet mRNA technology, despite:
- Reprogramming cells to produce foreign proteins linked to various health issues in studies
- Using novel delivery systems with limited long-term safety data
- Generating proteins that may persist longer than initially claimed
…somehow requires minimal long-term oversight.
A Call for Honest Language
Word choice shapes perception. Calling mRNA products “vaccines” evokes familiar medical treatments—polio drops, measles shots—making people feel at ease. Calling them “genetic engineering treatments” acknowledges their novel mechanism and prompts appropriate questions about long-term safety.
Let’s retire the euphemisms. If something walks like a duck and quacks like a duck, we shouldn’t have to call it a “temporary aquatic avian therapeutic.”
