The FDA’s approval process is designed to ensure the safety of new products introduced into the market. However, when it comes to mRNA technology, a form of gene therapy, COVID-19 vaccines were exempted from the typical testing requirements for gene therapy products.
This departure from standard protocol raises questions about the adequacy of FDA guidance in testing these new products.
The introduction of mRNA technology for COVID-19 vaccines led to the implementation of new regulatory rules to expedite production. These rules allowed manufacturers to submit test results on similar products, rather than conducting tests specifically on the vaccine components. This relaxation of the rules may have had unforeseen consequences.
Gene-based therapies, including mRNA vaccines, hold potential for personalized treatment of conditions like cancer, hereditary disorders, and autoimmune diseases. This approach involves delivering genetic material directly to affected cells to replace, deactivate, or modify disease-causing genes.
In the United States, both gene-based therapies and vaccines fall under the regulation of the FDA’s Center for Biologics Evaluation and Research (CBER). Both the EMA and the FDA mandate biodistribution studies before an RNA gene therapy undergoes human trials. These studies examine individual components, such as the LNP capsule, spike protein, and the final combined product.
If the FDA categorizes mRNA as gene therapy, then mRNA vaccines should have undergone the same safety testing as other gene therapy products. The omission of this testing raises concerns.
The FDA, as a key influencer in health policies, wields significant influence over the well-being of individuals on a national and global scale. There is potential for conflicts of interest when transitioning from a regulatory role to advising companies, or vice versa. This could lead to decisions influenced by economic gains rather than the principle of doing no harm.
Not all novel technologies come without risks, especially those with the potential to impact the human genome. Strict adherence to standard protocols for new drug registration, including pharmacokinetic, biodistribution, and safety data, should be maintained by the FDA.
However, the creation of separate pathways for RNA therapeutics and vaccines to hasten distribution, while expedient in a pandemic, undermined regulatory oversight. This has contributed to a loss of public trust in regulatory agencies, as many adverse events may have been foreseen with proper studies.
The urgency to produce a life-saving vaccine for high-risk individuals during the pandemic could have been viewed as reasonable if it hadn’t been coupled with a blanket vaccination recommendation for the entire population. Yet, critical studies remain unfinished, further eroding confidence in regulatory agencies.