In Part 6, we consider the ramifications of the “lagging” regulatory framework for COVID-19 vaccines. In June 2020, the U.S. Food and Drug Administration (FDA) set up special emergency guidance for the manufacturers making the COVID-19 vaccines; this special guidance expires on Nov. 7.
The FDA approval process is intended to safeguard human health when introducing new products. As established previously (in Part 1), mRNA is gene therapy yet the FDA has excluded vaccines from the normal testing requirements imposed on gene therapy products. The regulatory framework isn’t just “lagging,” the FDA guidance appears to have been derelict in its duty to properly test these new products.
FDA Negligence or Intentional Bypass?
Although ribonucleic acid (RNA) therapeutics have been in development for a decade, when messenger RNA (mRNA) technology was proposed for COVID-19 vaccines, a new set of regulatory rules were put in place to expedite production. The new rules allowed manufacturers to submit test results on similar products in lieu of submitting tests on the precise vaccine components.Did this relaxation of the rules have unforeseen consequences? Likely, yes.
Gene-based therapies offer the promise of personalized therapy to cure difficult conditions such as cancer, hereditary conditions, and autoimmune and infectious diseases. Theoretically, one can replace, inactivate, or modify the disease-causing gene by delivering DNA or RNA fragments directly to affected cells. It’s the platform upon which the mRNA vaccines were built.
However, several concerning findings about mRNA injections have emerged in the literature and in scientific circles which merit urgent consideration. These were the focus of Parts 2, 3, and 4 in our series. In this piece, we broadly discuss why mRNA gene therapy was developed and the rules that such products are supposed to follow.
Gene Therapy Technology
Delivering treatment by direct injection can be very complicated. In the case of proteins, they must meet size limitations, be folded properly, and must be stabilized so they can reach their intended target.In contrast, delivering genetic instructions to manufacture a lifesaving protein or to turn off a gene that isn’t working properly offers great promise for parents of children with a hereditary disorder.
Once inside the cell, a broken gene is replaced or a missing protein is produced, such as insulin among patients with Type 1 diabetes. The FDA approved the first RNA-based therapy to treat peripheral nerve disease in 2018. This is a beautiful model for delivering on-demand biologics needed by the body to function properly.
Delivering a snippet of genetic code via mRNA appears to be an attractive idea. The protein doesn’t need to be packaged perfectly because the human cells take over the production process.
Gene therapy was initially focused on DNA technology because RNA was too delicate. However, the DNA-based therapeutics did not work well in human trials. There was also the concern about integration into the human genome. Researchers then shifted to synthetic RNA-based therapeutics, which set the stage for the development of vaccines based on the new mRNA technology.
The Shift to RNA-Based Technology
The quickly disintegrating RNA appeared to offer some safety advantages over DNA, chiefly that RNA would stay in the cytoplasm and wouldn’t enter the nucleus, and therefore, would be in the body only transiently. The mRNA platform used to deliver the SARS-CoV-2 vaccine relied on these advantages. However, as we noted in Part 4, the vaccine mRNA does stay in the body after vaccination for at least 60 days.The in vitro-transcribed mRNA had the first proof-of-concept animal study in 1990. Since then, numerous studies have been conducted to overcome challenges related to the fragility of mRNA and the immune system’s tendency to attack foreign mRNA. In other words, if the mRNA is destroyed by the body before it can create new proteins, the vaccine is useless.
Vaccine technology is shifting toward this approach because it offers the advantage of stimulating not only antibodies, as the influenza (flu) shot does, but also cellular immunity (T-cells).
“Genetic immunization may promote superior adaptive immunity by activating both humoral and cell-mediated responses, and has manufacturing advantages over traditional vaccines,” according to a 2020 review by Bloom, et al. Both arms of the immune system are very important: antibodies block viruses and bacteria from entering cells while T-cells target and destroy infected cells.
Traditional flu shots work moderately well because they depend on antibodies to do the hard work of stopping the influenza virus from gaining entry into cells. However, without a good T-cell response, the body isn’t as well prepared to attack cells that are already infected.
FDA Avoided ‘Gene Therapy’ Testing Requirements
The regulatory framework keeping watch over gene therapies was established by the same agency charged with oversight of vaccines and other biologics.In the United States, gene-based therapies and vaccines both are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER).
Although CBER monitors both gene therapies and vaccines, the regulatory framework for DNA and RNA “therapeutics” is different than for “vaccines.” Guidance from the FDA excludes vaccines from the biodistribution studies otherwise required for gene therapy products.
A 2022 review by Vervaeke, et al. stated, “The success of the messenger RNA-based COVID-19 vaccines of Moderna and Pfizer/BioNTech marks the beginning of a new chapter in modern medicine. However, the rapid rise of mRNA therapeutics has resulted in a regulatory framework that is somewhat lagging.”
While the regulatory pathways share similar characteristics, RNA therapeutics are required to go through pharmacokinetic testing to see what happens to the product once it’s in the body. Oddly, as we discussed in Part 1, the mRNA vaccines weren’t required to go through human biodistribution testing and relied solely on animal studies. Further, these animal biodistribution studies only looked at the lipid nanoparticle (LNP) capsule, not the mRNA cargo as the studies used a luciferase-encoding mRNA surrogate to take the place of a spike protein-encoding mRNA.
With new technologies, it is important to study the actual components. Using a surrogate instead of the spike protein is a problem because it prevented the FDA from understanding the precise effects of the spike protein on the body. Additionally, the animal models did not examine the biodistribution of the spike protein or its subunit (S1) in the body, yet we were told it breaks down quickly.
The European Medicines Agency (EMA), which is the European Union’s equivalent to the FDA, refers to the World Health Organization for vaccine regulations. The FDA, on the other hand, created its own guidance in response to the pandemic.The EMA and the FDA both require biodistribution studies before an RNA gene therapy goes through human trials. These studies can test the components individually. In the case of the COVID-19 mRNA vaccines, this would include components such as the LNP capsule, the spike protein, and the combined final product.
However, both the EMA and the FDA don’t consider the mRNA vaccines to be “gene therapy” products, and therefore, they avoided the requirement for biodistribution studies (Vervaeke, et al. Table 1). While the FDA didn’t align the regulatory oversight for mRNA vaccines with the gene therapy rules, Moderna, which is funded by the National Institutes of Health, stated in a June 2020 Securities and Exchange Commission filing, “Currently, mRNA is considered a gene therapy product by the FDA.”
If mRNA is considered gene therapy by the FDA, the mRNA vaccines should have been put through the same safety testing as all other gene therapy products. How did they avoid this testing?
The risk-benefit analysis for a therapeutic used to treat someone with a serious terminal illness should be very different from that of a therapeutic targeting a large healthy population. The FDA should not have used the pandemic as a reason to abdicate its responsibility for stringent safety oversight and regulation of mRNA vaccines.
The FDA’s Failure to Protect the Public
Human studies could have been conducted, even in the context of the pandemic. For example, the rat models used to test biodistribution on the mRNA products began in July 2020 and were completed two months later. Human studies are typically completed very early in the drug development process and are required for an FDA investigational new drug application. Only six volunteers are needed for such a study, and it could have been completed quickly. In this research, for example, six volunteers participated in a biodistribution study that was completed in 24 hours.Given the FDA’s authority in shaping health policies, despite not engaging directly in patient treatment as doctors do, every policy or action they undertake carries substantial implications for the collective well-being of individuals nationwide or even globally.
The FDA is the gatekeeper of human safety. Its ultimate responsibility is safeguarding people’s health and wellness while remaining independent of pharmaceutical company influence. Yet the FDA still does not hold mRNA vaccines to the same standards as gene therapy products. The “Nonclinical Biodistribution Considerations for Gene Therapy Products Guidance for Industry,“ dated May 2023 states, ”This guidance does not apply to prophylactic vaccines.” Why?
The “revolving door” phenomenon—when people leave the FDA to work for a large pharmaceutical company—should be strictly prohibited, as this will jeopardize the mission of the FDA. This research letter by Prasad and co-authors found that 57 percent of drug reviewers who left the FDA went to work for or provided consulting to the pharmaceutical industry.
The transition from being a regulator to advising companies, or the other way around, would unavoidably raise conflict of interest concerns, creating doubts about whether someone could act in the public interest. Especially when evaluating novel biotechnology, they might be easily biased by the economic return rather than adhering to the ethical principle “first do no harm.”
Not every novel technology is safe and without risks. A technology with the potential to affect the human genome should be handled with a higher degree of caution due to the serious nature of the associated risks.
The FDA should strictly follow normal pharmacokinetic, biodistribution, and safety data that is required for a new drug registration.
The FDA should also follow the ethical principles that guide the regulation of a new drug intended for use in an otherwise healthy population. As a broad example, placebo controls should be biologically inert (i.e., saline) so that adverse events can be identified and their frequencies estimated more accurately. As seen with the HPV vaccine studies, a “pseudo” placebo was used, which disguised the vaccine’s safety issues.
The Erosion of Public Trust
The promise of mRNA vaccines to save lives was based on several factors. One was the improved safety profile of using RNA instead of DNA. Another was the novelty of quickly encoding an antigen (the spike protein) as an immune target. Finally, the mRNA and the lipid nanoparticle delivery capsule proved to be highly immunogenic, inducing a vigorous immune response even in older adults, making them an effective adjuvant.However, by intentionally creating two different pathways for RNA therapeutics and vaccines to expedite distribution, regulatory oversight was seriously undermined, resulting in the erosion of public trust in our regulatory agencies. Many of the adverse events now being detected would likely have been anticipated had the same human biodistribution studies and adequate safety and toxicological studies been performed as required for drugs.
Given the exigent nature of the pandemic, the urgent production of a lifesaving vaccine for those at high risk may have been considered reasonable had public health officials not simultaneously, and emphatically, urged a one-size-fits-all vaccination for the entire population. Yet these studies have still not been completed, inciting a catastrophic loss of confidence in our regulatory agencies.
We call for a reinvigorated FDA that diligently fulfills its paramount responsibilities in safeguarding the health and safety of the population. This includes upholding unwavering ethical principles rooted in human well-being for perpetuity.
Promise or Peril: COVID-19 mRNA Vaccine Issues Series
Part 1
FDA Overhaul Needed for New Vaccines and mRNA Therapies
Part 2
Health Implications of Poor COVID-19 mRNA Testing: Miscarriage, Vision Loss, Immunotoxicity
Part 3
Pulling Back the Curtain: mRNA Lipid Nanoparticle Design Created Potential for Clotting and Triggering Immune Overdrive
Part 4
A Deeper Dive Into Role of Spike Protein in Myocarditis, Blood Clotting After COVID-19 Vaccination
Part 5
COVID-19 mRNA Vaccine Contaminated by Mystery DNAs and Truncated mRNAs: Health Implications
Part 6
FDA’s Failure to Safeguard the Public Resulted in Irreparable Erosion of Trust
More from this series
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