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Moderna is rapidly expanding its mRNA vaccine pipeline, with recent U.S. Food and Drug Administration (FDA) approval for its respiratory syncytial virus (RSV) vaccine and ongoing clinical trials for vaccines targeting other diseases.
However, John Campbell, Ph.D., a prominent medical commentator, raised concerns about the onrushing “mRNA future” on his YouTube show this week, citing known safety issues of mRNA vaccines and the compromised regulatory process surrounding their development and deployment.
“All of the issues that have been raised — the concerns, the adverse reactions — don’t really seem to have been taken into full cognizance and they’re plowing ahead,” he said.
The FDA recently approved Moderna’s mRNA vaccine, mRESVIA, to protect adults 60 and older against RSV infection. It will be available in the U.S. by the 2024-2025 respiratory virus season and likely in multiple markets worldwide.
mRESVIA received the FDA’s “breakthrough therapy” designation, an expedited approval program for candidate drugs whose initial clinical results demonstrate a potential substantial improvement over available therapies.
This marks the second FDA-approved mRNA product from Moderna — the first was the vaccine maker’s COVID-19 vaccine.
Approval overlooks LNP risks, antigen production unpredictability
Moderna CEO Stéphane Bancel stated, “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.”
But Campbell questioned Bancel’s claims, expressing concerns about the systemic distribution of the lipid nanoparticles (LNPs) used to deliver the mRNA, which could potentially reach multiple organs and tissues.
He explained that when an mRNA vaccine is administered through an intramuscular injection into the deltoid muscle, the LNPs containing the mRNA can either remain at the injection site or enter the systemic circulation.
Campbell described how the nanoparticles travel through the veins, reaching the vena cava and the right side of the heart, which pumps blood to the lungs. From there, the blood returns to the left side of the heart via the pulmonary veins and is pumped into the aorta, which distributes the nanoparticles throughout the body.
“The aorta will take it everywhere apart from the lung tissue,” he said. “So it’ll take it to your ears … your nose … your toes … your myocardium … your brain … your testes or ovaries. This is the concern — the systemic distribution.”
Campbell also questioned the lack of control over the amount of antigen produced by the body’s cells following mRNA vaccination.
“This goes against one of the completely fundamental axioms of giving drugs,” he said. “You give the right dose of the right drug to the right patient at the right time via the right route.”
Campbell explained how the immune system’s response to the mRNA-produced antigens expressed on the surface of cells could lead to inflammation and cell death in various tissues.
“Your … cytotoxic T-cells, if they recognize this antigen as foreign, [will] start beating it up and probably could eventually kill the whole cell,” he said. “Now, if that’s in your arm, you get a sore arm. If it’s in your myocardium, you’ll get inflammation in your myocardium.”
Regarding the COVID-19 mRNA vaccine, Campbell said that the “spike protein was particularly pathogenic,” and that the choice to make it the antigen was “very, very strange.”
He said pharmaceutical companies and regulators have not addressed the issue of mRNA vaccines causing the body to fight against itself, leading to inflammation and autoimmune reactions.
“And yet the program plows on apace,” he said.
Several mRNA vaccines in late-stage trials
Moderna has several mRNA vaccines in development, Campbell said, including mRNA-1083, a combination vaccine targeting both the flu and COVID-19, now in Phase 3 trials.
Moderna announced positive data from the trial, claiming “‘statistically significantly higher immune responses’ compared to existing vaccines on the market.”
“So this would be giving two RNA vaccines to the same person in the same syringe, same injection site,” Campbell said.
The influenza portion of the vaccine is trivalent (targeting three strains), Campbell said, meaning the combined formulation would code four RNA sequences, including the spike protein — “assuming they’re still using the spike protein RNA.”
“Now this is not me making this up, honestly,” he said, pointing viewers to the links in the show notes and urging them to read the announcements for themselves.
Campbell expressed skepticism about replacing existing flu vaccines with mRNA-based alternatives, pointing to concerns about the potential for reverse transcription.
Reverse transcription is the process of converting RNA back into DNA, which is the opposite of the normal flow of genetic information in cells. This process is concerning in the context of mRNA vaccines, as it could lead to the integration of vaccine-related genetic material into the human genome.
Other pathogens Moderna is developing mRNA vaccines for include cytomegalovirus, Epstein-Barr virus, herpes simplex virus, varicella-zoster virus (for shingles, Campbell guessed) and norovirus. Campbell discussed each disease briefly and commented on its severity and risks.
These vaccine candidates are in various stages of clinical trials, with some fully enrolled and others progressing towards pivotal Phase 3 trials.
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‘I will not be accepting any of these vaccines’
Governments worldwide, including the United Kingdom, Australia and Canada, have made substantial investments in mRNA technology and are building large-scale production facilities, Campbell said.
While acknowledging regulators’ role in protecting public health, he questioned their independence from the pharmaceutical industry’s influence.
“mRNA looks like the future, doesn’t it?” Campbell asked. “Needless to say, I will not be enrolling for any of these trials. I will not be accepting any of these vaccines.”
Watch John Campbell’s ‘mRNA Future’ video:
