Medical commentator John Campbell, Ph.D., said it’s “bemusing” that the FDA could authorize a vaccine with such high risk and limited efficacy. The vaccine, mNEXSPIKE, uses the newer self-amplifying mRNA technology.
JUNE 3, 2025
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The U.S. Food and Drug Administration (FDA) last week approved Moderna’s new COVID-19 mRNA vaccine, mNEXSPIKE, for use in all adults 65 and older, and children and adults ages 12-64 who have at least one underlying condition.
The vaccine is associated with known serious adverse events, medical analyst John Campbell, Ph.D., told viewers of his YouTube show.
“This is disappointing, to put it mildly,” Campbell said. “I think we have to assume that the American bureaucracy and the FDA is more of an oil tanker, which is going to take a while to turn around, rather than a sailing yacht, which can tack quickly.”
Reviewing the package insert, Campbell said the vaccine caused serious adverse reactions in 2.7% of clinical trial participants.
“I would not dream in clinical practice of giving a treatment that had a 2.7% risk of serious adverse events unless there was a really big risk, and there was a really big risk-benefit analysis,” he said. “So if the patient is about to die of something, of course it’s an acceptable risk. But for any benefit you would get from this — 2.7%, I just find it bemusing that this could possibly be authorized.”
Campbell said data show exponentially more adverse reactions reported following the COVID-19vaccines than any other vaccines, including 118 times more than the flu vaccine. “How this can be approved is rather a mystery to me,” he said.
He also noted that the trials for mNEXSPIKE didn’t test the vaccine against a placebo. Instead, it was tested against Spikevax, Moderna’s previous COVID-19 mRNA vaccine, and it showed slightly higher efficacy. The trials didn’t test for efficacy against illness, hospitalization or death. Instead, they measure whether the vaccine triggered neutralizing antibody titers.
Campbell’s analysis focused on the new information on the package insert about myocarditis and pericarditis. He said the label reports a “confirmed risk” of myocarditis and pericarditis, which is higher in males ages 12-24. The onset of symptoms typically occurs in the first week following vaccination.
Some people who experience these conditions have required intensive care. The insert says that for most people, the symptoms resolve, but others have shown persistence of cardiac injury five months post-vaccination.
The insert also indicates that long-term data about heart damage is not yet available.
“Basically, what they’re saying is they’re seeing lesions in these patients in the myocardium,” he said. “When there’s damage to myocardial cells, they don’t regenerate, so those cells are lost for life. They’re lost for life, and it can be seen on MRI scanning.”
Campbell said long-term, the damage could lead to reduced fitness, heart failure, heart blockages and abnormal cardiac rhythms. “But ‘hey, myocardial lesions are an acceptable risk,’ is what it seems to be saying,” he said.
The package insert also concedes that the vaccine “might not work in some people.”
Campbell also noted that less serious adverse events, including pain at the injection site, headache, fatigue, muscle pain, lymph node swelling, nausea and vomiting were common. He said some of those effects could be symptomatic of issues in the immune system.
Given the high risk and very limited benefit, Campbell said he was disappointed the FDA had approved the drug. “Maybe this reflects the massive financial interest, I don’t know,” he concluded.
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mNEXSPIKE is a new, self-amplifying platform
James Lyons-Weiler, Ph.D., who also commented on the mNEXSPIKE approval in a Substack post, pointed out that the new vaccine uses a fundamentally different vaccine platform than Spikevax.
mNEXSPIKE is a self-amplifying mRNA product. “In reality, it marks a sharp pivot in platform regulatory precedent — a pivot that will almost certainly face future regulatory scrutiny as the consequences of this decision unfold,” he wrote.
Self-amplifying mRNA has an “entirely different molecular structure system” than previous mRNA shots, Lyons-Weiler said. It can replicate inside cells, which allows for heightened expression and longer duration of synthetic RNA.
He noted that the new platform has no baseline safety data, because it was compared only to the previous vaccine. Yet, this trial design is “fully compliant with the FDA’s newly issued guidance under the MAHA-era framework.”
Watch John Campbell discuss new Moderna vaccine here:
https://www.youtube.com/embed/BgWun8AkUWs?si=KTBGd2OT4DSkCeSX&enablejsapi=1&origin=https:%2F%2Fchildrenshealthdefense.orgRelated articles in The Defender
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Brenda Baletti, Ph.D.
Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
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