Despite mounting calls from physicians, researchers, and public health advocates to withdraw COVID-19 vaccines from the market entirely, the U.S. Food and Drug Administration (FDA) has once again moved in the opposite direction. Late last week, the agency approved a new Moderna COVID-19 vaccine without requiring the company to conduct pre-licensure clinical trials comparing the shot to a true placebo. Instead of relying on the scientific gold standard of randomized, placebo-controlled trials to evaluate safety and efficacy, the FDA allowed Moderna to base its application on a comparative study of its new formulation against the company’s previously authorized vaccine, Spikevax, which is notoriously ineffective and inherently unsafe.
The new vaccine, mNEXSPIKE, was granted standard FDA approval for adults 65 and older, and individuals aged 12 to 64 who have at least one medical condition that increases their risk of severe COVID-19. While that restriction appears, on its face, to reflect a more cautious stance, experts say the bar for approval was lowered significantly to allow Moderna to bring a shot to market.
Moderna’s clinical data, which formed the basis of the FDA’s approval, came from a Phase 3 study involving approximately 11,400 participants. Rather than comparing vaccine recipients to a saline placebo group, the trial evaluated the performance of mNEXSPIKE against Moderna’s earlier Spikevax formulation, meaning safety signals and potential adverse outcomes were only measured relative to a vaccine that itself has never undergone placebo-controlled trials for long-term outcomes and is associated with severe side effects. Additionally, the vaccine contains the outdated Omicron viral strain from two years ago.
According to the company, the new shot showed a modest 9.3% improvement in efficacy over Spikevax in individuals aged 12 and older, and a 13.5% improvement among those aged 65 and older.
“This is disappointing, to put it mildly,” medical analyst John Campbell, Ph.D., told viewers of his YouTube show. “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.”
Campbell, referencing the package insert, said the vaccine caused serious adverse reactions in 2.7% of clinical trial participants, which is higher than the 2.6% reported for the original shot.
“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.”
According to Campbell, more adverse reactions have been reported following COVID-19 vaccines than any other vaccine, including 118 times more than the flu vaccine. “How this can be approved is rather a mystery to me,” he said.
While the FDA touted these numbers as evidence of meaningful progress, public health watchdogs called them misleading. The public is being misled into believing that this vaccine underwent rigorous testing when in reality, it’s just a repackaging of the same technology, given a slight tweak and approved with comparative—not independent—data.
Adding to the unease is Moderna’s post-approval promise to finally conduct a placebo-controlled trial after the product has already been approved for public use. The new study will reportedly involve a saline placebo and aims to measure safety outcomes over time, but critics say it’s a textbook example of regulatory capture. “This is backwards. You don’t issue full approval first and then go looking for the data to justify it,” said an anonymous source close to the matter.
In addition to comparing the new vaccine to the “never should have been authorized” former vaccines, clinical 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 stated that the label reports a “confirmed risk” of heart damage, which is higher in males ages 12-24 and typically occurs in the first week following vaccination.
Some people who experience these conditions have required intensive care. The insert states that for most people, the symptoms resolve; however, others have shown persistence of cardiac injury five months post-vaccination. At the same time, 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,” Campbell 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.”
Government Response and Mounting Pushback
In an attempt to quell growing criticism, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. issued a public statement on social media:
“Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller protein,” Kennedy said. “The FDA will monitor and collect data throughout the trial for every adverse outcome—not just a table list of expected outcomes. The FDA will scrutinize every aspect of the trial. We will deliver on our promise to use gold standard science and common sense.”
The post, which was intended to reassure the public, was met with swift backlash.
“There’s no such thing as a postmarket RCT [randomized controlled trial]. You just made that up,” one medical researcher replied. “All of the study completion dates are after Trump has already left office (2029 to 2032),” Dr. Toby Rogers said in a post. “Tell the intern who wrote this to stop lying because it’s making @RobertKennedyJr look bad.”
Dr. William Makis, a nuclear medicine physician and vocal critic of the mRNA platform, issued a blistering response.
“There’s no such thing as a postmarket RCT [randomized controlled trial]. You just made that up. All of the study completion dates are after Trump has already left office (2029 to 2032). Tell the intern who wrote this to stop lying because it’s making @RobertKennedyJr look bad.
“This is insane,” he wrote. “This is an attempt to rehabilitate this toxic, contaminated mRNA vaccine technology. I knew they’d try this. But instead of cleaning up the DNA plasmid contamination, we’re getting ‘smaller parts of the spike’ instead? Really? This is the so-called ‘fix’?”
Makis pointed to what he called a disturbing trend: “Something like this has been attempted before when Pfizer and Moderna lowered the dose of mRNA for the pediatric mRNA vaccines for children under 12 years old—3mcg or 10mcg of mRNA instead of 30mcg for Pfizer, and 25mcg of mRNA instead of 50mcg for Moderna. Now these younger kids are getting leukemia. The older kids who got the higher adult dose are getting lymphomas, sarcomas, and brain tumors. This is criminal. The entire mRNA vaccine platform MUST be banned immediately. All 500+ mRNA vaccines in development must be banned immediately.”
Makis said he cannot support MAHA if it is going in this direction. “I’m done with this mRNA vaccine fraud. Going in this direction is absolutely criminal—with all that that implies.”
Whether these warnings will influence future regulatory policy or fall on deaf ears remains to be seen. However, one thing is clear: public trust in U.S. health agencies continues to deteriorate—not because of misinformation, but because of a pattern of rushed approvals, missing data, and dismissive responses to legitimate safety concerns. Americans want accountability, to restore scientific integrity, and to put an end to the mRNA vaccine agenda once and for all.
