Dr. Makis Is Outraged: FDA Approves New Moderna mRNA Shot Despite Serious Harms
Canadian physician and whistleblower Dr. William Makis is raising the alarm following the U.S. FDA’s approval of Moderna’s new COVID-19 vaccine, mNEXSPIKE, which uses an experimental self-amplifying mRNA platform. In a blistering Substack post, Makis called the move “criminal,” warning that health authorities are attempting to rehabilitate toxic mRNA vaccine technology under the guise of reform.
RFK Jr. addressed concerns on X:
I want to address those of you who have anxieties about @US_FDA’s limited approval of a new mRNA COVID vaccine for high-risk populations. 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…
— Secretary Kennedy (@SecKennedy) June 3, 2025
“This is INSANE,” wrote Dr. Makis. “Instead of cleaning up the DNA contamination, we’re getting smaller parts of the spike? This is the so-called fix? Oh hell NO.”
Makis, based in Alberta, has been documenting vaccine injury trends in young people — including rising rates of leukemia in children and brain tumours, lymphomas, and sarcomas in teens and young adults. He now says he can no longer support the U.S. “MAHA” (Make America Healthy Again) movement or its appointees, accusing them of protecting the mRNA platform at all costs.
His outrage is echoed by many in the medical community — including Dr. John Campbell, who reviewed mNEXSPIKE’s clinical trial data and called the FDA’s decision “bemusing” and deeply irresponsible.
The newly approved shot will be offered to all adults 65+, and to youth and adults (ages 12–64) with at least one underlying condition — despite data showing:
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2.7% of recipients experienced serious adverse events
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No placebo group — only compared to Moderna’s original Spikevax
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No evidence of reduced illness, hospitalization or death — only neutralizing antibodies
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A “confirmed risk” of myocarditis and pericarditis, especially in males aged 12–24
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Persistent cardiac injury seen up to five months post-vaccination
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A statement in the label that the vaccine “might not work in some people”
“Myocardial cells do not regenerate,” Campbell said. “Those cells are lost for life. And yet we’re told these lesions are an acceptable risk?”
He added that trial design and safety oversight appear to be eroding. “I would not dream in clinical practice of giving a treatment with a 2.7% serious adverse event rate unless the patient was at death’s door,” he said.
The mNEXSPIKE shot also uses a radically different mRNA platform than previous COVID vaccines. According to scientist Dr. James Lyons-Weiler, the new self-amplifying* mRNA technology allows synthetic RNA to replicate inside the body — leading to heightened and prolonged protein expression.
“There is no baseline safety data for this new platform,” Lyons-Weiler wrote, warning the FDA’s approval could mark a regulatory disaster in the making.
Makis is demanding a total ban on the entire mRNA vaccine platform, including the 500+ experimental mRNA shots currently in development worldwide.
Canadian regulators often follow the FDA’s lead. With Ottawa already funding mRNA vaccine infrastructure and research partnerships, critics are urging Canadian health officials to draw the line now — before this risky platform becomes further entrenched.
We announced today that the U.S. FDA has approved mNEXSPIKE®, a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes… pic.twitter.com/RJ1CezICKZ— Moderna (@moderna_tx) May 31, 2025
Sources:
Dr. William Makis, COVID Intel Substack
Brenda Baletti, Ph.D., CHD’s The Defender
Dr. John Campbell, YouTube
Dr. James Lyons-Weiler, Popular Rationalism Substack
*Self-amplifying mRNA vaccines and self-replicating mRNA vaccines generally refer to the same concept — they both describe mRNA vaccines engineered to make copies of the mRNA inside the cell to produce more antigen protein, thereby potentially boosting immune response with a smaller initial dose. Regular mRNA vaccines that do not replicate once inside the cell.
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