IMA Calls on CDC to Immediately Withdraw ‘Off-Label’ COVID Vaccine Recommendation for Healthy Children and Adults A week after The BMJ exposed a broken vaccine safety alarm, the CDC (@CDCgov) quietly recommended mRNA shots for healthy infants, children and adults beyond what the FDA has approved. 
 WASHINGTON, D.C. – The Independent Medical Alliance (IMA), a national coalition of independent physicians, researchers and clinicians, today called on the CDC to immediately withdraw its new COVID-19 vaccine guidance for healthy Americans. On September 23, with no public announcement, the CDC updated its guidance to recommend a 2026–2027 COVID vaccine for all adults and, through "shared clinical decision-making," for healthy children as young as 6 months. The agency's own page labels some of these uses off-label, which is significant because it opens the door for a wider use with the weight of government institution backing. Doctors reserve the use of drugs off-label very cautiously and one patient at a time. When the CDC recommends an off-label use, it becomes the standard for everyone: insurers typically have to cover it, pharmacists in many states can give it without a prescription, and pediatric offices, schools and daycares follow the CDC's lead. The FDA approved this season's COVID vaccines only for adults 65 and older and for younger people with at least one condition that raises their risk of severe illness. The CDC's guidance goes far beyond that, to healthy infants, healthy children and young men ages 12 to 24, the group most at risk of vaccine-related myocarditis. "The CDC just went much further than the FDA with their advice regarding this experimental drug, and they did it without telling anyone," said Dr. Joseph Varon, President (@joevaron) and Chief Medical Officer of the Independent Medical Alliance. "There is zero evidence to support giving a healthy baby the mRNA shot, and there’s plenty of evidence to avoid it. This administration promised Americans informed consent and gold-standard science. This recommendation delivers neither, and it should be withdrawn today." Unanswered safety questions Late last year, FDA vaccine chief Dr. Vinay Prasad wrote in a memo to agency staff that an internal review found at least 10 children had died "after and because of receiving" the COVID vaccine. He called for randomized studies in every group before vaccines are recommended for them. No randomized trial has shown that COVID vaccination prevents severe illness or death in healthy children. Adverse event reports after COVID vaccination continue to come into VAERS, the federal reporting system. Last week, The BMJ reported that federal officials relied for more than a year on a VAERS analysis they had been warned could not detect myocarditis and other harms from the mRNA shots. Other countries are far more cautious. Britain's vaccine advisers say current COVID vaccines offer limited protection against mild infection and no evident protection against transmission. Denmark says only a small number of children need seasonal COVID vaccination. "Our healthcare must be founded on transparency and informed consent, and that means parents need honest numbers," continued Dr. Varon. "What's the benefit to a healthy one-year-old? What are the risks? The CDC doesn't say. Until it can answer with real trial data, it has no business recommending these shots for healthy children."

IMA Calls for Probe After CDC and FDA Relied on a Safety Alarm They Knew Was Broken Internal emails show FDA leaders were warned in early 2021 that the algorithm scanning COVID vaccine injury reports could not detect myocarditis and other harms from mRNA shots. Officials kept using it anyway and pointed to its silence as proof of safety. FULL STATEMENT: WASHINGTON, D.C. – The Independent Medical Alliance (IMA), a national coalition of independent physicians, researchers and clinicians, today called on Congress and the Justice Department (@TheJusticeDept) to investigate how the @CDCgov and @FDA handled COVID vaccine safety surveillance. The call follows an investigation published in The BMJ @bmj_latest (formerly British Medical Journal) by reporter David Willman. Willman reconstructed the first year of the mRNA rollout using internal government emails released under the Freedom of Information Act and to U.S. Senate investigators. The CDC promoted its Vaccine Adverse Event Reporting System (VAERS) as "the nation's frontline system" and "the early warning system for detecting possible vaccine safety problems." Behind the scenes, federal officials had been told that the method used to analyze those reports could not reliably detect harm from the two dominant mRNA products. They did not fix the method. They told the FDA scientist who offered a fix to stand down. Then they cited the absence of alerts as public reassurance. One reason given in writing for leaving the method alone: a change could have "unintended consequences" for "vaccine confidence." "Frontline doctors like me were seeing these injuries in growing numbers. When we raised the alarm, we were dismissed because the 'official data' said otherwise," said Dr. Joseph Varon (@joevaron), President and Chief Medical Officer of the Independent Medical Alliance. "Now we know that data came from a tool the FDA had been warned was blind. This is a failure of our public health system that may well rise to criminal negligence, and patients paid the price." What The BMJ found Two methods were supposed to run side by side: the CDC's proportional reporting ratios (PRR) and the FDA's empirical Bayesian data mining, with the agencies sharing results. In a little-noticed September 2022 letter, CDC Director Rochelle Walensky said her agency did not run PRR analyses until 2022, more than a year into the vaccination campaign. Both agencies, she wrote, "chose to rely" on the FDA's Bayesian method, which she called "a more robust technique." In the weekly FDA reports The BMJ reviewed, that Bayesian method never signaled for myocarditis, pericarditis or tinnitus. The problem was a statistical effect called masking. In the first year, more than 90 percent of VAERS reports involved the two mRNA shots, so the algorithm was in effect comparing Pfizer against Moderna. If both raised the risk of the same injury, the elevated rate looked normal, and no alert fired. Timeline February 2021: FDA medical officer Dr. Ana Szarfman emailed Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and the government's top COVID vaccine regulator. She urged the agency to fix its monitoring and offered an updated algorithm developed by statistician William DuMouchel, who had designed the original Bayesian method the FDA was using. Late February 2021: The CDC and FDA received notice from Israel's Ministry of Health of a large number of myocarditis reports in young people after vaccination. Two weeks after Szarfman's email: Marks's office held a video conference with Szarfman. Her slides showed the PRR method lighting up with signals and the FDA's Bayesian method showing almost none: "You are not getting useful information with such low counts." DuMouchel's updated method, first published in 2012, caught signals without burying investigators in false alarms. Marks and his staff declined to change the FDA's approach. Spring 2021: Israeli officials told a CDC-convened safety committee that two of 77 vaccinated patients with myocarditis or pericarditis had died. The following week, the Pentagon's Defense Health Agency told the same committee about a cluster of myocarditis cases among male service members. April 27, 2021: Walensky told reporters, "We have not seen a signal [for myocarditis], and we've actually looked intentionally for the signal in the over 200 million doses we've given." May 7, 2021: Craig Zinderman, an FDA medical policy official, asked Szarfman to "please hold off on creating and sending data mining reports and analyses using COVID-19 vaccine AE [adverse event] data." Adjusting the method mid-campaign, he wrote, "could lead to confusion and have unintended consequences (eg, regarding vaccine confidence)." June 2021: A CDC presentation showed VAERS myocarditis and pericarditis reports in males ages 12 to 24 running 29 to 347 times higher than expected. The day before, Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, received the FDA's latest data-mining report, which still showed no alert. He emailed a colleague: "I'm perplexed that myocarditis isn't alerting for either of the mRNA vaccines." September 15, 2021: After Szarfman kept pressing, Marks wrote to his counterpart at the FDA's drug center that she had been asked to "cease and desist, because the strategy that she is using could create erroneous conflicts that feed into anti-vaccination rhetoric." 2022: When the CDC finally ran its PRR analyses, myocarditis, pericarditis, Bell's palsy and tinnitus met the agency's own signal criteria in all 13 consecutive weekly reports from May 6 to July 29. Hundreds of other event types also crossed the threshold. Walensky nonetheless wrote that the results were "generally consistent" with the Bayesian findings and revealed "no additional unexpected safety signals." The worksheets The BMJ examined do not support that description. October 2023: Dr. Narayan Nair, head of the FDA's vaccine pharmacovigilance division, wrote to CDC and FDA colleagues: "We were aware of this [data mining] limitation before and during the pandemic." "Officials protected the safety narrative instead of protecting patients," continued Varon. "They served the industry, not the individual. Groups like the American Medical Association and the American Academy of Pediatrics joined the chorus to drown out frontline doctors. It is long past time for Congress and the Justice Department to find out how this happened and why. It must never happen again."

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'How Genomics Can Guide Clinical Care for Long COVID/Long Vax' On this week's show, IMA President and Chief Medical Officer Dr. Joseph Varon (@joevaron) was joined by special guest Dr. Sharon Hausman-Cohen for an important discussion on how genomic testing may help clinicians identify biological pathways contributing to symptoms of Long COVID and Long Vax—and how those insights may help inform more personalized approaches to care. Watch now.

Read IMA's statement on the new issue of the Journal of Independent Medicine (@JIndepMed): imahealth.org/journal-of-ind… Find all issues of the Journal: JournalofIndependentMedicine…

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Don't miss next week's IMA show, 'Moderna's mRNA Flu Shot Under Scrutiny,' with host Dr. @joevaron and special guests Dr. Peter McCullough (@P_McCulloughMD), @NicHulscher, and Dr. John Catanzaro (@Docjohnc)—co-authors of a new paper published in the Journal of Independent Medicine (@JIndepMed), 'Reanalysis of FDA Clinical Data for mFLUSIVA (mRNA-1010).' Don't miss it! Wednesday, September 30 at 7pm ET.

How Genomics can Guide Clinical Care for Long COVID/Long Vax nitter.net/i/broadcasts/1RJZzBbyp…

🚨 BREAKING: Moderna’s mRNA Flu Shot Under Scrutiny Nicolas Hulscher (@NicHulscher) joins @drdrew to discuss his new paper, 'Reanalysis of FDA Clinical Data for mFLUSIVA (mRNA-1010),' co-authored with Dr. Peter McCullough (@P_McCulloughMD) and Dr. John A. Catanzaro (@Docjohnc) and published in the new issue of the Journal of Independent Medicine (@JIndepMed). The authors will join IMA President and Chief Medical Officer Dr. @joevaron on IMA's weekly show next Wednesday, September 30th at 7pm ET for an important discussion on the findings of their paper. Find links to register and read the full paper in the Journal - links below. 🔽

Don't miss next week's IMA show, 'Moderna’s mRNA Flu Shot Under Scrutiny,' with host Dr. @joevaron and special guests and co-authors of a new paper published @JIndepMed, 'Reanalysis of FDA Clinical Data for mFLUSIVA (mRNA-1010),' for an importand discussion on their findings. Wednesday, September 30th at 7pm ET. Register now: geni.us/register-for-webinar…

THIS WEEK: How Genomics Can Guide Clinical Care for Long COVID/Long Vax On this week's show, IMA President and Chief Medical Officer Dr. Joseph Varon (@joevaron) will be joined by special guest Dr. Sharon Hausman-Cohen for a discussion on how genomic testing may help clinicians identify biological pathways contributing to symptoms of Long COVID and Long Vax—and how those insights may help inform more personalized approaches to care. Don't miss it! Wednesday, September 23rd at 7pm ET. Livestream here on X!

Journal of Independent Medicine Features Global Scientific Perspectives in New Issue Volume 2, No. 5 brings together U.S. and international researchers to examine emerging questions in medicine, including a new reanalysis of FDA data co-authored by Dr. Peter McCullough Washington, D.C. (Sept 22, 2026) — The Independent Medical Alliance (IMA) today announced the publication of Volume 2, No. 5 of the Journal of Independent Medicine (JIM), continuing the journal’s growing international reach and its mission to advance rigorous, conflict-free scientific inquiry through collaboration among physicians, researchers, and experts from around the world. This latest issue reflects an increasingly global scientific community examining health challenges that extend far beyond national borders. Its ten articles span metabolic health and fasting, cancer biology, COVID-19 public health policy, pharmacovigilance, vaccine regulatory science, cardiovascular pathology, dermatology, medical publishing, and freedom of scientific discourse. “Medicine has always advanced when physicians and scientists learn from one another, and today that conversation must be global,” said Joseph Varon (@joevaron), MD, Editor-in-Chief of the Journal of Independent Medicine (@JIndepMed) and President and Chief Medical Officer of IMA. “The challenges facing patients do not stop at borders, and neither should scientific inquiry. As IMA continues to expand its international relationships, the Journal gives experts from different countries, specialties, and clinical environments a place to bring their observations and research into the same conversation—grounded in evidence, transparency, and a shared commitment to patients.” One of the issue’s featured original investigations is “Reanalysis of FDA Clinical Data for mFLUSIVA (mRNA-1010),” by Nicolas Hulscher (@NicHulscher), Peter A. McCullough, MD (@P_McCulloughMD), and John A. Catanzaro (@Docjohnc). The authors reexamine regulatory and clinical-trial data from Moderna’s (@moderna_tx) recently approved mRNA influenza vaccine, using absolute benefit-risk measures to evaluate efficacy, adverse events, evidentiary basis and question the vaccine’s overall benefit-risk profile and argue that their findings warrant further scrutiny of its continued licensure. The breadth of the new issue also underscores an important distinction at the heart of IMA’s approach to scientific independence: independent medicine does not mean working alone. “Scientific independence should expand the conversation, not narrow it,” Varon added. “When researchers with different backgrounds and perspectives can examine evidence openly, challenge assumptions, and publish findings without commercial or political pressure, science becomes stronger. That is what Honest Medicine is about, and it is exactly the kind of international scientific community we want this Journal to continue building.” Read the full statement and find Volume 2, No. 5 and all previous issues of the Journal of Independent Medicine - links below. 🔽

NEW ISSUE OF THE JOURNAL OF INDEPENDENT MEDICINE: Independent Research. Global Perspectives. A Wide Range of Medicine. Journal of Independent Medicine (@jindepmed) Editor-in-Chief Dr. Joseph Varon (@joevaron) gives an overview of the latest issue, featuring review articles and original research on autophagy, COVID-19, mRNA flu vaccines, spike protein and blood clots, integrative cancer care, melatonin and hair loss, and more. Watch now. Links to the full statement and all issues of the Journal below. 🔽

What Are We Losing When Medicine Moves Away From the Bedside? In his latest @brownstoneinst article, IMA President and Chief Medical Officer Dr. Joseph Varon (@joevaron) examines what medicine risks losing when screens, tests, and technology begin to replace bedside observation, physical examination, and human connection. Read now—link below. 🔽

Don't miss next week's IMA show! 'How Genomics Can Guide Clinical Care for Long COVID/Long Vax' with host Dr. @joevaron and special guest Dr. Sharon Hausman-Cohen. Wednesday, September 23 at 7pm ET.

Dr. Joseph Varon: Medicine Has Forgotten How to Touch the Patient Read IMA President and Chief Medical Officer Dr. Joseph Varon's (@joevaron) latest @brownstoneinst - link below. 🔽

My most recent OpEd published by the Brownstone Institute. Medicine Has Forgotten How to Touch the Patient brownstone.org/articles/medi…

Have we created the most technologically advanced medicine in history, while simultaneously forgetting how to practice medicine? ~@joevaron Medicine Has Forgotten How to Touch the Patient brownstone.org/articles/medi…

Who should control your medical decisions: you and your doctor, or hospitals, insurers, pharmaceutical companies, and government? @joevaron makes the case for taking medicine back from the institutions that have seized control of it. Watch his full speech at @polyface_farms: nitter.net/brownstoneinst/status/…

This 34-year old woman with breast cancer refused chemotherapy and radiation. She chose ivermectin, marijuana, and the right to make her own medical decisions. And 8 months later, her massive tumor was gone. Dr. Joseph Varon: “Can I tell you it was the ivermectin?” “I can’t. I’m a scientist.” “Was it the ivermectin? Was it the marijuana?” “Yet this woman had, from my standpoint, the Right to Try.” @joevaron @honest_medicine @Polyface_Farms