A week after The BMJ exposed a broken vaccine safety alarm, the CDC quietly recommended mRNA shots for healthy infants, children and adults beyond what the FDA has approved.
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 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 This recommendation delivers neither, and it should be withdrawn today.”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 is calling on the CDC and HHS to:
- Withdraw the recommendations for healthy children and adults that exceed FDA approval.
- Limit federal COVID vaccine guidance to the groups the FDA has approved.
- Require randomized trials with clinical outcomes before recommending any mRNA vaccine for healthy people under 65.
- Give parents and patients plain-language information on benefits and known risks, including myocarditis.
- Disclose who approved the September 23 update and on what evidence.
The CDC guidance is available at cdc.gov. To arrange an interview with one of our doctors, contact [email protected].
