RFK Jr. Orders Placebo-Controlled Testing for All New Vaccines — A Historic Policy Shift
In a landmark move, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that all new vaccines must undergo placebo-controlled clinical trials before being licensed — a major departure from decades of vaccine regulatory practice.
An HHS spokesperson confirmed to both The Defender and The Epoch Times that this new requirement will replace the long-standing method of testing vaccines against other vaccines or adjuvant-containing “placebos.” These older methods have drawn widespread criticism for obscuring safety signals by failing to use inert comparators.
Kennedy’s policy draws on long-held concerns that none of the vaccines on the CDC’s childhood schedule — except for the COVID-19 vaccines — were ever tested against a true placebo, a fact HHS acknowledged in a 2018 letter to the Informed Consent Action Network. This has left large gaps in knowledge about potential risks, particularly in children.
A Freeze on New Approvals
Since Kennedy took office in February 2025, no new vaccines have been approved by the FDA, which falls under HHS. One notable delay involved Novavax’s reformulated COVID-19 shot. Regulators cited the company’s reliance on outdated clinical trials, saying that “trials from four years ago… no longer suffice.”
Controversy Among Experts
The new policy has drawn both praise and alarm:
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CHD CEO Mary Holland hailed the move as “radical transparency” that could finally expose both the benefits and harms of vaccines.
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Cardiologist Dr. Peter McCullough called for independent safety monitoring boards and long-term follow-up, noting that “the public should have no tolerance for vaccines resulting in permanent disability and death.”
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Critics, including Dr. David Wohl of the University of North Carolina, argued the trials could be “unethical” in cases where effective vaccines already exist — a claim Kennedy supporters counter by pointing out the need for real safety science, especially with liability protections in place for manufacturers.
A Broken Surveillance System
Kennedy has also criticized the U.S. vaccine safety monitoring infrastructure, calling VAERS and the Vaccine Safety Datalink (VSD) “templates of regulatory malpractice.” An HHS spokesperson cited studies showing that VAERS captures only a small fraction of actual adverse events.
In response, the agency is now building a new post-market surveillance system designed to accurately measure both risks and benefits — a crucial step, according to Kennedy, in restoring public trust in vaccines.
COVID-19 Shot on the Chopping Block?
In a related development, Kennedy has suggested that the COVID-19 vaccine be removed from the CDC’s childhood immunization schedule, citing a lack of compelling data supporting its use in babies and young children. This position is reportedly backed by current FDA Commissioner Dr. Marty Makary, who recently stated there is a “void of data” on many 2025 COVID-19 booster products.
Why It Matters
This sweeping policy shift represents a return to scientific rigor in vaccine approval — requiring the same standard of evidence long applied to other pharmaceutical products. It may also signal a broader effort to reform an industry where safety has too often been assumed rather than proven.
With new oversight mechanisms, transparent trials, and a demand for data, Kennedy’s HHS is reshaping the future of immunization in the U.S. — and potentially the world.
Sources:
CHD’s The Defender
The Epoch Times
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