Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is requiring all new vaccines to undergo placebo-controlled trials in a policy change the agency described as a “radical departure from past practices.”
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” an HHS spokesperson said to Fox News Digital on Thursday.
HHS suggested that childhood-recommended vaccines listed under the Center for Disease Control and Prevention, for instance, should be tested.
“Except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products,” the HHS spokesperson said.
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Placebo testing, which involves volunteers receiving dummy injections such as saline shots, is already a common practice for new pathogens. Updated versions of proven protective immunizations, however, often do not undergo new placebo trials and are instead tested against existing vaccines.
Some health experts have raised concerns about conducting placebo trials, arguing that such tests could expose people to illnesses that otherwise could have been prevented.
“Vaccine trial design can raise challenging ethical questions, especially regarding the use of placebo controls when an efficacious vaccine exists,” a 2014 World Health Organization report published on the National Institutes of Health’s website says.
The risks of using a placebo control may be ethically justified even when an efficacious vaccine exists if the trial is “in settings where vaccine supplies are limited, where vaccines remain investigational and/or where public health recommendations for use of these vaccines have not been made,” according to an article from the European Society of Clinical Microbiology and Infectious Diseases, also on the NIH website, citing a trial from a pharmaceutical company.
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HHS also claimed that the CDC has not been monitoring vaccine complications adequately, and criticized its current surveillance system.
“The CDC’s former practice of suppressing information about vaccine injuries has badly eroded trust in our public health agencies,” the agency said.
“The CDC’s own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries,” the HHS spokesperson said. “It’s a system that was designed to fail. The Vaccine Safety Datalink (VSD) — intended as a backup to VAERS — is virtually unusable for serious research. Both systems have become templates of regulatory malpractice.”
Kennedy, who has repeatedly said vaccines are not adequately tested for safety, is calling for greater transparency in its testing and approval process.
“Secretary Kennedy’s HHS has pledged radical transparency to the American public,” the spokesperson said. “This means being honest and straightforward about what we know — and what we don’t know — about medical products, including vaccines.”
“HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits — because real science demands both transparency and accountability,” the spokesperson added.
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