The Department of Health and Human Services (HHS) announced it will enact a new policy requiring placebo-controlled trials for all new vaccines.
The Washington Post reported on May 1 that HHS sent the outlet a statement that said, in part, “All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices.”
Placebo testing has long been the gold standard for safety testing of pharmaceutical products. Vaccines in current use have generally been tested against a control of another vaccine consisting of some of the ingredients used in the manufacture of the vaccine being tested, often including additives known as adjuvants to increase the drug’s potency.
Placebo Substitutes
“Until now, many vaccines—particularly those on the Centers for Disease Control and Prevention childhood immunization schedule—were licensed without being tested against an inert placebo,” said Maryanne Demasi, Ph.D., Australian investigative journalist.
“Instead of being compared to a neutral substance, they were often tested against another vaccine or an active ingredient, such as an aluminum adjuvant—making it nearly impossible to isolate genuine safety signals,” said Demasi.
“This approach defies basic scientific principles,” said Demasi. “An inert placebo group is essential to determine whether an adverse event is caused by the vaccine or would have occurred regardless. These vaccines are administered to perfectly healthy children, which means the safety threshold must be exceptionally high. Yet regulators have routinely accepted comparisons that obscure potential harms rather than clarify them.”
Implicit Admission of Failure
Demasi says criticism of the HHS statement, as reported by The Washington Post, reveals a “deep resistance to scientific transparency” and shows “deeply entrenched assumptions” that have allowed vaccines to evade the safety scrutiny required of other drugs.
“Paul Offit, co-inventor of a rotavirus vaccine and frequent media spokesperson on vaccine safety, warned, ‘You are watching the gradual dissolution of the vaccine infrastructure in this country. The goal is to make vaccines less available and less affordable,’” said Demasi.
That admission by Offit is a red flag, says Demasi.
“Let me be blunt: if your ‘infrastructure’ depends on avoiding gold-standard safety trials, then perhaps it deserves what’s coming,” said Demasi. “Offit’s statement isn’t a defense of science or public health; it’s an admission that the system cannot withstand scrutiny. He’s effectively arguing that vaccines must remain exempt from proper testing to stay commercially viable.”
Ethical Concerns
Driving the new policy is the idea that many adverse effects of new vaccines may not be observed if they are tested only against existing vaccines or adjuvants, as is generally the case with the vaccines in the childhood vaccine schedule. Using a different vaccine as a control in a study group fails to provide a true control, nor does it protect the test subject against the disease for which it is being tested, says Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
“They claim it is ‘unethical’ to deprive a subject in a study of a vaccine, but I don’t see how giving a different vaccine responds to that,” said Orient. “It is interesting to compare adverse effects of the new vaccine vs. the supposedly safe control. They may be about the same and very high compared with what saline would give.”
Using an adjuvant as a substitute for a placebo does not reveal the safety of a product if the adjuvant itself carries potential side effects, says Orient.
“Gardasil was supposedly tested against saline, but one subject got a very serious reaction: the placebo turned out not to be saline but rather the new adjuvant, which deliberately inflames the immune system,” said Orient. “Adjuvants, usually aluminum, are not well-tested and are much more reactogenic than the antigens, which don’t work well or are needed in much larger—and expensive—quantities without the adjuvant.”
Risk-Benefit Neglect
Given all these problems, rushing a vaccine into production using such shortcuts may cause more problems than it solves, says Orient
“Risks from a future pandemic are hypothetical, and vaccines are not very good in pandemics anyway,” said Orient. “Some say you should never vaccinate into an active pandemic. Risks to healthy experimental subjects are real, and there may be no benefit.”
Watching the Watchmen
With objections against the policy by individuals such as former FDA advisory board member Offit and Michael Osterholm, a University of Minnesota infectious-disease expert who served on President Joe Biden’s transition team being widely reported, Orient and others supporting full testing to ensure safety say it is a sign of the revolving door between regulators and the industries they oversee, a practice that can put the public at risk.
“Regulatory capture is a real issue,” said Orient. “Paul Offit is heavily conflicted, in my opinion. Most vaccines in the schedule are for currently rare diseases. Some are not readily transmissible and/or are treatable and/or preventable with post-exposure antibiotic prophylaxis.
“We need to work much harder on finding treatments,” said Orient. “Investigating repurposed drugs is the most efficient method. Better to treat people who are sick than to inject the whole population, who might never get sick but could suffer harm from a vaccine.”
Kevin Stone ([email protected]) writes from Arlington, Texas.
