Source: Children’s Health Defense

All new vaccines will have to be tested against a placebo before they can be approved, the U.S. Department of Health and Human Services (HHS) confirmed to The Washington Post on Wednesday.

An HHS spokesperson told The Defender that in “a radical departure from past practices,” the agency will set a new rule. “All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.”

The news drew both praise and criticism, with the Post citing medical experts who said testing vaccines against a placebo “could limit access to vaccines and undermine the public’s trust in immunization” and that the rule “could be unethical” because people in the placebo group wouldn’t receive an effective intervention.

Calley Means, an adviser to HHS Secretary Robert F. Kennedy Jr., questioned why “‘health experts’ would be alarmed at conducting science on new drugs?”

Can someone please explain to me why “health experts” would be alarmed at conducting science on new drugs? pic.twitter.com/7GfOQxxkjo

— Calley Means (@calleymeans) May 1, 2025

The Post stated that “many vaccines have been tested against placebos,” but didn’t name any of those vaccines, other than the COVID-19 vaccine.

Children’s Health Defense (CHD) CEO Mary Holland was among those who praised the decision. She said:

“Requiring placebo-controlled trials for vaccine approvals is more of the ‘radical transparency’ HHS Secretary Robert F. Kennedy Jr. promised us.

“These trials will tell us more about the true efficacy of vaccines and help identify any harm they might cause. This is a first for our country and another welcome advancement from the administration in protecting our children.”

Kennedy has history of criticizing vaccine testing in U.S.

Kennedy has for years raised concerns that, apart from the COVID-19 vaccines, no other vaccines listed on the Centers for Disease Control and Prevention’s (CDC) child and adolescent immunization schedule have ever undergone placebo-controlled trials.

Placebo-controlled trials, where a drug is tested against an inert substance like saline solution, are considered the gold standard for evaluating the safety of most pharmaceutical products.

However, vaccines licensed in the U.S. are typically tested against other vaccines, or against a so-called “placebo” that contains the same ingredients as the vaccine being tested, often including adjuvants to increase the drug’s potency.

This type of testing makes it nearly impossible to effectively evaluate the vaccines for safety because everyone in the trials is exposed to some of the same ingredients that could cause adverse events, explained CHD Senior Research Scientist Karl Jablonowski.

Cardiologist Dr. Peter McCullough said such testing is standard practice for drug safety and should already have been in place for vaccines.

“All new vaccine products and combinations of existing vaccines should be tested in large prospective, double-blind, randomized, placebo-controlled, parallel group trials with long-term outcomes,” McCullough said. “This is standard for pharmaceuticals and it should be no different for vaccines.”

McCullough also suggested that HHS establish an oversight infrastructure to evaluate the outcomes of the placebo-controlled testing. He said:

”Adverse and serious adverse events, as well as efficacy endpoints, like hospitalization and death, should be adjudicated by endpoint committees. Data safety monitoring boards should be in place, fully independent of the sponsor, with authorization to stop trials for safety concerns and futility.”

McCullough also said the “public should have no tolerance for vaccines resulting in permanent disability and death making their way onto the market.”

In the post-marketing period, independent safety committees should be in place and empowered to recommend product withdrawal if serious adverse events emerge after large-scale use, he said. “Such safety mechanisms should be in place for at least 5-15 years.”

But Dr. David Wohl, of the University of North Carolina at Chapel Hill’s Division of Infectious Diseases, who worked on Pfizer’s COVID-19 vaccine, told The Epoch Times he believes placebo-controlled trials aren’t ethical for infectious diseases for which there are vaccines.

“For infections where a vaccine does not exist, a placebo can be considered,” he said.

Daniel O’Connor, founder and publisher of Trial Site News, said any discussion of placebo-controlled trials has to be nuanced.

“Placebo-controlled trials are the gold standard for scientific rigor, but when applied universally without regard to disease context or existing alternatives, they can potentially risk delaying life-saving vaccines.”

O’Connor suggested that a “risk-based approach — requiring placebo use for novel pathogens while allowing adaptive designs for well-understood diseases — balances transparency with ethical and practical realities.”

“To the extent there are vaccines that are suspected of serious safety signals, they should be considered for the placebo group in keeping with Secretary Kennedy’s safety mission,” he added.

Will new rule affect COVID vaccines?

The agency didn’t specify how or when the change would go into effect, or whether it would apply to the COVID-19 booster shots.

The news followed remarks Tuesday by U.S. Food and Drug Administration (FDA) Commissioner Marty Makary that his agency is still considering whether to approve COVID-19 vaccines for this winter, citing a lack of data on booster shots.

In an interview with CBS, Makary said the agency has received “a bunch of applications” from COVID-19 vaccine manufacturers for their 2025 booster products, but that he thought there was “a void of data” for many of them.

The FDA also recently rejected Novavax’s application for a license for its COVID-19 vaccine. The agency asked the vaccine maker to do clinical studies on its product.

Makary’s comments came a week after internal sources told Politico that Kennedy is advocating to remove the COVID-19 shot from the CDC’s list of recommended vaccines for children, arguing there is little scientific evidence that the shot provides a benefit to babies and young children.

Related articles in The Defender

• RFK Jr. Wants CDC to Stop Recommending COVID Shots for Kids, Inside Sources Say
• Kennedy Hits Pause on COVID Vaccine Project Worth Hundreds of Millions
• RFK Jr. Proves HHS is in Violation of Vaccine Safety Requirements Under the Law — “Mandate for Safer Childhood Vaccines”
• Why Won’t the CDC Do Proper Safety Trials on Childhood Vaccines? Follow the Money.
• ‘Vax-Unvax: Let the Science Speak’ — Why RFK Jr. and I Wrote This Book