By Jill Erzen

Speaking March 23 at the Kennedy Center, attorney Aaron Siri called for sweeping changes to U.S. vaccine oversight. Siri said federal agencies have failed to ensure safety and transparency under a system that shields manufacturers from liability.

He pointed to “useless” clinical trials and growing rates of chronic illness in children as proof that the current approach isn’t working. He called on federal agencies to make specific changes, including releasing health data, strengthening study standards and restoring accountability for vaccine makers.

Siri homed in on the National Childhood Vaccine Injury Act of 1986, which largely protects vaccine makers from lawsuits and routes injury claims through a government compensation program.

Congress passed the law, sometimes referred to as the “Vaccine Act,” after significant numbers of vaccine injury claims led vaccine makers to threaten to stop making the products to avoid liability and expensive litigation.

The law, passed during the Reagan administration, fundamentally changed how vaccines are regulated and litigated in the U.S.

Siri said the Vaccine Act removed a key incentive to improve safety. Vaccines are “the only product in America” where families can’t sue a manufacturer for a safer design, he argued.

With vaccines, Congress “did something different,” Siri said. “It said to the companies, ‘You know what we’re going to do? Instead of making you create a better, safer product, we’re just going to make it so nobody can sue you.’”

That decision “broke the economic self-interest” that usually pushes companies to make products safer, he said.

‘All vaccine safety in America’ hinges on one section of 1986 law

Siri said Congress tried to balance liability protections by putting federal health agencies — especially the U.S. Department of Health and Human Services (HHS) — in charge of vaccine safety.

The Mandate for Safer Childhood Vaccines, a key section of the 1986 law, requires the HHS secretary to:

• Make vaccines as safe as possible.
• Create a task force on testing and manufacturing improvements.
• Report to Congress every two years.

“I view this one section of law as basically underpinning all vaccine safety in America,” Siri said. However, those requirements have largely gone unmet, he said.

Recent developments may signal a change. Siri noted that HHS Secretary Robert F. Kennedy Jr. has reinstated the task force for the first time in decades, which could mark a potential turning point if the group produces meaningful recommendations.

Siri called for several changes at HHS that he believes would restore trust and accountability:

• Ban the “revolving door”: Public health officials should commit to never working in related industries after leaving government.
• Release data: “HHS should be making available to the public all available health data” in deidentified form, he said.
• Enforce scientific transparency: “Design a study, post it, implement it, publish the results no matter what they show. That’s science,” Siri said.
• Emphasize accountability: Strengthen transparency and timeliness for public records requests and limit liability under the 1986 law. “If it’s not a routinely recommended vaccine … remove it from the Vaccine Injury Table and then the manufacturers could finally be held accountable like every other product,” he said.

FDA relying on ‘useless’ trials to approve vaccines

The U.S. Food and Drug Administration (FDA) says vaccines go through a “rigorous review” before approval. Siri challenged that claim, arguing that the underlying trials often fall short.

He pointed to problems like:

• Small study sizes.
• Short follow-up periods.
• Lack of true placebo control groups.

In one example, he cited a hepatitis B (Hep B) vaccine trial that followed 147 children for five days.

“There’s no way they license this product to be given to millions of babies based on that,” he said. “No control group … not enough kids in it. It’s useless.”

Yet, FDA records show the agency relied on that data to approve the vaccine, Siri said.

He also criticized trials that use other vaccines instead of inert placebos as controls. For example, Prevnar 7, a pneumococcal vaccine, was tested without a placebo group even though no prior vaccine existed at the time. “There was no ethical reason not to do one,” he said.

Siri cited concerns raised by FDA scientists in a Journal of the American Medical Association article describing trials where control groups received other experimental vaccines instead of placebos. The scientists “go on to lament” the research, he said.

By contrast, Siri highlighted a dengue vaccine trial that used a placebo control. It followed about 35,000 children over several years and identified higher risks of injury and death in certain groups. The dengue vaccine is not a covered vaccine, so “you can hold the manufacturer liable,” Siri said.

“This is the type of clinical trial that you would want,” he said, arguing that stronger safety trials happen when companies face liability.

He also cited The BMJ on flawed trials. “Studies destined to produce unreliable results should themselves be considered unethical,” according to the journal.

This is the case in “every single clinical trial relied upon to license” a routine childhood vaccine, Siri said. “They’re all, by this definition, unethical.”

He recommended changes at the FDA:

• Remove conflicted officials: “After you have unleashed these products on millions of children … unless you can publicly admit that you made a mistake, you’re going to be too conflicted to properly do your job going forward.”
• Notify doctors: “The FDA should be sending notice to every single practitioner, pediatrician, family doctor, OB-GYN of the details of each trial relied upon to license each routine injected childhood vaccine. They should know. They should understand. They could just pull up the package insert, but I’ve deposed endless pediatricians. They don’t know.”
• Set minimum standards for vaccine testing: “I mean real licensure standards, like what the controls should be, how long safety should be reviewed, proper blinding, so on and so forth. That doesn’t exist for vaccines, certainly not for childhood vaccines.”

‘CDC has not done its job when it comes to vaccine safety’

Siri directed some of his sharpest criticism at the Centers for Disease Control and Prevention (CDC), which monitors vaccine safety in the U.S.

He targeted the agency’s previously long-standing position that vaccines do not cause autism.

“It is the issue they say they have most thoroughly and completely studied more than any other vaccine injury,” Siri said. “So if they haven’t done that well, that probably reflects how well they’ve studied all the other injuries.”

Siri said he filed Freedom of Information Act requests and a lawsuit seeking studies showing that vaccines given in the first six months of life — like Hep B and DTaP — do not cause autism. He said the CDC did not produce any research directly addressing that question.

He also pointed to findings from the National Academy of Medicine, formerly the Institute of Medicine, which concluded there was insufficient evidence to confirm or reject links between vaccines and several health conditions, including autism, due to limited data.

In a deposition highlighted by Siri, vaccine expert Dr. Stanley Plotkin said he was “absolutely” comfortable assuring parents that vaccines don’t cause autism, even though the science fails to support that claim.

Siri also criticized how safety data is analyzed, saying studies rarely compare vaccinated and unvaccinated populations.

“They don’t want to actually compare exposed to unexposed, which is the way you would do rudimentary science,” he said. “The CDC has not done its job when it comes to vaccine safety.”

Siri suggested that the CDC:

• Remove officials: “Absent public contrition, remove anyone in CDC involved in … misleading reports or promotion of vaccines,” he said.
• Revise the immunization schedule: Remove all improperly licensed vaccines from the schedule, and classify all remaining vaccines as “shared clinical decision-making.” “Anybody should be able to still get a vaccine. It’s America, that’s freedom. … But the government shouldn’t be promoting them like a pom-pom cheerleader without proper evidence,” Siri said.
• Make data public: Expand public access to de-identified safety data, including the Vaccine Safety Datalink. “That’s a database of over 10 million Americans … along with their vaccination records,” Siri said. “It used to be housed at the CDC. … In 2001, they moved it out of the CDC so that you can’t get access to it. That should be reversed.”
• Increase transparency in research: Retract studies “where deidentified data is not made public within 60 days,” he said.

‘Explosion’ in childhood vaccines mirrors ‘explosion’ in health issues

Beyond specific agencies, Siri pointed to a broader concern: more childhood vaccines alongside rising chronic health issues like asthma, attention-deficit/hyperactivity disorder (ADHD) and allergies.

He said federal agencies haven’t fully studied possible connections.

“We have … an explosion in the vaccine schedule” alongside an “explosion in chronic health issues,” he said. “And our federal health authorities still can’t explain what’s causing it.”

At the same time, he emphasized that every kind of health risk matters.

“We should care about kids who are going to be hurt by infectious disease, but we also need to care about children who can be harmed by these products,” he said.

The federal government must “put the safety back on the industry” by lifting immunity and depoliticizing vaccines, Siri said.

“By mandating a vaccine, you make it political,” he said. “By using the argument that a vaccine is safe and effective to take away somebody’s civil individual rights, you made the safety and efficacy of that product a legal and a political issue.”

Watch Siri at the Kennedy Center here:

Video of my talk at the Kennedy Center this week in which I got to tell members of FDA, CDC, etc., the desperately needed changes they need to make!

(0:00) Intro by Senator Ron Johnson

(14:23) Aaron Siri Begins Presentation

(17:02) Why Vaccine Companies Can Kill With Impunity… pic.twitter.com/2LSj7LbnhO

— Aaron Siri (@AaronSiriSG) March 25, 2026

Related articles in The Defender

• Lawyers Threaten to Sue HHS Unless RFK Jr. Amends Vaccine Injury Table
• Babies Deserve More Protection Than Vaccine Makers, Aaron Siri Tells Joe Rogan
• Breaking: HHS Reinstates Task Force on Safer Childhood Vaccines in Response to Lawsuit Funded by Children’s Health Defense
• ‘Vaccines Do Not Cause Autism’ Claim Built on ‘House of Cards,’ Authors of New Review Say
• ‘A Giant Problem’: Experts Address ‘Massive Epidemic of Vaccine Injury’
• MAHA Commission Outlines Sweeping Agenda to Target Chronic Disease

The post Attorney Calls for Sweeping Vaccine Reforms, Citing ‘Useless’ Safety Studies appeared first on Children’s Health Defense.

 

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