Source: Children’s Health Defense

The Informed Action Consent Network (ICAN) is calling on top federal health officials to adopt sweeping reforms aimed at increasing transparency and safety oversight of the nation’s vaccine system.

In a March 6 letter to U.S. Health Secretary Robert F. Kennedy Jr., U.S. Food and Drug Administration (FDA) Commissioner Marty Makary, and National Institutes of Health (NIH) Director Jay Bhattacharya, ICAN attorney Aaron Siri outlined the organization’s recommendations for the recently reinstated Task Force on Safer Childhood Vaccines.

The National Childhood Vaccine Injury Act of 1986 mandated top health officials create the task force to reduce vaccine adverse reactions and improve oversight of licensing, manufacturing, testing, labeling, distribution and safety monitoring.

The law charged the task force with reporting to Congress every two years on its progress, but the body was disbanded in 1998.

The U.S. Department of Health and Human Services (HHS) reinstated the task force in August 2025, in response to a lawsuit filed in May by attorney Ray Flores. The lawsuit alleged that Kennedy was violating the 1986 Act by failing to establish the task force. Children’s Health Defense (CHD) funded the lawsuit.

HHS reinstated the task force one day before it was legally obligated to respond to the lawsuit, and Flores dropped the case.

Flores told The Defender he was pleased that ICAN’s letter was drawing attention to the task force the lawsuit had succeeded in reviving.

“With all the focus on MAHA, I trust that the task force is quietly working behind the scenes to achieve its mandate for safer childhood vaccines. That should be the primary focus,” he added.

In its letter, ICAN said it “was pleased to see HHS’s announcement of the Task Force’s reinstatement.” ICAN offered comprehensive recommendations, which it argued HHS and its agencies must implement to fulfill the task force’s statutory obligations that amount to a revamp of the entire national vaccination program.  

Call for expanded data access

ICAN urged federal agencies to release health and vaccine-related datasets so independent researchers can conduct their own vaccine safety studies.

Anonymized data from federal health systems, including datasets from the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS) and several other federal surveillance systems should be made publicly available, it said.

Under ICAN’s proposal, agencies would also publish detailed study designs online before research begins, and later post full results on the same public webpage. If a study is discontinued before completion, the agency would need to explain why.

CHD Senior Research Scientist Karl Jablonowski has long called for greater access to study methods and vaccine-related public data for independent research and verification.

“A scientific conclusion is just an opinion until it is independently verified,” he said. “A lot of decisions are made in designing and executing a study, decisions that could drastically change the outcomes. One study yields an opinion, many studies agreeing yield a consensus.”

Greater transparency under the Freedom of Information Act

ICAN and CHD have faced significant opposition from the NIH, CDC and FDA when requesting vaccine safety data. CHD and ICAN have both sued the agencies to compel release of public information on COVID-19 vaccine clinical trials, adverse event reporting, and other vaccine injury data.

Several of those lawsuits have been languishing in the courts for years.

ICAN proposed that agencies eliminate existing backlogs of public records requests within 60 days, retrain staff on Freedom of Information Act (FOIA) compliance and allocate at least 1% of each agency’s budget to FOIA operations.

It also proposed that “Any Department employee who intentionally evades FOIA (through the use of private communication channels for official business, code words, deliberate misspellings, disappearing messages, etc.) is subject to termination.”

A congressional investigation in 2024 revealed that Dr. David Morens, a longtime aide to Dr. Anthony Fauci, engaged in these practices to conceal sensitive information from the public.

Morens deleted sensitive emails, conducted official business on a private email account, and worked with an administrator in the National Institute of Allergy and Infectious Diseases’ FOIA office to strategically misspell keywords that the public might request to be searched, the congressional committee alleged.

Addressing conflict-of-interest concerns

Another set of recommendations focused on reducing potential conflicts of interest between federal health officials and pharmaceutical companies.

ICAN suggested HHS ask — not require — federal employees and advisory committee members to pledge not to accept pharma compensation after leaving government service, and post their responses on agency websites where the public can see them. They also said the agencies should not hire anyone who formerly received funding from pharmaceutical companies.

This “revolving door” practice is common. For example, Dr. Julie Gerberding, former director of the CDC, became president of Merck’s vaccine division when she left the agency.

During her tenure at Merck, Gerberding accumulated over $100 million in personal wealth.

Peter Marks, M.D., Ph.D., who headed up the FDA’s Center for Biologics Evaluation and Research (CBER) during the COVID-19 pandemic, joined Eli Lilly as senior vice president of molecule discovery and head of infectious disease after he left the FDA in April 2025.

The ICAN letter further recommends limiting federal agencies’ ability to accept outside funding and restricting grants to organizations that receive pharmaceutical industry funding.

ICAN also recommended limiting NIH grants to studies on disease root causes, non-pharmaceutical prevention and research replication, and blocking NIH employees from receiving more than “one penny per year” in patent royalties on vaccine-related technology.

In a 2023 investigation, Adam Andrzejewski, founder of OpenTheBooks.com, reported that each year the NIH awards about $32 billion in grants to 54,000 healthcare entities — including pharmaceutical companies, universities and research organizations.

Through over 50,000 FOIA requests, Andrzejewski found that over the previous 12 years, $1.4 billion worth of those grants went back to NIH leadership and 2,400 NIH scientists in secret “third-party royalties” — royalties paid by pharmaceutical companies back to the NIH or its scientists who are credited as co-inventors of pharmaceutical products.

Ending mandates and ensuring vaccine safety

All mandates of any medical products or procedures by HHS agencies should be prohibited, ICAN said. And any mandates implemented by organizations outside of HHS — such as the president or Congress — should maintain an option for religious exemptions.

According to ICAN, the Centers for Medicare and Medicaid Services should restrict funding to states that do not provide for religious and medical exemptions to mandates. Currently, California, Connecticut, Maine, and New York do not allow religious exemptions. West Virginia’s executive order allowing such exemptions is currently being challenged.

ICAN also proposed that all CDC vaccine recommendations shift from “routine” guidance to “shared clinical decision-making” between doctors and patients.

ICAN proposed that the CDC recommend vaccines for the childhood immunization schedule only if they meet a series of new licensure standards, including randomized, double-blinded clinical trials with safety monitoring periods of up to four years for infants.

The group also called for large placebo-controlled trials, mandatory post-administration safety reviews, increased FDA inspections of manufacturing facilities and public disclosure of vial testing results.

Existing vaccines that cannot provide safety data under those proposed licensure standards within two years should be removed from the schedule, ICAN said.

The letter also called for stricter reporting requirements for adverse events following vaccination and improvements to VAERS.

Additionally, ICAN suggested that vaccine information statements provided to patients include more detailed descriptions of clinical trials, ingredient lists and post-marketing adverse events reported by manufacturers.

ICAN also called for expanding the National Vaccine Injury Compensation Program so it can serve as the “accessible and efficient forum” for timely compensation it was designed to be.

ICAN asked federal officials to share the letter with all members of the task force and to confirm whether it adopts the recommendations or to explain why it chooses not to.

HHS did not respond to The Defender’s inquiry about whether the task force or the agency intends to respond.

Related articles in The Defender

• Breaking: HHS Reinstates Task Force on Safer Childhood Vaccines in Response to Lawsuit Funded by Children’s Health Defense
• Lawsuit Targets HHS for Failing to Set Up Task Force on Childhood Vaccine Safety
• RFK Jr. Seeks Extra Time to Explore ‘Early Resolution’ in Vaccine Safety Lawsuit