AI generated imageBy TrialSite News <div data-rt-embed-type='true'>Illinois Gov. JB Pritzker has issued a sweeping executive order barring state agencies from collecting or sharing autism-related data unless narrowly required by law, claiming the move protects the rights and privacy of individuals with autism.
The order is a direct rebuke to a new federal initiative — backed by U.S. Secretary of Health and Human Services (HHS) <a href="https://childrenshealthdefense.org/defender/rfk-jr-hhs-launch-research-autism-epidemic/">Robert F. Kennedy Jr.</a> — to create a large-scale <a href="https://childrenshealthdefense.org/defender/nih-health-records-public-private-databases-study-autism/">autism database</a> using Medicare and Medicaid data to better understand diagnosis trends, treatment outcomes and access disparities.
The stakes are high. Rates of <a href="https://childrenshealthdefense.org/defender/autism-prevalence-rise-1-in-31-cdc-study/">autism spectrum disorder</a> (ASD) diagnoses have climbed dramatically over the past two decades, prompting calls from both researchers and families for more robust epidemiological and outcomes data.
Kennedy’s initiative, developed in collaboration with the <a href="https://childrenshealthdefense.org/defender_category/nih/">National Institutes of Health</a> and the Centers for Medicare &amp; Medicaid Services, aims to build a national “real-world data” platform incorporating claims data, electronic health records and other health information, including wearable device metrics.
Yet in a surprise move, Pritzker has shut Illinois out of the effort entirely, fueling a growing controversy that pits privacy against scientific transparency and, arguably, political maneuvering.
An act of protection — or obstruction?
Pritzker framed his order as a necessary defense of individual liberty.
“Every Illinoisan deserves dignity, privacy, and the freedom to live without fear of surveillance or discrimination,” he said, characterizing the federal database as a potential <a href="https://childrenshealthdefense.org/defender_category/censorship-surveillance/">surveillance</a> threat linked to President Donald Trump-era policies.
The executive order bars any autism-related data collection by state agencies unless fully HIPAA-compliant and strictly necessary for service delivery. Even then, personally identifiable data may only be shared externally under narrow conditions, including court orders or written consent.
Several Illinois-based advocacy organizations — including The Autism Program of Illinois, the Southern Illinois Autism Society and the Autistic Self Advocacy Network — backed the order.
Hope, a Springfield-based service provider, praised Pritzker for taking a stand “against reducing individuals to data points.”
Critics of the federal initiative argue that autism research has a history of stigmatization, and that any national database — especially one involving politically sensitive actors — could enable discrimination or future restrictions in education, employment or healthcare.
What’s really driving the pushback?
But the timing and framing of the executive order have raised eyebrows. Is the governor genuinely concerned about medical privacy — or is he politicizing <a href="https://childrenshealthdefense.org/defender_category/autism-health-conditions/">autism</a> to score points against a Trump-Kennedy alliance?
It’s worth noting that the federal program, led by Kennedy, explicitly states it will comply with all privacy regulations. Kennedy himself emphasized the goal of transparency, accountability and long-overdue answers for families living with autism.
TrialSite News has previously reported on the broad scientific consensus that ASD research suffers from fragmented data, delayed diagnoses and inconsistent care — especially in underserved and minority communities.
A centralized database could help resolve longstanding gaps in real-world evidence and inform policy for everything from early intervention to Medicaid coverage rules.
Moreover, critics argue that invoking privacy in this case may be a red herring. Medical records, Medicaid claims and anonymized epidemiological data are already collected under HIPAA.
Most health surveillance data — including that used to track cancer incidence, opioid abuse or vaccine adverse events — is collected in similar ways and rarely provokes such sweeping executive interventions.
The question remains: why is autism different?
A troubling precedent for science and policy?
If Pritzker’s order stands, it may set a precedent for other states to opt out of national health data initiatives based on speculative privacy claims or ideological objections.
That could hinder efforts to track emerging health crises or evaluate long-term treatment safety and effectiveness. It also undercuts scientific independence by implying that autism research tied to federal agencies — or political figures — should be viewed with inherent suspicion.
Meanwhile, the autism rate continues to climb. According to the CDC, 1 in 36 children in the U.S. were diagnosed with ASD by age 8 in 2020, up from 1 in 150 in 2000. Some researchers argue that this steep rise, even accounting for increased awareness and diagnostic shifts, demands urgent and comprehensive investigation.
TrialSite News has covered the limitations of current data silos in understanding the interplay of environmental, genetic and pharmaceutical factors in ASD — issues that a federated research database might help resolve.
Pritzker’s order, though popular with some advocacy groups, risks alienating families who want answers. It also sends a chilling message to scientists that <a href="https://childrenshealthdefense.org/defender_category/health/">health policy</a> data collection can be blocked at the state level based on fears of discrimination, however unfounded or speculative.
While the protection of individual privacy is paramount, the order conflates informed consent with the rejection of institutional research and raises questions about whether political rivalry is taking precedence over evidence-based inquiry.
Conclusion
At its core, this battle is about who gets to define the boundaries of ethical research and whether political polarization should shape public health science. Pritzker has positioned himself as a defender of privacy, but critics see an opportunistic move to stoke distrust against the Trump-Kennedy administration.
According to TrialSite News founder and publisher <a href="https://www.linkedin.com/in/oconnordaniel/">Daniel O’Connor</a>, “This move by Pritzker is very questionable, interfering with federal research programs seeking answers — and adhering to existing privacy protection laws.”
Kennedy, for his part, must now decide how to navigate resistance from states like Illinois while advancing what many scientists consider an overdue and essential autism research infrastructure.
TrialSite News will continue monitoring the legal, political and ethical fallout of this executive order as it reverberates through the autism research community and beyond.
Originally published by <a href="https://www.trialsitenews.com/a/illinois-governor-blocks-federal-autism-data-projecta-blow-for-privacy-or-a-political-smokescreen-dc9bff4e">TrialSite News</a>. </div>TrialSite News is the only digital media dedicated 100% to transparent and open coverage of medical research and developments from around the globe. This article was <a href="https://childrenshealthdefense.org/defender/illinois-governor-blocks-agencies-collecting-data-national-autism-project/" id="">originally published by The Defender</a> — Children’s Health Defense’s News &amp; Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider<a href="https://childrenshealthdefense.org/about-us/sign-up/" id=""> subscribing to The Defender</a> or<a href="https://childrenshealthdefense.org/about-us/donate/" id=""> donating to Children’s Health Defense</a>.&nbsp;&nbsp;‍

Illinois Governor Blocks Agencies From Collecting Data for National Autism Project  

What’s His Motivation?

<figure class="w-richtext-figure-type-video w-richtext-align-center" style="padding-bottom:" data-rt-type="video" data-rt-align="center" data-rt-max-width="" data-rt-max-height="" data-rt-dimensions="" data-page-url=""><div><iframe src="https://play.ht/embed/?article_url=https://play.ht/drafts/VNtZn92Yxve7RsXivZySefxGa2k2/gK2Gz8ymg&voice=en-US-Wavenet-J" scrolling="no" frameborder="0" allowfullscreen=""></iframe></div></figure>By Bert OlivierI have <a href="https://www.frontnieuws.com/zullen-alle-recente-onthullingen-over-het-dodental-van-de-covid-injecties-enige-gerechtigheid-brengen/" id="">previously</a> wondered whether the recent (and continuing) revelations about the Covid injections’ death toll would bring any justice. Given the rapidly increasing number of studies and reports concerning the rising death toll that may arguably be causally linked to the so-called Covid ‘vaccines,’ one can therefore quite reasonably ask: why has there still been no concrete attempt to prosecute the pharmaceutical companies and individuals who were directly involved with the manufacture and promotion of these potentially (and in millions of cases actually) lethal shots? In light of these studies, it is hardly surprising that many people are raising critical questions about the perceptible consequences of the jabs. Just today, I read an <a href="https://usawatchdog.com/government-admits-it-knew-covid-vax-shots-were-fraud-president-trump-pull-them-off-the-market-karen-kingston/" id="">article</a> titled ‘Government Admits it Knew Covid Vax Shots were Fraud – President Trump, Pull Them Off the Market! – Karen Kingston.’ Greg Hunter, who interviewed Kingston, writes:<blockquote id="">Karen Kingston is a biotech analyst and former Pfizer employee who is back with some grotesque news about what the US government knew about the CV19 bioweapon vax. &nbsp;They knew it was not safe at all, and the FDA also knew Pfizer committed fraud to get the CV19 injections approved. &nbsp;Kingston says, <a href="https://karenkingston.substack.com/p/is-it-legal-for-the-us-government?utm_source=post-email-title&publication_id=1103773&post_id=162630850&utm_campaign=email-post-title&isFreemail=true&r=35fk8s&triedRedirect=true&utm_medium=email" id="">‘This is the government’s words exactly: &nbsp;“The FDA was aware of the protocol violations.”’</a> &nbsp;So, the FDA was aware of the fraud that was reported . . . before it granted emergency use authorization (EUA) for its vaccine. &nbsp;They were aware of the fraud. </blockquote>The cat is out of the bag as far as the US government’s tacit, unacknowledged awareness of the dangers attached to the Covid ‘vaccines’ is concerned. In light of the confirmation of these dangers in numerous studies, in retrospect, the reports of mortality rates and other indications of injury would appear to provide further confirmation – all that should be needed to prosecute those responsible, such as Bill <a href="https://www.infowars.com/posts/breaking-video-bill-gates-defends-himself-against-documented-charges-of-genocide-and-apologizes-for-working-closely-with-jeffrey-epstein" id="">Gates</a>, on whom I have written <a href="https://brownstone.org/articles/when-psychopathic-is-no-exaggeration/" id="">here</a> before. Dr Joseph <a href="https://josephsansone.substack.com/p/depopulation-food-shortages-real" id="">Sansone</a> reports as follows on one of these studies:<blockquote id="">The mRNA nanoparticle injections are associated with neurological disorders, autoimmune diseases, heart problems, strokes, cancers, metabolic disorders, and a host of other diseases and disorders, including death. One need not be a scientist or medical doctor to figure out that by giving people chronic diseases and illnesses, that you are shortening their life spans. A recent study was published showing a <a href="https://x.com/stkirsch/status/1807879912059199919" id="">shocking 37% decrease in life span after COVID injections</a>. If this data is extrapolated out over the course of a life span that would mean an approximate <a href="https://slaynews.com/news/3-decades-wiped-life-expectancy-covid-vaxxed/" id="">29 year reduction in life span</a>.</blockquote>Needless to point out, this information is nowhere to be found in the mainstream media, which does not seem to matter any longer, given the plethora of alternative news and discussion sites available to people doing their own research, as long as one remembers to cross-check information, to the fullest possible extent, before accepting its accuracy.The studies in question are, in most cases I have investigated, published in reputable journals, such as <a href="https://link.springer.com/article/10.1007/s44337-025-00274-0" id="">this one</a>, which appeared in Springer’s Discover Medicine journal. In the author’s discussion of ‘problems associated with mRNA vaccines,’ one reads:In Japan, a 26-year-old healthcare worker reportedly died of a brain hemorrhage 4 days after receiving a single dose of the mRNA vaccine early in the vaccination campaign. This case was potentially linked to vaccine-induced immune thrombotic thrombocytopenia. Despite this, the vaccination program continued, becoming nearly mandatory. &nbsp; &nbsp;The publication of an article on the adverse effects of COVID-19 vaccines in the Virology Journal &nbsp;marked a turning point, halting further vaccinations worldwide after June 2022. This is because, for the first time, in the peer-reviewed article, the cause of the immunodeficiency was clearly presented, a request was made to discontinue the booster mRNA vaccination, and the information was spread worldwide through social networking sites and other means. Although a new type of mRNA vaccine was approved afterward, Japan remains the only country actively vaccinating its population. [This claim is questionable, in my view. B.O.] Despite the declining number of vaccinators, the routine administration of the eighth coronavirus vaccine dose for older adults began in October 2024.It beggars the imagination that in a country where the population seems to have been wide awake regarding the dangers of these jabs, the authorities have forged ahead with their ‘vaccination’ programme regardless. In <a href="https://rumble.com/v5dgzzp-japan-warns-covid-vaccines-causing-global-population-collapse.html" id="">this video</a>, for example, we are informed that Japanese scientists have raised the alarm about signs that Covid ‘vaccines’ are ‘causing a global population collapse.’ In addition to this, a new Japanese <a href="https://rumble.com/v6mnlyi-new-japanese-cancer-study-reveals-more-covid-vaccine-risks-kevin-mckernan.html" id="">cancer study</a> has disclosed the links between the Covid vax and cancer. In a summary of the video discussion of this alarming evidence, it is stated that:<blockquote id="">Kevin McKernan discusses new Japanese research revealing alarming cancer mortality patterns following mRNA vaccination. The study shows how vaccine-induced cancer profiles completely shifted, with tumors appearing where lipid nanoparticles accumulate. McKernan analyzes pharmaceutical corruption, regulatory capture, and the Bradford Hill criteria supporting causation. The conversation explores RFK Jr.’s HHS appointment, treatment alternatives including cannabinoids and psilocybin, problematic hemp regulation, SSRI dangers, and self-amplifying vaccine risks. McKernan details how excess mortality post-vaccination in Japan now surpasses their 2011 tsunami death toll.</blockquote>Small wonder that Japan has launched an ‘official <a href="https://rumble.com/v23pxww-japan-launches-official-investigation-into-millions-of-covid-vaccine-deaths.html" id="">investigation</a> into the unprecedented numbers (said to run into millions) of people dying after receiving the Covid-19 vaccination.’ It is puzzling that a country where such a consequential step can be taken, can at the same time (as stated in the Springer study referenced earlier) continue unabated with its mRNA ‘vaccination’ programme, despite the most <a href="https://rumble.com/v4sei96-japans-most-senior-oncologist-condemns-mrna-vaccines-as-evil-practices-of-s.html" id="">senior oncologist</a> in the country referring to the mRNA ‘vaccinations’ as ‘evil practices.’ In 2024 already, Japanese <a href="https://rumble.com/v5doie1-international-public-notice-japanese-research-links-201-diseases-to-covid-i.html" id="">research</a> connected no fewer than 201 diseases with the Covid injections. Add to this that the Pfizer mRNA ‘vaccine’ has no fewer than <a href="https://www.globalresearch.ca/pfizer-vaccine-only-has-1291-side-effects/5773091" id="">1,291 adverse side-effects</a> (which Pfizer was forced to publish in 2022 as clinical data), and already it would appear that one can start heading to court. As may be seen from the examples listed above, once one starts looking for studies pertaining to emerging evidence about the consequences of the Covid shots on the part of recipients, one’s research uncovers numerous relevant instances, such as <a href="https://slaynews.com/news/major-investigation-confirms-covid-vaccines-laced-cancer-causing-dna/" id="">this recent one</a> on cancer-causing DNA fragments in mRNA ‘vaccines:’A major investigation by a group of renowned German researchers has confirmed that Pfizer’s Covid mRNA “vaccines” are laced with dangerous levels of DNA contaminants.While the presence of DNA contamination in Covid injections is not a new discovery, this latest study uses advanced techniques for more reliable quantification, making it the most significant investigation to date.As Slay News has previously <a href="https://slaynews.com/news/fda-admits-covid-mrna-vaccines-cause-cancer/" id="">reported</a>, leading scientists have been warning for some time that surges in deadly cancers among the Covid-vaccinated were <a href="https://slaynews.com/news/moderna-admits-covid-mrna-shots-cause-cancer/" id="">caused</a> by <a href="https://slaynews.com/news/top-molecular-scientist-confirms-dna-contamination-covid-vaccines-integrates-human-cells/" id="">DNA fragments</a> in the mRNA injections.The study was led by Jürgen O. Kirchner, an Independent Researcher in Hamburg, and Professor Brigitte König of the University of Leipzig.The results of the study were <a href="https://www.preprints.org/frontend/manuscript/8ca842e8d2530e46a7b17cbd51c631c4/download_pub" id="">published</a> in the Preprints journal.The researchers hypothesized that residual DNA contaminants in multiple batches of Pfizer’s Covid mRNA “vaccine” significantly exceed regulatory safety thresholds.This finding is not to be sneezed at, given the indications that ‘turbo cancer’ is exploding among the vaxxed, as the following two reports emphasise – one of them particularly pointing to its rise among <a href="https://rumble.com/v4699ii-bombshell-vaccine-data-mystery-turbo-cancer-rise-in-young-people.html" id="">young people</a>. The other <a href="https://rumble.com/v47lb0n-dr.-peter-mccullough-a-lethal-turbo-cancer-appearing-soon-after-mrna-vaccin.html" id="">video discussion</a> between Dr Peter McCullough and Dr Drew Pinsky focuses on a specific study concerning such evidence of turbo cancer manifesting itself among those who have been ‘vaccinated.’ The discussion is summarised as follows below the video:In a medical paper coauthored by Dr. Peter McCullough, researchers reported evidence of “turbo cancer” – an “aggressive, infiltrating, metastatic, and ultimately lethal basaloid type of carcinoma” appearing soon after mRNA vaccination for COVID-19…The world-renowned heart health expert says the mRNA shots “should be off the market completely.”“We have a lot of information suggesting these are no good for the heart…” Dr. McCullough told Real America’s Voice. “Now we have data…of the heart change in almost everybody who took the shot, at least for six months or longer…”Dr. Peter McCullough is an internist, cardiologist, epidemiologist, and the Chief Scientific Officer of The Wellness Company. As an expert on cardiovascular medicine with over 30 years of experience, Dr. McCullough has spoken widely about the heart-related risks that he believes could be attributed to mRNA technology. One could go on and list many more such reports on studies, but I think my point has been made and therefore I shall list only one more, by <a href="https://expose-news.com/2025/01/12/covid-vaccines-cause-turbo-cancers/" id="">Rhoda Wilson</a> of that intrepid investigative British newspaper, The Exposé, where she writes:Multiple doctors and scientists, including Dr. David Rasnick, Dr. Ryan Cole, Dr. Roger Hodkinson, and Scientist Kevin McKernan, say that covid injections cause “turbo cancers” due to immune system suppression.The injections contain DNA plasmids with the SV40 promoter sequence, which has been associated with oncogenesis and can bind with P53, “the guardian of the genome.”Doctors and experts report a significant increase in aggressive cancers, often in younger people, with rapid growth to Stage 3 or Stage 4, and link this phenomenon to the covid injections’ degradation of the immune system.Multiple case reports and studies suggest a potential link between covid injections and an increased risk of cancer, including aggressive and metastatic types. Specific cases reported include colon cancer, breast cancer, skin cancer, gastric cancer, basaloid carcinoma, melanoma, adenoid cystic carcinoma and acute lymphoblastic leukaemia/lymphoblastic lymphoma, among others. Researchers propose that the vaccines may cause immune suppression, leading to accelerated cancer progression and that certain modifications in mRNA vaccines (e.g., 100% N1-methyl-pseudouridine) enhance tumour growth.Hence, given that these reports are known to a lot of people, which must surely include representatives of governments around the world, to reiterate: why have no prosecutions of those responsible for the deaths resulting from the clot-shot been initiated? I should add ‘yet,’ but given the inexplicable inaction regarding this elephant in the room, one is tempted to speculate that some organisation(s) lurking in the shadows may have a hold over those who are in positions where they can proceed with prosecutions. Call it a <a href="https://www.frontnieuws.com/de-theorie-in-samenzweringstheorie/" id="">conspiracy theory</a>, if you like, but what else could be the explanation? To be sure, there have been ‘official inquiries,’ such as the one referred to in <a href="https://expose-news.com/2025/02/11/the-peoples-vaccine-inquiry/" id="">this report</a>, but nothing has been forthcoming, which is indicative of suppression of potentially damning information. Interestingly, when confronted with this silence, a ‘people’s vaccine inquiry’ was launched:On the first day of the long-awaited Module 4 of the UK Covid Inquiry, <a href="https://expose-news.com/2025/01/17/hart-group-reviews-uk-covid-inquirys-hearings/" id="">it became clear</a> that the Inquiry was going to do everything it could to bury evidence that does not suit the narrative of “vaccines are safe and effective” and continue to gaslight the many who have been vaccine injured. In response, a group of experts held a press conference to set the record straight. &nbsp;In their press conference, the group, called The People’s Vaccine Inquiry, lays bare the theatre that is known as the <a href="https://covid19.public-inquiry.uk/modules/vaccines-and-therapeutics-module-4/" id="">UK Covid Inquiry Vaccines and therapeutics (Module 4)</a>. &nbsp;[…you can find all the videos and transcripts from the press conference on the People’s Vaccine Inquiry website <a href="https://peoplesvaccineinquiry.co.uk/press-conference/" id="">HERE</a>.] Is it too much to insist on justice being seen to be done as far as the perpetrators are concerned? I don’t think so. A few years ago, I published a paper on ‘How (most) philosophers have failed humanity’ (which, amazingly, after peer review, was accepted) in an academic journal (Phronimon). In it, I drew on the historical example of Socrates, to illustrate my claim, that it is one of the characteristic traits of a true philosopher to have a keen sense of justice, as displayed by Socrates in his famous trial in Athens. Which does not preclude non-philosophers from displaying such a sense of justice, of course, but it does disqualify a great many individuals who work as professional philosophers, from passing the test of authenticity. In South Africa, where I live, most professional philosophers have failed this test dismally as far as their response to the tyrannical Covid measures and the aftermath of the Covid ‘vaccines’ being administered are concerned. I have a strong feeling that, unless large numbers of citizens start coming forward and insisting on justice being done in light of the burgeoning numbers of studies and reports demonstrating beyond any reasonable doubt that the very composition of these so-called ‘vaccines’ testify to them as dangerous, this whole lamentable episode will just be swept under the carpet. The obvious person to take the requisite action is Robert F. Kennedy (Jr), of course, in his capacity as America’s Health Secretary. Perhaps he will still do so, pending the accumulating evidence of malfeasance, as well as pressure from concerned citizens, reaching ‘critical mass.’<a href="https://brownstone.org/author/bert-olivier/" id="">Bert Olivier</a>Bert Olivier works at the Department of Philosophy, University of the Free State. Bert does research in Psychoanalysis, poststructuralism, ecological philosophy and the philosophy of technology, Literature, cinema, architecture and Aesthetics. His current project is 'Understanding the subject in relation to the hegemony of neoliberalism.'<a href="https://creativecommons.org/licenses/by/4.0/" id="">Published under a</a><a href="http://creativecommons.org/licenses/by/4.0/"> Creative Commons Attribution 4.0 International License</a><a href="https://creativecommons.org/licenses/by/4.0/">. </a>For reprints, please set the canonical link back to the <a href="https://brownstone.org/articles/why-no-justice-for-shot-victims/">original Brownstone Institute Article</a> and Author.

Why No Justice for Shot Victims?

Despite rising death toll linked to so-called Covid ‘vaccines,’ still no concrete attempt to prosecute pharmaceutical companies

By Michael Nevradakis, Ph.D. This <a href="https://childrenshealthdefense.org/defender/fda-announces-radical-framework-for-overhauling-vaccine-approval-process/" id="">article </a>was originally published by The Defender — Children’s Health Defense.<div data-rt-embed-type='true'>The U.S. Food and Drug Administration (FDA) is preparing to issue <a href="https://www.washingtonpost.com/health/2025/05/15/fda-vaccine-guidance-update/">new guidance for vaccine manufacturers</a> in the coming days as part of a new “radical framework.” The guidance will likely focus on the COVID-19 shots, The Washington Post reported Thursday, citing comments by FDA Commissioner Marty Makary earlier this week.
The Post published its story earlier Thursday, before The Wall Street Journal reported that unnamed sources at the U.S. Department of Health and Human Services (HHS) said HHS is expected to announce within days that it will <a href="https://childrenshealthdefense.org/defender/hhs-stop-recommending-covid-vaccines-kids-teens-pregnant-women/">no longer recommend COVID-19 shots</a> for children, teens and pregnant women.
Speaking at the <a href="https://www.fdli.org/2025/05/2025-fdli-annual-conference/">Food &amp; Drug Law Institute’s conference</a> in Washington, Makary gave few specifics about the upcoming new framework but said it will help ensure the pharmaceutical industry understands “exactly what we’re thinking,” <a href="https://endpts.com/new-cber-chief-is-readying-massive-framework-for-vaccines-makary-says/">Endpoints News</a> reported.
According to the Post, this may entail “guidance to companies so that they know the agency’s approach to vaccine approvals.”
“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry, ‘How is this going to be received?&#8217;” Makary said at the conference.
The announcement comes just a month before government regulators are set to review <a href="https://childrenshealthdefense.org/defender_category/covid/">COVID-19</a> <a href="https://childrenshealthdefense.org/defender_category/vaccines-2/">vaccines</a> for the next cold and flu season.
<a href="https://substack.com/@popularrationalism">James Lyon-Weiler, Ph.D.</a>, president and CEO of the <a href="https://ipaknowledge.org/">Institute for Pure and Applied Knowledge</a> and editor-in-chief of the journal <a href="https://publichealthpolicyjournal.com">Science, Public Health Policy &amp; the Law</a>, said the new framework is “long overdue” and “may represent an inflection point — if it goes beyond mere optics and addresses the core systemic failures that have plagued vaccine <a href="https://childrenshealthdefense.org/defender_category/health/">policy</a> for decades.”
Lyons-Weiler said:
“For decades, vaccine licensure has operated on a foundation riddled with shortcuts. What we need now is a true break from the past — a regulatory framework grounded in the principles of precision public health, stratified risk, and individualized safety.”
Makary said <a href="https://childrenshealthdefense.org/defender/dr-vinay-prasad-replaces-ousted-peter-marks-chief-fda-vaccine-regulator/">Dr. Vinay Prasad</a>, the new director of the FDA’s <a href="https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber">Center for Biologics Evaluation and Research</a> (CBER) — which oversees the <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-names-agency-critic-vinay-prasad-top-vaccine-official-2025-05-06">approval and regulation of vaccines</a>, gene therapies and other biologic drugs — will oversee the new framework and has been meeting with industry representatives and FDA staff.
Makary said he and Prasad believe “in <a href="https://childrenshealthdefense.org/defender/robert-f-kennedy-jr-confirmed-hhs-secretary/">gold standard science</a> and common sense, especially when it comes to rare diseases,” Endpoints News reported.
<a href="https://childrenshealthdefense.org/defender/zoloft-suicide-fda-drug-approval-process/">Kim Witczak</a>, a drug safety advocate who has worked with the FDA as a consumer representative, said the proposed framework is “encouraging.”
Witczak said:
“Vaccine oversight has operated under a patchwork system without transparency, from placebo discussion to lack of discussion around safety.
“The fact that this is even being acknowledged is a major step forward, but the real test will be in the details. We’ve seen too many promises of FDA reform that end up being more about optics than substance.”
Makary questions COVID vaccine approval process
According to the Post, the <a href="https://www.washingtonpost.com/health/2025/05/15/fda-vaccine-guidance-update/">FDA’s announcement</a> comes amid “uncertainty” that the first Trump administration introduced “into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.”
Speaking at the conference, Makary questioned the continued approval of COVID-19 vaccines based on years-old clinical trial data.
“Should we be making recommendations based on a randomized trial that’s three or four years old with the new variant and a delta in population immunity?” Makary asked reporters. “So a lot of those original randomized trials were done at a time when there was very low population immunity.”
Karl Jablonowski, Ph.D., senior research scientist at <a href="https://childrenshealthdefense.org">Children’s Health Defense</a>, said “a new randomized trial on the COVID-19 vaccines would be a death blow to their EUA status” — referring to the <a href="https://childrenshealthdefense.org/defender/covid-vaccine-emergency-use-fda/">emergency use authorization</a> (EUA) under which they were released and through which they continue to enjoy a federal <a href="https://childrenshealthdefense.org/defender/biden-extend-covid-vaccine-liability-shield-2029/">liability shield</a>.
Jablonowski cited a presentation delivered during the October 2024 meeting of the CDC’s Advisory Committee on Immunization Practices (<a href="https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/04-COVID-Link-Gelles-508.pdf">ACIP</a>), which stated that the long-term efficacy of the COVID-19 vaccines was statistically negative for adults 18-64 years old.
<a href="https://faculty.rx.umaryland.edu/lsimoni-wastila/">Linda Simoni-Wastila, Ph.D.</a>, a professor at the University of Maryland School of Pharmacy, said a re-examination of the COVID-19 shots may also include “reassessment of whether use of mRNA and other platforms constitute gene therapeutics as opposed to vaccine therapeutics.”
“Products developed using mRNA as a platform are different than vaccines developed using traditional, non-mRNA platforms — and thus, should have different guidance and thresholds for market approval,” Simoni-Wastila said.
Simoni-Wastila also called for the elimination of vaccine manufacturers’ liability shield and more “research on so-called ‘<a href="https://cen.acs.org/pharmaceuticals/Drug-ingredients-considered-inert-might/98/web/2020/07">inert</a>’ and ‘<a href="https://childrenshealthdefense.org/defender/aluminum-adjuvant-covid-vaccines-respiratory-disease/">adjuvant</a>’ materials added to vaccines.”
At the conference, Makary expressed support for “good science” and “some good clinical data” in the <a href="https://endpts.com/new-cber-chief-is-readying-massive-framework-for-vaccines-makary-says/">vaccine approval process</a>, adding that the process should be tailored “to the condition being treated” and should include better safety surveillance.
“Is there a safety signal we didn’t see in the trial, and is there a benefit that we didn’t see in the trial?” Makary asked. “We should also be looking at post-approval monitoring about what’s actually going on.”
Witczak said she expects the framework to “emphasize transparency, independent data review, and a slowing of the <a href="https://childrenshealthdefense.org/defender/big-pharma-drug-regulators/">accelerated approval pathways</a> — especially EUA mechanisms that bypass traditional safety guardrails.” She said this “could signal a shift away from the &#8216;<a href="https://childrenshealthdefense.org/defender/operation-warp-speed-big-payouts-pharma-execs/">warp speed</a>&#8216; mentality and toward restoring <a href="https://childrenshealthdefense.org/defender/public-support-vaccines-declines-health-freedom/">public confidence</a>.”
Lyons-Weiler suggested the framework include mandatory long-term follow-up of vaccine-related adverse events, a requirement for placebo-controlled clinical trials and pre-vaccination risk screening, establishing regulatory independence, revisiting existing vaccine recommendations, and establishing data transparency.
Earlier this month, Makary announced the development of a new <a href="https://childrenshealthdefense.org/defender/u-s-will-track-vaccine-injuries-real-time-electronic-patient-records/">real-time surveillance system</a> to capture data on vaccine injuries. At the conference, Makary said this database will help support the new vaccine framework.
“Νow with big data, we are assembling some of the biggest electronic health record databases, and we will be able to query those databases in real time as soon as we approve a drug,” Makary said.
<a href="https://childrenshealthdefense.org/defender_category/big-pharma/">Big Pharma</a> has been jittery about the new administration’s vaccine approval process plans. Biopharma stocks dropped when <a href="https://childrenshealthdefense.org/defender/dr-vinay-prasad-replaces-ousted-peter-marks-chief-fda-vaccine-regulator/">Prasad was named director of CBER</a> earlier this month — and when his predecessor, <a href="https://childrenshealthdefense.org/defender/hhs-peter-marks-fda-forced-resignation-vaccine-stocks-tumble-biopharma/">Peter Marks, M.D., Ph.D.</a>, widely viewed as being industry-friendly, resigned in March.
According to Endpoints News, Makary responded to these concerns, saying “we do want to get decisions to sponsors quickly” and suggesting that the approval process could be made more efficient.
Prasad had previously <a href="https://childrenshealthdefense.org/defender/vinay-prasad-rfk-jr-first-steps-federal-health-agency-reform/">criticized public health agencies</a> — and Marks — for what he described as a lax approval process for vaccines. In a post on X in March, Prasad said Marks could be replaced “with a <a href="https://x.com/VPrasadMDMPH/status/1902820280369914165">bobblehead doll</a> that just stamps approval and you would have the same outcome.”
Public trust has been broken
According to Endpoints, Makary’s announcement reflects “the latest in a series of changes the administration is considering on the vaccine front,” including changes in how vaccine trials are conducted and increased scrutiny of existing vaccines.
Last month, HHS announced that all new vaccines will have to be <a href="https://childrenshealthdefense.org/defender/rfk-jr-order-new-vaccines-undergo-placebo-controlled-testing/">tested against a placebo</a> before they can be approved, in what the department described as “a radical departure from past practices.”
Also last month, HHS suggested the COVID-19 vaccines could be removed from the <a href="https://childrenshealthdefense.org/defender/childhood-vaccine-schedule-public-health-decline-senate-roundtable/">childhood immunization schedule</a> — a proposal that was then made at the <a href="https://childrenshealthdefense.org/defender/chd-funds-lawsuit-cdc-program-forces-pediatricians-covid-vaccines-medicaid/">April meeting</a> of ACIP, despite pushback by some of the committee’s members.
According to the Post, <a href="https://www.washingtonpost.com/health/2025/05/15/fda-vaccine-guidance-update/">ACIP will vote</a> on recommendations for fall COVID-19 vaccines at its June 25 meeting.
The FDA recently asked Novavax, which sought full approval of its COVID-19 vaccine, to commit to performing a new clinical trial after its vaccine gets approved.
According to <a href="https://apnews.com/article/vaccine-novavax-fda-trump-covid-study-4b4465ad77cfb0554b27b7d59c40ae32">The Associated Press</a>, the FDA’s increased scrutiny of the Novavax COVID-19 vaccine “is sowing uncertainty about updates to other vaccines, too.”
Earlier this month, HHS and the National Institutes of Health (NIH) announced that the Trump administration will invest $500 million into research on vaccines that protect against multiple strains of “<a href="https://www.hhs.gov/press-room/hhs-nih-announces-generation-gold-standard.html">pandemic-prone viruses</a>,” as part of a program that will be known as <a href="https://childrenshealthdefense.org/defender/hhs-nih-launch-500-million-project-develop-universal-vaccines-pandemic-viruses/">Generation Gold Standard</a>.

Simoni-Wastila suggested that possible interactions between <a href="https://childrenshealthdefense.org/vaccines/">vaccinations</a> frequently administered together, such as those on the childhood schedule, warrant more research and should be included in the new framework.
“At present, there is no agency that is equipped and required to do such analyses,” she said. “The FDA could contribute to this vital need by requiring new applications to conduct, at the least, post-marketing analyses.”
Witczak said public trust in government health agencies has been broken, and that the new framework can help restore it.
“If we want to restore faith in the system, we must be willing to look at the process with clear eyes and the courage to make meaningful changes. After all, these are products being injected into our bodies — safety, transparency, and choice must come first,” Witczak said.
“We cannot allow this moment to become another missed opportunity,” Lyons-Weiler said. “The public deserves an FDA that puts safety science ahead of market speed and that is transparent and humble enough to acknowledge past errors.”
</li>
</ul></div><h4 id=""><a href="https://childrenshealthdefense.org/authors/michael-nevradakis-ph-d/" id="">Michael Nevradakis, Ph.D.</a></h4>Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and host of "The Defender In-Depth" on CHD.TV.This <a href="https://childrenshealthdefense.org/defender/fda-announces-radical-framework-for-overhauling-vaccine-approval-process/">article </a>was originally published by The Defender — Children’s Health Defense’s News &amp; Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider<a href="https://childrenshealthdefense.org/about-us/sign-up/" id=""> subscribing to The Defender</a> or<a href="https://childrenshealthdefense.org/about-us/donate/" id=""> donating to Children’s Health Defense</a>.&nbsp;&nbsp;

FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process

Agency to issue new guidance for vaccine manufacturers in the coming days 

By Lika Kobeshavidze, Foundation for Economic EducationAcross college campuses, on TikTok feeds, and in everyday conversations, a familiar narrative is gaining <a href="https://www.tiktok.com/discover/gen-z-percent-capitalist" target="_blank" id="">steam</a>: capitalism is broken.Rising rents and stagnant wages fuel the claim among some young people that free markets have failed an entire generation. According to a 2024 poll by the Institute of Economic Affairs, more than 60% of young <a href="https://iea.org.uk/media/new-polling-shows-ongoing-support-for-socialism-among-young-britons/?utm_source=chatgpt.com" target="_blank" id="">Britons</a> now view socialism favorably. In the United States, the <a href="https://news.gallup.com/poll/268766/socialism-popular-capitalism-among-young-adults.aspx?utm_source=chatgpt.com" target="_blank" id="">trend</a> is similar, with Generation Z increasingly skeptical of capitalism’s promises.But much of this idealism is rooted in distance—many of the young people romanticizing socialism have never lived through the economic dysfunction or political repression it often brings. For those who experienced Soviet shortages, Venezuelan collapse, or East Germany’s surveillance, the word socialism doesn’t suggest fairness or opportunity—it suggests fear, failure, and control. There’s a reason so many fled those systems to come to freer countries. What sounds utopian in theory has too often turned dystopian in practice.But blaming capitalism misses the mark. The real culprit is cronyism, the unholy alliance between big government and big business that twists markets, blocks competition, and rewards political connections over genuine innovation.<h2 id="">The Myth of Market Failure</h2>Capitalism, in its true form, is based on voluntary exchange. It rewards businesses that meet people’s needs and wants, with consumers deciding what succeeds and what fails. Competition drives improvement, innovation, and lower prices. No one is forced to buy or sell anything; choice reigns.Cronyism is a different beast altogether. In a crony system, businesses succeed not by serving customers but by lobbying politicians. Profits come through subsidies, bailouts, and regulations designed to crush competition.The 2008 financial <a href="https://www.britannica.com/money/financial-crisis-of-2007-2008" target="_blank" id="">crisis</a>, often cited as proof of capitalism’s failures, actually showcased what happens when markets are rigged. Reckless banks, instead of collapsing as they deserved, were bailed out with taxpayer money. Ordinary people lost jobs and homes, while the politically connected survived and thrived.This wasn’t free enterprise. It was cronyism.The COVID-19 pandemic provided a grim sequel. Small businesses were forced to shut their doors under government mandates. Meanwhile, corporate giants like Amazon, able to operate under looser restrictions or pivot online, soared to record profits. Policies, written in the name of public health, often privileged the biggest players while leaving Main Street devastated.<h2 id="">Cronyism on Both Sides of the Atlantic</h2>Cronyism is not limited to one country or one political party. Across the United States and Europe, the symptoms are the same.In the US, Canada, and the UK, the dream of homeownership slips further away for young people. Sky-high housing prices are blamed on “market failure,” but the real cause lies in layers of government-imposed barriers: restrictive zoning laws, burdensome permitting requirements, and endless bureaucratic delays. Big developers who can afford to navigate or influence the system survive. Everyone else gets locked out.In Europe, the pattern repeats. France’s labor <a href="https://cepr.org/voxeu/columns/small-isnt-always-beautiful-cost-french-regulation?utm_source=chatgpt.com" target="_blank" id="">laws</a>, designed to protect workers, instead stifle opportunity. Hiring becomes risky and expensive, especially for young people. Large corporations, with the resources to manage compliance costs, consolidate their dominance. Small firms and startups never get off the ground.There’s also a persistent myth that big business fears government intervention. In reality, the largest corporations often embrace it, because it keeps them on top. Tech giants like Facebook and Google now lobby for more regulation, knowing that complex new rules will strangle smaller competitors who can’t afford fleets of compliance officers. Green energy subsidies, meant to combat climate change, often end up showering billions on well-connected firms while locking out emerging innovators.Cronyism doesn’t reward the best ideas. It rewards the best lobbyists.<h2 id="">Why Gen Z’s Frustration Is Justified</h2>Gen Z <a href="https://www.freiheit.org/human-rights-hub-geneva/focus/gen-z-survey?utm_source=chatgpt.com" target="_blank" id="">values</a> fairness, creativity, and freedom. The very principles cronyism undermines. When political influence matters more than merit, and when success depends on government favoritism instead of consumer satisfaction, opportunity shrinks and innovation slows. But they are wrong when they think “socialism” would be a better option, not least because of the rampant cronyism that has existed in every socialist state.The temptation to seek salvation through government power is not new. The Soviet Union began with a promise of equality and delivered oppression and scarcity (except for the party elites). Venezuela promised 21st-century socialism and delivered hunger, economic collapse, and political repression. Meanwhile, countries that embraced market freedom—even imperfectly—created unparalleled prosperity. Free markets have lifted billions out of poverty, and unleashed innovation that reshaped the modern world.Markets aren’t flawless. But they leave the door open for anyone to succeed, not just those born into privilege or connected to power.<h2 id="">Aim Your Anger at the Right Target</h2>Gen Z’s frustration is real, and it deserves an outlet. But the answer is not to tear down capitalism; it’s to tear down cronyism. A freer, fairer future depends on separating business from political power, not binding them closer together. It means ending corporate welfare, simplifying the rules of the game, and making sure that competition, not connections, decides who wins.The fight for fairness is worth waging. But it must be aimed in the right direction. If we rage against cronyism, not capitalism, we can build a future where innovation thrives, opportunity is real, and every member of Generation Z has a genuine chance to rise.<a href="https://fee.org/author/lika-kobeshavidze/" id="">Lika Kobeshavidze</a>Lika Kobeshavidze is a Georgian political writer, analytical journalist and fellow with Young Voices Europe, specialising in EU policy and regional security in Europe. She is currently based in Lund, Sweden, pursuing advanced studies in European Studies. This article was originally published on FEE.org. Read the <a href="https://fee.org/articles/falling-for-socialism/">original article</a>.‍

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