{"id":589933,"date":"2026-04-21T21:40:00","date_gmt":"2026-04-21T21:40:00","guid":{"rendered":"https:\/\/buglecall.org\/?p=589933"},"modified":"2026-04-21T21:40:00","modified_gmt":"2026-04-21T21:40:00","slug":"a-reckoning-is-underway-at-the-fda-3","status":"publish","type":"post","link":"https:\/\/buglecall.org\/?p=589933","title":{"rendered":"A Reckoning Is Underway At The FDA"},"content":{"rendered":"

A Reckoning Is Underway At The FDA<\/span><\/p>\n

\n

Authored by Maryanne Demasi via The Brownstone Institute,<\/em><\/a><\/p>\n

For months, a quiet battle has been unfolding inside the US Food and Drug Administration (FDA).<\/strong><\/p>\n

\"\"<\/a><\/p>\n

It began with an analysis of child deaths after Covid vaccination, followed by strategic leaks to major media outlets, and has now erupted into the open with a memo from the regulator\u2019s own vaccine chief.<\/strong><\/p>\n

In September, it was\u00a0reported<\/a>\u00a0that FDA officials had privately investigated 25 paediatric deaths following Covid vaccination \u2014 the first systematic review of such cases since the rollout began.<\/p>\n

The findings were meant to be presented to the CDC\u2019s Advisory Committee on Immunization Practices (ACIP). But the presentation never came. The meeting passed without a word. Something had happened behind closed doors.<\/p>\n

Now we know what.<\/p>\n

On 13 November 2025, STAT\u00a0published<\/a>\u00a0an extraordinary insider account describing a tense internal meeting in which FDA scientist Dr Tracy Beth H\u00f8eg presented evidence of young people who had died after Covid vaccination.<\/strong><\/p>\n

According to STAT, her findings triggered pushback from career FDA regulators who feared the implications of acknowledging fatal cases.<\/p>\n

Now, comes the explosive memo from FDA vaccine chief Dr Vinay Prasad, confirming \u2014 for the first time \u2014 that US regulators have formally attributed at least 10 of these children\u2019s deaths to Covid vaccination.<\/p>\n

Prasad called it \u201ca profound revelation\u201d with far-reaching implications for American vaccine policy, adding that the true number is \u201ccertainly an underestimate.\u201d<\/strong><\/p>\n

Here, I\u2019ll take you through the memo, the leaks, the internal rebellion at FDA, and what this means \u2014 not just for Covid vaccines, but for all vaccine approvals going forward.<\/p>\n

This story marks a turning point in US vaccine regulation.<\/strong><\/p>\n

The Story That Divided the Regulator<\/h2>\n

In early September, insiders at the FDA and CDC quietly told\u00a0the\u00a0New York Times<\/em>\u00a0and\u00a0the\u00a0Washington Post<\/em>\u00a0that the agency had begun investigating child deaths reported to VAERS.<\/p>\n

My reporting\u00a0confirmed<\/a>\u00a0that Dr Tracy Beth H\u00f8eg, a senior adviser within the FDA\u2019s vaccine division, had led the review \u2014 contacting families, gathering medical records, and obtaining autopsy findings.<\/p>\n

\"\"<\/a><\/p>\n

click image for story<\/em><\/p>\n

It was the first case-by-case evaluation of paediatric deaths conducted since the vaccines were authorised.<\/strong><\/p>\n

The review identified twenty-five children whose deaths occurred following vaccination. Those findings were expected to be presented to ACIP on 18\u201319 September. Instead, without explanation, the discussion disappeared from the agenda.<\/p>\n

Even FDA Commissioner Dr Marty Makary had hinted at the findings on CNN, saying, \u201cWe\u2019ve been looking into the VAERS database self-reports, [and] there have been children that have died from the Covid vaccine.\u201d<\/p>\n

He described an \u201cintense\u201d investigation involving doctors, autopsies, and family interviews. Yet ACIP heard nothing.<\/strong><\/p>\n

Had the FDA reversed course \u2014 or had internal forces blocked disclosure?<\/p>\n

STAT\u2019s reporting offered the first real clues.<\/p>\n

Inside the FDA: The Meeting That Changed Everything<\/h2>\n

STAT described a confidential gathering of FDA vaccine scientists in which H\u00f8eg presented slides listing roughly two dozen deaths of young people following vaccination.<\/p>\n

One slide reportedly read: \u201cTiming fits. Diagnosis fits. No better explanation found. Sufficient information provided.\u201d<\/strong><\/p>\n

According to STAT, some career regulators reacted with \u201cquiet horror\u201d \u2014 not at the deaths themselves, but at the policy implications of acknowledging them.<\/p>\n

The article portrayed H\u00f8eg as pushing to bring the findings to ACIP and to amend vaccine labels for younger males, while longtime staff resisted, describing the evidence as \u201cthin\u201d and worrying about restricting vaccine access.<\/p>\n

STAT reported that \u201cno career regulator would stand by the decision,\u201d and H\u00f8eg backed away from presenting the cases to ACIP.<\/p>\n

It was a rare glimpse of a regulator divided against itself: career staff trying to contain the findings, and FDA leadership apparently trying to surface them.<\/strong><\/p>\n

Nothing more was said publicly \u2014 until Prasad\u2019s memo detonated inside the agency.<\/p>\n

Prasad\u2019s Explosive Memo<\/h2>\n

The memo from Dr Vinay Prasad, Director of the FDA\u2019s Centre for Biologics Evaluation and Research (CBER), is unlike anything ever issued by a senior US vaccine regulator.<\/p>\n

Addressed to all CBER staff, it confirmed what STAT only implied: FDA scientists had determined that \u201cat least 10 children have died after and because of receiving Covid-19 vaccination.\u201d<\/p>\n

Prasad wrote that the true number is \u201ccertainly an underestimate\u201d and that \u201cthe real number is higher.\u201d<\/strong><\/p>\n

He wrote that \u201cdeaths were reported between 2021 and 2024, and ignored for years,\u201d calling it a systemic failure that \u201crequires humility and introspection.\u201d<\/p>\n

\u201cIt is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved,\u201d he wrote.<\/strong><\/p>\n

Prasad defended H\u00f8eg\u2019s analysis, saying \u201cDr Hoeg was correct in her assessment,\u201d and that disagreements reflected subjective coding \u2014 not differing facts.<\/p>\n

He also noted that healthy children at extremely low risk from Covid had been \u201ccoerced\u201d into vaccination under Biden-era mandates, some of which he said \u201cwere harmful.\u201d<\/p>\n

He added that it was \u201cdifficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.\u201d<\/strong><\/p>\n

Prasad also challenged one of the most repeated claims in pandemic messaging \u2014 that Covid infection causes more myocarditis than vaccination.<\/p>\n

He argued that these comparisons rely on faulty denominators, because they count only people sick enough to seek hospital care while ignoring the far larger number of infections that never present to clinics.<\/p>\n

He underscored that vaccination does not prevent eventual infection, so the comparison cannot be framed as \u201cvirus versus vaccine.\u201d<\/strong><\/p>\n

A vaccinated child still encounters the virus over their lifetime \u2014 but now carries the additional myocarditis risk from the vaccine itself.<\/p>\n

The Leaks<\/h2>\n

Prasad\u2019s memo contained another revelation \u2014 confirmation of internal sabotage inside the FDA.<\/strong><\/p>\n

He wrote that \u201cslides she presented, emails she sent, and distorted firsthand reports\u201d from H\u00f8eg\u2019s meeting had been leaked to media outlets by staff who believed they were acting appropriately.<\/p>\n

He condemned the behaviour as \u201cunethical, illegal, and\u2026factually incorrect,\u201d a blunt repudiation of how the STAT narrative had framed events.<\/strong><\/p>\n

In Prasad\u2019s telling, H\u00f8eg had not exaggerated the evidence at all. She had uncovered what the FDA had failed to recognise for nearly three years \u2014 that Covid vaccines had killed children.<\/p>\n

Far from being the rogue figure depicted in selective leaks, she was doing precisely what the public assumes a regulator does: investigating deaths, contacting families, gathering records, and treating each case as a potential signal that demands scrutiny.<\/p>\n

For Prasad, the leaks weren\u2019t merely improper \u2014 they betrayed the core obligation of a scientific agency.<\/strong><\/p>\n

He said internal debates must remain inside the FDA until ready for public release, and that he would not \u201cendorse selective reporting of our meetings and documents.\u201d Anyone unwilling to follow that principle, he said, should\u00a0resign<\/strong>.<\/p>\n

It was an extraordinary directive \u2014 and a clear sign that the internal battle over whether to acknowledge children\u2019s deaths had reached a breaking point.<\/p>\n

A Reaction from Inside ACIP<\/h2>\n

When the memo surfaced, ACIP vice-chair Dr Robert Malone\u00a0issued<\/a>\u00a0his own statement.<\/p>\n

He wrote that he had been aware of the review through ACIP\u2019s internal working group, and that the child deaths \u201chave been known since this summer but not released to the public due to the need to validate the initial findings independently.\u201d<\/p>\n

Bound by confidentiality, he could only say, \u201cI have seen the data and findings, and they are even more stunning than this strongly worded letter indicates.\u201d<\/p>\n

He said he was \u201cstunned, gobsmacked,\u201d adding: \u201cThe significance and importance of this letter in the context of US and global vaccine policy cannot be overestimated. This is a revolution, the likes of which I never expected to see in my lifetime.\u201d<\/strong><\/p>\n

Malone then took aim at the Covid-19 mRNA products: \u201cThese products do not work. They do not prevent disease and death. And as Secretary Kennedy testified in the Senate, objective analysis cannot even demonstrate that, on balance, they saved lives.\u201d<\/p>\n

MIT professor Retsef Levi \u2014 who leads ACIP\u2019s Covid-19 Vaccines Workgroup \u2014\u00a0issued<\/a>\u00a0a similarly forceful response.<\/p>\n

He wrote, \u201cthe acknowledgement that at least 10 children died from COVID vaccination must be followed with disclosure to the parents,\u201d and said regulators and media \u201chave gaslighted the vaccine injured, including the parents who lost their precious child.\u201d<\/strong><\/p>\n

He described disclosure as \u201ca moral imperative\u201d and essential for any hope of trustworthy vaccine programs.<\/p>\n

Inside ACIP, the memo is being understood not only as a scientific shift \u2014 but an ethical reckoning.<\/p>\n

Critics Rise Up<\/h2>\n

Predictably, the memo\u00a0triggered<\/a>\u00a0pushback from establishment figures who have spent years defending the Covid vaccines from scrutiny.<\/strong><\/p>\n

Dr Paul Offit \u2014 a long-time industry-aligned vaccine promoter and a familiar voice deployed whenever safety concerns arise \u2014\u00a0dismissed<\/a>\u00a0the memo as \u201cscience by press-release.\u201d<\/p>\n

He argued that the memo lacked context and should not be treated as evidence, calling the memo \u201cirresponsible\u201d and \u201cdangerous.\u201d<\/p>\n

But Prasad\u2019s communication was never presented as a scientific publication. It was an internal memo to staff. Offit\u2019s attempt to judge it by academic-paper standards is a tactic to avoid addressing what the memo actually says \u2014 that children died and regulators overlooked it.<\/p>\n

Former CBER director Dr Peter Marks \u2014 whose tenure is explicitly criticised in the memo for failing to identify child deaths for years \u2014\u00a0said<\/a>\u00a0he was \u201ctaken aback by the clearly political tone of the communication.\u201d<\/strong><\/p>\n

But Prasad\u2019s memo details precisely why Marks\u2019s era is under scrutiny, including his 2021 decision to push out senior FDA officials Marion Gruber and Philip Krause after they objected to the Biden administration\u2019s rush toward booster approval.<\/p>\n

If anything was political, it was\u00a0that<\/em>\u00a0episode.<\/p>\n

For years, figures like Offit and Marks insisted that VAERS was a robust early-warning system \u2014 and that anyone citing it without follow-up investigation \u201cdidn\u2019t understand pharmacovigilance.\u201d<\/p>\n

Now that FDA investigators have actually done the follow-up \u2014 contacting families, obtaining medical records, and reviewing autopsies \u2014 these same voices suddenly claim VAERS can\u2019t establish causality at all.<\/p>\n

This is the core hypocrisy. You cannot praise VAERS as the backbone of vaccine safety, then declare its signals meaningless once they are properly investigated.<\/strong><\/p>\n

Critics also warned that stricter evidence requirements \u2014 such as randomised trials and rejection of surrogate endpoints \u2014 would \u201cslow innovation\u201d or \u201charm vaccine confidence.\u201d<\/p>\n

But vaccine confidence is already shattered. Fewer than 10% of American healthcare workers took last season\u2019s Covid booster.<\/p>\n

Trust collapsed not because regulators asked too many questions \u2014 but because they asked too few, dismissed safety concerns that later proved real, and insisted on messaging long after the data had shifted.<\/strong><\/p>\n

The problem for these critics is not that children have died after vaccination. The problem is that the regulators have finally acknowledged it.<\/p>\n

The Future of Vaccine Regulation in the United States<\/h2>\n

Prasad\u2019s memo goes far beyond confirming child deaths. It announces a structural overhaul of vaccine oversight.<\/strong><\/p>\n

He wrote that future vaccine approvals would require randomised trials for most new products; that immunogenicity studies would no longer be accepted as proof of effectiveness in new populations; and that vaccines for pregnant women would not be authorised on unproven surrogate markers.<\/p>\n

He committed to rewriting the US influenza vaccine framework and overhauling assessments of concomitant vaccination.<\/p>\n

Most strikingly, he declared that vaccines would be treated as \u201cno better or worse\u201d than any other medical product \u2014 ending decades of special regulatory leniency.<\/p>\n

\u201cNever again,\u201d he wrote, \u201cwill the US FDA commissioner have to himself find deaths in children for staff to identify it.\u201d<\/strong><\/em><\/p>\n

A Global Shift Begins<\/h2>\n

The ACIP\u00a0meeting<\/a>\u00a0on 4\u20135 December will be the first held under these new realities \u2014 with the knowledge that the FDA has attributed paediatric deaths to Covid vaccination, that senior leadership has repudiated the previous regulatory approach, and that a revolution in evidentiary standards is underway.<\/p>\n

Because many international regulators track the FDA, the acknowledgment that children died from the Covid-19 vaccine \u2014 and that the agency failed to detect it \u2014 marks a seismic moment in global vaccine policy.<\/strong><\/p>\n

For bereaved families, the acknowledgment is devastating but necessary. For the public, it signals that the institutional silence of the pandemic era is beginning to fracture.<\/p>\n

The reckoning has begun.<\/strong><\/p>\n

Republished from the author\u2019s\u00a0Substack<\/a><\/em><\/p>\n<\/div>\n

Tyler Durden<\/a><\/span>
\nTue, 04\/21\/2026 – 17:40<\/span><\/p>","protected":false},"excerpt":{"rendered":"

A Reckoning Is Underway At The FDA Authored by Maryanne Demasi via The Brownstone Institute, For months, a quiet battle has been unfolding inside the US Food and Drug Administration (FDA). It began with an analysis of child deaths after Covid vaccination, followed by strategic leaks to major media outlets, and has now erupted into… Continue reading A Reckoning Is Underway At The FDA<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":589919,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[20,23],"tags":[],"class_list":["post-589933","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-economic-empowerment","category-national-security","entry"],"_links":{"self":[{"href":"https:\/\/buglecall.org\/index.php?rest_route=\/wp\/v2\/posts\/589933","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buglecall.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buglecall.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buglecall.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buglecall.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=589933"}],"version-history":[{"count":0,"href":"https:\/\/buglecall.org\/index.php?rest_route=\/wp\/v2\/posts\/589933\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buglecall.org\/index.php?rest_route=\/wp\/v2\/media\/589919"}],"wp:attachment":[{"href":"https:\/\/buglecall.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=589933"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buglecall.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=589933"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buglecall.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=589933"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}