Tag: fda

In September 2025, then-US Food and Drug Administration (FDA) Commissioner Dr Marty Makary publicly acknowledged that the agency was investigating reports of child deaths following Covid-19 vaccination.

“We do know at the FDA…that there had been children who have died from the COVID vaccine,” Makary said during a CNN interview.

By that stage, however, a fierce internal dispute had already emerged inside the FDA over what investigators believed the evidence showed – and whether the public should ever see the full findings.

“It really did feel like there was some sort of cover-up going on about the Covid-19 vaccines,” said one individual familiar with the discussions.

MD Reports spoke with several current/former agency officials, advisers, and individuals briefed on the discussions, all of whom requested anonymity because they were not authorised to publicly discuss internal FDA deliberations.

At the centre of the controversy was an internal FDA review led by Dr Tracy Beth Høeg, a physician-scientist who was working as a senior scientist inside the FDA’s vaccine division at the time.

FDA officials examined roughly 96 paediatric death reports submitted to the Vaccine Adverse Event Reporting System (VAERS), the government database used to detect potential vaccine-related adverse events.

The review included medical records, autopsy reports, pathology findings, and follow-up investigations conducted by agency staff.

About 25 deaths following Covid vaccination were ultimately considered serious enough for high-level internal discussion inside the agency.

The findings were expected to be presented at a September 2025 meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), the federal panel that shapes US vaccine recommendations.

But before that could happen, details of the review leaked to the New York Times and the Washington Post.

Høeg quickly became the focus of intense media scrutiny and criticism from vaccine advocates and unnamed FDA officials who argued she was relying too heavily on VAERS reports and overstating preliminary findings.

People familiar with the fallout said some FDA staff strongly objected to Høeg’s methods and conclusions and allegedly sought to undermine her credibility by leaking details of the review.

The leak effectively ended plans for a public ACIP discussion and deepened divisions within the FDA over how the findings should be handled.

Some officials believed the findings warranted stronger warnings and greater transparency. Others feared public acknowledgement of vaccine-linked child deaths would damage confidence in the Covid vaccines.

“We know that there are these deaths that are due to the vaccine,” said one source, referring to myocarditis cases and published reports from countries including Korea and Israel.

The controversy intensified after then-FDA vaccine chief Dr Vinay Prasad ordered additional investigation into the deaths identified in Høeg’s review.

Months later, another leak brought the issue back into public view.

In November 2025, an internal memo circulated by Prasad became public. In it, Prasad acknowledged that “at least 10” children had died “after and because of receiving Covid-19 vaccination.”

He described the findings as “a profound revelation.”

“COVID-19 vaccines did result in the death of children,” Prasad wrote. “Dr. Hoeg was correct in her assessment.”

The memo triggered another round of backlash from media outlets and vaccine advocates, many of whom accused Prasad of overstating the evidence before the agency’s analysis had been finalised.

Inside Medicine reported on a Dec 5 memo about a subsequent FDA analysis using a World Health Organization causality framework, which classified zero deaths as “certain,” two as “probable/likely,” and five as “possible.”

But individuals involved in the discussions said pressure steadily mounted inside the agency to “downgrade” the findings with each successive review.

“It seemed like there was a lot of pressure to keep decreasing the number of deaths,” said one source.

Keep reading

The FDA knew the COVID shots would kill and maim countless Americans.

They kept injecting anyway.

One government employee tried to sound the alarm about “49 examples” of deadly side effects that conventional safety analyses weren’t detecting.

She was shut down.

Her name was Dr. Ana Szarfman.

On March 1, 2021, less than three months after the rollout of the COVID-19 injections, Dr. Ana Szarfman, an employee at CDER and safety data mining developer, warned that the FDA’s existing system could hide vaccine safety signals due to a flaw called “masking.”

She proposed a newer method developed by statistician Dr. William DuMouchel that corrected for this issue and, when applied, detected “49 examples of extreme masking” that the standard system did not.

These “49 examples of extreme masking” include not “minor” but serious adverse events:

• Bell’s palsy

• Cardiac failure

• Acute left ventricular failure

• Agonal rhythm (severe end-of-life arrhythmia)

• Pulmonary infarction

• Cerebral artery occlusion

• Aortic stenosis

• Sudden cardiac death

• Hypertensive emergency

• Basal ganglia stroke

When Dr. Szarfman proposed a new method, she was told to “hold off on creating and sending data mining reports and analyses.”

Later, they “made it clear” that she “needs to focus on her assigned work” and “should not be discussing or providing internal analyses externally.”

Keep reading

Senator Ron Johnson raised concerns during an exchange with Robert F. Kennedy Jr. regarding a memo he said originated from a senior official within the Food and Drug Administration, describing findings tied to child deaths following COVID-19 mRNA vaccinations.

Johnson said the memo was “apparently from CBER director, Doctor Prasad,” and referenced its contents as part of an FDA review.

He stated the document described an internal analysis involving “96 autopsies of child death following the covid mRNA injection.”

According to Johnson, the memo included language he described as significant in acknowledging outcomes tied to the vaccines.

“In that memo, Doctor Persad writes, this is a profound revelation,” Johnson said.

He continued, “For the first time, the US FDA will acknowledge that covid 19 vaccines killed American children, healthy young children who face tremendously low risk of death.”

Johnson added that these children were “coerced at the behest of the Biden administration via school and work mandates to receive a vaccine that could result in death.”

Johnson said the memo raised questions about the impact of pandemic-era mandates. “In many cases, such mandates were harmful,” he said.

Keep reading