FDA's "Proper Investigation" into Child Deaths Post COVID Shot

Five years too late

The U.S. Food and Drug Administration (FDA), led by Commissioner Dr. Marty Makary, is investigating reports of child deaths following the COVID shot, focusing on data from the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the Centers for Disease Control and Prevention (CDC) and the FDA to monitor vaccine safety in the United States.

In a recent CNN interview with Jake Tapper, Dr. Makary revealed:

“We do know at the FDA, because we’ve been looking into the VAERS database self-reports, that there have been children who have died from the COVID vaccine. And so, we’re doing a proper investigation..We're going to release a report in the coming few weeks and we're going to let people know we're doing an intense investigation. We’re talking to the primary sources, the family members who lost a child- we're reviewing the autopsy reports. We’re having physicians do the investigation and we think the public deserves to have that information. It was not released in the last administration and it should have been.”

Dr. Makary went on to state that since the FDA began its investigation, it faced resistance from CDC leadership, who “blocked” data access with “different excuses” and delays. He specifically mentioned that these individuals, who were in leadership positions, have resigned.

Several prominent CDC officials stepped down amid tensions with HHS Secretary Robert F. Kennedy Jr.’s vaccine policy reforms, particularly over the overhaul of the CDC’s Advisory Committee on Immunization Practices (ACIP), when all 17 ACIP members were removed due to cited conflicts of interest and after the firing of Dr. Susan Monarez, the former CDC Director.

When looking at the number of children aged 17 and under who have died after taking the COVID shot, according to VAERS data, as of August 29, 2025, there has been 202 deaths.

Source: MedAlerts.org a public interface for VAERS data

However, this number is likely far higher for several reasons. Firstly, it’s long been recognised that VAERS data significantly underreports adverse events, including deaths, due to its passive reporting system. A Harvard study, back in 2011, found that less than 1% of adverse events are reported. In addition, issues like missing age data and a private CDC/FDA database further obscure the true count.

The Defender reported on the FDA’s investigation into child deaths following COVID vaccination :

According to analyst, Albert Benavides, founder of VAERSAware.com, the summaries that accompany the reports often contain the victim’s age, but this information won’t appear when searching for reports by age in VAERS if the age field in the report is empty.

“This is clearly where most dead children are hiding in VAERS,” said analyst Albert Benavides, founder of VAERSAware.com. Benavides said the summaries of reports with an “unknown” age listed show “three times the amount of dead children ‘hiding’ in VAERS” compared to the official figure.

As of Aug. 29, VAERS contains 13,457 reports of deaths following COVID-19 vaccination that list an “unknown” age, and 73,176 COVID-19 vaccine injury reports involving people under 18.

Two years ago, my investigative report for Children’s Health Defense Europe, revealed a disturbing 82 child deaths under the age of 17, following the COVID shot, in just a six-month period.

The report was based on data buried in the Periodic Safety Update Reports (PSURs) submitted by Pfizer/BioNTech to the European Medicines Agency (EMA), which was only made public thanks to the persistent efforts by a group of European doctors known as PSUR4doctors. The group repeatedly filed Freedom of Information Act (FOIA) requests to secure the release of thousands of pages of PSUR safety data for all the COVID shots. It must be noted that PSURs contain worldwide data, including adverse event reports from the United States and other regions. All available PSURs can be accessed from Dr. Silvia Behrendt’s Substack and the German blog, tkp.

Below is a summary of key findings (with screenshots from source documents) based on my original investigation analysing PSUR#3, covering the six-month period of December 2021 through to June 2022, for the Pfizer/BioNTech COVID shot.

For 5–11-Year-Olds:

• Adverse Events: 9,605 individual cases (1.9% of 507,683 total cases), a 683% increase from 1,227 cases in PSUR #2 (covering the second half of 2021). The U.S., Australia, Philippines, and Germany reported the most cases.

• Seriousness and Outcomes: 17% of 22,457 AEs were serious, 40% had “unknown” outcomes, and 14.5% were “not resolved.”

• Deaths: 20 fatal cases reported.

  Myocarditis Cases: Two deaths (ages 6 and 7) linked to myocarditis and cardio-respiratory arrest post-vaccination (dose 1 or 2). One case, a 6-year-old boy, was dismissed as “natural causes” despite myocarditis onset 7 days post-dose 1, with a pending autopsy.

  

  • Other Cases: Two deaths dismissed due to “death” as the only reported event, two due to underlying conditions (autopsies not performed or unknown), and six where causality could not be ruled out due to temporal proximity, though no autopsy/lab data confirmed vaccine linkage. No confounding factors were identified in 15 cases.

For the 12–17-Year-Olds:

• Adverse Events: 21,945 cases (4.3% of total), a 20% increase from 18,451 in PSUR #2. Germany, Philippines, and Australia led in reports.

• Seriousness and Outcomes: 32% of 61,071 AEs were serious, 33% had “unknown” outcomes, and 20% were “not resolved.”

• Deaths: 62 fatal cases reported, three times higher than the younger group.

  Myocarditis Cases: Three deaths (all age 13) linked to myocarditis; two lacked autopsy data, one cited “adverse event following immunization.”

  

  

  • Other Cases: 15 deaths lacked sufficient detail (“death” only), two were accidents, six involved underlying conditions (e.g., a 16-year-old girl with pulmonary embolism and cardiac arrest 2 days post-dose 3, autopsy performed but results not provided), and 20 where causality could not be excluded due to temporal links, though unconfirmed by lab/autopsy data. No confounding factors were noted in 39 cases. 19 cases were dismissed due to “limited information,” reflecting Pfizer/BioNTech’s failure to investigate further.

My further investigation into child deaths following the original report can be read below.

An extract from the article reads: As of June 2022, 161 fatal paediatric cases were recorded from the reporting interval of PSUR #1 through to PSUR#3. Even though this technically covered an 18-month period, regulators like the EMA and FDA first authorised the Pfizer/BioNTech vaccine for 12-15-year-olds at the end of May 2021 and for 5-11-year-olds, from October that year. This means that these paediatric deaths would have occurred in just 12 months.

The number of deaths recorded across all ages groups including the unknown age group (which was a staggering 1072 cases) was 13,509, from the post-marketing data.

Turning back to Dr. Marty Makary’s CNN interview, he stated, “We’re reviewing the autopsy reports” as part of the FDA investigation into child deaths following COVID vaccination. However, my analysis of the Periodic Safety Update Reports (PSURs) revealed that autopsies were frequently not performed, not reported, or results were unavailable for many pediatric cases. This lack of critical data is particularly egregious given that these deaths involved young children.

Tragically, the FDA’s “proper investigation” into child deaths following COVID vaccination, widely promoted as “safe and effective,” arrives five years too late for the many families who lost a child. Why wasn’t a thorough investigation launched from the start?

Perhaps, the controversial statement made by Dr. Eric Rubin (member of the FDA’s Vaccines and Related Biological Products Advisory Committee) during a public meeting on December 17, 2020, discussing the Pfizer-BioNTech COVID shot’s Emergency Use Authorization (EUA) lends a reason why:

“We won’t know if the vaccine is safe until we roll it out.”

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