New Information Disclosed: 10 Deaths in Children found by FDA Career Staff to be Probably or Possibly due to COVID-19 mRNA Vaccination

The latest FDA email release & a discussion of autopsies repeated by the CDC

Jun 19, 2026

Intro added 6/22/2026- there are a lot of new readers coming to this Substack and I want to provide relevant background: I was head of CDER at FDA from Dec.15, 2025-May 15, 2026. Prior to that, and staring March 27th, 22025, I was Special Assistant to the Commissioner and then from May, 2025, Senior Advisor for Clinical Sciences to the Commissioner and to the CBER Director. I served as FDA ex officio to ACIP from April 2025-December 2025.

Two days ago, Senator Johnson (WI) (whom, in all transparency, I know fairly well) released important internal FDA emails from CBER career staff to Dr. Vinay Prasad (CBER Director at the time) regarding their analysis of “the 97 unique cases of pediatric death following COVID-19 vaccines” they had identified in VAERS.

This newly-released emails shows they found ten (10) deaths, which they felt were “probably or possibly" related to the vaccine. The emails indicate the VAERS analysis was done by the DPV/OBPV FDA career staff team; I specifically point this out as there seems to be speculation in the public that either Dr. Prasad or I performed this analysis finding 10 deaths probably/possibly linked to the vaccine)

Some details of the cases are described below. Previously-released information revealed these were all mRNA vaccines.

It’s important to point out here that, up until the above email was released two days ago, the information in the public (also obtained by Senator Johnson) suggested the FDA internal analysis found seven (7) deaths probably/possibly related- not 10. In the Nov. 22nd email above, there is no indication the assessment was preliminary.

Given the Nov. 22 date on the email and the “Happy Thanksgiving” from Meghna, this newly-released email is presumably the information Vinay had while writing his November 28, 2025 (Black Friday) memo.

As Vinay said in that memo, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death…It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.”

I agree.

As Vinay further explained (I’m relying on public documents for my substack when it comes to internal FDA communications), I had presented a number of these cases to CBER and leaked reports of my presentation suggested “[I] was attempting to create a false fear regarding vaccines”

Questions: Would these 10 cases have come to light if I had not given that presentation of concerning cases in VAERS and Vinay had not asked for a”detailed analysis” of the cases? And then if Senator Johnson had not pursued getting the information?

Edit 6/22/2026: It’s worth recalling a couple quotes that were given to the mainstream media in 2025 by 1. A former FDA official and 2. By Peter Marks (head of CBER during COVID) that are real head scratchers now given the above information

From Sept 2025 (after my presentation leaked): https://www.nbcnews.com/health/health-news/fda-covid-vaccine-child-deaths-data-cdc-meeting-rcna230849

(If this is true, why are 10 probable/possible cases being reported now?)

From Nov 29th, 2025 (after Vinay’s Black Friday memo) https://www.nbcnews.com/health/health-news/fda-covid-vaccines-children-deaths-rcna246437
The above quote is strange considering the analysis he is criticizing was done by FDA career staff (DPV/OBPV) as shown in the email below and notable that he was head of CBER at the time of the deaths (or those we have been provided dates on) and also presumably when they initially “looked through all of the autopsy reports” as the above quote states from the anonymous former FDA official.

Emily Kopp reached out to me yesterday about my willingness to give a quote for her Daily Caller article- out today- on this release of FDA emails. (She is a fantastic journalist and someone I consider a friend ever since we got to know each other after the SSRIs in pregnancy FDA panel)

This email below, included in her article, describes the revisions made to the initial analysis identifying 10 concerning deaths and was what she asked me to comment on.

Here was the revised analysis -now 7 deaths- post-Black Friday memo

I did get her a quote late last night, but think it was too late. However, now I’ve had more time to gather my thoughts and here they are- all in the form of questions:

Why did the CBER team redo (& downgrade the findings of) their initial VAERS analysis after Vinay released the Black Friday memo? Was there internal pressure to do so?
What was the adjudication process & determination of the other 86 cases? (as a friend & colleague just asked me- can the de-identified information from the entire VAERS investigation be made available to independent reviewers in the public? - good question!)
Was it appropriate to just entirely remove the case of “florid lymphocytic myocarditis” post vaccine? Looking at the two memos side by side you can see the symptoms started for this girl <28 days before vaccination (even though the death occurred >28 days)
Why in one case was parvovirus considered “equally as possible” as the vaccine in terms of etiology when, as described here, parvovirus is a common incidental finding on autopsy and may have appeared pathologically very distinct from vaccine injury (see more on this below)
Was it appropriate to entirely remove the 15 yo M removed who drowned with myocarditis 6 days post vaccine and not consider the vaccine to be possibly or probably contributory?
What happened in the planned December 11th SWG meeting about “including myocarditis with fatal outcome” in the label of COVID-19 vaccines? (I had been appointed Acting CDER director by this point)
Why (given the 2021-2022 dates of the deaths, as shown in a previous Substack post) did it take over 3 years for these cases of concern -involving deaths of children probably or possibly due to a vaccine -with uncertain meaningful benefit in children-to be disclosed to the public?
Note- they make it clear in these emails they had autopsy information already available and the NBC quote above from the former official indicates they had already looked through autopsy reports. Obtaining autopsy and medical record information is typical for deaths and serious outcomes as described in this CDC manual (image below)
What are the implications for the public’s trust in the safety of vaccines and other medical products if the FDA does not disclose deaths in children that may be/are probably related to medical products in a timely manner? (It’s important to remember the initial RCTs used for authorization/approval are not powered to find safety information like this)
Can we feel confident VAERS death reports are being objectively adjudicated if the initial analysis (which was not described as preliminary) was subsequently revised and downgraded in its findings following the leaked Black Friday email?

More on deaths in children attributed to the mRNA COVID-19 vaccines & CDC’s repeat autopsies

A while back, I suggested to Emily Kopp she reach out to Dr. James Gill, a Yale pathologist for her article, and I am glad she did. She included wonderful quotes from him (though I suspect parvovirus is in fewer children’s hearts than adults, you get the point— and his point about the pathology I think is crucial):

“Parvovirus can be found in the tissues of about half of the population, and sensitive PCR tests can pick up the virus years after the infection, Gill told the DCNF.

But heart issues from parvovirus and the heart issues discovered after the vaccine have different histologies, or microscopic markers, Gill said.

“It’s like saying everyone with blue eyes must be excluded. It’s kind of arbitrary I think,” he said. “It’s a red herring. Whether or not it was intentionally used as one, I don’t know, but certainly that would be a case of looking at the pathology.”

In 2022, Gill et al published descriptions of 2 cases of teenage boys who died of “myocardial injury” 3 and 4 days after receiving the second dose of Pfizer mRNA COVID-19 vaccine- and described histopathologically unique findings in terms of the myocarditis appearance” “not the alterations seen with typical myocarditis”

When people ask me if children have died due to the COVID-19 vaccine, the above article is the first thing I will point them to. It’s very difficult to establish causality with any certainty based on case reports unless you have highly atypical pathological findings (think mesothelioma from asbestos) or another situation that comes to mind is when the vaccine stain of a live-attenuated virus causes death from meningitis or encephalitis. What Gill describes sounds like a highly unusual myocardial injury pattern, which he and his co-authors attribute to “postvaccine reaction”.

Gill’s group’s report also ended up raising important questions about the CDC: The CDC redid the autopsies his group performed they performed (why?) and attributed one of the deaths to clostridium septicum (which is common bacterial overgrowth in corpses) and is the cause of gas gangrene. And for the second, the CDC stated they found parvovirus in the heart. Both of these causes Gill et al I think very convincingly dismissed as potential causes of death or even contributory.

Finally, you might be asking yourself: if the CDC performed repeat autopsies on these cases, were these cases not among the reports submitted to VAERS & analyzed by the FDA scientists? If these 2 cases were indeed included in the 10, it does not appear (given the information we have) that both were considered “probable” . If not, why not?

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In summary, thank you to Senator Johnson and Emily Kopp for their work in bringing this important internal FDA information to light concerning probable/possible deaths in children due to COVID-19 mRNA vaccines. Transparency from the FDA & CDC in situations like this is critical.

I hope you find my description of the situation and additional information about the Yale and CDC autopsies helpful.