Dr. Vinay Prasad circulated a memo before FDA scientists finished their work. His conclusions overshot what the agency’s own analysts ultimately found.
What Vinay Prasad did here is not a good faith scientific disagreement. He asserted that “at least 10 children died because of Covid vaccination” before the FDA scientists he assigned had finished their analysis. When that analysis was completed, it found zero deaths that were certain, two that were probable, and five that were only possible, meaning alternative causes were equally likely. His number was inflated by hundreds of percent relative to his own staff’s conclusions, and he has not corrected the record.
This matters because Prasad is not confused or incapable. He understands causality frameworks, uncertainty, and regulatory responsibility. He chose to misstate incomplete findings, preemptively claim undercounting, and frame a settled risk benefit question as if it were in doubt. That is not error. It is distortion.
Power without a moral compass is dangerous. Prasad has shown he cannot be trusted to make decisions that affect other people.
I agree, and I think that’s precisely what makes this so disturbing. When someone is capable in the sense of having the training and experience to understand uncertainty, causality, and process, the concern shifts from sloppiness to judgment. In positions of authority, capability only matters if it is exercised with intellectual honesty and ethical restraint. Without that, it stops being reassuring and becomes dangerous.
What’s happening here isn’t just disagreement — it’s misleading framing.
The Prasad memo says “this is preliminary” and “these cases are possible or probable, not certain” is retold as if it claimed 10 confirmed deaths.
But the later review found 0 deaths judged “certain,” 2 “probable,” and 5 “possible” — a total of 7 cases under review, not proven causation.
JF creates unneeded drama by claiming the memo was “200–500% wrong,” even though those percentages come from relabeling uncertainty, not correcting a factual error.
This is how misinformation spreads without lying outright: you don’t add facts — you strip away context and inflate the gap.
Why do this?
Attention seeking: A careful story about uncertainty doesn’t grab attention.
Drama Villian: Casting internal review as recklessness creates a clear villain.
Danager Drama: It protects a preferred narrative by making debate look dangerous.
The irony is that this approach creates the mistrust it claims to fight. When people later see the memo never said what they were told it said, confidence drops — not just in the writer, but in institutions more broadly.
If trust matters, then accuracy matters — especially when the issue is uncertainty itself
Here is the exact text of the Prasad's leaked memo. To you--as a physician or person just interested in the best for people---what point is most important? And who is false?
Sent: Friday, November 28, 2025 4:21 PM To: CBER-SUBSCRIBERS-ALL <CBER-SUBSCRIBERS-ALL@fda.hhs.gov> Subject: Deaths in children due to COVID-19 vaccines and CBER’s path forward
Dear Team CBER,
I am writing to report that OBPV career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination. These deaths are related to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution. This safety signal has far reaching implications for Americans, the US pandemic response, and the agency itself, which I wish to discuss here. I also want to address some frequent objections.
Prior to joining the US FDA, the FDA Commissioner closely followed reports of vaccine-induced myocarditis. Unlike the COVID virus, which has a steep age gradient — being at least 1000 times more likely to kill an 80 year old than an 8 year old — myocarditis appeared to have the opposite pattern. Young, healthy boys and men — those least likely to experience bad covid outcomes — bore the greatest risk. The risk was as high as ~200–330 per million doses given in the highest risk demographic groups. Notably, the US FDA and CDC were not the first to recognize the safety signal — instead the Israelis were — and worse in May of 2021, then CDC director Rochelle Walensky stated, “We have not seen a signal and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given,” Many felt this statement was dishonest and manipulative.
Inside Medicine editorial: there is no evidence for a FDA december 5th memo on this subject. is it possible to provide the source document referred to in this article as "the december 5th memo" (see text below)?
“According to a December 5 post-marketing safety memo prepared by FDA scientists assigned to study the issue, agency scientists concluded that the actual number of deaths linked to Covid-19 vaccines in the United States is somewhere between zero and seven….
…f the ten deaths he reported to FDA staff (a number which we now know is incorrect), he wrote that “that number is certainly an underestimate due to underreporting, and inherent bias in attribution,” and that, of the 96 cases initially found in VAERS (HHS’s Vaccine Adverse Event Reporting System) between 2021 and 2025, “no fewer than 10 are related….The real number is higher.”
The December 5 memo, written by FDA scientists under Prasad’s direction, contradicts this directly.”
Thanks again for your reporting.
Happy to do it—feels necessary
What Vinay Prasad did here is not a good faith scientific disagreement. He asserted that “at least 10 children died because of Covid vaccination” before the FDA scientists he assigned had finished their analysis. When that analysis was completed, it found zero deaths that were certain, two that were probable, and five that were only possible, meaning alternative causes were equally likely. His number was inflated by hundreds of percent relative to his own staff’s conclusions, and he has not corrected the record.
This matters because Prasad is not confused or incapable. He understands causality frameworks, uncertainty, and regulatory responsibility. He chose to misstate incomplete findings, preemptively claim undercounting, and frame a settled risk benefit question as if it were in doubt. That is not error. It is distortion.
Power without a moral compass is dangerous. Prasad has shown he cannot be trusted to make decisions that affect other people.
I think the medical community is indeed most disturbed by the sloppy approach taken by somebody as capable as Prasad is.
I agree, and I think that’s precisely what makes this so disturbing. When someone is capable in the sense of having the training and experience to understand uncertainty, causality, and process, the concern shifts from sloppiness to judgment. In positions of authority, capability only matters if it is exercised with intellectual honesty and ethical restraint. Without that, it stops being reassuring and becomes dangerous.
What’s happening here isn’t just disagreement — it’s misleading framing.
The Prasad memo says “this is preliminary” and “these cases are possible or probable, not certain” is retold as if it claimed 10 confirmed deaths.
But the later review found 0 deaths judged “certain,” 2 “probable,” and 5 “possible” — a total of 7 cases under review, not proven causation.
JF creates unneeded drama by claiming the memo was “200–500% wrong,” even though those percentages come from relabeling uncertainty, not correcting a factual error.
This is how misinformation spreads without lying outright: you don’t add facts — you strip away context and inflate the gap.
Why do this?
Attention seeking: A careful story about uncertainty doesn’t grab attention.
Drama Villian: Casting internal review as recklessness creates a clear villain.
Danager Drama: It protects a preferred narrative by making debate look dangerous.
The irony is that this approach creates the mistrust it claims to fight. When people later see the memo never said what they were told it said, confidence drops — not just in the writer, but in institutions more broadly.
If trust matters, then accuracy matters — especially when the issue is uncertainty itself
Here is the exact text of the Prasad's leaked memo. To you--as a physician or person just interested in the best for people---what point is most important? And who is false?
From: Prasad, Vinayak <Vinayak.Prasad@fda.hhs.gov>
Sent: Friday, November 28, 2025 4:21 PM To: CBER-SUBSCRIBERS-ALL <CBER-SUBSCRIBERS-ALL@fda.hhs.gov> Subject: Deaths in children due to COVID-19 vaccines and CBER’s path forward
Dear Team CBER,
I am writing to report that OBPV career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination. These deaths are related to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution. This safety signal has far reaching implications for Americans, the US pandemic response, and the agency itself, which I wish to discuss here. I also want to address some frequent objections.
Prior to joining the US FDA, the FDA Commissioner closely followed reports of vaccine-induced myocarditis. Unlike the COVID virus, which has a steep age gradient — being at least 1000 times more likely to kill an 80 year old than an 8 year old — myocarditis appeared to have the opposite pattern. Young, healthy boys and men — those least likely to experience bad covid outcomes — bore the greatest risk. The risk was as high as ~200–330 per million doses given in the highest risk demographic groups. Notably, the US FDA and CDC were not the first to recognize the safety signal — instead the Israelis were — and worse in May of 2021, then CDC director Rochelle Walensky stated, “We have not seen a signal and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given,” Many felt this statement was dishonest and manipulative.
Not surprising he did this, but very disturbing. Thanks for letting us know.
🙏
Inside Medicine editorial: there is no evidence for a FDA december 5th memo on this subject. is it possible to provide the source document referred to in this article as "the december 5th memo" (see text below)?
“According to a December 5 post-marketing safety memo prepared by FDA scientists assigned to study the issue, agency scientists concluded that the actual number of deaths linked to Covid-19 vaccines in the United States is somewhere between zero and seven….
…f the ten deaths he reported to FDA staff (a number which we now know is incorrect), he wrote that “that number is certainly an underestimate due to underreporting, and inherent bias in attribution,” and that, of the 96 cases initially found in VAERS (HHS’s Vaccine Adverse Event Reporting System) between 2021 and 2025, “no fewer than 10 are related….The real number is higher.”
The December 5 memo, written by FDA scientists under Prasad’s direction, contradicts this directly.”
Today CNN is reporting a "Black Box" warning will be assigned to the CoVID vaccine packing...😥
JJF Phm 🇨🇦
I have in the story that there will be a label change. But hadn’t heard any “black box” language.