There is one statement that Adam made that I have to take exception to, and seems awfully strange for an evidence-based medicine afficianodo. Adam states that a temporal relationship does not imply causation. That is only true if you're referring to a single event since obviously the temporal relationship in that instance could be de to pure chance. However, once you start seeing a pattern and several such events temporally linked, you automatically have established a direct causative connection. For example, consider cholera and water from the Broad Street pump. See one patient who went down with cholera a couple of days after drinking water from the Broad Street pump and you can conclude nothing. But see, 2, 3, 4, 5 cases then you absolutely know that something in the Broad Street Pump water is responsible for the development of cholera. Of course in John Snow's time, he didn't not what the responsible agent was, simply that it was carried in the water and didn't float around in the air. Same is true for adverse events, including death, following the covid mRNA shots. See one case of myocarditis with a few days of the covid shot and you can't say anything. If a bunch of cases then appear, especially involving a group that is very unlikely to ever have myocarditis, you know there's a link. e.g. a bunch of fit 20 year old marines in tip top shape, don't just get myocarditis just like that.
Just one question: After finding out that Pfizer hid data on the effects of its covid vax for a few years, how can you be confident about anything that we’ve been told about the vax efficacy? Thank you for listening.
1. It has been widely accepted that the mortality rate from Covid in children is extraordinarily rare and confined to those few with significant immune dysfunction.
2. The Israeli and other data from 2020 & 2021 demonstrated the “vaccine” did not stop infection or transmission.
3. You said “I take it at face value the report’s contention that at least 10 children died from the COVID vaccine. I do not find that number surprising. We vaccinated millions.” That was 10 deaths attributed to the “vaccine” out of 96 deaths investigated. Your wording of that sentence might lead the less cautious and less informed reader to view those 10 deaths as trivial since “we vaccinated millions”.
4. By historical standards, 10 deaths following vaccination would have been considered a safety signal of sufficient concern to immediately stop further use of a vaccine until objective investigation could be conducted.
5. Millions were vaccinated because in Oct 2021, the injections became mandated. Parents and grandparents accepted the “safe and effective” coercive mantra and were submissive to those mandates.
6. You stated “Knowledge of these deaths ….could not have changed our response much earlier.” That comment of yours ignores and disregards the many physicians and scientists who were censored and lost their jobs, medical licenses, and board certification because they were expressing alarm regarding the deaths and adverse reactions during the 2021 - 2024 timeframe.
7. We do not know the incidence of myocarditis in children following mRNA injections because we do not know the denominator. That would have required high-sensitivity troponin, ECGs, and perhaps echocardiography on a large number of children following mRNA injections. As a cardiologist, I do not view subclinical myocarditis as a benign process, particularly in children and young adults. Lethal arrhythmias may occur later.
Wrt to #7, we actually do know the incidence of sub-clinical myocarditis from a study carried out in Thailand where they found elevated troponin-C levels in 1 in 500 children subsequent to the mRNA vaccine. And I fully agree with you that sub-clinical myocarditis is not benign, especially in the long terms (i.e. 50-60 years out where these children may suffer from premature cardiac events).
Nice piece, and a nice companion to Dr. Mandrola’s post.
I agree that the finding that some children died as a result of the vaccine to be entirely unsurprising. I would be far more shocked with an assertion that none did.
Any treatment has costs. The balance always comes down to whether the benefits outweigh those costs.
And I agree with Dr. Prasad on first principles. Before any therapy is approved, the regulator has to be convinced that the benefits do in fact outweigh the costs. One travesty with covid has been the lack of rigorous assessments of vaccine benefit in some of the non high risk populations, before broad usage was permitted/ recommended/ required.
The other issue in terms of benefits and costs is that the virus was continually evolving which rendered the vaccine less and less effective: (a) every subsequent strain was less pathogenic that the one, such that the current strain amount to no more than a bad cold or regular ILI; and (b) the vaccine targeted for the original strain was progressively less effective as the strains departed more and more from the original. So even if the benefit/risk ratio was positive initially, by the summer of 2020 it was likely in negative territory for everybvody.
What’s “acceptable “ depends on the benefits. And that’s the part that hasn’t been properly studied in young kids.
As Prasad notes, young kids do in fact get covid, and they can in fact get myocarditis from it. But we don’t know the denominator, so we can’t properly judge what the natural risk is. Nor can we quantify the magnitude of vaccine benefit.
What’s “acceptable “ depends on the benefits. And that’s the part that hasn’t been properly studied in young kids.
As Prasad notes, young kids do in fact get covid, and they can in fact get myocarditis from it. But we don’t know the denominator, so we can’t properly judge what the natural risk is. Nor can we quantify the magnitude of vaccine benefit.
I thought I would make a comment about VPs first email which was entirely to the point and spot on. I don't work at the FDA but at the NIH, and the NIH is entirely different with a quite different mission. The purpose of intramural NIH PIs is to carry out blue sky research just as at universities. But that's absolutely not the case at the FDA. Even those FDA PIs who engage in actual research at the FDA (whether bench research or epidemiological research) can only do so on a part time basis as they are obligated to do regulatory work. The latter cannot just be done on the side since it involves serious matters and requires very careful appraisal of the material presented to them.
That the vaccines were mandated despite the side effects to me is most troublesome. I believe VP has that as a target. I am so relieved he is in this position.
I agree with the overall balance of this piece, and I know your focus here is on kids, not adults. But since you note at the end that “the vaccine was clearly beneficial in older age groups,” I think it’s worth being equally precise about what the pivotal adult RCT actually established.
When you read the FDA briefing book closely, a few things stand out.
First, the trial population wasn’t at high risk. These were mostly healthy adults with extremely low rates of severe COVID, which means the RCT couldn’t tell us much about protection against the outcomes that ultimately mattered most…especially since we know the vaccine ultimately did very little to prevent infection long-term (some large observational studies found higher incidence over time).
Second, the number of confirmed infections in both arms was tiny relative to what the general population was experiencing at the time. The trial looks clean in part because it captured a much lower level of COVID exposure than existed in the community.
Third—and this rarely gets mentioned—the briefing book shows very large numbers of “suspected but unconfirmed” infections. Those suspected illnesses look much closer to the real-world burden of respiratory disease during that period. If a vaccine only affects a narrow slice of that illness spectrum (the small fraction that is PCR-confirmed COVID), then even a high efficacy number can overstate its impact on the actual infections people were experiencing. Vaccine doesn’t clear hurdle if those suspected illnesses are included.
None of this diminishes the real benefits for older, high-risk adults—you’re absolutely right about that. But as a reader, I sometimes feel a disconnect when the pivotal RCT is described in glamorized terms, because its findings in younger, healthy adults were much narrower than the headline efficacy implied. The RCT convincingly showed a reduction in lab-confirmed symptomatic COVID in a low-risk cohort; it didn’t—and probably couldn’t—answer the broader questions about total infection burden, transmission, or the full landscape of respiratory illness at the time.
The FDA took a notably permissive approach to mRNA vaccines in children 6 months to 4 years old. The pediatric trials were small, side effects were relatively common, and even the strongest-looking efficacy estimates were based on only a handful of infections. Despite this uncertainty—and without lot-testing for issues like residual DNA—the agency authorized the product for a very low-risk population, accepting a high degree of imprecision.
The ByHeart situation shows the opposite regulatory posture for infant formula. Here, the FDA applies a zero-tolerance standard: a single consumer complaint prompted a recall, and there are now 37 confirmed infant botulism cases linked to ByHeart formula use. None of these cases resulted in death or permanent injury. For perspective, the U.S. typically sees roughly 80–100 infant botulism cases per year from all causes; this year, dozens of those non-ByHeart cases have been investigated and determined not to be connected to ByHeart or formula at all. That broader context highlights how aggressively the FDA traces even the possibility of contamination when formula is involved.
The contrast is clear. For pediatric mRNA vaccines, the FDA tolerated substantial uncertainty in the supporting evidence. For infant formula, it assumes a maximal-precaution approach, treating every potential safety signal as urgent until ruled out.
The November 20 2025 NEJM illustrates a problem of selective reporting of vaccine results that the FDA and Dr Prasad should address. The headline article describes some increased efficacy of Pfizer mRNA influenza vaccine compared to non-mRNA vaccine, at the price of considerably more local reactions. Not included were the results in age 65+, which showed no increased efficacy and more side effects. These results were buried in Clinicaltrials.govhttps://www.clinicaltrials.gov/study/NCT05540522?tab=results#outcome-measures
Surely the FDA should regulate some of this selective reporting.
It's not so much selective reporting (which is what the MSM does especially in matters scientific where they rarely get things right), as selective publishing leaving out inconvenient data. Now the fact of the matter is that cherry picking data for a manuscript destined to be published in a scientific or serious medical journal is completely unethical and represents scientific misconduct and frankly outright fraud. As for the NEJM editor-in-chief, he is so tarred by incidents such as the recent Pfizer publication and so corrupted by big Pharma, that he should be forced to sep down before further tarnishing the NEJM. The same is true of the Lancet Editor-in-Chief.
I am trying to look at all of this with an open mind. I followed Vinay’s work for years and there was a time when I really appreciated how he approached evidence. Over time his tone shifted. His takes became more contrarian and many of his interpretations of oncology trials felt settled before he even talked through the data. When people in our field raised concerns, the responses did not show much humility or willingness to revisit his conclusions.
What is happening at CBER feels very similar. These are serious claims and they need to be supported by a clear, transparent process. Right now it is difficult to understand how strong the signal actually is because none of that context has been shown. Time will sort out the evidence and the true causes. This early communication did not help with clarity.
The tone of his memo
was sharp and very certain. I am not even sure it sounded like him. Part of me wonders if he was encouraged to word it that way. And once a letter like that goes out to thousands of people, it is hard to imagine it was ever going to stay internal. The way it was written made a leak almost expected.
That mix of tone, lack of context, and the way it immediately spilled into public view makes it hard to separate the science from the messaging. It feels far from the thoughtful evidence based voice I used to read. I could be wrong in how I am seeing this and I am open to that.
I would respectfully disagree with you. There is no question that children died because of the covid vaccines. How do we know this because we know that the vaccines can result in vaccine-induced myocarditis, and we know that quite a number of children had to go on ECMO and never could get off it. So that is not in question. What is in question is the degree to which the mRNA vaccines are being protected by the FDA despite all evidence to the contrary. Recall, the H1N1 swine flu vaccine had to be withdrawn because of a few cases of narcolepsy (some fatal) in children. Yet the FDA is still prepared to continue having the mRNA vaccines on the market despite the huge uncertainties in dosage (i.e. how much spike protein is produced is hugely variable from person to person), pharmacokinetics (it has been shown that the mRNA persists upwards of 6 months in certain individuals by several studies, including from Yale), pharmaco-distribution (the mRNA and spike protein have been shown to be distributed in almost every organ system in the body, which ones and where varying hugely from individual to individual), an DNA contamination during the manufacturing process (i.e. DNA used as atemplate for the mRNA not be purified away sufficiently so that the levels of DNA are many orders of magnitude higher than the allowed limits). This amounts to playing Russian roulette with peoples lives. Just imagine if the dosage of tylenol in your regular extra-strength tylenol pill could vary by an order of magnitude from pill to pill, and how many livers would be completely destoyed!
I disagree. This felt very much in tone with how he usually writes. Clear, concise and effective. It is an internal memo. And there is clearly humility in there because he says nothing is set in stone. I don't object to any of the content though I do take Adam's point that the political digs may have been avoided. But even if he had avoided that kind of language "profound" for example- I doubt it would have mattered. The sense I get is that the staff at the FDA that were second guessing these issues in real time were pushed out. That left good smart people who now believe in the Covid vaccines safety as though it was annointed by a higher power. I am worried that no matter the data they are presented with, they will dig in and defend their original stance.
I don't look at those things as political digs. The fact is that massive mistakes were made at the FDA under the previous administration, including willfully neglecting mounting negative evidence in relation to severe adverse events associated with the mRNA vaccines, and that needs to be admitted and called out. Failure to do so will only result in even less trust in the FDA and associated agencies.
Agreed. I started following Dr. Prasad in 2021, and I really appreciated his measured, evidence based approach to navigating the pandemic. Especially as someone with a great deal of anxiety. It is hard not to view him as another sellout who is abandoning science to kiss the ring of the current regime because I expected the same evidence and rigor he demanded from others. I do understand it will all come out in the wash, but I miss the old Vinay Prasad.
Let’s not forget that the claim is that at least 10 children died. Additionally, VAERS is highly underreported. It's been suggested that as little as 1% of temporal events are reported. If that’s the case, there could be more than 1000 child deaths. What about the other age groups?
The current dogma holds that the vaccine was a miracle for the old and frail, but this, like most other COVID claims, has never been proven. The clinical trials omitted this cohort – why? COVID-19 vaccine promoters continue to rely on highly confounded studies. Causation of deaths in the old and frail is the most difficult to assess because they are expected to die.
The burden of proof has clearly shifted from proving that vaccines are safe and effective to proving the opposite. This makes them unreliable.
Good read. What a horrible job VP currently has. Any physicians who worked for the federal government at any point understands his current uphill battle. Most all of us trained at a VAMC -the vets are the best, some staff (MD’s, students, nurses, RT, PT, OT, ST, environmental services, kitchen staff, security) are absolutely wonderful, some of the healthcare state of the art, the rest was governmental crap– keep the status quo no matter how crappy it is and don’t rock the boat or question the forms.
In light of renewed media attention on COVID vaccination in young children—sparked in part by the recent leak of Prasad’s email raising questions about the evidence behind these policies—the numbers in the FDA’s own documents are especially relevant.
The tables in the FDA VRBPAC Briefing Document, Pfizer COVID-19 Vaccine EUA Amendment for Use in Children 6 Months–4 Years, page 39, present COVID-19 case counts and vaccine-efficacy estimates for Pfizer’s 3-dose, 3-µg pediatric regimen.
For children 6–23 months (Table 19), 1,178 received vaccine and 598 received placebo. After Dose 1, there were 98 cases in the vaccine group and 58 in placebo, yielding an estimated efficacy of 14 percent with a confidence interval from –21 percent to +38 percent. Before Dose 3, efficacy estimates fluctuate from negative to modestly positive because many intervals contain only 1–3 cases in each group. After Dose 3, the primary comparison (≥7 days post Dose 3) shows 1 vaccinated case versus 2 placebo cases, producing a nominal efficacy of 75.5 percent, but with an extremely wide confidence interval spanning –370 percent to +99.6 percent. These very wide intervals reflect how little information the trial actually captured.
For children 2–4 years (Table 20), 1,835 received vaccine and 915 received placebo. After Dose 1, there were 127 cases in vaccinated children and 92 in placebo, with an estimated efficacy of 32.6 percent (CI 10.8–48.8 percent). After Dose 2, the same pattern appears: very small case numbers (e.g., 4 vs. 5; 21 vs. 8), resulting in efficacy estimates that vary widely and have confidence intervals encompassing both harm and benefit. After Dose 3 (≥7 days), there were 2 cases in the vaccine group versus 5 in placebo. This generates a point estimate of 82.3 percent efficacy—roughly in line with the informal ≥80 percent benchmark that was often referenced for meaningful protection in the general adult population early in the pandemic. However, because these figures rest on only seven total infections, the confidence interval still ranges from –8 percent to +98.3 percent. In other words, even the strongest-looking estimate is not statistically secure.
Across both age groups, the key limitation is the extremely small number of COVID-19 infections captured after Dose 3, precisely where the vaccine would be expected to show its effect. These small numbers—representing only a tiny fraction of the likely true infections in the cohort over the study period—produce efficacy estimates with very wide confidence intervals. As a result, the data from the VRBPAC briefing document do not provide a precise or reliable measurement of real-world protection in children under 5, even though the point estimates after Dose 3 trend in a positive direction. Yet, the vaccine was heavily pushed among this age group.
But isn't it the case that children under 5 were simply not at high risk of death or hospitalization from Covid. On the other hand, you have a vaccine with known severe adverse events (e.g. myocarditis, both overt and subclinical which may have significant sequelae later on in life) whose real dosage is completely unknown and whose pharmacokinetics and pharmacodistribution are very variable. Recall, that mRNA from the vaccine has been detected upwards of 6 months from vaccination and is also known to be distributed in virtually every organ system in the body. That's an extremely dangerous situation because any cell bearing spike protein on its surface will be destroyed by the immune system leading to localized inflammation, tissue destruction, etc..... In a skeletal muscle that's no big deal, but in an organ where dead cells are not replaced (e.g. brain and heart) it obviously is a big deal.
So in the end one really has to ask oneself whether it is truly sensible and ethical to vaccinate kids against a basically harmless infection (especially with the current SARS-CoV2 strain) at the risk of some really bad sequelae of vaccination.
Can you walk us through your back of the envelope calculation that the health benefit was a wash, or elaborate on why we can’t really know? Considering the huge numbers of kids that got the shot, if the vaccine reduced hospitalization as much as you report, it seems like many more kids would be saved? Would love to hear more about this — this seems by far the most important point.
Most of you people here are doctors, I am not. But in my opinion, I believe child vaccination needs to STOP! (Actually I believe that all mRNA should be removed at this point) For example, see below the Danish vaccine program. They never offered it to babies!
GROK: Yes, Denmark administered COVID-19 vaccines to children at various points during the pandemic and afterward.
- **Children aged 12–17**: Denmark began offering Pfizer-BioNTech vaccines to this age group in **July 2021**, initially on a voluntary basis and later as part of the general vaccination program.
- **Children aged 5–11**: Denmark opened vaccination for this younger group on **November 26, 2021**, using the pediatric Pfizer-BioNTech formulation (lower dose). It was offered but not mandatory.
- **Policy changes in 2022**: On **July 1, 2022**, the Danish Health Authority (Sundhedsstyrelsen) announced that children and adolescents under 18 would **no longer be offered primary COVID-19 vaccination** as part of the general program, because the overall benefits were deemed marginal in a situation where most children had already acquired immunity through infection and severe outcomes were extremely rare. Revaccination (boosters) for healthy children were also stopped.
- **Exceptions**: Children in high-risk groups (e.g., with severe chronic illnesses) could still be offered vaccination upon medical recommendation even after July 2022.
- **Later developments (2023–2025)**: Denmark has occasionally re-opened vaccination for 5–17-year-olds during autumn/winter campaigns (e.g., 2023–2024 and 2024–2025 seasons), but only as a targeted offer, primarily for children with medical risk factors. Healthy children are generally not actively invited or recommended to get vaccinated or boosted.
So in summary:
Yes, Denmark did vaccinate children (both 5–11 and 12–17) quite extensively in late 2021 and early 2022, but later shifted to a very restrictive policy for healthy children, which remains largely in place as of 2025.
As an Australian observer it is unfathomable that that merely suggesting a policy that Australia adopted almost after everyone had a first dose is controversial in the US. It was decided early on that boosters were for the elderly and immune compromised. It is not recommended for children or the otherwise healthy. It was possibly a mistake to ever give them to this population, but at least policy has moved on. Medicine and science has become hopelessly political in the US.
There is one statement that Adam made that I have to take exception to, and seems awfully strange for an evidence-based medicine afficianodo. Adam states that a temporal relationship does not imply causation. That is only true if you're referring to a single event since obviously the temporal relationship in that instance could be de to pure chance. However, once you start seeing a pattern and several such events temporally linked, you automatically have established a direct causative connection. For example, consider cholera and water from the Broad Street pump. See one patient who went down with cholera a couple of days after drinking water from the Broad Street pump and you can conclude nothing. But see, 2, 3, 4, 5 cases then you absolutely know that something in the Broad Street Pump water is responsible for the development of cholera. Of course in John Snow's time, he didn't not what the responsible agent was, simply that it was carried in the water and didn't float around in the air. Same is true for adverse events, including death, following the covid mRNA shots. See one case of myocarditis with a few days of the covid shot and you can't say anything. If a bunch of cases then appear, especially involving a group that is very unlikely to ever have myocarditis, you know there's a link. e.g. a bunch of fit 20 year old marines in tip top shape, don't just get myocarditis just like that.
Just one question: After finding out that Pfizer hid data on the effects of its covid vax for a few years, how can you be confident about anything that we’ve been told about the vax efficacy? Thank you for listening.
Adam, A few thoughts on your comments:
1. It has been widely accepted that the mortality rate from Covid in children is extraordinarily rare and confined to those few with significant immune dysfunction.
2. The Israeli and other data from 2020 & 2021 demonstrated the “vaccine” did not stop infection or transmission.
3. You said “I take it at face value the report’s contention that at least 10 children died from the COVID vaccine. I do not find that number surprising. We vaccinated millions.” That was 10 deaths attributed to the “vaccine” out of 96 deaths investigated. Your wording of that sentence might lead the less cautious and less informed reader to view those 10 deaths as trivial since “we vaccinated millions”.
4. By historical standards, 10 deaths following vaccination would have been considered a safety signal of sufficient concern to immediately stop further use of a vaccine until objective investigation could be conducted.
5. Millions were vaccinated because in Oct 2021, the injections became mandated. Parents and grandparents accepted the “safe and effective” coercive mantra and were submissive to those mandates.
6. You stated “Knowledge of these deaths ….could not have changed our response much earlier.” That comment of yours ignores and disregards the many physicians and scientists who were censored and lost their jobs, medical licenses, and board certification because they were expressing alarm regarding the deaths and adverse reactions during the 2021 - 2024 timeframe.
7. We do not know the incidence of myocarditis in children following mRNA injections because we do not know the denominator. That would have required high-sensitivity troponin, ECGs, and perhaps echocardiography on a large number of children following mRNA injections. As a cardiologist, I do not view subclinical myocarditis as a benign process, particularly in children and young adults. Lethal arrhythmias may occur later.
Wrt to #7, we actually do know the incidence of sub-clinical myocarditis from a study carried out in Thailand where they found elevated troponin-C levels in 1 in 500 children subsequent to the mRNA vaccine. And I fully agree with you that sub-clinical myocarditis is not benign, especially in the long terms (i.e. 50-60 years out where these children may suffer from premature cardiac events).
Appreciated #6. Knowledge of these death SHOULD have changed the response including no mandates for young people by 2022 and beyond
Nice piece, and a nice companion to Dr. Mandrola’s post.
I agree that the finding that some children died as a result of the vaccine to be entirely unsurprising. I would be far more shocked with an assertion that none did.
Any treatment has costs. The balance always comes down to whether the benefits outweigh those costs.
And I agree with Dr. Prasad on first principles. Before any therapy is approved, the regulator has to be convinced that the benefits do in fact outweigh the costs. One travesty with covid has been the lack of rigorous assessments of vaccine benefit in some of the non high risk populations, before broad usage was permitted/ recommended/ required.
The other issue in terms of benefits and costs is that the virus was continually evolving which rendered the vaccine less and less effective: (a) every subsequent strain was less pathogenic that the one, such that the current strain amount to no more than a bad cold or regular ILI; and (b) the vaccine targeted for the original strain was progressively less effective as the strains departed more and more from the original. So even if the benefit/risk ratio was positive initially, by the summer of 2020 it was likely in negative territory for everybvody.
Are you kidding me? 10 deaths in a population that had virtually zero risk of disease is totally unacceptable.
What’s “acceptable “ depends on the benefits. And that’s the part that hasn’t been properly studied in young kids.
As Prasad notes, young kids do in fact get covid, and they can in fact get myocarditis from it. But we don’t know the denominator, so we can’t properly judge what the natural risk is. Nor can we quantify the magnitude of vaccine benefit.
What’s “acceptable “ depends on the benefits. And that’s the part that hasn’t been properly studied in young kids.
As Prasad notes, young kids do in fact get covid, and they can in fact get myocarditis from it. But we don’t know the denominator, so we can’t properly judge what the natural risk is. Nor can we quantify the magnitude of vaccine benefit.
I thought I would make a comment about VPs first email which was entirely to the point and spot on. I don't work at the FDA but at the NIH, and the NIH is entirely different with a quite different mission. The purpose of intramural NIH PIs is to carry out blue sky research just as at universities. But that's absolutely not the case at the FDA. Even those FDA PIs who engage in actual research at the FDA (whether bench research or epidemiological research) can only do so on a part time basis as they are obligated to do regulatory work. The latter cannot just be done on the side since it involves serious matters and requires very careful appraisal of the material presented to them.
That the vaccines were mandated despite the side effects to me is most troublesome. I believe VP has that as a target. I am so relieved he is in this position.
I agree with the overall balance of this piece, and I know your focus here is on kids, not adults. But since you note at the end that “the vaccine was clearly beneficial in older age groups,” I think it’s worth being equally precise about what the pivotal adult RCT actually established.
When you read the FDA briefing book closely, a few things stand out.
First, the trial population wasn’t at high risk. These were mostly healthy adults with extremely low rates of severe COVID, which means the RCT couldn’t tell us much about protection against the outcomes that ultimately mattered most…especially since we know the vaccine ultimately did very little to prevent infection long-term (some large observational studies found higher incidence over time).
Second, the number of confirmed infections in both arms was tiny relative to what the general population was experiencing at the time. The trial looks clean in part because it captured a much lower level of COVID exposure than existed in the community.
Third—and this rarely gets mentioned—the briefing book shows very large numbers of “suspected but unconfirmed” infections. Those suspected illnesses look much closer to the real-world burden of respiratory disease during that period. If a vaccine only affects a narrow slice of that illness spectrum (the small fraction that is PCR-confirmed COVID), then even a high efficacy number can overstate its impact on the actual infections people were experiencing. Vaccine doesn’t clear hurdle if those suspected illnesses are included.
None of this diminishes the real benefits for older, high-risk adults—you’re absolutely right about that. But as a reader, I sometimes feel a disconnect when the pivotal RCT is described in glamorized terms, because its findings in younger, healthy adults were much narrower than the headline efficacy implied. The RCT convincingly showed a reduction in lab-confirmed symptomatic COVID in a low-risk cohort; it didn’t—and probably couldn’t—answer the broader questions about total infection burden, transmission, or the full landscape of respiratory illness at the time.
The FDA took a notably permissive approach to mRNA vaccines in children 6 months to 4 years old. The pediatric trials were small, side effects were relatively common, and even the strongest-looking efficacy estimates were based on only a handful of infections. Despite this uncertainty—and without lot-testing for issues like residual DNA—the agency authorized the product for a very low-risk population, accepting a high degree of imprecision.
The ByHeart situation shows the opposite regulatory posture for infant formula. Here, the FDA applies a zero-tolerance standard: a single consumer complaint prompted a recall, and there are now 37 confirmed infant botulism cases linked to ByHeart formula use. None of these cases resulted in death or permanent injury. For perspective, the U.S. typically sees roughly 80–100 infant botulism cases per year from all causes; this year, dozens of those non-ByHeart cases have been investigated and determined not to be connected to ByHeart or formula at all. That broader context highlights how aggressively the FDA traces even the possibility of contamination when formula is involved.
The contrast is clear. For pediatric mRNA vaccines, the FDA tolerated substantial uncertainty in the supporting evidence. For infant formula, it assumes a maximal-precaution approach, treating every potential safety signal as urgent until ruled out.
The November 20 2025 NEJM illustrates a problem of selective reporting of vaccine results that the FDA and Dr Prasad should address. The headline article describes some increased efficacy of Pfizer mRNA influenza vaccine compared to non-mRNA vaccine, at the price of considerably more local reactions. Not included were the results in age 65+, which showed no increased efficacy and more side effects. These results were buried in Clinicaltrials.gov https://www.clinicaltrials.gov/study/NCT05540522?tab=results#outcome-measures
Surely the FDA should regulate some of this selective reporting.
It's not so much selective reporting (which is what the MSM does especially in matters scientific where they rarely get things right), as selective publishing leaving out inconvenient data. Now the fact of the matter is that cherry picking data for a manuscript destined to be published in a scientific or serious medical journal is completely unethical and represents scientific misconduct and frankly outright fraud. As for the NEJM editor-in-chief, he is so tarred by incidents such as the recent Pfizer publication and so corrupted by big Pharma, that he should be forced to sep down before further tarnishing the NEJM. The same is true of the Lancet Editor-in-Chief.
I am trying to look at all of this with an open mind. I followed Vinay’s work for years and there was a time when I really appreciated how he approached evidence. Over time his tone shifted. His takes became more contrarian and many of his interpretations of oncology trials felt settled before he even talked through the data. When people in our field raised concerns, the responses did not show much humility or willingness to revisit his conclusions.
What is happening at CBER feels very similar. These are serious claims and they need to be supported by a clear, transparent process. Right now it is difficult to understand how strong the signal actually is because none of that context has been shown. Time will sort out the evidence and the true causes. This early communication did not help with clarity.
The tone of his memo
was sharp and very certain. I am not even sure it sounded like him. Part of me wonders if he was encouraged to word it that way. And once a letter like that goes out to thousands of people, it is hard to imagine it was ever going to stay internal. The way it was written made a leak almost expected.
That mix of tone, lack of context, and the way it immediately spilled into public view makes it hard to separate the science from the messaging. It feels far from the thoughtful evidence based voice I used to read. I could be wrong in how I am seeing this and I am open to that.
I would respectfully disagree with you. There is no question that children died because of the covid vaccines. How do we know this because we know that the vaccines can result in vaccine-induced myocarditis, and we know that quite a number of children had to go on ECMO and never could get off it. So that is not in question. What is in question is the degree to which the mRNA vaccines are being protected by the FDA despite all evidence to the contrary. Recall, the H1N1 swine flu vaccine had to be withdrawn because of a few cases of narcolepsy (some fatal) in children. Yet the FDA is still prepared to continue having the mRNA vaccines on the market despite the huge uncertainties in dosage (i.e. how much spike protein is produced is hugely variable from person to person), pharmacokinetics (it has been shown that the mRNA persists upwards of 6 months in certain individuals by several studies, including from Yale), pharmaco-distribution (the mRNA and spike protein have been shown to be distributed in almost every organ system in the body, which ones and where varying hugely from individual to individual), an DNA contamination during the manufacturing process (i.e. DNA used as atemplate for the mRNA not be purified away sufficiently so that the levels of DNA are many orders of magnitude higher than the allowed limits). This amounts to playing Russian roulette with peoples lives. Just imagine if the dosage of tylenol in your regular extra-strength tylenol pill could vary by an order of magnitude from pill to pill, and how many livers would be completely destoyed!
I disagree. This felt very much in tone with how he usually writes. Clear, concise and effective. It is an internal memo. And there is clearly humility in there because he says nothing is set in stone. I don't object to any of the content though I do take Adam's point that the political digs may have been avoided. But even if he had avoided that kind of language "profound" for example- I doubt it would have mattered. The sense I get is that the staff at the FDA that were second guessing these issues in real time were pushed out. That left good smart people who now believe in the Covid vaccines safety as though it was annointed by a higher power. I am worried that no matter the data they are presented with, they will dig in and defend their original stance.
I don't look at those things as political digs. The fact is that massive mistakes were made at the FDA under the previous administration, including willfully neglecting mounting negative evidence in relation to severe adverse events associated with the mRNA vaccines, and that needs to be admitted and called out. Failure to do so will only result in even less trust in the FDA and associated agencies.
Thanks for sharing that perspective!
Agreed. I started following Dr. Prasad in 2021, and I really appreciated his measured, evidence based approach to navigating the pandemic. Especially as someone with a great deal of anxiety. It is hard not to view him as another sellout who is abandoning science to kiss the ring of the current regime because I expected the same evidence and rigor he demanded from others. I do understand it will all come out in the wash, but I miss the old Vinay Prasad.
100%
Let’s not forget that the claim is that at least 10 children died. Additionally, VAERS is highly underreported. It's been suggested that as little as 1% of temporal events are reported. If that’s the case, there could be more than 1000 child deaths. What about the other age groups?
The current dogma holds that the vaccine was a miracle for the old and frail, but this, like most other COVID claims, has never been proven. The clinical trials omitted this cohort – why? COVID-19 vaccine promoters continue to rely on highly confounded studies. Causation of deaths in the old and frail is the most difficult to assess because they are expected to die.
The burden of proof has clearly shifted from proving that vaccines are safe and effective to proving the opposite. This makes them unreliable.
Good read. What a horrible job VP currently has. Any physicians who worked for the federal government at any point understands his current uphill battle. Most all of us trained at a VAMC -the vets are the best, some staff (MD’s, students, nurses, RT, PT, OT, ST, environmental services, kitchen staff, security) are absolutely wonderful, some of the healthcare state of the art, the rest was governmental crap– keep the status quo no matter how crappy it is and don’t rock the boat or question the forms.
In light of renewed media attention on COVID vaccination in young children—sparked in part by the recent leak of Prasad’s email raising questions about the evidence behind these policies—the numbers in the FDA’s own documents are especially relevant.
The tables in the FDA VRBPAC Briefing Document, Pfizer COVID-19 Vaccine EUA Amendment for Use in Children 6 Months–4 Years, page 39, present COVID-19 case counts and vaccine-efficacy estimates for Pfizer’s 3-dose, 3-µg pediatric regimen.
For children 6–23 months (Table 19), 1,178 received vaccine and 598 received placebo. After Dose 1, there were 98 cases in the vaccine group and 58 in placebo, yielding an estimated efficacy of 14 percent with a confidence interval from –21 percent to +38 percent. Before Dose 3, efficacy estimates fluctuate from negative to modestly positive because many intervals contain only 1–3 cases in each group. After Dose 3, the primary comparison (≥7 days post Dose 3) shows 1 vaccinated case versus 2 placebo cases, producing a nominal efficacy of 75.5 percent, but with an extremely wide confidence interval spanning –370 percent to +99.6 percent. These very wide intervals reflect how little information the trial actually captured.
For children 2–4 years (Table 20), 1,835 received vaccine and 915 received placebo. After Dose 1, there were 127 cases in vaccinated children and 92 in placebo, with an estimated efficacy of 32.6 percent (CI 10.8–48.8 percent). After Dose 2, the same pattern appears: very small case numbers (e.g., 4 vs. 5; 21 vs. 8), resulting in efficacy estimates that vary widely and have confidence intervals encompassing both harm and benefit. After Dose 3 (≥7 days), there were 2 cases in the vaccine group versus 5 in placebo. This generates a point estimate of 82.3 percent efficacy—roughly in line with the informal ≥80 percent benchmark that was often referenced for meaningful protection in the general adult population early in the pandemic. However, because these figures rest on only seven total infections, the confidence interval still ranges from –8 percent to +98.3 percent. In other words, even the strongest-looking estimate is not statistically secure.
Across both age groups, the key limitation is the extremely small number of COVID-19 infections captured after Dose 3, precisely where the vaccine would be expected to show its effect. These small numbers—representing only a tiny fraction of the likely true infections in the cohort over the study period—produce efficacy estimates with very wide confidence intervals. As a result, the data from the VRBPAC briefing document do not provide a precise or reliable measurement of real-world protection in children under 5, even though the point estimates after Dose 3 trend in a positive direction. Yet, the vaccine was heavily pushed among this age group.
But isn't it the case that children under 5 were simply not at high risk of death or hospitalization from Covid. On the other hand, you have a vaccine with known severe adverse events (e.g. myocarditis, both overt and subclinical which may have significant sequelae later on in life) whose real dosage is completely unknown and whose pharmacokinetics and pharmacodistribution are very variable. Recall, that mRNA from the vaccine has been detected upwards of 6 months from vaccination and is also known to be distributed in virtually every organ system in the body. That's an extremely dangerous situation because any cell bearing spike protein on its surface will be destroyed by the immune system leading to localized inflammation, tissue destruction, etc..... In a skeletal muscle that's no big deal, but in an organ where dead cells are not replaced (e.g. brain and heart) it obviously is a big deal.
So in the end one really has to ask oneself whether it is truly sensible and ethical to vaccinate kids against a basically harmless infection (especially with the current SARS-CoV2 strain) at the risk of some really bad sequelae of vaccination.
Can you walk us through your back of the envelope calculation that the health benefit was a wash, or elaborate on why we can’t really know? Considering the huge numbers of kids that got the shot, if the vaccine reduced hospitalization as much as you report, it seems like many more kids would be saved? Would love to hear more about this — this seems by far the most important point.
Most of you people here are doctors, I am not. But in my opinion, I believe child vaccination needs to STOP! (Actually I believe that all mRNA should be removed at this point) For example, see below the Danish vaccine program. They never offered it to babies!
GROK: Yes, Denmark administered COVID-19 vaccines to children at various points during the pandemic and afterward.
- **Children aged 12–17**: Denmark began offering Pfizer-BioNTech vaccines to this age group in **July 2021**, initially on a voluntary basis and later as part of the general vaccination program.
- **Children aged 5–11**: Denmark opened vaccination for this younger group on **November 26, 2021**, using the pediatric Pfizer-BioNTech formulation (lower dose). It was offered but not mandatory.
- **Policy changes in 2022**: On **July 1, 2022**, the Danish Health Authority (Sundhedsstyrelsen) announced that children and adolescents under 18 would **no longer be offered primary COVID-19 vaccination** as part of the general program, because the overall benefits were deemed marginal in a situation where most children had already acquired immunity through infection and severe outcomes were extremely rare. Revaccination (boosters) for healthy children were also stopped.
- **Exceptions**: Children in high-risk groups (e.g., with severe chronic illnesses) could still be offered vaccination upon medical recommendation even after July 2022.
- **Later developments (2023–2025)**: Denmark has occasionally re-opened vaccination for 5–17-year-olds during autumn/winter campaigns (e.g., 2023–2024 and 2024–2025 seasons), but only as a targeted offer, primarily for children with medical risk factors. Healthy children are generally not actively invited or recommended to get vaccinated or boosted.
So in summary:
Yes, Denmark did vaccinate children (both 5–11 and 12–17) quite extensively in late 2021 and early 2022, but later shifted to a very restrictive policy for healthy children, which remains largely in place as of 2025.
As an Australian observer it is unfathomable that that merely suggesting a policy that Australia adopted almost after everyone had a first dose is controversial in the US. It was decided early on that boosters were for the elderly and immune compromised. It is not recommended for children or the otherwise healthy. It was possibly a mistake to ever give them to this population, but at least policy has moved on. Medicine and science has become hopelessly political in the US.