It seems like ancient history now, but it was really only three months ago that I first wrote a post entitled Robert F. Kennedy Jr. is definitely coming for your vaccines. Basically, it was a followup to a post that I had written in July in the wake of RFK Jr.’s having sacked all the experts on the CDC Advisory Committee on Immunization Practices (ACIP) and replaced them with antivaxxers or antivax-sympathetic physicians and scientists. In that July post, I predicted how the longtime antivax activist now in charge of all non-military federal health programs, Secretary of Health and Human Services Robert F. Kennedy, Jr. would dismantle federal vaccine infrastructure in his quest to eliminate vaccines and then in September basically discussed how those predictions were coming true. Unfortunately, my “RFK Jr. is coming for your vaccines” post soon became a series, with parts 2, 3, and 4 following in fairly rapid succession over the intervening weeks. Starting with the first post and continuing through its sequels, I outlined several tactics that RFK Jr. is using to realize his longstanding dream of eliminating all vaccines, or at least as many vaccines as he can while he hold his current office.
To recap, here are the tactics I first predicted and then, depressingly, started describing as he began to use them:
- Co-opt the CDC to change its evidence-based policy-making apparatus to policy-based evidence-making designed to fuel antivax messaging.
- Co-opt the NIH to direct research funds away from vaccines and towards studying “vaccine injury” and other antivax narratives (to support the policy-based evidence-making).
- Remake ACIP as an antivax committee, in order to remove recommended vaccines from the CDC recommended immunization schedule and refuse to approve new vaccines.
- Influence the Vaccine Court and the NVICP to compensate “vaccine injuries” that antivaxxers believe in but that are not supported by science.
- Take control of the vaccine safety monitoring systems, the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safetylink Database (VSD), to cherry-pick evidence designed to portray vaccines as dangerous.
- Co-opt the FDA to make approval of new vaccines more difficult and issue black-box warnings based on antivax fear mongering for existing vaccines.
Unfortunately, over the holiday weekend, while I was away in Ohio with my wife visiting friends of hers, news broke that demanded that I add part 5 to this series in the form of articles in the New York Times (with the bland and misleading headline F.D.A. Seeks More Oversight of Vaccine Trials and Approvals) and The Washington Post (with the better, but still wimpy headline Blaming some child deaths on covid shots, FDA vows stricter vaccine rules). This new development is a clear implementation of tactics #5 and #6 (although it also touches on #1). Specifically, through his useful idiots at the FDA, RFK Jr. is working to weaponize VAERS data to justify making vaccines harder to approve. In this case, the useful is an old “friend” of the blog, Dr. Vinay Prasad, the medical oncologist turned COVID-19 contrarian turned antivax-adjacent who is now in charge of the Center for Biologics Evaluation and Research (CBER), the center at the Food and Drug Administration responsible for approving and regulating vaccines and biologics. His boss is Dr. Marty Makary, fellow COVID contrarian turned FDA Commissioner. Both stories are based on a leaked email from Dr. Prasad sent to CBER staff.
Because I think it’s necessary, I will be quoting extensively from the long email, because I don’t see how I can adequately address the propaganda and misinformation without doing so. Moreover, reading Dr. Prasad’s own words (and I encourage you to read the whole email, linked to in my discussion, the better to experience it for yourself) makes it very clear that he is quite paranoid about leaks and, his protestations otherwise notwithstanding, dismissive of legitimate criticism and debate, to the point of telling career staff who disagree with his “core principles” on this analysis to resign. I will then explain why this memo (and the “reanalysis” it vaguely describes) is so problematic and how Dr. Prasad, no doubt the useful idiot for RFK Jr., plans to use it, in essence, to make COVID-19 vaccines (and possibly other vaccines) so difficult to approve that manufacturers will just give up in the US market.
A VAERS dumpster dive with an astounding lack of transparency, even for Dr. Prasad
Does anyone remember Biden-era pandemic-era Dr. Prasad? One of his main complaints about The Powers That Be at FDA and CDC was a “lack of transparency” in how the CDC developed its recommendations and the FDA approved vaccines and evaluated adverse events due to vaccines. This story, more than anything else, shows that, under the guise of “greater transparency” what Dr. Prasad is doing is anything but transparency and basically boils down to, “Trust me, bro.” Indeed, one of the first things that struck me about these stories and about Dr. Prasad’s email, the full text of which is now widely available, is the utter lack of transparency and the arrogance and dismissiveness of its author. Let’s start with how the NYT is reporting this story:
The Trump administration is casting more doubt on the safety of vaccines, with an internal memo from the Food and Drug Administration linking the deaths of at least 10 children to the Covid vaccine and proposing new regulatory measures as a result.
The memo was obtained by The New York Times and not publicly released. It did not provide details such as the ages of the children, whether they had any health problems or how the agency determined the vaccine-death link. Nor did it disclose the maker of the vaccines involved.
The findings have not been published in a peer-reviewed medical journal, drawing suspicion from some critics of Health Secretary Robert F. Kennedy Jr., who has repeatedly criticized the Covid shots as deadly despite the scientific consensus that they are safe.
The memo was written by Dr. Vinay Prasad, the director of the F.D.A.’s vaccine division. He sent it to agency staff members on Friday, outlining findings from a review of reports concerning childhood deaths and attributing them to myocarditis, or inflammation of the heart muscle.
From WaPo:
The nation’s top vaccine regulator on Friday laid out a stricter approach for federal vaccine approvals, citing his team’s conclusion, without detailing the evidence, that coronavirus vaccines had contributed to the deaths of at least 10 children, according to an internal Food and Drug Administration email obtained by The Washington Post.
Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by Health Secretary Robert F. Kennedy Jr., told agency officials that the FDA will rethink its framework for annual flu shots, examine whether Americans should be receiving multiple vaccines at the same time and require vaccine makers to show far more data to prove the safety and value of their products. For instance, Prasad said that pneumonia vaccine makers must demonstrate that their products reduce pneumonia, at least after they become available in the market, rather than just generate antibodies to fight infections.
Prasad also wrote that the new approach means the agency will have strict requirements for authorizing new vaccines for pregnant women. He concluded his lengthy email by maintaining that he was open-minded about next steps.
“I remain open to vigorous discussions and debate,” Prasad wrote to his team, adding that staff who did not agree with the core principles of his new approach should submit their resignations.
Now there’s the arrogant, dismissive Dr. Prasad we’ve all come to know and detest! Just listen to him! He proclaims himself to be open to “vigorous discussion and debate”; that is, unless you disagree with the core principles of his new approach, in which case you should resign. Indeed, this email is quite consistent with previous reports of the vindictiveness and paranoia with which Dr. Prasad runs CBER, which have led to a hemorrhaging of career scientists.
To recap, yes, myocarditis among young people was an adverse event noted in Israel and the US within a few months of the rollout of the mRNA-based COVID-19 vaccines. This discovery, according to Dr. Prasad in his email, was “missed” by the CDC and FDA (it wasn’t). Dr. Angela Rasmussen provides a nice summary, describing a study in which Høeg and Prasad dumpster-dove into the VAERS database:
In reality, Høeg and colleagues estimated a rate of myocarditis in adolescent boys receiving the second dose of an mRNA vaccine to be more than twice the rate (162/million vaccines) calculated by an actually qualified team led by vaccine safety experts from CDC (71/million vaccines). Both studies used data from VAERS, although the CDC inclusion criteria were more stringent than Høeg’s, and thus more likely to exclude cases that were not relevant to assessing the risk of myocarditis from vaccination.
Prasad and Høeg also evidently ignored data showing that vaccine-induced myocarditis rates have declined further in the years since Høeg’s initial study, as well as data showing that the risk of myocarditis is much, much higher from COVID infection than vaccination.
I also deconstructed the Høeg/Prasad study, characterizing it as typical VAERS dumpster-diving, a continuation of a common antivax trope of weaponizing VAERS to portray vaccines as dangerous. I also have to tip my hat to our own Dr. Jonathan Howard for steering me to this paper, which suggests that myocarditis after vaccination might actually be less common than thought, based on:
And:
The point is that myocarditis after COVID-19 vaccination is a real AE. However, no one “covered it up.” Nor did the CDC and FDA “miss it,” even if Israeli health authorities noticed a safety signal before the FDA did. Importantly, most cases are benign and self-limited.
Before I move on to what Dr. Prasad is doing with this memo, let’s briefly discuss what VAERS is, what it can be used for, what it shouldn’t be used for, and how antivaxxers have been weaponizing it for at least a quarter of a century.
VAERS and antivaxxers
Antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. The reason, to reiterate, is that VAERS is a passive surveillance system. It relies on healthcare workers, relatives, and patients who think they’ve suffered a vaccine injury to submit reports of adverse reactions to vaccines; it doesn’t actively look for them, as active surveillance systems do. Moreover, anyone can submit a report to VAERS, and they do, including parents of autistic children seeking compensation for their children’s autism as being due to “vaccine injury”. Indeed, I long ago discussed how lawyers have long gamed VAERS to support their litigation, reporting lots of cases of autism as supposedly an “adverse reaction” to vaccines.
It’s not just vaccines and autism, either. The easily-abused nature of VAERS data is one huge reason why those of us who’ve been following the antivaccine movement a long time like to refer to the bad “scientific studies” published by antivaccine physicians and scientists that use VAERS as their data source as “dumpster diving“. Examples abound, including a study claiming to find a link between the H1N1 vaccine and miscarriages or one of the earliest examples that I ever encountered, Mark and David Geier’s epically bad study trying to link thimerosal-containing vaccines to autism. As an amusing aside, when I discuss VAERS, I (and many other science-based vaccine advocates) sometimes like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. True, someone did contact him to question it. If Laidler hadn’t been honest, he could have insisted that the report remain, and it would still be there today.
You might wonder: Why would anyone set up a system like VAERS, which is co-managed by The CDC and FDA? First, you must understand that, as I alluded to above, VAERS isn’t intended to give an accurate estimate of the prevalence of various adverse events after vaccination. Rather, it was always intended to serve as an early warning system, a “canary in the coalmine”, so to speak. Consequently, even though antivaxxers like to harp on how passive surveillance systems generally capture only a small fraction of adverse reactions, one thing VAERS does do well is to capture severe reactions, while it misses most mild reactions. After all, practically no one is going to report to VAERS an adverse reaction like a sore arm or transient fever, but you know damned well they’ll report more serious ones, such as a seizure or death. (In his email, Dr. Prasad tries to claim that deaths from vaccines are underreported in VAERS, but there is no evidence to suggest that.) The problem is that the natural human tendency to seek patterns, coupled with the way antivaccine lawyers game VAERS by having their clients report all sorts of spurious “adverse events” to the database after vaccination, means that VAERS is a very noisy, distorted, and unreliable database.
Even VAERS cautions people about how to interpret its data, at least it did in the versions prior to January 20 archived by the almighty Wayback Machine:
When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.
And:
“Underreporting” is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. The degree of underreporting varies widely. As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes.
A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. It only confirms that the reported event occurred sometime after vaccine was given. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.
Still, its limitations aside, VAERS has its place if you understand its intended purpose rather than what antivaxxers try to use it for. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. Moreover, the utility of VAERS depends on knowing its limitations, using it only as a hypothesis-generating tool, and rigorous examination of its reports before inferring causation, none of which appears to have been done here. What appears to have been done is something similar to what Dr. Prasad did in 2021 when with Dr. Tracy Høeg he dumpster-dived (dove?) into VAERS to trumpet a horrific risk of myocarditis attributable to the vaccine, while other antivaxxers weaponized VAERS against COVID-19 vaccines, just as those of us who’ve been paying attention to them warned that they would and just as they’ve continued to do.
Now, back to the memo.
Høeg dumpster dives into VAERS yet again and—surprise!—finds (apparently) myocarditis, death, and destruction
After warming up with a discussion of myocarditis and COVID-19 vaccines, Dr. Prasad refers his staff to a reanalysis of VAERS reports carried out by Dr. Tracy Beth Høeg, who is now, alas, Senior Advisor for Clinical Sciences FDA-OC & FDA-CBER. Here is how he describes her reanalysis:
In the summer of 2025, Dr. Hoeg began investigating VAERS reports of children who had died after administration of the COVID-19 vaccine. By late summer, she had concluded that there were in fact deaths– a fact this agency had never publicly admitted.
Dr. Hoeg organized a small meeting to discuss these deaths with OVRR and OBPV stakeholders. The slides she presented, emails she sent, and distorted firsthand reports was shared with media outlets. The general narrative was that OVRR staff disagreed with Dr. Hoeg’s assessment that the deaths were due to vaccine receipt. Some staff present who leaked portrayed the incident as Dr. Hoeg attempting to create a false fear regarding vaccines.
I then asked OBPV to perform a detailed analysis of deaths voluntarily reported to the VAERS system– in full interest of balance. Causality is easy to assess in a randomized trial, but with case reports, causality is typically assessed on a subjective scale. In this scale ranging from certain to unlikely– certain, possible/ likely, and probable are broadly considered as related to the product. The team has performed an initial analysis of 96 deaths between 2021 and 2024, and concludes that no fewer than 10 are related. If anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher.
This is a profound revelation. 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. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.
What it sounds like is that Dr. Prasad tasked sports medicine physician turned COVID-19 contrarian and “Urgency of Normal” misinformation spreader Dr. Tracy Beth Høeg with re-analyzing VAERS reports of children who died after receiving COVID-19 vaccinations. I note that Dr. Prasad’s first assumption is clear that the FDA either never adequately investigated all these deaths or “covered up” that they were due to the vaccine and were therefore forced by Dr. Høeg to “admit” that there were at least ten pediatric deaths attributable to the vaccines. This is a classic antivax trope—actually, a trope of all scientific conspiracy theories—that “They” (be “They” the FDA, CDC, the entire medical profession, or whatever) couldn’t admit that vaccines caused horrific harms and therefore were either ideologically blinded or actively covered up data demonstrating those horrific harms; that is, until the brave maverick outsider, with her apparently superior open-mindedness and scientific acumen, rubbed their noses in the data and forced them to admit.
Notably, this is really fast for an analysis of so many complex case reports. Apparently, Dr. Høeg started her “analysis” in July and by late summer had come to her conclusions! Maybe she’s a fast worker, but more likely she found what she wanted. Moreover, there is nothing in Dr. Høeg’s pre-pandemic career as a sports medicine doctor to suggest why we should consider her evaluation of VAERS reports to be superior to that of FDA career professionals. Even though she does have a PhD in epidemiology and public health, her subject of expertise was not infectious disease or vaccines, but rather eye disease, with a focus on adult visual impairment, eye disease prevalence, and vision-screening outcomes in a Danish adult population (via the Danish Rural Eye Study). It is remarkably difficult to find her PhD thesis (and I’ve failed thus far). As a result, I’ve had to rely on her submitted CV (which, oddly enough, does not list the title of her PhD thesis) and other disparate sources to make this best guess. I am, however certain that her PhD and pre-pandemic research had nothing to do with vaccines or respiratory viruses like SARS-CoV-2 and that her prepandemic publications nearly all had to do with ophthalmology or sports medicine.
It would be one thing if we could examine the methodology used by Dr. Høeg and her team to assess causality. Who knows? Although it’s unlikely, she might actually have figured out a better way of assessing VAERS reports for causality than what the FDA used before. Without knowing how this new analysis is carried out, though, it is not unreasonable to be very doubtful, given her background.
It’s also very convenient for Dr. Prasad that none of the CBER staff can really respond publicly and even more convenient that he doesn’t actually present data and analysis of the cases. He didn’t describe how Høeg re-examined the cases and what she did that was different from career FDA staff did. Nor did he explain how her methods were superior to existing longstanding FDA processes for evaluating adverse events after not just the use of a vaccine, but the use of any drug regulated by the FDA. His entire argument in this email seems to boil down to, “Trust us, bro” and “My way or the highway.”
Another thing that got my skeptical antennae a’twitchin’ was, despite Dr. Prasad’s expressed anger at leaks, a sneaking suspicion that I can’t shake that wonders: Was this memo meant to be leaked? Otherwise, why send it by general email to CBER staff, given how easy it is to forward an email to a reporter and knowing that most CBER staff are hostile to his approach, mainly because Dr. Prasad has no special expertise in vaccines or biologics, certainly not compared to career CBER staff. If so, this memo/email falls clearly under Tactic #1: Co-opt the CDC to change its evidence-based policy-making apparatus to policy-based evidence-making designed to fuel antivax messaging. Dr. Prasad has both co-opted CBER evidence-based policy-making and turned it into policy-based evidence-making, the results of which he is using to have CBER and the FDA fuel antivax messaging the “Truth” that COVID-19 vaccines killed at least ten children, a “Truth” covered up by the previous FDA administration.
Another funny thing about this passage is Dr. Prasad’s blind confidence when he asserts that causality of an adverse event (AE) is “easy to assess in a randomized trial.” Not quite. Anyone who has ever reviewed adverse events reports for a randomized clinical trial (RCT) knows that sometimes causality is not too difficult to assess, but sometimes it is. Surely, Dr. Prasad, as the self-proclaimed expert that he is on RCT methodology knows this. It’s why there are so many tools and statistical tests to assess causality of adverse events. Indeed, one 2017 analysis found that across “all trials and settings, a very high proportion of AEs reported as related to treatment were classified as possibly related, a significant proportion of AEs in the placebo arm were incorrectly reported as related to treatment, and clinician-reported attribution over-estimated the rate of AEs related to treatment” and further concluded that “assigning causality to AE is a complex and difficult process that produces unreliable and subjective data.” Yes, I’ll conceded that assigning causality in an RCT, particularly for severe AEs, is easier than it is for a case report, but that doesn’t mean that causality is as “easy to assess” as Dr. Prasad seems to think.
As Ed Nirenberg put it:
This one is an important point. Many millions of doses of COVID-19 vaccines were administered to children, which would, even if you take the estimate of 10 fatalities due to the vaccines, a very rare AE indeed. No RCT would ever have the power to suss out whether there was a statistically significant difference in death as an AE between the control group and the vaccine group.
That’s why, as Dr. Nirenberg says:
I’ll also note that we’re not even talking about real case reports, but VAERS reports. We at SBM have discussed how antivaxxers like to weaponize VAERS reports of adverse events after vaccination, and I’ve done so here and at my not-so-super-secret other blog going back to 2006 at least.
Now that Dr. Prasad has “proven” that COVID-19 vaccines are dangerous, he does seem to realize that he has a problem. Even if all ten cases (none of which he describes) did indeed die of mRNA vaccine-induced myocarditis (which is highly debatable and almost certainly untrue), that would still be an incredibly rare event. In such a case, it would make sense to make an argument that far fewer children died as a result of vaccination compared to how many died of COVID-19, or even far fewer children developed myocarditis as a result of COVID-19 vaccination compared to the children who developed myocarditis, even asking “Did COVID-19 vaccine programs kill more healthy kids than it saved?”
No doubt you can easily guess his answer to that question:
We do not have reliable data estimating the absolute benefit (absolute risk reduction) regarding severe disease and death in healthy children from vaccine receipt. OVRR and OBPV rely on observation cohort or case control data with notorious methodologic biases. FDA has never requested the manufacturers demonstrate in randomized fashion that vaccinating children improves these outcomes. The available randomized data in children is deeply limited, and broadly negative for symptomatic infection, as discussed in prior ad-coms. Furthermore, COVID-19 was never highly lethal for children, and now MIS-c has decreased drastically, and the harms, to kids, are comparable to many respiratory viruses for which we do not provide annual immunization.
Comparing the number of kids who died from COVID against these deaths would be a flawed comparison. We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported. Instead, the truth is we do not know if we saved lives on balance.
When it comes to vaccine deaths, VAERS is passively reported. It requires a motivated person, often a doctor, to submit the information. The submission process is tedious and most people who start the form give up along the way. Many more deaths may be unreported. Finally, the FDA has failed to properly enforce many required post market commitments for COVID-19 vaccines, including for pregnant women and to document subclinical myocarditis.
Putting these facts together, it is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection.
All I need to do is to refer back to Dr. Rasmussen’s discussion of the safety of COVID-19 vaccines among children, as well as to a number of large studies showing a favorable risk-benefit profile in children under 18 as well as children age 5-11. I also note that in the same post, Dr. Rasmussen makes a rather hilarious analogy to how Dr. Prasad is using VAERS data that revealed a possible aspect of Dr. Prasad’s personality that, although I don’t know if it’s true or not, would not surprise me in the least if it did indeed turn out to be true.
Finally, there is plenty of reason to be suspicious of Dr. Høeg’s scientific rigor in approaching these suspected deaths from the vaccine. I was reminded of this by a post on X, the hellsite formerly known as Twitter, by a man named Ernest Ramirez:
In the images above, Mr. Ramirez is posing for photos in what looks like the FDA lobby with Dr. Høeg and another woman whom I didn’t recognize. I checked out the Twitter handle tagged, though, and discovered that this is Lindsay Paul, who bills herself as “vaccine-injured” by Moderna, citing a plethora of side effects and adverse events. Both appear to be visiting as guests of Dr. Høeg. Now, note in the photo on the right the back of Mr. Ramirez’s vest: “Ernesto Ramirez, Jr. murdered by Pfizer.” Also note that Dr. Høeg has a silly grin on her face and is pointing to this text, as well as the text beneath it, “Make vaccine manufacturers liable,” from a website React19.org, the same website where Ms. Paul’s “vaccine injuries” are featured. (So is Ernesto Ramirez Jr.) But what about Ernest Ramirez? Who is he?
It turns out that I’ve written about him before, as he was featured in a particularly vile bit of antivax propaganda, a film called Shot Dead. Here’s the logo:
You can guess what the movie was about. Basically, it was a version of the “Died Suddenly” conspiracy theory that was really popular among antivaxxers in 2023. Reviewing it filled me with disgust, because the filmmakers clearly exploited the grief of parents who had lost their children, parents like Mr. Rodriguez, helping to feed their belief that vaccines killed their children. I wrote a long deconstruction of the film here, but the CliffsNotes version is that Ernest Ramirez’s son died five days after receiving the Pfizer vaccine. The film portrayed this poor child’s sudden death as a slam dunk clean kill by the vaccine, but left out some very critical information, namely that the autopsy report found that the boy had a preexisting cardiomyopathy with chronic scarring of his ventricles, and likely had a condition that predisposed to sudden cardiac death. His case is thus far more complex than the film portrays it. Could the vaccine have contributed to his death, given his apparent undiagnosed cardiac condition? It is, of course, possible. However, it’s also quite possible—probable, even—that the vaccine had nothing to do with it. The narrative in the movie leaves no room for nuance; indeed, the movie doesn’t even mention this finding.
Is Ernesto Ramirez Jr. one of the ten children whose deaths Dr. Høeg “uncovered” in VAERS as actually having been caused by COVID-19 vaccines. What do you think? Personally, I bet that he is. Certainly, it’s very suspicious that Mr. Ramirez visited Dr. Høeg at the FDA just a month ago and posed for friendly photos with her promoting the narrative that Pfizer had killed his son. I’m also guessing that the inference of “causality” for the rest of the ten cases is no more science-based than Shot Dead‘s assertion that vaccines killed the three subjects of the film. In fact, it wouldn’t surprise me if the other two subjects of the film, an 18 year old female who died 112 days after vaccination and a woman who blamed the vaccine during her first trimester for delivering an infant with a congenital hernia who died shortly after, are among the ten cases as well.
What this report will be used for: Eliminating COVID-19 and annual flu vaccines
One quote in the news articles that stood out to me was from Dr. Peter Hotez, a real vaccine expert at Baylor, who was quoted in the WaPo article thusly:
Peter Hotez, the director of the Center for Vaccine Development at Texas Children’s Hospital, said in a text message that he wanted to see Prasad’s statement about a link between coronavirus vaccines and children’s deaths supported with more data as well as information about any underlying health conditions.
“With almost one billion COVID immunizations administered to Americans during the pandemic, and perhaps close to 100 million for children and adolescents, it is conceivable that such a one in 10 million or 100 million event occurred,” such as a child’s death, Hotez wrote, later adding, “given the public health implications, this is not something one casually blurts out in an email.”
Exactly. As I said above, it’s not impossible that there have been ten deaths in children attributable to COVID-19 vaccines, but even if true it would represent a rare event. That’s not to say that, again if you trust Dr. Høeg’s analysis, the link should be investigated. However, once again, Dr. Prasad falsely assumes that these deaths weren’t properly investigated during the previous administration and, tellingly, does not explain the deficiencies or shortcomings in the previous analysis.
From a previous NBC News report on Høeg and Prasad’s quest to prove COVID-19 vaccines kill children:
But, two of the sources said, the agency is misusing the database which allows anyone — including doctors, patients and caregivers — to submit reports to VAERS about adverse events they believe are linked to vaccines. The reports are unverified, but the health agencies use the database as a guide for topics to investigate further.
And:
One former FDA official, who requested anonymity to speak freely, pushed back on the findings.
“I can tell you on a stack of Bibles that we looked through all of the autopsy reports and that we didn’t find anything,” the official said in a text message. “Unless someone was hiding them from us I don’t know what they’re referring to.”
The question then becomes: Why did Dr. Prasad send out this email so close to the holiday weekend? If he thought it less likely to cause a news kerfuffle, he was sadly mistaken. In any case, what is his purpose here? Personally, I agree with Drs. Angela Rasmussen and Gavin Yamey:
Precisely. The first thing that you have to remember is that Drs. Makary and Prasad are both tools of RFK Jr. and his antivax “make America healthy again” (MAHA) agenda, and that RFK Jr. is a tool of President Donald Trump’s “make America great again” (MAGA) and Project 2020 agenda. Second, you have to remember that, if Drs. Makary and Prasad don’t deliver, RFK Jr. will likely get rid of them, and Dr. Makary (who first said the FDA was going to “re-examine” the deaths”) and Dr. Prasad (Makary’s loyal underling) know it. Indeed, there are some rather obsequious passages in Dr. Prasad’s lengthy email, such as:
There is no doubt that without this FDA commissioner, we would not have performed this investigation and identified this safety concern. This fact also demands serious introspection and reform. Why were these deaths not actively reviewed in real time? Why did it take until 2025 to perform this analysis, and take necessary further actions? Deaths were reported between 2021 and 2024, and ignored for years.
I suspect the answer is cultural and systemic. I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product. The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm. The same is true for vaccines. The US government’s coercive and unethical covid-19 vaccine mandates in young people may have been harmful. In contrast, there is no doubt that an elderly, un-immune American benefitted from Doses 1 and 2 in 2020. The people who might have benefit most from vaccination were those too old to be affected by workplace mandates—another Biden administration blunder.
Not only is Dr. Prasad sucking up to his boss, FDA Commissioner Dr. Marty Makary, here, but he’s parroting the typical “I have no doubt vaccines have saved millions of lives” followed by the “I’m not antivax, I’m pro-safety” line that antivaxxers frequently use, while attacking the Biden administration, which no doubt pleases President Trump. It’s no surprise to me that Dr. Prasad is so good at kissing his bosses posteriors that he has likely seen their uvulas from the esophageal side. He’s also good at spinning conspiracy theories about Big Pharma in which the supposed “coverup” of vaccine-related deaths is due to the profit motive:
It is well acknowledged that the FDA does not consider the cost of drugs in our approval decisions, and similarly it is not our role to lower evidentiary standards or mask safety concerns to create artificial financial incentives to make vaccines. That said there are unique financial incentives for vaccine markers.
Covid-19 vaccines earned 100 billion dollars globally. The annual US vaccine market is estimated to be over 30 billion dollars, projected to pass 50 billion in a decade, and a single new vaccine for pregnant women has industry analysts estimating 1 billion a year in annual returns.
Additionally, vaccines do not go “generic.” There is no biosimilar pathway. You can’t show your biosimilar vaccine has the same antibody titer and get approval. This means two things: companies can expect long tails of earnings, and FDA acknowledges that cell and humoral immunity surrogates are insufficient for generic approvals– a position I agree with.
You can see where this is going. At least I can. Cell and humoral immunity surrogates are basically tests to see if a new formulation of a vaccine results in antibody production against the pathogen targeted. It’s how, for instance, flu vaccines are updated every year. Experts make their best estimate of what strains of influenza will be circulating every winter based on a number of observations and factors, and influenza vaccines are updated to use the suggested strains. Then the new vaccines are tested to see if they provoke an adequate antibody response. They aren’t tested in full-blown RCTs because (1) the updated vaccines are using a formulation that was already approved and (2) it’s way too expensive and slow to do RCTs every year for new influenza vaccines. By the time the RCTs would be finished, it would be too late to get the vaccines into production.
Manufacturers of COVID-19 vaccines used the same strategy to design updated vaccines/boosters based on the actual strains of COVID-19 that predominate each year. One can argue whether this model is entirely appropriate for COVID-19, but it is not an unreasonable approach. Indeed, for COVID-19 vaccines one can argue that it’s much faster to reengineer the vaccines because of how easy it is to use a new mRNA template based on circulating strains than it is to change strains for flu vaccines.
What follows from these observations is nothing less than a declaration of war on many vaccines by Dr. Prasad, parroting long-trodden antivax pathways:
We will revise the annual flu vaccine framework, which is an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods. We will re-appraise safety and be honest in vaccine labels. I look forward to hearing your thoughts on how to do this better.
Yes, he’s coming for flu vaccines, even though the current framework has served us well for literally decades. Look for CBER to require RCTs every year for new flu vaccine formulations, which will, if Dr. Prasad succeeds, be the end of annual flu vaccines in the US and leave us stuck with the current formulation until some future administration corrects his policy. The same is likely true of COVID-19 vaccines; that is, if Dr. Prasad doesn’t find a way to take them away altogether, starting with children based on the “analysis” touted above. Again, it’s all about doing RFK Jr.’s bidding to decrease access to not just COVID-19 vaccines and flu vaccines, but to all vaccines.
Don’t believe me? Then read this next part of Dr. Prasad’s memo, which to me is the most chilling part of all and not a section that has been well-covered in the media:
Additionally, at FDA, we have not been focused on understanding the benefits and harms of giving multiple vaccines at the same time. This is a concern shared by many Americans. The FDA’s standard has been to require randomized studies too small to draw any conclusions from– creating a false sense of efficacy and safety.
Yes, you read that right. This is a longtime antivax false claim somehow the vaccine schedule is the problem. It is basically a restatement of the old antivax trope, “Too many too soon,” parroted by Jenny McCarthy back in 2008 and remaining a favorite among antivaxxers. The reason this particular trope is so popular among antivaxxers is because it is damned near unfalsifiable as a hypothesis; at the very least it is incredibly difficult to falsify because all the combinations that would have to be tested—in RCTs, of course!—are so large as to be impractically expensive and onerous in terms of the number of subject needed.
Next up, more antivax tropes:
OVRR and OBPV staff will be tasked with writing guidelines to reflect these changes, and the mission of CBER will change to reflect this worldview. Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it. Vaccines will be treated like all other medication classes– no better or worse than AAV vectors, monoclonal antibodies, or anti-sense oligonucleotides.
Longtime readers will recognize that antivaxxers have long claimed that vaccines are somehow “privileged” or “given a pass” in terms of regulation compared to “all other medication classes.” That is, quite simply, not true. If anything, vaccines are subject to stricter standards, if only because they are designed to be given to healthy children and adults to prevent disease, which means that AEs are less tolerable. As I like to say, we accept severe toxicity from chemotherapy because the cancers for which chemotherapy is employed are deadly diseases that will kill the patient in very unpleasant ways if not treated. Vaccines, on the other hand, are administered to healthy people in huge numbers.
Finally, we come around to the antivax ethos that community benefits of vaccines don’t matter, that “you” can’t make “me” vaccinate “my child” because it contributes to herd immunity:
Insofar as vaccines have third party benefits, and many do, these will be judged just like drugs may have third party benefits– a person who takes an appropriate psychiatric medicine may be a better parent or spouse– but this requires data and cannot be assumed. I have seen no evidence that COVID-19 vaccines, which do not halt transmission, benefit third parties. I have no doubt that MMR vaccines do provide third party benefits when administered to high enough fractions of society.
It’s nice that he admits that MMR vaccines produce herd immunity “when administered to high enough fractions of society.” Apparently, he prefers mass infection, because he’s long claimed that “natural herd immunity” is at least as good as vaccine-induced immunity. Too bad you have to risk severe disease and death to get that sweet, sweet “natural immunity” (more properly, postinfection immunity) and that that immunity doesn’t really last much longer than vaccine-induced immunity because SARS-CoV-2, clever virus that it is, is as good at evolving to evade preexisting natural immunity as it is at evolving to evade vaccine-induced immunity.
Make no mistake here. Dr. Prasad is delivering for RFK Jr. on strategies #1, #5, and #6. He’s co-opted normal scientific channels and regulatory investigations away from evidence-based policy-making to policy-based evidence-making designed to fuel antivax messaging, in this case by using a non-transparent pseudo-“investigation” of VAERS deaths to produce evidence to justify restricting access to COVID vaccines, as well as making boosters impossible to approve, with the added antivax benefit of casting extreme doubt about whether yearly flu vaccines can be approved next year under this new regulatory framework. Meanwhile, his collaborator and minion, Dr. Tracy Beth Høeg, has clearly taken control of at least one vaccine safety monitoring systems (VAERS) and using it to cherry-pick evidence designed to portray vaccines as dangerous.
As STAT News reported three weeks ago:
A small jump in myocarditis cases — a side effect caused more commonly by Covid-19 infection — could be enough to effectively pull the vaccines off the market for certain populations, for example.
“We’re not going to be able to do studies that are large enough to rule out that the vaccines cause 1 in 100,000, 1 in a million serious adverse events,” said Susan Ellenberg, the first director of the FDA vaccine center’s biostatistics department. “If we decide that we need that level of assurance, we’re not going to have vaccines.”
Despite wanting to raise the regulatory bar for vaccines and conduct more intensive surveillance, the FDA significantly cut down on its vaccine surveillance resources this year. According to a review of federal contracting data, the agency slashed its budget by around half for three contractors and appears to have declined to renew contracts with at least one. It’s not clear why — the move may be part of the FDA and Trump administration’s efforts to cut costs and centralize functions.
The consolidation may have the effect of bringing vaccine surveillance more closely under Prasad and Høeg’s control.
This is, of course, a feature, not a bug, of what Drs. Makary and Prasad are doing, all, no doubt, at the behest of RFK Jr. Now that control of VAERS is established and Dr. Prasad’s minions weaponizing it, look for Dr. Prasad to move to make approval of new vaccines more difficult. Who knows? In the meantime, he might even use Dr. Høeg’s analysis to issue a black-box warning based on antivax fear mongering for existing vaccines. RFK strategies #1, #5, and #6 indeed.
I can’t say whether, in his heart of hearts, Vinay Prasad has become truly antivaccine, although I certainly have long suspected that he’s been increasingly trending that way since 2021. On the other hand, when he writes something like this memo, which sounds as though it could have come from RFK Jr. himself, complete with “Dear Leader” obsequiousness and contempt for the old order, does it really matter what he truly believes about vaccines? The same goes for Dr. Marty Makary. Both have chosen to throw in their lot with RFK Jr., who has been the most famous antivax activist in the US for two decades and is fanatically opposed to all vaccines. At best, they are useful idiots for RFK Jr. wiling to be complicit in doing whatever demands in return for power. At worst they have embraced RFK Jr.’s antivax crusade as their own and are happily working to undermine first trust in vaccines and then vaccines themselves.
Either way, RFK Jr. is definitely coming for your vaccines. Drs. Vinay Prasad and Marty Makary are but his tools. And if you’re in CBER, Prasad has a message for you:
Having said this, I remain open to vigorous discussions and debate on these topics, as I have always been. I am open minded to modifications or alterations. As you can imagine, I believe these debates should be private, internal to FDA, until they are ready to be made public. I don’t endorse selective reporting of our meetings and documents. Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor and CC my deputy Katherine Szarama.
Clearly, no debate will be tolerated, as it might slow down RFK Jr.’s quest to eliminate all vaccines.
