In pat 5 of his series Robert F. Kennedy, Jr. is Definitely Coming for Your Vaccines, Dr. David Gorski discussed a “leaked” memo by Drs. Vinay Prasad, which claimed that he and Dr. Tracy Hoeg had identified at least 10 children who died from the COVID vaccine. Though there will be some overlap, I’d like to add my own thoughts to Dr. Gorski’s devastating takedown.
1. The FDA identified, publicized, and acted on problems with COVID vaccines in 2021
In April 2021, the FDA paused the J&J vaccine after 6 cases of clotting were reported after 6.8 million doses. They published 12 cases in JAMA that month. The next month, the CDC published an MMWR of 17 cases. Deaths from the J&J vaccine were confirmed by the CDC and publicized in the media. Use of the vaccine plummeted, and eventually the FDA revoked it authorization. None of this was hidden, and the AstraZeneca vaccine was never approved in the US for this reason. Similarly, the FDA added a warning label about vaccine-myocarditis in June 2021. Vaccine-advocates trusted this and because we value science and evidence, we supported it 100%. There was 0 controversy about this, a pandemic rarity.
However, our current FDA leadership would have us believe that the same FDA and CDC employees who identified, publicized, and acted on these safety signals, missed or covered up children who were killed by the mRNA vaccines. They are making very serious allegations against their predecessors and they are not shy about that.
However, that’s unlikely. As Dr. Amy Cho said about the FDA memo:
It doesn’t even pass the smell test. I know (because I actually practice medicine) that pediatric deaths that are unexpected are *always* medical examiner cases. I also have made multiple submissions to VAERS and the CDC contacted me as part of their investigation so I know they follow-up. One was for a Bell’s palsy that occurred a few weeks after a vaccination. So it seems inconceivable they wouldn’t investigate a child’s death.
Indeed.
2. Actual FDA experts do not trust Drs. Prasad and Hoeg
Dr. Prasad is an oncologist while Dr. Hoeg is a sports medicine doctor who has offered unproven treatments previously. Neither has expertise in cardiology or vaccines, which has been evident for years. Multiple articles report that genuine experts at the FDA do not trust their integrity regarding the COVID vaccine. According to an article titled How two FDA Officials, Prasad and Hoeg, Seized Vaccine Oversight:
She (Dr. Tracy Hoeg) pointed to a recent label change that required vaccine makers to warn of the risk of myocarditis for young men. And she displayed about two dozen reports of young people who had died after getting the vaccine, found in the agency’s adverse event database. While such reports do not prove causality, Høeg seemed convinced. “Timing fits,” read a slide in her presentation, viewed by STAT. “Diagnosis fits. No better explanation found. Sufficient information provided.”
Cautiously, despite fears that they might face retribution, some of the scientists began to push back at Hoeg’s suggestion to effectively take the vaccine away from millions based on thin evidence. One participant described the mood in the room as “quiet horror.” “It was so far off base,” said the agency official, who was not authorized to speak publicly.
When it became clear that no career regulator would stand by the decision, and when vaccine center director Vinay Prasad said the move wasn’t necessary because he had already limited access to the shots, Høeg backed down.
Another article titled FDA to Present Data it Claims Ties Covid Shots to Child Deaths at CDC Meeting reported that:
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.”
Another article titled FDA Claims Covid Vaccine Caused Kids’ Deaths. Experts are Skeptical said:
Several CBER staff members who work with vaccines, and who were granted anonymity for fear of repercussions, told STAT they were upset over what they called a “misleading” and “politically charged” email. One worried a team member would ask to be moved to another center.
“Jumping from these case reports to their preexisting vaccine policy preferences is awfully convenient,” said another employee.
Exactly.
I trust that these journalists have vetted their anonymous sources, and I trust them more than our current FDA leadership.
3. Our FDA leadership previously made false claims that the COVID vaccine killed people
In February 2022, Dr. Hoeg posted the following:
This was false, as I pointed out to Dr. Hoeg at the time. This young man died around six weeks after his 2nd vaccine dose. He had no cardiac symptoms, only sinus symptoms, and the coroner who blamed the vaccine couldn’t even pronounce “myocarditis.”
However, Dr. Hoeg did not care at all that she was spreading obvious anti-vaccine misinformation. She responded to me by posting a “more clear cut” case of a vaccine-fatality, and her dishonest post about George Jr. remains up and uncorrected to this day. As I recognized nearly 4 years ago:
Her goal is to undermine vaccine confidence. She’s succeeded.
Similarly, in 2023 Dr. Marty Makary amplified the disinformation of his eventual boss, claiming that Kennedy shared “true stories of children who died immediately after the vaccine”. That’s false. In reality, Kennedy stole pictures of unvaccinated children who died of other causes to deceive parents about the COVID vaccine. These are the FDA officials who are asking us to blindly trust them today.
Of course, the anti movement, especially Kennedy, has long exploited deaths of children to advance their agenda. Dr. Gorski has discussed these tragedies for years, and I remember the article Medical examiner: Girl’s Death Not Caused by HPV Vaccination from 2014. That’s why I wrote in my first SBM article:
Unfortunately, those of us who are familiar with the anti-vaccine movement know what is about to happen. Millions of children ages 12-15 years will soon be vaccinated against COVID-19. Horrible, improbable things will happen to a few of them. The media will write emotionally powerful stories about some these children. Parents of these children will implore others “not to make the same mistake I did”. The anti-vaccine movement will amplify and distort these tragedies to implicate the vaccine, though of course we must always keep an open-mind and consider that the vaccine is responsible. Anti-vaccine activists will claim the COVID-19 vaccines were “rushed” and “not properly studied”. Parents will be frightened. Of course, this has been the pattern with nearly every vaccine for years before COVID-19 emerged.
That article, from May 2021, refuted Dr. Prasad’s early anti-vaccine writing.
4. Where are the case reports?
Although Dr. Prasad implied that VAERS is the only way doctors communicate information about vaccine side effects, this is not true. We also publish in medical journals. Multiple case series of vaccine-myocarditis had already been published by June 2021, and as pediatric cardiologist Dr. Frank Han wrote:
If I were to meet a patient with COVID vaccine myocarditis who was deathly ill, I would announce it to the world, and warn everyone of the risks.
I’ll revise this article if readers share examples, but I am unaware of any reports published in the medical literature of American children who died from the vaccine. Is it possible that dozens of doctors saw children die of vaccine-myocarditis and filled out VAERS reports but did not publish their cases? Sure. Is it likely? No.
5. Kennedy purges doctors who don’t confirm his anti-vaccine views
Kennedy is the boss here. He is the one calling the shots. As virologist Dr. Angela Rasmussen wrote:
Prasad can heap suffering on CBER staff all he likes, but it always must be in the service of Kennedy’s MAHA agenda. What Kennedy asks, Prasad will deliver. He will overrule career agency scientists to delay vaccine licensure. He will force FDA scientists to withhold or hide data from public view or scrutiny, even when it was generated and analyzed by government employees with taxpayer funds. He will put his thumb on the scale of vaccine evaluations and call it Gold Standard.
I am sure the FDA leadership is aware of articles titled NIH Whistleblower Fired Amid Turmoil Over Vaccine Policy and Fired CDC Chief Says She Was Ousted for Refusing to Blindly Back Vaccine Guidance. They know their continued employment depends on them providing Kennedy with anti-vaccine talking points and policies. It also forbids them from contradicting Kennedy’s disinformation or promoting vaccines in any way.
6. Drs. Prasad and Hoeg are fine with anti-vaccine data fraud
After Florida surgeon general Dr. Joseph Ladapo was caught altering data to defend his mystical anti-vaccine beliefs, Dr. Prasad rose to his defense. “This is a stupid news story,” he said. “Ladapo is close to correct that his critics.”
Dr. Hoeg similarly showered Dr. Ladapo with praise, describing him as a “friend and colleague.” That neither doctor cares about data fraud, as long as it was for the sake of infecting unvaccinated children with COVID, reveals their total disregard for basic research ethics.
7. Diagnosis myocarditis can be challenging
To neurologists, the heart is a pump to deliver blood to the brain, and Dr. Han wrote a nice explainer for folks like me titled Myocarditis and How to Think About it… Like a Cardiologist. Apparently, making the right diagnosis can be challenging. One NEJM study reported that:
A total of 61 patients underwent endomyocardial biopsy. Myocarditis was confirmed by biopsy in 40 of 61 patients.
Incredibly, 33% of patients with suspected myocarditis who were sick enough to need a biopsy, did not end up having myocarditis.
Ruling out other causes of myocarditis to isolate the vaccine as the sole cause adds another layer of complexity. Several of the “vaccine fatalities” in VAERS also tested positive for COVID, for example. It’s often not cut and dry.
8. Our FDA leaders were always against vaccinating children and they were never trustworthy
We are not starting from scratch with our FDA leaders. We don’t have to play dumb and pretend they are neutral scientists objectively evaluating the data to generate reliable evidence for the American public. We are all very familiar with their abysmal COVID track record, and it’s vital that we interpret their current statements with this in mind.
Dr. Prasad, for example, was against the pediatric COVID vaccine months before there was a pediatric COVID vaccine, and he never wavered, no matter what happened on the ground. As the pandemic progressed, Dr. Prasad offered entirely contradictory reasons to oppose the vaccine:
Dr. Prasad causally blew off anything the virus did to children, including killing 19 of them in a single month. 19 is more than 10 last I checked.
In February 2022, as the pediatric death toll surged past 1,000, Dr. Prasad authored blatantly pro-infection articles. “Getting sick and recovering is part of a natural and healthy life,” he wrote in his article Should We Let Children Catch Omicron? “It is reckless to let children age into a more serious encounter with a disease best dealt with while younger,” he said. This was at the end of the Omicron wave, the worst part of the pandemic for children, when 5-6 children died daily and nearly 1,000 children were hospitalized daily. None of this moved Dr. Prasad at all. He said people who even acknowledge it were “idiots“.
Our FDA leaders literally spread volumes of fake statistics and disinformation (volume 1 and volume 2), and there’s no reason to think they instantly morphed into ethical truth-tellers the moment they entered the government. Our baseline assumption should be that they remain indifferent to children hurt by viruses and utterly untrustworthy today. That’s entirely their fault, and it’s their job to fix it. It’s the responsibly of government doctors to earn our trust, not our obligation to gift it to them.
Dr. Hoeg laughing at a “murdered by Pfizer” sign
9. There is no risk-benefit analysis
Everything in medicine is about balancing risk versus benefit, which previous public health officials recognized. As one article reported:
An analysis presented at a CDC meeting in June 2021 focused on people aged 12 to 29 — those at highest risk for myocarditis. In that population, Covid had killed 2,767 since the beginning of the pandemic.
Although COVID’s harms are not limited to myocarditis, every study I know of found the virus causes both a higher rate and more severe myocarditis than the vaccine. This includes the work of Dr. Prasad who found in a systemic review:
The incidence of myocarditis found for young men after SARS-CoV-2 infection is larger than what we found for myocarditis following COVID-19 vaccination.
Fortunately, both the risk of severe outcomes from the virus and the vaccine have dropped since the pandemic’s first years, except for babies who have neither immunity nor any risk from the vaccine. However, Dr. Prasad’s memo attempted no such analysis. As law professor Dorit Reiss wrote:
Dr. Prasad sent an email to CBER suggesting changes to the approval for respiratory vaccines based, apparently, on the conclusion of an unpublished investigation into VAERS report by unknown people. A few thoughts beyond what was already reported, based on the full email.
Dr. Prasad is expressly saying he is not going to do a risk/benefit analysis, even for COVID-19 vaccines, let alone for any other vaccines. Based on this internal investigation of VAERS report, he decided there’s a problem. There is no more thorough review of the data.
Dr. Prasad does not want transparency on this. He is threatening against leaks in the email, he is not suggesting to publish any of these as case studies or give the methodology, and he is upset over previous leaks. We do not know who investigated, either. Much of the email is devoted to justifying public claims made by Prasad, his colleagues, before and to try and counter criticism of previous VAERS claims by Dr. Hoeg. This is an act of justification.
Dr. Prasad is not suggesting a deliberative process to assess next steps, as was FDA’s usual practice. He has decided, apparently without consulting with anyone. That is not good governance. It is more problematic given that Dr. Prasad’s expertise is not in vaccines, but it would be problematic even if he were a vaccine expert.
10. Dr. Prasad’s unprofessional memo was a distraction
Our medical establishment is failing. While they fear monger about vaccines, measles and pertussis are spreading and killing children. Meanwhile, the leadership of the FDA, CDC, and NIH are universally distrusted by respectable doctors, their own employees, and large swaths of the American public. It’s been nothing but media drama from our medical establishment, daily for months.
However, Drs. Prasad’s overtly political and inflammatory, unprofessional memo- 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– successfully took off the spotlight, at least for now.
Moving forward, we need to hold our medical establishment accountable for what’s happening today not relitigate supposed ultrarare vaccine harms from years ago. Don’t let the performative drama distract from the incompetence and malevolence of our medical establishment.
11. Quacks and sycophants feel it is wrong for citizens to question to their government.
Quacks like Sayer Ji and sycophants like Dr. Anish Koka were gleeful at the possibility the vaccine killed children. They rushed to defend our medical establishment and implied that it was inappropriate for citizens to question government doctors of Dr. Prasad’s stature. They demanded we accept that the COVID vaccine killed children because Dr. Prasad was honest and reliable, while his critics were fools, in a cult. They demanded faith in Dr. Prasad. Dr. Koka wrote:
Prasad is a prolific clinical researcher , a clinical practicing oncologist and an epidemiologist who quickly climbed the ladder of academia publishing papers about pharmaceutical industry gamesmanship and spoke about regulatory capture frequently. This made him very popular among academic lefties who enjoyed his broadsides against big pharma. This is why he ended up as a professor at the elite University of California San Francisco .
The problems for Vinay started when he refused to blindly go along with his tribe on lockdowns and school closures because they appeared to violate basic common sense as well as principles that demand strong hard evidence before administering therapeutics with very real / expensive downsides!! Then when he took the same skepticism he always had towards overly broad therapies from the pharmaceutical industry to the push for the Covid vaccine for everyone regardless of their risk from the vaccine .. he really became an outcast.
The truth is Prasad is very smart, very accomplished and way more logically consistent than his former tribe who can best be described as cultists. They hate him because he was the best of them and can’t be dismissed as some random eccentric crank on YouTube. America is very lucky to have him leading an agency that has lost its way.
Of course, neither Dr. Prasad’s credentials nor Dr. Koka’s juvenile accusations substitutes for evidence, and in reality Dr. Prasad an enormous amount of content about this vaccine-side effect on multiple platforms- blogs, social media, podcasts, and yes YouTube. Here are some of his YouTube videos:
- Our New Myocarditis Paper – Shows the Risk Highest in Young Men
- Myocarditis From Moderna 2nd Dose Higher in Men Under 40 Than Covid19
- Myocarditis & Teens: Vaccine Benefit & Risk
- New MMWR CDC Study Compares Covid Myocarditis to Vax Myocarditis | Is It Good Science?
- The Good, The Bad, and The Ugly of the Covid Vaccine
- Thailand Myocarditis After Vaccine Study
- New Study Documents Covid19 Vaccine Harms – Low Platelets, GBS, Myocarditis – I Unpack
- “UPDATED DATA: UK Myocarditis Authors Stratify by Sex for Men under 40- Vax vs Virus”
- How Are Kids and Young Adults Doing 90 Days After Vaccine Myocarditis? Kaiser Northwest Estimate of Myocarditis/Pericarditis Compared to CDC’s Estimate
- How CDC’s Vaccine Safety Missed Cases of Myocarditis | ID doc Dr. Katie Sharff Discusses New Study
- Myocarditis | Kids Vax | Kids Mask
- Myocarditis Data from Ontario Province: Specific Vaccine & Interval Between Doses
- CDC Director Is Wrong Re Myocarditis Numbers 5-11 & CDC Cannot Count Vaccine Doses – Huge Blunders!
- Myocarditis Update – Israeli Data – Sweden – Denmark – So Much More
- Closing Thoughts on Myocarditis and Vaccines
- Myocarditis In The UK: Moderna Vs. The Virus! New Nature Medicine Paper
While Dr. Prasad wasn’t “random”, he was absolutely an “eccentric crank” on YouTube, and given his obsession with this side effect and inability to admit error, we have every right to be suspicious of his objectivity today. There was absolutely zero chance that he was going to conclude “You know what, the vaccine was safe after all. I’ve been wrong the whole time.”
12. All vaccines are in danger
As Dr. Gorski discussed in detail, Dr. Prasad’s memo is a bad omen for all vaccines. It threatens multiple existing vaccines as well as future vaccine-development. The article A Bad Omen for Vaccine Development at the FDA added:
The cumulative effect of these changes, if realized, would be a far more difficult path for developers to get any new vaccine approved by the FDA. Even annual updates, such as for flu shots, would be subject to strict scrutiny. Companies would need to spend much more time and money to get their vaccines to market, and the uncertainty surrounding their approval would be significantly higher.
Prasad’s plan would change the vaccine landscape in two big ways — both of which would harm the large majority of Americans who appreciate vaccination. Most immediately, it would mean vaccines take months or years longer to become approved as developers labor to meet the FDA’s new requirements. The large clinical trials that Prasad is demanding take a lot of time and resources to complete. While the FDA double-checks whether a vaccine is perfectly safe, Americans will enjoy all the safety of no vaccine.
As a result of Dr. Prasad’s memo, many parents will be tricked into believing that tried and true vaccines haven’t really been properly tested and we can’t really be sure they are safe and effective. The damage will last for decades, and the price will be paid in sick and suffering children, as it was with COVID.
This time last year he wrote an article titled Sabotaging RFK Jr’s Confirmation Will Increase Vaccine Hesitancy. Today the headlines read New ACIP Chair Compares Covid Requirements to Holocaust, Says Shots Caused Cancer, Miscarriages. It’s no surprise that Andrew Wakefield is feeling vindicated today and is making a comeback. Dr. Prasad helped unleashed this on all of us.
13. Show us the evidence
We also need to be both aware of our biases and open about them. I hope the COVID vaccine didn’t kill any children, however, my mind is wide open. I previously discussed a study from Korea where 2 out of 2,076,259 adolescents had fulminant myocarditis, though neither died. Given that tens of millions of American children were vaccinated, I would not be surprised if some died, and I won’t blow off their deaths by saying 10 is a small number. Every life matters, especially children.
However, the burden of proof is entirely on the FDA to provide the evidence. Wiping away all drama and deliberate distractions, that’s all that matters, and thus far we have none. As the article FDA and Prasad’s Covid Vaccine Death Claims Lack Ley Details reported:
“You need clear evidence to make a statement like that” about deaths, Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, told Endpoints. By clear evidence, Offit pointed to an autopsy showing “a damaged myocardium was the reason that that child died,” as well as proof that the child wasn’t also infected with Covid and/or another virus that could cause myocarditis.
Otherwise, “all you’re doing is scaring people. It’s completely unprofessional, dangerous and irresponsible to do this.”
He’s entirely right, and over and over again, evidence is all experts asked for:
- Jesse Goodman: When you send a letter to a thousand people or more, this is a really extraordinary claim that would normally merit a very detailed scientific analysis and presentation at an appropriate forum.
- Daniel Jernigan: It is not clear what process was used for attributing deaths to the vaccine. Some greater transparency is needed.
- Kathyrn Edwards: We don’t know where it’s coming from. We don’t know which vaccines. We don’t know what the time frame was. We don’t know how many of these cases have an autopsy that shows actual cardiac involvement.
- Peter Hotez: 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. Given the public health implications, this is not something one casually blurts out in an email.
- Jason Schwartz: In any prior administration would have been very clearly presented, typically at public meetings. Instead, we are left to parse the subtleties of an internal email.
I predict that when and if the FDA reveals their cases, they will be like that of Ernesto Ramirez, Jr., suggestive, but hardly definitive. As with Dr. Prasad’s initial memo, they will be a Rorschach test that will cause more anger, division, and doubt. Dr. Prasad’s defenders will say his evidence is unassailable, no matter how thin it is. That’s baked in. However, Dr. Prasad’s premature “leak” has already poisoned the inevitable debate about his actual evidence.
But my mind is open. Maybe the FDA leaders will surprise me and do something they’ve not done the entire pandemic. If they produce high quality evidence, which is authored by reliable, apolitical FDA professionals and widely accepted by trusted experts, then I will accept it, exactly as I accepted the J&J vaccine killed some people. I will be critical of the FDA officials who missed this important signal. My loyalty is to a process, not an outcome.
In contrast, our FDA leaders will never accept the overwhelming evidence that the COVID vaccine prevented rare but grave harms in some children. That’s the difference between them and those of us who value data and evidence above politics and ideology.