New FDA Study Reports Elevated Post-Vaccination Seizure Risk In Toddlers
I got the chance to ask FDA how it can still recommend Covid vaccination in children despite the newly emerging risks. Their response was all-too-revealing.
On April 24th, a team of FDA-supported scientists published a new study in JAMA Pediatrics investigating serious adverse events associated with mRNA vaccines in children.
This comprehensive and well-constructed cohort study focused on post market surveillance of the Covid vaccines in over 4 million children, confirming the well-documented risk of myocarditis — inflammation of the heart muscle — in adolescents 12-17 who take the mRNA Covid vaccines.
However, the most shocking finding was the discovery of a new safety signal which hadn't been reported before:
"In the primary analysis, seizure met the statistical threshold for a signal in children aged 2 to 4 years after BNT162b2 vaccination in all 3 databases and in children aged 2 to 5 years after mRNA-1273 vaccination in 2 of the 3 databases."
In other words, the study authors found a statistically significant signal of seizures in children aged 2 to 4 years after the Pfizer vaccine and children 2 to 5 years after the Moderna vaccine.
"The statistical signal for seizure in children aged 2 to 4 or 5 years has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines," the study states.
More specifically, the study finds a significantly elevated risk of seizures after doses one and two of the Pfizer vaccine in kids ages 2 to 4 and dose two of the Moderna vaccine for kids ages 2 to 5. It's worth noting, if this finding was merely incidental and unrelated, it wouldn't have been found for both mRNA vaccines. Moreover, the scientists note they couldn't identify any "data quality concerns" which would compromise or bias the results.
The true scale of seizures caused by mRNA vaccines in kids across the United States (and other countries) is unclear, but it is likely quite concerning.
1 in 5,000 Risk of seizures In Kids Following Vaccination
To be clear, not because the absolute number of seizures caused is alarmingly high. According to the limited data, the rate of vaccine-related seizures in young kids is approximately 1 in 5,000. Put differently, .02% of mRNA-injected kids developed seizures in the first couple of weeks following vaccination.
While it is true this is an extremely small absolute figure, critics are wrong to view such risks as "rare" and trivial because the vaccine does not confer any significant benefit in young kids to outweigh such risks. In other words, compared to the extremely low risk of Covid in young children, even a very small number of seizures would sway the risk-benefit analysis towards not getting vaccinated.
The study identifies 72 seizures in kids following vaccination. What benefit did those kids seek to attain? They had a survival rate of more than 99.9997% (this statistic is for ages 0 to 19, not 2 to 5 which the seizure signal has appeared in. The survival rate in younger groups would be far higher.)
As my colleague Jay Bhattacharya elaborated, "the benefits are likely to be small in these groups since nearly 100% of individuals in these groups have already had covid and recovered." "Such recovered immunity provides stronger protection against severe disease on reinfection than the vaccine," he added.
"Even for the first infection, the risk of death from covid infection for adolescents and toddlers is incredibly low," he explained.
Yet, the study bizarrely states that "The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection."
How does that make sense when the study itself does not conduct any assessment of the health benefits and harms of the Covid vaccine for toddlers or adolescents?
My Correspondence with the FDA
Stunned by the incongruous study conclusion, I decided to contact the FDA to ask them how they continue to support Covid vaccination in children absent any supportive risk-reward analyses. I ended up getting in touch with an FDA spokesperson.
To their credit, they decided to engage with me on this contentious topic. I did not expect that. Here was their response to my question on unproven Covid vaccine safety in children:
"The focus of this manuscript was the safety of the Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 vaccines in U.S. children aged 6 Months to 17 years, so we focused on the fact that the vaccine was safe."
Wait, what?
I had to read this over a couple of times because I was so perplexed by this sentence.
The explicitly stated objective of the study was "To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population."
As a result, they decided to focus on the opinion, not "fact," that "the vaccine was safe"?
This is essentially like saying, "the focus of our work was to clean the house so we focused on the fact that the house was clean." (Let me know your thoughts in the comments below)
Unless I'm tripping, my bullshit meter was already ringing. Only to make matters worse, they went on to say,
"The benefits of the vaccine have been reported elsewhere, which include, but are not limited to the reduced incidence of medically diagnosed and hospital and emergency department diagnosed COVID-19, as reported here: Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study - PMC (nih.gov)."
This cited study has numerous issues. For one, the study population is 5 to 17-year-olds, not 2 to 5-year-olds which is the cohort for whom the risk of seizures was found. So how can the FDA use this as their primary evidentiary source to support vaccination in young kids.
Moreover, the cited study on vaccine effectiveness in children aged 5 - 17 may be severely compromised by incidental Covid cases. A number of estimates have shown 40 - 60% of Covid hospitalizations are incidental (the cause of the hospitalization was unrelated to the positive Covid test result).
Dr. Tracy Beth Hoeg, epidemiologist and vaccine myocarditis researcher, stated "even for that tiny numerical difference in rates most of those are probably incidental hospitalizations and so the chance to benefit is so small and could easily all be explained by transient healthy vaccinee effect mostly attributable to hospitalization with and not for covid."
"We would have needed a very large randomized study among children to know what the real effect if any of the vaccine was. I would not rely on the results of this study," she added.
I emailed back the FDA, highlighting these concerns, and they took a few days because the spokesperson was working on the response (I followed up a couple of times). I thought they were going to address my concerns point by point with honest transparency.
Well, they fooled me.
I got an email back from the FDA with the most frustratingly cookie-cutter, generic response possible:
The FDA is confident in the safety and effectiveness of the COVID-19 vaccines approved or authorized for use in the U.S. The vaccines’ benefit-risk profiles are well understood and demonstrate that the known and potential benefits for individuals 6 months of age and older outweigh their risks.
With over a billion doses administered, we have data from real-world use of these vaccines demonstrating that the benefits of getting vaccinated, which include a clear reduction in hospitalization and death, outweigh potential risks.
Further information related to the FDA’s conclusions regarding benefit-risk assessment can be found within the respective decision and review memoranda available on FDA’s website here.
And that's that.
This is an illustrative, real-time example of what I told Russell Brand once as "when the narrative trumps the facts." They initially engaged with me, seemingly in earnest, but we came to a point where I was questioning the unquestionable. I collided with the sacred orthodoxy of "vaccines are safe and effective for kids" driven by a toxic cocktail of political, financial, pharmaceutical, and quasi-scientific institutional interests.
The plain reality is Covid vaccines were never necessary or proven to be safe and effective to administer in children on a mass scale.
Even the most zealous mRNA advocates admitted, when faced with pediatric vaccine hesitancy, that the primary purpose of vaccinating young kids was to protect adults and the elderly.
This was a fundamental error from the start because dosing kids with the mRNAs was nothing as safe as dosing them with apple sauce or vitamin D. There were serious safety concerns from the start, some substantiated by the data and others unclear, but the FDA and the CDC should have never mass-recommended the Covid vaccines as an urgent, essential intervention for children who had a near-zero infection fatality rate.
The true scale of harm from seizures and other serious adverse events is unknown. As Johns Hopkins researcher Dr. Marty Makary once said, "a baby can't tell you they have myocarditis" (let alone subclinical myocarditis which does not produce any symptoms).
“Child Sacrifice”
Coincidentally, earlier this week, Joe Rogan brought up the travesty of mass mRNA child vaccination in a conversation with comedian Deric Poston, and referred to it as a "child sacrifice'“:
Provocative but far from hyperbolic, that is exactly how public health treated children. In the name of "protecting the elderly" or "herd immunity" they neglected and sacrificed the health of young children, who had the least to gain and most to suffer, with the experimental mRNA shots.
As we are finding out now, the potentiality of harm that was feared by the unhinged "conspiracy theorists" (which is what I thought), is coming to bear as more and more serious side effects emerge and indict the corrupt regulatory agencies and public health authorities who pushed the shots with unwavering religious zeal.