The EUA expansion1 for Pfizer BNT162b2 vaccine for kids aged 12–15 was done after it failed (as I will show below) its pro-forma clinical trial2.
Abysmal Safety
Only 1,131 kids received at least one injection of the experimental vaccine. Most of them experienced side effects. Within a few days after the second shot, 66% of the kids developed fatigue, 65% developed headaches, 42% developed chills, and so on. The first shot was tolerated only slightly better. Symptoms varied from mild to severe. More than half of the kids had to resort to painkillers or antipyretics after the second injection. Given such frequency and severity of adverse effects, the sponsor had to either stop the trial because of safety, or to significantly increase its size to exclude high likelihood of death. At the trial size, if the risk of immediate death were 1 per 1,000, the trial had only a 32% probability of missing it. We are lucky that this is not the case.
From 1, Table 17. Frequency of Solicited Systemic Adverse Events Within 7 Days After Each Dose, by Maximum Severity, Participants 12 Through 15
| Event |
BNT162b2 Dose 1, N=1127 n (%) |
BNT162b2Dose 2, N=1097n (%) |
| Fatigue, any |
677 (60.1) |
726 (66.2) |
| Fatigue moderate or severe |
399 (35.4) |
494 (45.1) |
| Headache, any |
623 (55.3) |
708 (64.5) |
| Headache moderate or severe |
262 (23.3) |
406 (37.0) |
| Chills |
311 (27.6) |
455 (41.5) |
| Chills moderate or severe |
116 (10.2) |
234 (21.3) |
| Fever (≥38.0°C) |
114 (10.1) |
215 (19.6) |
| Muscle Pain |
272 (24.1) |
355 (32.4) |
| Muscle Pain moderate or severe |
147 (13.1) |
203 (18.5) |
| Joints Pain |
109 ( 9.7) |
173 (15.8) |
| Joints Pain moderate or severe |
43 ( 3.8) |
82 ( 7.5) |
Efficacy was not Shown
The media heralded 100% efficacy in COVID-19 prevention because 16 kids (1.5%) in the placebo group had putatively developed COVID-19 within 2 months after the second shot, while no kids in the experimental group had. The study reported no severe cases in the placebo group. At closer look at the definition of a case and the conduct of the trial, very mild disease or even a positive test associated with non-specific symptoms were counted as cases.
“For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period: • Fever; • New or increased cough; • New or increased shortness of breath; • Chills; • New or increased muscle pain; • New loss of taste or smell; • Sore throat; • Diarrhea; • Vomiting.”
Add to this that the trial was in winter and the researchers solicited answers about COVID-19 symptoms, encouraging kids to keep e-diaries. Thus, a kid getting a sore throat or fever for any reason and a positive PCR test within four days of each other was counted as a case. Solicitation leads for excessive reporting of symptoms. We do not know how many of the “cases” would be more correctly classified as asymptomatic infection if not for symptoms solicitation. Also, only 1.5% of the placebo group has got adverse symptoms, compared with at least 90% in the vaccinated group. Where is efficacy?
Further, “The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown.” Thus, this trial was a fiction from the beginning—an excuse for the HHS to start injecting 12-year-olds.
The conclusion: the COVID-19 vaccine FAILED in both safety and efficacy for 12–15-year-olds.
Possible Errors in the Trial
There are indications of other errors in the study. With the rate of treatment adverse effects close to 100%, maintaining placebo blinding was very unlikely. If a kid comes home after an injection with an unusual fatigue and headache, what parent would believe he had received placebo?
An interesting detail is that, within the first 2 months after the 2nd shot, 1.5% of the placebo group had a COVID-19 case, but only 0.3% had it within the next 2+ months. This is not necessarily an indication of foul play. It is another demonstration of uselessness of COVID-19 vaccination for kids.
The way in which PCR testing was used in the trial raises additional questions. COVID-19 PCR tests are notorious for their inaccuracy and ease of manipulation, including by selecting the amplification cycles number. The Supplemental Appendix2 says:
“The central laboratory NAAT [nucleic acid amplification test] result was used for the case definition. If no result was available from the central laboratory, a local NAAT result could be used if it was obtained using either the Cepheid Xpert Xpress SARS-CoV-2, Roche cobas SARS-CoV-2 real-time RT-PCR test, or the Abbott Molecular/RealTime SARS-CoV-2 assay.”
This sounds like an open door for cherry-picking testing facilities on case-by-case basis.
Legal Aspects
Now this study is used to coerce and/or trick kids and young adults into getting vaccinated against COVID-19. Luckily, we have a legal recourse. Government-sponsored medical procedures require informed consent of the patients – see In re Cincinnati Radiation Litigation, 874 F. Supp. 796 – Dist. Court, SD Ohio 1995. Otherwise, they violate the due process clauses of the XIV and V Amendments. Deceit (including denying futility of COVID-19 vaccines for 12–15-year-olds, denying effectiveness of ivermectin for COVID-19 treatment and prophylaxis, or failure to disclose the risk of future ADE) and coercion (including blocking access to ivermectin and hydroxychloroquine) invalidate the apparent consent. For minors, consent of the parents is also mandatory. Medical procedures that involve no more than trivial risk might be an exception, but COVID-19 vaccines are certainly not such a case.
The vaccination of the young people is not just government-sponsored, but almost entirely conducted by the government. The government cannot bypass the Constitution by relying on the opinion of the FDA, which is itself a government agency. Truth matters.
The cherry on top of the cake: government officials carry personal responsibility for their actions in violation of this principle. They cannot assert qualified immunity.
Reference
1. FDA re-Amendment. Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Review Memorandum 05262021. Published online May 10, 2021.
2. Robert W. Frenck J, Klein NP, Kitchin N, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. New England Journal of Medicine. Published online May 27, 2021. doi:10.1056/NEJMoa2107456
July 7, 2021
Posted by aletho |
Deception, Science and Pseudo-Science, Timeless or most popular | Covid-19, COVID-19 Vaccine |
3 Comments
With many countries rapidly reaching the point where most adults have been vaccinated against covid, attention has been turning to the issue of whether or not children should also be vaccinated. This has been accompanied by an increase in claims in the media that covid is in fact more dangerous to children than was previously thought.
I think most people intuitively agree that children shouldn’t be vaccinated unless the benefits to them outweigh the risks. That is probably the reason for the sudden up-tick in the claims of danger. While you might convince young adults to vaccinate themselves “for the greater good”, even though there is almost certainly no benefit to them personally, you will have a harder time convincing parents to let their children be vaccinated if there is no actual benefit to the children.
That is especially true in light of the mounting evidence that the covid vaccines can cause harm, such as findings from the CDC that some of the vaccines cause an increased risk of myocarditis (inflammation of the heart muscle), particularly in boys and young men. This comes on the heels of earlier findings that some of the vaccines increase the risk of serious blood clotting disorders, particularly in young women. Let’s remember, the vaccines were invented only a little over a year ago. It is possible (in fact quite likely) that there will be new revelations of harm going forward. So if you want to convince parents to let their children be vaccinated in spite of this increasing evidence of harm, then you need to convince them that covid is in fact a real danger to their children.
With that in mind, let’s look in to the claim that covid is a danger to children. I’m going to be using mainly Swedish statistics, since those are the ones I’m most familiar with, and since Sweden is better than virtually every other country in the world at producing reliable statistics. In Sweden, nine children (i.e. people under the age of twenty) have so far died of covid, according to official statistics. In total, 13,913 people have died of covid in Sweden, which means that people aged 20 or over constitute the remaining 13,904 covid deaths.
There are currently around 2,414,000 children in Sweden (four of which are mine). If we divide the number of deaths by the number of children, then we find that the risk of having died of covid for a Swedish child is 0.00037% (one in 268,000). That is after a full year and a half of the pandemic. To put that in some perspective, in 2020, 15 children in Sweden died in traffic accidents. So the risk of a child in Sweden dying of covid during the pandemic has been around half the risk of that child dying in a traffic accident. Note also that Sweden has the safest roads in the world, yet children are still twice as likely to die in a traffic accident as they are to die of covid, and that’s during a raging pandemic.
Let’s move on and look at this from another angle. Sweden’s adult population is around 7,980,000 people. The risk of a Swedish adult thus far having died of covid is 0.17%. As mentioned, the risk of a child having died is 0.00037%. What that means is that children are 500 times less likely to die of covid than adults!
Ok, I think we’ve established that the risk covid poses to children is infinitesimal. At least the risk of dying is infinitesimal. I can already hear two counter-arguments being trotted out, however. The first is that children can get long covid. This argument is weak. It’s been shown that long covid is rare in adults, and there is no reason to think that it is more common in children. In fact, the opposite is almost certainly true.
The second counter-argument is that covid can cause MIS-C in children, the Kawasaki-like disease that people were getting all hot and bothered about last summer when it was first discovered. I recently listened to an interview with Paul Offit (an American pediatrician who has managed the impressive feat of first grossly underestimating the severity of the pandemic and then grossly overestimating its severity) in which he said that MIS-C “isn’t that uncommon”. I thought that was a pretty funny thing to say. Either something is uncommon or it isn’t. It can’t be both. Well, is it uncommon or isn’t it?
According to the CDC, there have at present been 4,018 cases of MIS-C in the US. There are around 73,000,000 children in the country. What that means is that the risk of a child in the US having experienced MIS-C up to now is 0,006% (one in 18,000). In other words, MIS-C is rare. And of the children who are unfortunate enough to get it, more than 99% recover. Out of 73,000,000 children in the US, only 37 have actually died of MIS-C over the course of the pandemic (one in 1,970,000). Children do many things every day that are more likely to kill them, and we don’t bat an eyelid.
To sum up, covid is not a threat to children. At least not more of a threat than many other risks we take for granted and happily let our children take, like riding in cars and crossing streets. In order for it to make sense to vaccinate children with this being the case, it has to be clear beyond any reasonable doubt that there are virtually zero risks associated with the vaccine. Why? Because if the covid vaccine is associated with even a very small risk of harm, then the risk associated with the vaccine could well be greater than the risk associated with the infection. Since it is at present far from clear that vaccination is less risky to children than infection, it is deeply unethical to vaccinate them.
If we go ahead and vaccinate children because we hope that it will marginally decrease the risk to adults (on top of the risk reduction already seen from vaccinating almost the entire adult population), then we are putting our children at risk for our own gain. We should be the ones taking risks for our children. It shouldn’t be the other way around.
July 7, 2021
Posted by aletho |
Timeless or most popular | Covid-19, COVID-19 Vaccine |
2 Comments
“New Normal Newspeak” is a new series of short articles highlighting how our language has come under assault in the past eighteen months.
***
Ever since the beginning of the “pandemic”, and its transition into the clear “New Normal” (or “Great Reset) agenda, the English language itself has become a battleground. Words and phrases are being stretched and twisted into new, bizarre or contradictory meanings, or weighted with implications that never existed before.
“New Normal Newspeak” is our attempt to catalogue these changes, and stop the real meaning of words being memory-holed forever.
Our first example is a very, very literal one.
The phrase “Herd Immunity” has existed for decades, and most of us had probably come across it at some point prior to March 2020. It had a clear meaning, which was available from (among other places) the World Health Organization website:
Herd immunity is the indirect protection from an infectious disease that happens when a population is immune either through vaccination or immunity developed through previous infection.”
However, after the “pandemic” hit, this erstwhile totally uncontroversial theory became the subject of fierce debate, and proponents of it suddenly found themselves described as “genocidal”.
It was at this point that the WHO changed their website, updating their definition of “herd immunity” to totally remove the concept of “natural immunity”:
‘Herd immunity’, also known as ‘population immunity’, is a concept used for vaccination, in which a population can be protected from a certain virus if a threshold of vaccination is reached. Herd immunity is achieved by protecting people from a virus, not by exposing them to it.
You can check their old site through the wayback machine, or with this screencap (in case the archive gets wiped)
Vaccination has never before been considered the only path to herd immunity and adding that you can’t create immunity through exposure is completely unscientific, flying in the face of centuries of medical knowledge.
Changing this definition during an alleged pandemic, just before experimental and untested vaccines were about to be released, is a clear sign that they were pushing an agenda.
Nothing else need be said.
July 7, 2021
Posted by aletho |
Deception, Science and Pseudo-Science, Timeless or most popular | Covid-19, WHO |
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