So you may have recently seen or heard the headline reading something like “Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years”. Wow, pretty convincing; “POSITIVE TOPLINE RESULTS” and all. Now we just have to get the FDA, which of course we can trust, to give their stamp of approval and we can rush Junior off to get his shot. Here’s the important info from Pfizer’s press release. See if you can tell what looks fishy and what’s missing (caps mine for emphasis):
“The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268 participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, USED AS THE CONTROL GROUP for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.”
Now we’ll have to wait for the full data to be released to see how “generally” the side effects were comparable, but the big problem here is using the 16-25 year olds as the “control group”. A control group is defined as a group in a scientific experiment that is “separated from the rest of the experiment, where the independent variable being tested cannot influence the results. This isolates the independent variables’s effects on the experiment and can help rule out alternative explanations of the experimental results.”
First, the “control group” used here was not only a different age range, but also vaccinated, and vaccinated with a different dosage so there is no way to parse out how the “independent variable” (the vaccine) may have influenced the results. In any real scientific trial, you have two groups of similar subjects. You try to keep the mixture of sex, age, and things like smoking and other risk factors about the same in each group to give you more confidence that your results are not impacted by some other cause. Normally, you have one group getting vaccinated (experimental group), and one group not getting vaccinated (control group). Then you compare who got infected and who didn’t (that’s called efficacy) and also what kind of “side effects” may be noticed in the experimental group that would stand out from what you might see in the control group who had no treatment. Without a true control group (same age range with no vaccine), how can you determine the efficacy of the vaccine? Oh wait, there is no mention in the Pfizer release of any measured metric concerning infection rate. It doesn’t appear that they even attempted to see what, if any, “protection” from infection this vaccine actually imparted to these children. In fact they state the trial “…was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule.” So basically what they tested for apparently was how well the little kids “tolerated” the vaccine. Pfizer does note the immune response rate of the tykes was “non-inferior” to the older group and that the kiddies showed side effects “generally comparable” to the older group, but just because a 5 year old shows the same antibody response as a 20 year old, doesn’t mean he will have the same “protection”. A 5 year old’s body is different than a 20 year old’s. That is self-evidenced by the fact that we’re doing this kind of trial at all. Otherwise the 5 year olds would just be getting the same treatment as everyone else. And by the way, this trial was carried out on just over two thousand subjects and from that experiment we are saying it’s OK to vaccinate tens of millions of kids. Sweet.
Pfizer also warns: Individuals should NOT [their emphasis] get the Pfizer-BioNTech COVID-19 Vaccine if they:
· had a severe allergic reaction after a previous dose of this vaccine
· had a severe allergic reaction to any ingredient of this vaccine
Double-Sweet. Now to be fair, that’s a pretty standard warning. But of course you won’t know if Junior had a severe allergic reaction until after he has the shot, and you’re a better man than me if you know if your kids have ever had a severe allergic reaction to any ingredient in this vaccine. Just for sh*ts and giggles, here’s some of what’s in Pfizer’s vaccine: Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2, 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), and so on and so forth. Now you may know if your kid’s allergic to peanuts or eggs (which I’m sure we’re all relieved to know are not in this vax), but do you know how your kid’s going to react to Dibasic sodium phosphate dehydrate? Me neither.
So just be aware that even though these are “TOPLINE RESULTS” from a “PIVOTAL” trial, you may be being sold some hokum. And more importantly remember as I have said before, your kids age 5-11 (really age 0-17) are at ZERO risk from COVID and therefore nothing you can do can improve their risk. You cannot do better than zero. And please also remember, attestations to the “safety” of this vaccine notwithstanding, there is NO WAY to know what kind of long term adverse effects this vaccine may have on any of us, let alone young undeveloped children. So there’s that.
Please just remember to consume your COVID information with a discerning eye. We have been lied to constantly for the last 20 months, largely by completely incompetent buffoons. I have no confidence that these “POSITIVE RESULTS” will prove to be any benefit to children, and may very well prove to be of significant harm. But as always, you do you.