22 June 2022 - 4:51 pm
Because of course they were. Here is the document the FDA used to approve them (PDF). The document is titled “Vaccines and Related Biological Products Advisory Committee Meeting June 15, 2022 – FDA Briefing Document – EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age”.
Rochelle Walensky, the director of the CDC was apparently extremely happy about this, and decided to make a promotional video about it…
“We now know” says Walensky, “based on rigorous scientific review, that the vaccines available here in the U.S. can be used safely and effectively in children under 5”. Well, let’s have a quick look at the data the FDA conducted their “rigorous scientific review” on, namely the document mentioned at the start of this article.
Looking at page 36 of the PDF document at section “220.127.116.11 Descriptive efficacy analyses” it begins with “Participants 6-23 months of age” and says…
A preliminary descriptive efficacy analysis of COVID-19 cases occurring at least 7 days post-Dose 3 among participants 6-23 months of age in the Dose 3 evaluable efficacy population included a total of 3 confirmed cases accrued in participants with and without evidence of prior SARS-CoV-2 infection up to the data cutoff of April 29, 2022. The Dose 3 evaluable efficacy population included 376 participants randomized to BNT162b2 and 179 participants randomized to placebo. The VE estimate in this preliminary analysis was 75.6% (95% CI: -369.1%, 99.6%), with 1 COVID-19 case in the BNT162b2 group compared to 2 in the placebo group (2:1 randomization BNT162b2 to placebo).Page 36 – https://www.fda.gov/media/159195/download
So trial was a 3 dose course of injections, where there was 555 “participants”, as if you could possibly describe children under 2 years of age as having participated in this horror show. The Cambridge Dictionary website defines the word “participant” as…
a person who takes part in or becomes involved in a particular activity
…which implies some choice in the matter and self-action in the process. To suggest these infants were taking part in or becoming involved seems like a not unintentionally obtuse way of phrasing helpless young children getting injected with what we already know and has been proven to be harmful genetic products. But hey, this is virology and pharmaceutical talk so let’s not bother ourselves with pesky definitions of words.
So they “estimate” the vaccine efficacy (VE) at 75.6%. Estimate. That sounds super-rigorous. The reported Confidence Interval for that estimate is:
(95% CI: -369.1%, 99.6%)
For the non-statisticians out there, here is a link to an explanation of how Confidence Intervals (CI) work. It is not clear from this document when they constructed their CI, which out of “validity, optimality, and invariance” they sought as the most desirable property, but I would suggest a CI range from minus 369.1 percent up to 99.6 percent is ludicrous for an application that is alleged to rigorously and scientifically evidence a case for injecting 20,000,000 children with something. If -369.1% is a typo, then rigour seems to be lacking again.
All that, based on comparing 1 “case” out of 376 versus 2 “cases” out of 179, where we know the diagnostic criteria for a “case” are somewhat malleable to say the least.
Then we come to the bit about “Participants 2-4 years of age”, who I would also argue are unlikely to have willingly and in full knowledge of what they were subjecting themselves to, volunteered to take part in this experiment. That bit says…
A preliminary descriptive efficacy analysis of COVID-19 cases occurring at least 7 days post-Dose 3 among participants 2-4 years of age in the Dose 3 evaluable efficacy population included a total of 7 confirmed cases accrued in participants with or without evidence of prior SARS-CoV-2 infection up to the data cutoff of April 29, 2022. The Dose 3 evaluable efficacy population with and without evidence of prior SARS CoV-2 infection included 589 participants randomized to BNT162b2 and 271 participants randomized to placebo. The VE estimate in this preliminary analysis was 82.4% (95% CI: -7.6%, 98.3%), with 2 COVID-19 cases in the BNT162b2 group compared to 5 in the placebo group (2:1 randomization BNT162b2 to placebo). One confirmed case in the placebo group occurred in a participant with evidence of SARS-CoV-2 infection prior to 7 days post-Dose 3.
Here the “estimate” of VE is 82.4%, with another silly CI based on 2 “cases” in the so-called vaccine group and 5 “cases” in the placebo group.
If those ridiculous numbers aren’t enough evidence that this was in no way, shape or form, “rigorous” science, on page 5 in section 1, the “Executive summary” it says…
In study C4591007, vaccine effectiveness was inferred by immunobridging based on SARS-CoV-2 50% neutralizing antibody titers (NT50, SARS-CoV-2 mNG microneutralization assay). In each of two further divided age groups (6-23 months and 2-4 years), neutralizing antibody titers at 1 month post-Dose 3 were compared to titers at 1 month post-Dose 2 from a randomly selected subset of 16-25-year-old participants who had received two doses of 30 μg BNT162b2 in the Phase 2/3 efficacy study, C4591001. A preliminary descriptive analysis of vaccine efficacy (VE) among participants who received 3 study vaccinations (following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days post-Dose 3) was also provided.Page 5 – https://www.fda.gov/media/159195/download
The alleged “vaccine effectiveness” was “inferred”. Not evidenced, inferred. How? With a magic new process called “immunobridging”. What is that? Well it appears, according to the above quoted paragraph, they are comparing antibody titers of 6-23 month old infants and 2-4 year old children with 16-25 year old adults.
Yes, you read that correctly. They are generating vaccine efficacy numbers that are then used as evidence to approve and recommend this crap get injected into babies and young children, based on some statistical magic they have branded “immunobridging”. This was recently approved in Europe by the Access Consortium as you can read here on the European Pharmaceutical Review website. As they state in this piece titled “Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators”…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that, though placebo-controlled disease endpoint trials are the gold standard for authorising vaccines, well-justified and appropriately designed immuno-bridging studies are an acceptable approach for authorising COVID-19 vaccines.https://www.europeanpharmaceuticalreview.com/news/162653/immuno-bridging-studies-are-sufficient-for-authorising-new-covid-19-vaccines-say-regulators/
Immuno-bridging studies are controlled trials, leveraging placebo or other controls and correlates of protection such as humoral and/or cellular immune parameters to establish whether an intervention is effective.
The MHRA’s decision to support immuno-bridging studies for authorising COVID-19 vaccines was based on a workshop in 24 June 2021, convened by the International Coalition of Medicines Regulatory Authorities (ICMRA), to consider the development of COVID-19 vaccines.
So who are the “International Coalition of Medicines Regulatory Authorities”? They have a website obviously, heavily focused on COVID-19 of course. They are exactly what their name implies. The medicine and health regulators from most of the influential countries, and the World Health Organisation as an “observer”. As we have already established these regulators get their funding from pharmaceutical corporations and the likes of the Bill & Melinda Gates Foundation, it shouldn’t be a surprise at all to find them all collectively agreeing to introduce a new, easier to rig, non-scientific method for approving products made by their paymasters and sold to a public who is lied to constantly about the “rigorous” and “scientific” nature of any of this corrupt and incestuous relationship.
Finally, back to the FDA Briefing Document for one last look. On page 37 they helpfully explain why these figures are all junk and should be ignored. It says…
Subgroup analyses of VE were not conducted because of the limited number of confirmed COVID-19 cases that occurred 7 days after Dose 3. Nine of the 10 cases were in participants who were seronegative at baseline, and one (a placebo recipient) had missing serostatus.Page 37 – https://www.fda.gov/media/159195/download
Yes, they couldn’t analyse the subgroups because the numbers were so small. Not only that…
In a combined analysis of both age groups, VE was 80.4% (95% CI: 14.1%, 96.7%) with 3 cases in the BNT162b2 group and 7 cases in the placebo group. Interpretation of post-Dose 3 efficacy data for both age groups, and for the age group of 6 months through 4 years overall, is limited for the following reasons:
• Vaccine efficacy post Dose 3 cannot be precisely estimated due to the limited number of cases accrued during blinded follow-up, as reflected in the wide confidence intervals associated with the estimates.
• These descriptive efficacy data are preliminary, as the protocol specified 21 cases have not yet been achieved.
• There were highly variable dosing intervals between doses 2 and 3, with median intervals of 112 (range 56 to 245) days among participants 6-23 months of age and 77 (range 42 to 239) days among participants 2-4 years of age in the Dose 3 evaluable efficacy population.
• The median blinded follow-up time post Dose 3 in the analyses was only 35 days for participants 6-23 months of age and 40 days for participants 2-4 years of age.
It’s a 3 dose trial, but “interpretation of post-Dose 3 efficacy data” is “limited”. That must be a pharmaceutical word for garbage. Just like “participant” means ‘involuntary submission to experimentation’, “limited” means ‘complete and utter worthless garbage’, with one small caveat which is that the FDA will rubber-stamp and approve it anyway, and dear Rochelle can make a video evangelising about the “rigorous scientific review” and how they can be used “safely and effectively” on tiny children.
We can only hope that parents will see that their children are not, and were never at any major risk from what people believe is COVID-19, and not get their children injected with this harmful gunk.