By T.J. Coles
This is part 7 in our series. Parts 1 to 6 can be read here.
A few months ago, I wrote to both Pfizer and to the US Food and Drug Administration (FDA) to ask for information about their use of children in COVID vaccine experiments.
I wanted to know how many kids had been injected, what was their socioeconomic background (i.e., were children from poorer households and thus more likely to be exploited), and what compensation their parents/guardians received (i.e., were some parents selling their babies to Pfizer for money?).
THE F.D.A.’S RESPONSE
“We are denying your entire request,” replied Juris Doctor, Sarah Kotler, Director of the FDA’s Division of Freedom of Information.
The exemptions cited included: “Information about individuals in personnel, medical and similar files when disclosure would constitute a clearly unwarranted invasion of privacy.”
But, hang on, my original freedom of information (FOI) request clearly said that the patients’ and parents/guardians’ names and personal details can be redacted/anonymised.
Another reason cited was: “Trade secret and confidential commercial information.”
But COVID and the experimental product are public health emergencies.
What right do they have to deny the public information about a product injected into the public?
Secondly, my FOI asked for zero information about the product or the internal operations of Pfizer. My questions concerned what compensation, if any, parents/guardians received.
Laws cited included the Code of Federal Regulations and the Federal Trade Secrets Act.
To my surprise, Pfizer were more helpful.
Olivia Campanella, Pfizer’s Medical Information Associate, provided me with a document, which does not appear to be available online, on which most of this article is based.
My letter to Pfizer was open, my request to the FDA was a FOI submission. This is because, in the US, public bodies (the FDA) are subject to FOI and corporations (Pfizer) are not.
The injectable Pfizer product, BNT162b2, goes under the brand name Comirnaty. Its international non-proprietary name (or generic) is nucleoside modified tozinameran.
“Comirnaty has been authorised under a ‘conditional approval’ scheme,” said the information sheet in the body of the email.
In response to my question, neither the information sheet nor the attached document gave specific numbers, but did admit: “Pfizer offers reasonable payment for the time and effort to participate in a study.”
So, there it is: Pfizer pays parents to inject their kids. Unlike the attached document, a quick search showed that this information sheet is available online (here).
“In addition, Pfizer may offer reasonable payment to parents, guardians, or caregivers of minor children or incapacitated study participants.”
As we shall see, the data show a high level of adverse events in babies and children who, according to other data, did not even need to be injected.
“Nominal gifts for study participation are allowed as long as the item does not display Pfizer (or affiliate) branding. For example, in studies involving minor children, a small, age-appropriate gift or gift certificate may be provided to the child.”
So, Pfizer rewards pain, distress, and potential long-term damage in infants, toddlers, and children with toys.
With regards my question on the status of the kids: “socioeconomic background is not listed as part of the inclusion/exclusion criteria for Phase 1/2/3 Trial.”
So, poorer families are at risk of being exploited for financial gain.
In the US, the product is recommended by the Centers for Disease Control and Prevention (CDC) for children aged 6 months to 5 years.
But the document I was given not only shows that Pfizer itself did not recommend giving under-5s the product, the trial was still in Phase I when the CDC issued the recommendation.
According to the document I received: In March 2021, the Pfizer trials enrolled an “estimated” 11.4k people, including kids aged 6 months to 12 years, in the US, Finland, Poland, and Spain for a two-dose trial.
(They don’t even know for sure how many children they enrolled?)
Unhealthy children (whatever that’s supposed to mean), were excluded from the study.
But in the real world, children, like adults, suffer ill health.
So, the efficacy of the product was artificially boosted because it was impossible to tell whether the product or the natural immunity of the children prevented COVID.
Usually, Phase I includes pre-clinical trials, but as we’ve noted in other articles in the Pfizer Papers series, the company mixed up the trial phases.
For the kids, Phase I included five-to-12-year-old receiving 10 mcg doses and under-5s received 3 mcgs. Both age groups received a two-dose schedule.
With the document I was given last updated in July, the trial is still at Phase I.
In June this year, the Vaccine and Related Biological Products Advisory Committee (US) met to discuss Emergency Use Authorization and approved the injection for 6 month to 5 year-olds.
According to the document, of the children who had two doses of the 10 mcgs (over 5s), 43.8 percent experienced adverse events.
Nearly one-in-five 5 to 11 year-olds experienced redness at the injection site.
For the 6 month to 23 month-old participants, 51.2 percent experienced post-injection irritability, 27 percent drowsiness, 22 percent decreased appetite, and 16 percent injection-site tenderness.
Of the 2 to 4 year-olds, one-in-three had pain at the injection site, a similar percentage had fatigue, and 11.4 percent redness.
In the 6 to 23 month cohort, three infants were withdrawn after experiencing pyrexia (severe fever).
The document claims no heart-related adverse events were recorded, but then there appears to be a redaction in the form of an ellipsis in square brackets.
Despite the CDC pushing the product, Pfizer says:
“Post-licensure and post-authorization observational studies of Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, respectively, have demonstrated decreased effectiveness of a primary series against the currently predominant Omicron variant, compared with effectiveness against the ancestral strain and variants (Alpha, Delta) that were predominant during pre-authorization trials in adults and older pediatric age groups.”
In June this year, the CDC recommended the product under Emergency Use Authorization for under-5s.
Yet, the Pfizer document given to me was updated one month later in July.
It says: “The safety and efficacy of Comirnaty in paediatric children aged less than 5 years have not yet been established. Comirnaty is not approved for use in children aged less than 5 years.”
Although that full document refers to February data (before the CDC recommendation), it is important to stress that it was updated in July (as shown).
This created a discrepancy which no one seems to have noticed between Pfizer’s own position and that of the CDC.
It is also important to reiterate that the CDC is an outlier because other governments–those of the EU etc.–do not recommend the product to under-5s.
Rather appallingly, the CDC seems to have made its recommendation for under-5s to be jabbed on the basis of poor data given by Pfizer.
When it comes to a criterion called immunobridging, the Pfizer document I was given, speaking of 6 month to four year-olds, says “some subgroups were too small to draw meaningful conclusions.”
Another, Preliminary Descriptive Efficacy, notes that the type of infection was typically Omicron: the least severe to date.
As far as I’m aware, none of the discrepancies above has been disclosed as of yet.
As we await November’s release, I will launch an appeal to try to get the FDA data.
Watch this space…
Dr. T.J. Coles is the author of several books, including — The War on You.
Check out T.J’s Amazon page by clicking here.
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