The Food and Drug Administration’s approval of the Pfizer shot for children to six months old can potentially affect millions of babies and small children worldwide.
I have many questions about the FDA News Release on June 17, 2022.
The following quote can be found almost at the bottom of the FDA webpage under the Moderna part. (which most people skip). I copied and pasted it below,
Evaluation of the Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months through 4 Years of Age
The effectiveness and safety data evaluated and analyzed by the FDA for the Pfizer-BioNTech COVID-19 Vaccine were generated in an ongoing, randomized, blinded, placebo-controlled clinical trial in the United States and internationally, which enrolled infants and children.
Effectiveness
The effectiveness data to support the EUA in children is based on a comparison of immune responses following three doses of the Pfizer-BioNTech COVID-19 Vaccine in a subset of children in this age group to the immune responses among adults 16 through 25 years of age who received two higher doses of the Pfizer-BioNTech COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The study was conducted in two age subgroups. The immune response to the vaccine of approximately 80 children, 6 through 23 months of age, and approximately 140 children, 2 through 4 years of age, were compared to the immune response of approximately 170 of the older participants. In these FDA analyses, the immune response to the vaccine for both age groups of children was comparable to the immune response of the older participants. An additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.
It’s a bit hard to read. It sounds impressive and has lots of industry jargon. But there are many issues with it.
Analysis
instead of covid-19 prevention as the primary goal, Pfizer used A substitute
The Pfizer shot should lead to protection against getting COVID-19. Therefore, the study’s primary objective should compare how many of those given the Pfizer jab did not get COVID to those not given the jabs (control group).
Instead, they used immune response as the endpoint. The FDA did not specify what part of the immune response was evaluated, but most likely, it is the neutralizing antibodies.
The immune response to the vaccine of approximately 80 children, 6 through 23 months of age, and approximately 140 children, 2 through 4 years of age, were compared to the immune response of approximately 170 of the older participants.
Did the Pfizer shot prevent COVID-19? A Pfizer press release from May 23, 2022, said,
Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available.
In an email to the Epoch Times, Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health, said, The claimed efficacy is “a meaningless statistic.”
Why only ten? Can you make a reliable conclusion from ten cases?
The answer is no. That is from the FDA press release,
An additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.
A low number of COVID-19 cases. Hmm. I thought this was an emergency use authorization? The first line of this press release on top says,
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
Where is the emergency? Where are the records of the high number of cases and Infection Fatality Rates for COVID-19 in children and babies? There is none.
The infection fatality rates are from 0.00 to 0.03. You can find the studies in this article. The FDA approved COVID-19 shots for babies and toddlers, and that is wrong!
Source: Avsar Aras at Wikipedia
Questions about the study
Why is the immune response study group only a fraction of the whole group?
Only 7% of the study group was evaluated for the immune response. The study group totaled 220 (80 plus 140).
The study was conducted in two age subgroups. The immune response to the vaccine of approximately 80 children, 6 through 23 months of age, and approximately 140 children, 2 through 4 years of age, were compared to the immune response of approximately 170 of the older participants.
Why am I asking? Because the safety data included a total of 2,970 Pfizer shot recipients. (1,170 6 to 23 months plus 1,800 two to four years old)
The available safety data to support the EUA in children 6 through 23 months of age include approximately 1,170 who received the vaccine and approximately 600 who received placebo
For the participants 2 through 4 years of age, approximately 1,800 received the vaccine and approximately 900 received placebo; approximately 600 vaccine recipients were followed for safety for at least two months following the third dose.
What is the immune response of the rest of the 93%? (220/2970) Why are they not included? Could it be that the 93% did not produce a high enough or robust immune response?
Questions about safety
The side effects of the shots can manifest months later, as shown in the Pfizer post-authorization study that I talked about at Pfizer BNT162b2 adverse events as of February 28, 2021.
How long were the children monitored for adverse effects? The document says — at least two months. It is more reassuring to know if Pfizer followed them for years.
Plus, Pfizer did not follow all jab recipients for side effects. Only 34% of the 6 through 23 months of age (400 followed for safety out of 1,170 shot recipients) were observed.
The available safety data to support the EUA in children 6 through 23 months of age include approximately 1,170 who received the vaccine and approximately 600 who received placebo; approximately 400 vaccine recipients were followed for safety for at least two months following the third dose.
For the two to four years of age, only one-third were followed for safety. (600 followed for safety out of 1,800 recipients)
For the participants 2 through 4 years of age, approximately 1,800 received the vaccine and approximately 900 received placebo; approximately 600 vaccine recipients were followed for safety for at least two months following the third dose.
What is the diagnosis of the side effects?
The FDA News release says:
The most commonly reported side effects in clinical trial participants 6 through 23 months of age who received the vaccine were irritability, decreased appetite, fever and pain, tenderness, redness and swelling at the injection site.
These side effects were also reported for the vaccine recipients 2 through 4 years age, in addition to fever, headache, and chills.
The side effects sound mild, right? But did they look if a severe medical condition exists after the injections?
Can a baby complain of chest pain or shortness of breath? I bet babies get irritable and have a poor appetite if something hurts!
Is the fever and chills from an infection due to a lowered immune response? Is the headache due to a blood clot in the brain? Was any imaging of the brain (MRI) done?
Is there any blood work like a troponin to identify myocarditis? Why do I ask?
Myocarditis and Pericarditis after the shots
Because the same FDA news release says that.
Risks of Myocarditis and Pericarditis
The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose.
The observed risk is highest in males 18 through 24 years of age for the Moderna COVID-19 Vaccine and in males 12 through 17 years of age for the Pfizer-BioNTech COVID-19 Vaccine.
If it happens to the older age group, can it happen to the younger ones?
Did they check for these conditions in these age groups who cannot communicate specific symptoms? Wouldn’t you like to know?
If I have a baby or a small child, I won’t consent to a “vaccine” for a disease with a low fatality rate.
Truth heals. Lies kill. Don’t Get Sick!
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Related:
- Dr. Clare Craig exposes the twisted Pfizer COVID trial for babies and young children
- USA study: Adults and children with the Omicron variant have milder COVID-19
- COVID-19 infections among infants: Symptoms and who gets hospitalized
- USA study: Adults and children with the Omicron variant have milder COVID-19
- COVID-19 in children 0-17 years old have a low risk of death and hospitalization
- Children 5-11 Years Old have Mild COVID-19
- Asymptomatic or mild symptomatic COVID-19 elicits effective and long-lasting antibody responses in children and adolescents
- The Updated List of Covid-19 Articles
- Cerebral Thrombosis after the Pfizer Covid-19 Vaccine
- Retinal complications after COVID shots
- Platelet Changes Causes Blood Clots in COVID-19
- Unidentified Foreign Bodies in the Vaccines Form Clots
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