Dear FDA,
Over the past two days, you have put the nail in the coffin that confirms your regulatory capture by the corrupt pharmaceutical industry. The industry that clearly prioritizes profit over the health of our population. The one that cannot seem to find the ceiling on its profit from this experiment. Your actions speak volumes to the citizens you are charged to protect. By authorizing these products for the youngest amongst us, you have created an entirely new class of parents that questions the safety and efficacy of all 72 shots you want to put in our children’s arms from birth to age 18.
How do we know this? You considered the introduction of a novel therapeutic to be authorized for emergency use in children as young as 6 months through 17 years of age. To be considered for EUA, an emergency so deadly must exist that we would allow for underpowered trials of short duration that yield no long term safety data. As you rubber stamp the authorization for a poorly performing genetic treatment being lauded as a vaccine, you have opened the eyes of many. Never before have we placed an mRNA sequence into our bodies that requests our cells to produce the antigen. So we train our God given immune system to recognize our own cells as the enemy. What could ever go wrong?
Let's begin with what we know. The CDC recently acknowledged that 74.2% of children and adolescents had serologic evidence of previous infection. We also understand that children have a 99.997% chance of surviving COVID. Said differently, they essentially have zero chance of dying from this virus, therefore NO EMERGENCY EXISTS. It has become widely accepted that children are not major vectors of disease and only in rare instances was the spread from child to adult. Some researchers have suggested that children are our shield and we are about to destroy their robust immune systems. Dr. Paul Offit, VRBPAC member vaccinologist, admits that vaccinating for the original strain during circulation of Omicron runs the risk of harming the immune system with Original Antigenic Sin. This will make it harder for children to fight the virus than if relying on their God given immune response.
In the adult trials, the end point determinant of success was the ability to decrease cases of severe illness and disease. Since this risk is non-existent in children under the age of 18, they made the end point immunobridging (antibody levels). Even Eric Rubin has admitted during the April VRBPAC meeting that the antibody response is a foregone conclusion BUT what those antibodies can do to protect a child is NOT understood.
The Pfizer trial enrolled a total of 4526 children. They only tested the serum blood levels of 82 in the 6-23 month trial arm and 143 in the 2-4 yr trial arm who had no prior history of COVID. No explanation is given for this small sample size. Who were the samples compared to? A group of their peers? NO! They did not compare to the blood samples of any other children in the trial but a retroactive comparison to a random sample of 170 16-25 year old from Pfizer's previous adult trials.
During the Pfizer trial there were more cases of COVID in the trial arm than the placebo. Between shots 1 and 2 there was actually a negative vaccine efficacy of 29.7-32.1%. All of these cases of COVID during the trial were ignored. To come to the conclusion that there is positive efficacy, the researchers only counted the cases of COVID seven days following the third shot. They came to an 80% efficacy based on 10 cases of COVID during this time, 7 in the placebo and 7 in the trial. Shortly thereafter, they unblinded the trial and the placebo arm was offered the vaccine. Therefore we do not know the long term efficacy of this product in children because the control group has been eliminated.
From page 39 of the 66 page briefing report.
They even ignored the fact that during the trial 8 kids had a serious case of COVID, 6 from the trial arm and 2 from the placebo arm. Of those 8 children, one was hospitalized from the trial arm.
Several researchers are expressing concern about the content of the placebo vials. There potentially appears to be something fraudulent due to the high number of Severe Adverse Events (SAE) in the placebo arm. For example, in the 6-23 month trial arm (N=1178), 61% of the children had a reported systemic reaction in less than 7 days. Comparatively, in the 6-23 month placebo arm (N=598), 58% had a reported systemic reaction in less than 7 days. That is not theoretically possible from a saline injection. Putting this concern aside, the trial arm demonstrated a rate of 1.4% Severe Adverse Events which is on par for what is being seen amongst the general population. But is it worth putting our children at risk for an SAE that requires hospitalization if they have only a 0.0008% chance of being hospitalized from the virus?
Other worthy notes regarding adverse reactions/events from the trial:
6 total children withdrew from the trial arm after an AE vs only 1 child from the placebo.
the study proved that in the 6 month through 4 years trial group there were numerically higher rates of solicited local and systemic adverse events than in placebo.
during the VRBPAC meeting they discussed that a 17 month old baby was injected with the 2nd dose after experiencing multiple seizures from the first dose.
convulsions and seizures were reported in 4 from the trial arm but the researchers said all cases were unrelated to the vaccine. Of course they said this!
1/71 of the infants in the 6-23 month trial arm reported experiencing an SAE
a 4 year old was reported to have an SAE of severe appendicitis with onset 11 days post dose 2. The event was reported as resolved the same day following the appendectomy.
a 2 year old recipient had a febrile convulsion 21 days post dose 1, which resolved the same day. The participant went on to receive dose 2 without incident.
For most incidences, Pfizer and you (the FDA) waved away the serious adverse events as unrelated and with little explanation other than ‘we conclude it was not related’. We are just to believe you with no justification offered. When you did associate the adverse event as being related, you note it and move on.
What are we doing? What has medical research become? It was concerning enough that we coerced, bribed and nearly forced this novel product on the adult population. It is an entirely more heinous crime to consider injecting the most innocent amongst us, the ones we are charged to care for and protect. Will doctors offer informed consent to the parents of these children? Will they be told that their baby has essentially zero chance of dying from COVID? Will they tell that their child as a 1/71 chance of having a severe adverse event from this experimental shot that has no long term safety data?
Sincerely,
One VERY Concerned American Parent
We cannot rely on the medical profession to say anything other than ‘safe and effective’. Healthcare providers that do not follow ‘The Narrative’ are putting themselves at risk for discipline or losing their job. In some states, it could cause the review of their medical license. It will be up to us as friends and family members to educate those who are uninformed on the topic of COVID and its risks in children. Please share this with anyone who you think may be considering injecting their young child with this novel therapeutic that is all risk and NO BENEFIT!!
I think innate natural acquired immunity is proof of Goddess or God concept.
I like that you call it God given.
Praise the good Lord.
You are loved...
Thank you Jessica for standing up for the helpless babies. God help us. This is a good piece of writing about the shameful events of last days