Deaths from COVID ‘incredibly rare’ among children
Pfizer–BioNTech COVID-19 vaccine
In January 2021, Pfizer said it had finished enrolling 2,259 children aged between 12 and 15 years to study the vaccine's safety and efficacy.[146] On 31 March 2021, Pfizer and BioNTech announced from initial Phase III trial data that the vaccine is 100% effective for those aged 12 to 15 years of age, with trials for those younger still in progress.[147]
The world had to rejoice, learning that the Pfizer vaccine was 100% effective for kids. There remained the issue of safety, on which not everyone agreed.
WHO experts felt that the satisfaction of Pfizer with their results was insufficient; they maintained that "the COVID-19 vaccines are safe for most people 18 years and older...Children should not be vaccinated for the moment." https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice
Someone noticed the conflict between WHO and FDA. Some calls were made, and a compromise was reached. For more on the adjustment process, see at https://www.covidr.org/en/98-who-fda-in-conflict-on-safety-of-vaccine-for-kids-up-to-18
At 14.00 EST, on June 23, 2021, the above-cited line was gone from the WHO site. Now it says that "COVID-19 vaccines are safe for most people 18 years and older... WHO's Strategic Advisory Group of Experts (SAGE) has concluded that the Pfizer/BionTech vaccine is suitable for use by people aged 12 years and above. Children aged between 12 and 15 who are at high risk may be offered this vaccine alongside other priority groups for vaccination. Vaccine trials for children are ongoing and WHO will update its recommendations when the evidence or epidemiological situation warrants a change in policy...the SAGE... will look at this data as it comes and make recommendations on how the vaccine should be used in children, at what dosage, what interval." www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice
So, now, the vaccines are "safe" for 18-year-olds and only "suitable" for 12-year-olds up to 15-year-olds if "at high risk"--that means kids who suffer from debilitating conditions. Nothing about 15, 16, and 17-year-olds.
Someone gave orders. Someone at WHO was not pleased but obeyed, when ordered to remove the "no vaccine for kids" directive. So she left a non sequitur, that "suitable but not necessarily safe". Did she intend to point out out how absurd the new policy is? Was this an example of daring sabotage by dissenters at WHO? We know that at WHO, the doctors have been very unhappy, for ten years, about the WHO silence on vitamin D against respiratory infections in children.
Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Pfizer-BioNTech COVID-19 Vaccine
Serious Adverse Events
The proportions of participants who reported at least 1 serious adverse event were 0.4% in the vaccine group and 0.2% in the placebo group. No serious adverse events were considered by FDA as possibly related to vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html
New England Journal of Medicine
Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. https://www.nejm.org/doi/full/10.1056/NEJMoa2107456
What is a Serious Adverse Event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
Life-threatening
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other serious medically important event).
Disability or Permanent Damage
Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.
Congenital Anomaly/Birth Defect
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.
Other Serious (Important Medical Events)
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.
https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
It would thus appear that a SAE is a pretty serious event, something that you would not want to happen to your kid.
One participant experienced an SAE reported as generalized neuralgia, and also reported 3 concurrent non-serious AEs (abdominal pain, abscess, gastritis) and 1 concurrent SAE (constipation) within the same week. The participant was eventually diagnosed with functional abdominal pain. The event was reported as ongoing at the time of the cutoff date.
Placebo: • One participant was hospitalized for appendicitis 19 days after Dose 2. The event resolved after 2 days and the participant continued in the study.
https://www.fda.gov/media/148542/download
So, it's 4 SAE's in the Pfizer cohort and 1 SAE in the placebo cohort, 4 among 1131, and 1 among 1121, so it's 0.88/1000 for placebo and 3.53/1000 for Pfizer.
Yet, FDA said 0.2 and 0.4%, otherwise 2/1000 in placebo cohort and 4/1000 in the Pfizer cohort. Did they round up the events? No, that would have given 4/1000 and 1/1000. It would appear that the CDC asserted its liberty from mathematics.
Four kids, out of 1131 healthy young people, ended up in hospital, and the NEJM editors offensively repeat the CDC slogan, "unrelated to the vaccine". They hide the victims from view, hundreds of thousands of them. Many in situations not as serious--sudden death for healthy young people is a stroke of luck, compared to paralysis or total disability.
"None of our business" says the FDA, as the victims line up at their door, asking for help. The FDA doors remain shut, they have no time for them, they have big plans, they have to go save the world, so no explanation will be coming now. They will give due consideration to the cases of the poor unfortunates after the world is saved. Prayer is the answer, show more faith next time, put some money in the box on the way out.
12-15-year-olds: SAEs [serious adverse events] from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of BNT162b2 recipients and 0.1% of placebo recipients. A total of 5 SAEs were reported by 5 recipients (4 BNT162b2, 1 placebo), all who had no history of prior SARS-CoV-2 infection (SARS-CoV-2 negative at baseline).
BNT162b2: • 3 participants, all with pre-existing anxiety and depression, were hospitalized for medical management of depression exacerbation that started 7 days after Dose 1, 1 day after Dose 2, and 15 days after Dose 1, respectively. All 3 participants reported treatment with a selective serotonin reuptake inhibitor (SSRI) that began within 1-2 months prior to vaccination. Worsening suicidal ideas with initial SSRI treatment in adolescents is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients. One participant experienced an SAE reported as generalized neuralgia, and also reported 3 concurrent non-serious AEs (abdominal pain, abscess, gastritis) and 1 concurrent SAE (constipation) within the same week.
Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Review Memorandum 1 -- Emergency Use Authorization (EUA) Amendment for an Unapproved Product Review Memorandum
WAS THIS CASE COUNTED BY PFIZER AT ALL?
Among the "few overall severe adverse events" there was the case of Maddie de Garay, heroic victim of bad science, a 12-year-old honours student who, with her brothers, volunteered for the trlals, became paralyzed, and was swept under the carpet of oblivion, until the day when U.S. Senator Ron Johnson of Wisconsin did not organize a press conference for her and six other victims.
The national media cooperated fully with the regime, and ignored the press conference. Local papers wrote two hostile articles, and Fox 6 TV in Milwaukee had a hostile piece on the event, while Tucker Carlson on Fox News gave a sympathetic presentation. That was the entirety of the response of the mass media in the United States.
The video of Senator Johnson's press conference has not been canceled yet, as of October 2021. https://www.youtube.com/watch?v=lAeVLdMnerQ Ms. De Garay appears to be paralyzed, she uses a feeding tube. However, of the four SAE's, three are psychiatric hospitalisations and the fourth does not to properly describe the conditions of M. De Garay.
It would then appear that the case of Ms. De Garay was incorrectly described in the FDA document. Or, could the truth be that that her case was so embarrassing to the regime, that her case could have been disappeared. Just as Ms. De Garay and her unfortunate mother were just disappeared by US media.
Coronavirus spike protein
Misinformation[edit]
During the COVID-19 pandemic, anti-vaccination misinformation about COVID-19 circulated on social media platforms related to the spike protein's role in COVID-19 vaccines.
So Pfizer checked on Ms.De Garay one last time and left; that must have been January or February. The constant complaint we hear from the victims of SAE's is that the vaccine victims feel abandoned.
What obligation does Pfizer have towards Maddie de Garay? She volunteered, they met, they jabbed her and watched what was happening to her for two months.
One paralysis case, 0.08% of the vaccinees. So, almost 0 chance of such an event, not even 1/1000! Why worry about this? How could this have been related to the vaccine, anyway? How irresponsible can those novax be! However, the news about the spike protein did not appear on social media. It appeared in a medical journal, Circulation Research:
"We administered a pseudovirus expressing S protein (Pseu-Spike) to Syrian hamsters... Lung damage was apparent in animals receiving Pseu-Spike ...our data reveals that S protein alone can damage endothelium.
For more evidence from the scientific literature, see under the heading Spike protein.