Pfizer Manipulated Study Data to Get Emergency Use Authorization 12-to-15 Year-olds
In an October 2, 2021 article published by The Exposé, we are presented with evidence that Pfizer violated study protocols and manipulated data to gain emergency use authorization (EUA) for their experimental Covid-19 mRNA vaccine for children.
The article features analysis and comparison by Yaffa Shir-Raz, Ph.D., a risk-communication researcher and a teaching fellow from the Interdisciplinary Center Herzliya in Israel and the University of Haifa. Dr. Shir-Raz reviewed a document submitted by Pfizer to the US Food and Drug Administration (FDA), on which FDA had based their decision to expand the EUA to include children aged 12-15.
Dr. Shir-Raz’s analysis revealed concerning findings. These include violations of the protocol established by Pfizer itself, as discussed below:
- Violation of protocol conditions – Four of the 1131 children who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (SAEs). Of these four children, three had such severe depression that they were hospitalized shortly after vaccination. This means that one in every 350-400 children who are vaccinated might suffer from severe depression and would need hospitalization. Violation: Participants with a previous psychiatric diagnosis should never have been included in the study in the first place (see page 41 in the protocol).
- Pfizer designed the clinical trial protocol in a way that will allow the company to present positive findings regarding the safety of the vaccine. In the Pediatric Study Protocol (see table on page 12 of the Pfizer document), Pfizer said that the duration of follow-up for serious adverse events (SAEs) would be “from Dose 1 to 6 months after the second dose.” However, Pfizer only had 30 days of SAE monitoring.
Furthermore, Dr. Shir-Raz raises these important questions for the FDA to answer:
- How is it possible that the FDA approved a protocol that allows such manipulations?
- Why did the FDA allow the company to perform the data analysis and submit the application for the emergency permit in children after such a short follow-up time of only 30 days?
- What made the FDA so eager to approve the emergency permit for children? Why is this approval given based on a safety report that is not even “cooked” halfway? After all, there is no emergency situation for children.
- Why did the FDA not address these manipulations and violations of the protocol after the company submitted its review?
See actual document from Pfizerhttps://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdfhttps://clinicaltrials.gov/ct2/show/NCT04368728.
Editor’s Note: This assessment proves that there is no safety data to back the claim that children need to get COVID vaccination [this is a fact that has been repeated by many experts already, see European doctors and lawyers launch lawsuit against the authorization of Pfizer COVID vaccine for children, WHO: Children should not be vaccinated “for now”, Top scientist calls for halt to COVID vaccination of children, Children must not be inoculated with experimental vaccines, 93 Israeli doctors: Do not use COVID vaccines on children].
Suppose authorities and Big Pharma truly trying to find the cure for the pandemic. In that case, their documents should be flawless. They don’t need to employ misinformation and influence to conceal some of the violations.[See FDA knew COVID vaccines would lead to severe adverse events, sanitized info was given to people to prevent vaccine-hesitancy; FDA knew there would be many COVID cases among the fully vaccinated; Leaked Pfizer contracts show they knew of adverse effects and lack of long-term efficacy of vaccines.] But regardless, Pfizer/BioNTech has been granted the EAU for teenagers 12-17 years old. And soon, it will commence in the Philippines. [See COVID vaccination of children aged 12 to 17 to start on October 15 in six hospital sites (eaglenews.ph)]
With this analysis, we can’t help but wonder, what else is being concealed by Pfizer to get the EAU? We know that this is the same preparation as adults, and the safety studies are minimal. Are we willing to inoculate our kids with these jabs? Here are the iteration of the risks vs. benefits you have to consider:
- Covid-19 is not something we should be scared of, particularly among children. The infection fatality rate (IFR) in this age group is lower than the flu at 0.00003 and the survival rate at 99.997%. [See CDC updates planning scenarios, shows IFR lower than flu] In the current assessments, children who died with COVID or were hospitalized with COVID were already sick to begin with. [See New Study: All children in UK who died of COVID-19 were already seriously ill; CDC Update: 75% of children who died from COVID had underlying diseases]
- This pandemic has already caused damage to the young, and their development has already been impeded. [See COVID-19 Pandemic Affected Children’s IQ: Lockdowns leave half of teenagers battling anxiety and trauma; COVID’s deadly toll on the youth, sharp increase in suicides recorded.] The government implemented draconian measures that ignited fear and were scientifically baseless. Governments should have allowed children to live a normal life, [see The Great Barrington Declaration: Life must return to normal for the healthy, the vulnerable must be protected.] Children are not spreaders of COVID [read Why is the coronavirus sparing kids?; Study: Children are not superspreaders, time to go back to school; Science shows schools must re-open for in-person learning].
- Experts have been recommending to open schools since 2020, yet it seems that the Philippine government, particularly, is either playing deaf or ignorant. [See American Academy of Pediatrics release recommendations for school re-opening; CDC: Risk of coronavirus in schools is small; Expert panel recommends reopening of schools for young children and children with special needs; German experts: Schools and day care centers should be reopened; Philippine doctors weigh in on the educational situation of children and adolescents.]
- The risks of vaccination among children is real [Read 15-year old dies after Pfizer COVID injection; EMA: 10,570 dead, 405,259 injured following COVID injections; At least 18 young people develop symptoms of heart problem after COVID injection; Pediatrician says heart inflammation following vaccination looked like kids were having a heart attack; Experimental mRNA vaccines could cause long term chronic illnesses; Long-term dangers of experimental mRNA shots; Peer-reviewed research shows mRNA vaccines can cause neurodegenerative diseases; Research suggests Pfizer-BioNTech COVID-19 vaccine reprograms innate immune responses.]
- In the Philippines, there are reported covid-19 cases among the younger children with flu-like symptoms and RT-PCR test results. Can we say they are all confirmed COVID-19 cases? Or as an addition to statistics? [See Results of investigation on false positive RT-PCR tests conducted in the Philippines to be released on October 8.] Why is the Philippine government still use the RT-PCR anyway? [See CDC revokes EUA for RT-PCR test kits; Manitoba Government Chief Microbiologist: 56% of positive “cases” are not infectious, but products of misleading RT-PCR tests; The danger of over-reliance on RT-PCR tests; New York Times: More experts questioning RT-PCR testing.]
Why are governments pushing so hard with these covid injections despite reported injury and deaths following vaccination? Are they innocent or simply ignorant? [See Covid Vaccines are Bioweapons for Mass Genocide; Experts Find Inflammation, Organ Damages on Autopsies of Vaccinated Individuals; Confirms Vaccines Contain Toxic Chemicals.]
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