Malfeasance Behind the FDA Vax OK for Children
Malfeasance Behind the FDA Vax OK for Children
by F. William Engdahl, Global Research
November 2, 2021
On October 27 the US Food and Drug Administration Advisory Panel on Vaccines recommended the agency allow Pfizer to amend its Emergency Use Authorization for its COVID vaccine to include children 5 through 11 years old. Two days later the FDA officially approved the rollout. Major media are treating this as a positive development to protect young children. On closer inspection it is anything but that. The FDA is today shockingly corrupt under the Acting Director and is little more than a rubber stamp for Big Pharma, and especially Pfizer, where the former FDA head sits on the board.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 0, with one abstention, to give a green light allowing Emergency Use Authorization for the Pfizer-BioNTech experimental mRNA to children between 5 and 12 years. The expert who abstained later explained he did so because of limited safety and efficacy data provided. Previously the FDA had approved the vaccine for 12 and older. Adding to the stench of corruption around the latest vote, the Biden Administration a week earlier announced it had already purchased enough Pfizer vaccine to inoculate all 28 million 5- to 11-year-olds in the US. Did they know the fix was in?
‘…Just the Way it Goes’
The record of the FDA, the major drug oversight agency in the US Government, regarding safety and risks of the experimental gene-altered mRNA vaccines of Pfizer, is one of criminal malfeasance, defined as willful violation of a public trust or obligation that causes harm or death. Their latest ruling is even more egregious for blatant conflicts of interest and scientific fraud. Both Pfizer, who conducted the tests on the efficacy of their own vaccine on the 5-11 year age group, and the FDA experts, admitted that they had no idea if the vaccine was safe for such a young population.
Dr. Eric Rubin, professor of immunology at the Harvard T.H. Chan School of Public Health voted to approve the Pfizer-BioNTech vaccine, noting, “The data show that the vaccine works and is pretty safe … and yet we’re worried about a side effect that we can’t measure yet, but it’s probably real.” That is hardly confidence-building. He then stated, “we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.”
This cold-blooded nonchalance is even more astonishing in light of the fact that the incidence of serious side effects in the 5-11 age group who allegedly have tested positive for the corona virus is essentially zero. According to data of the US Government Centers for Disease Control, the Infection Fatality Rate for children from 0-17 years is 0.0002 per 100,000 and far lower for the 5-11 years. A research study by Johns Hopkins University found that risk of severe illness or death from covid19 in a study of 48,000 children is essentially zero if no other morbidity risk such as leukemia, diabetes or asthma is present. Moreover, risk of infecting other children is also very low.
In their submission to FDA for approval, Pfizer stated the vaccination was needed for the 5-11 age group to prevent covid disease transmission. Yet in their FDA hearing on questioning, Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not even assess whether the vaccine prevents transmission. We might ask why is this at all needed then if the risk to children is zero and there is no evidence of children transmission?
Even more shocking is the statement by Pfizer about its tests. First there were no animal tests on rats or such first. They admitted that the tested human group was so small that they could not test for myocarditis or pericarditis. Yet those are among the most reported negative effects for all others that have had the Pfizer jab. In its FDA application Pfizer noted that the number of participants in the current clinical development program was “too small to detect any potential risks of myocarditis associated with vaccination,” and that “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children.”
Flawed Pfizer Tests
The tests Pfizer made were also fatally flawed. According to Dr. Josh Guetzkow, of the Hebrew University of Jerusalem, the Pfizer study was not double-blind. Further, Pfizer cherry-picked subjects to evidently better their results. Three thousand children age 5-11 received Pfizer’s COVID vaccine, but only 750 of those children were selectively included in the company’s safety analysis. And Pfizer dismissed cases with adverse vaccine effects in their FDA filing: “Few serious Adverse Events, none of which were related to vaccine, and no AEs leading to withdrawal were reported.” They give no explanation how that was determined. Just trust Pfizer.
And post-vaccination follow up was less than 2 months for one test cohort and only 2.4 weeks for a second. The Pfizer report to FDA read, “Supplemental safety expansion group data were analyzed from approximately 1500 vaccine recipients with a median follow-up time of 2.4 weeks after Dose 2. These supplemental data demonstrate an acceptable safety profile…” It can take months or longer for side effects to manifest. Vaccine experts recommend at least 18-24 month post-vaccine follow up, not 3 months or 2.4 weeks. This is not serious science.
As well, it seems the FDA and or Pfizer wrongly name the vaccine in the title as “BNT162B2 [COMIRNATY (COVID-19 VACCINE, MRNA)] .“Yet the actual FDA text calls it “Pfizer-BioNTech COVID-19 Vaccine (BNT162b2).”
The separate company, BioNTech of Mainz, Germany, has a similar but “legally different” vaccine, trade-named Comirnaty, that is not available in the USA. The distinction is essential as it was the basis in August for the corrupt FDA to give Pfizer-BioNTech vaccine an extension of Emergency Use Authorization but to misleadingly declare its full approval for Comirnaty vaccine of BioNTech. This is deliberate fraud and allowed the Biden Administration to mandate vaccination of US government workers (curiously except for White House and Congress), military, and any company with more than 100 employees.
Conflicts of Interest?
The corruption of the FDA extends to the members of the Vaccine Advisory Committee. Many of the members of the current 18 person committee have direct ties to Pfizer or to the pro-Pfizer Gates Foundation.
Prof. Holly Janes of the Fred Hutch Cancer Research Center in Seattle designed the flawed Pfizer tests. Her institute is funded by Gates Foundation money. FDA committee member Dr. Steven Pergam is also with the Gates-funded Fred Hutch center. Acting committee chair, Arnold S. Monto was a paid consultant to Pfizer. Committee member Archana Chatterjee worked on a Pfizer research project related to vaccines for infants between 2018-2020. Geeta K. Swamy is chair of the “Independent Data Monitoring Committee for the Pfizer Group B Streptococcus Vaccine Program,” a committee sponsored by Pfizer. Duke University states that “Dr. Swamy serves as a co-investigator for the Pfizer COVID-19 vaccine trial.” FDA Committee member Gregg Sylvester was a vice president for Pfizer Vaccines. Ofer Levy, professor of pediatrics at Harvard Medical School is on record vigorously supporting Pfizer covid vaccines for children 12 and older. And FDA committee member Paul Offit professor of pediatrics at The Children’s Hospital of Philadelphia called openly last June for covid vaccine permission for children.
When we compare the actions of corrupt FDA Acting Director Janet Woodcock during the August FDA extension of emergency use authorization for Pfizer-BioNTech vaccine, she refused then to even allow the vaccine committee to meet to debate the issue. Several months before in June 2021 three members of the FDA Vaccine Committee resigned in protest over Woodcock’s refusal to heed the near unanimous vote of the advisory committee to approve an Alzheimer’s drug called Aduhelm against the wishes of nearly every member on the panel.
Clearly Woodcock has been busy in the meantime stacking the advisory committee with pro-Pfizer members. Not to be forgotten is the fact that after he left as head of the FDA under Trump, Scott Gottlieb immediately joined the board of directors of…Pfizer Inc. Woodcock served under him at FDA.Woodcock has been at FDA since 1986, almost as long as Fauci at NIAID. Woodcock was Biden’s choice to head FDA, but a massive opposition from 28 groups including state attorneys general and citizen groups forced him to name her “acting,” which does not need Congressional scrutiny. Woodcock was directly responsible for the original FDA approval of deadly opioids over the objections of her own scientists and other advisors.
Already California has moved to make public school admission contingent on covid vaccination, anticipating Pfizer approval. This spread of the deadly Pfizer vaccine to children who have near zero risk of serious disease makes no public health sense. It is simply prima facie evidence of medical malfeasance at the highest levels of the US Government including FDA, with plausible criminal intent. The FDA decision will now be used to argue for similar inclusion of essentially no risk children for the vaccine jab.
cover image credit: squarefrog / pixabay