As the U.S. Food and Drug Administration discusses administering COVID-19 vaccines to young children, an independent group of Israeli physicians, lawyers, scientists and researchers is advising the FDA of their "severe concerns" regarding the reliability and legality of official Israeli vaccine data.
The Israeli group, the Israeli Professional Ethics Front, said it recognizes the Jewish state has been seen as "the world laboratory" regarding the safety and efficacy of the Pfizer-BioNTech vaccine.
But the data is flawed, the group said in its letter.
"We believe that the significant failures underlying the Israeli database, which have been brought to our attention by numerous testimonies, impair its reliability and legality to such an extent that it should not be used for making any critical decisions regarding the COVID-19 vaccines," the letter said.
Ahead of a meeting of expert advisers to the FDA scheduled for Tuesday, the agency released a briefing document from Pfizer and its partner BioNTech in which the companies state their data supporting authorization of their COVID-19 vaccine for children ages 5 to 11.
The letter by the Israeli Professional Ethics Front outlines what it describes as "the main failures" of Israel's data and reporting.
1. Lack of a Public and Transparent Adverse Events Reporting System
2. Severe Impairments in Healthcare Professionals’ Adverse Events Reporting System
3. Data Distortion (including the deletion of thousands of citizen responses to a post by the Israeli Ministry of Health)
4. Legal and Ethical Violations in Data Collection Processes
The group told the FDA its conclusion is "reinforced by the significant doubts about the reliability of the data reported by Israel, as detailed above, and the consequent major concern that their use might be misleading and thus disrupt the decision-making processes pertaining to the Pfizer-BioNtech COVID-19 vaccines."
The group cited a verse from the biblical book of Leviticus that says, "Do not stand idly by while your neighbor's blood is shed."
"In the spirit of those words, we implore the committee to take into consideration our urgent warnings and adopt utmost precaution when referring to the Israeli data concerning the safety and efficacy of the Pfizer-BioNtech COVID-19 vaccines."
We'll examine myocarditis risk after shot approved
The FDA advisory panel is scheduled to meet Tuesday to discuss Pfizer's request to administer its vaccine to children ages 5 to 11.
A briefing document, which relies extensively on Israeli data, has been posted by the FDA in preparation for the meeting.
A slide in the document indicates that for every 10 million children who receive a dose of the vaccine, as many as 6 million will experience fatigue, up to 5 million will have headaches and up to 1 million will have a fever.
The document, on page 10, says "the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination."
"Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis."
The risk of myocarditis was cited last month by an FDA advisory panel that voted 16-2 against Pfizer booster shots for people 16 to 65.
Earlier this week, the FDA delayed its decision on administration to young people of the Moderna vaccine. Pfizer and Moderna employ the messenger RNA technology, which "teach" cells to make a protein that triggers an immune response rather than inserting a live virus, as do traditional vaccines.
The agency is planning to review the data regarding myocarditis further before making a decision, the Wall Street Journal reported.
Sweden, Finland and Norway have halted the Moderna COVID-19 vaccine for younger people, and Iceland has stopped administering the shot to everyone, as WND reported.
Last Friday, France's health authority advised against using the Moderna vaccine because of the myocarditis risk.
White House coronavirus adviser Dr. Anthony Fauci said Friday in an MSNBC interview he expects a CDC recommendation on whether to approve the Pfizer vaccine for children 5-11 to come the week following the FDA's Oct. 26 meeting.
The White House said Wednesday on Twitter that in "anticipation of upcoming FDA and CDC independent advisory committee meetings," President Biden "announced his plan to ensure that if a vaccine is authorized for children ages 5-11, it is quickly and equitably distributed to families across the country."
A fact sheet said the administration "has procured enough vaccine to support vaccination for the country’s 28 million children ages 5-11 years old."
Vaccine doesn't stop the spread
Public health officials and the vaccine makers have shifted from claiming the vaccines stop the spread of COVID-19 to touting their effectiveness at minimizing symptoms.
Pfizer emphasized this week that its smaller dose for children is nearly 91% effective in preventing symptomatic COVID-19.
On Friday, British Prime Minister Boris Johnson conceded -- as has CDC Director Rochelle Walensky -- that vaccination does not offer protection from catching COVID and from spreading it.
BREAKING: UK Prime Minister Boris Johnson concedes vaccination does NOT offer protection from catching COVID, nor from spreading it.
Vax mandates are, therefore, a fraud. pic.twitter.com/M6aE3DRDoW
— Raheem J. Kassam (@RaheemKassam) October 22, 2021
Johnson made the statement as an argument for getting a booster.
Dr. Robert W. Malone, who invented the mRNA technology but opposes vaccinating children who statistically have virutally no risk of serious illness from COVID-19, said Friday on Twitter that public health officials should just be open about the fact that "the jabs for kids are not going to be one-and-done."
"They will likely have to be repeated twice for each school year, at approx six month intervals. For minimal if any direct clinical benefit to the child. And will not prevent infection."
It will change, they know it will change, but they want to turn the tyranny temperature up slowly so the frogs don’t know they’re boiling until it’s too late
Boosters forever. That’s their plan. https://t.co/bDFPfmMwBa
— Buck Sexton (@BuckSexton) October 22, 2021
Walensky said Thursday that the definition of "fully vaccinated" is unchanged, because not everyone is yet eligible for boosters.
But she said the agency "may need to update our definition of 'fully vaccinated' in the future."
Earlier this week -- underscoring her lack of confidence in vaccines stopping the spread -- Walensky said the CDC will continue to recommend masks in all schools, even after the vaccines are rolled out.
Today: CDC Director Walensky confirms that boosters may soon be mandatory to be considered “fully vaccinated.”
“We have not yet changed the definition of fully vaccinated. We will continue to look at this. We may need to update our definition of fully vaccinated in the future.” pic.twitter.com/mVgfSteYxp
— Michael P Senger (@MichaelPSenger) October 22, 2021
Canadian Prime Minister Justin Trudeau said his government has a deal with Pfizer for 35 million booster doses for 2022 and 30 million for 2023, with options for another 30 million in each of those years. In addition, there's an option for 60 million doses in 2024.
If you think it will end soon, think again! pic.twitter.com/oD3hKJwJlN
— Dr. Urso (@richardursomd) October 22, 2021
Why aren't European nations vaccinating kids?
While the U.S. is weeks away from rolling out a COVID-19 vaccine to children as young as 5, European nations are not vaccinating their young children, and they're taking off the masks, noted Michael Brendon Dougherty in a National Review column.
He said Walensky's announcement that children should continue to mask after being vaccinated raises many questions.
"If not when vaccines become available to children, then when? When a certain number take them? When they get boosters six months later? Given that unvaccinated children are demonstrably safer from COVID than are vaccinated adults who often live and work without the mask requirement, what other possible milestone is there?"
Dougherty also wondered why "the United States so far out on the limb with childhood vaccines."
Most countries aren't close to vaccinating children under 12, he noted. And Israel offers COVID vaccines only to children ages 5 to 11 who have chronic lung illnesses or who are severely immunocompromised.
"Do U.S. health officials, and those laymen and -women who are supremely anxious that all children get vaccinated, think that Europe lacks medical and scientific wisdom?" he asked.
European countries largely are not mandating masks for young schoolchildren, Dougherty noted, and the European Centre for Disease Prevention and Control is strongly against school closures.
"The negative physical, mental and educational impacts of proactive school closures on children, as well as the economic impact on society more broadly, would likely outweigh the benefits," the guidance says.
In contrast, the CDC has no mention of developmental, social or mental-health impacts of masking children.
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