Pfizer: “An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA)”
by Fabio Giuseppe Carlo Carisio
All linked articles in Italian version are available in English with simultaneous machine translation
The Food and Drug Administration on Thursday authorized updated COVID shots that target the Omicron variant for children as young as 6 months old.
The eligibility rules vary depending on whether children received Moderna’s or Pfizer’s original vaccines as their primary series. Children 6 months through 5 years old who received Moderna’s two-dose primary series are now eligible for an Omicron booster two months after their second shot.
Kids ages 6 months through 4 years old who have not yet received the third dose of Pfizer’s primary series will now receive the Omicron shot as their third dose. But kids in the same age group who have already completed Pfizer’s three-dose primary series cannot get the Omicron shot as a booster, or fourth dose, at this time.
The FDA, in a statement, said it did not authorize Omicron shots for those children who already received three doses of Pfizer’s vaccine because the agency is still waiting on supporting data for the booster dose. That data is expected in January and the FDA will review it as quickly as possible, the agency said.
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“This authorization offers an opportunity for parents to help better protect their young children against COVID-19, including disease caused by Omicron sublineages,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, who was denounced in the United Kingdom for spreading misleading information on the safety and efficacy of messenger RNA gene serums in children.
“Nearly 40 million Americans have received a booster dose of an updated vaccine. It is critical that we all continue to do our part to help protect ourselves by staying up to date with COVID-19 vaccinations, as recommended by public health authorities, especially now as we plan to gather for the holidays and head into the winter season.” CEO added.
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The approval of the Food and Drug Administration took place in record time, just three days after the submission of the applications, so as to prevent scientists critical of the anti-Covid vaccines from pointing out again the data on the dangers of boosters for the human immune system and the children one in particular.
But above all it happened by ignoring those studies, such as the one published in Germany and reported in a world preview by Gospa News, which highlighted the very high risks from the new bivalent boosters, capable of causing more numerous and serious adverse reactions than monovalent ones.
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As now underlined by authoritative scientists, these are still experimental gene serums (only the now “old” Comirnaty of the first doses had obtained definitive authorization amid a thousand controversies only in the USA) which are causing enormous damage to the immune system (as confirmed by the epidemic of serious forms of Herpes Zoster, even lethal).
This was demonstrated by biophysicist Stephanie Seneff, a researcher at the famous Massachusetts Institute of Technology in Cambridge for decades, explaining the mechanisms by which Covid-19 vaccines can kill.
The suspended doctor Peter McCullough and the inventor of the mRNA technique Robert Malone remarked this during a. recent panel of experts organized by US Senator Ron Johnson (Republican of Wisconsin) in which experts discussed vaccine development, vaccine composition, data from insurance systems and adverse events, and other topics (summary following this post).
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This was supported by former Pfizer vice president Michael Yeadon, stating that it is a tremendous experiment on human guinea pigs.
The Japanese biomedical doctor Masanori Fukushima shouted it arguing that billions of lives will be endangered due to the anti-Covid vaccines!
But the FDA, the US pharmaceutical regulatory body repeatedly accused of concealing scientific data on clinical trials and lethal adverse reactions by the British Medical Journal, has not taken this into consideration and has approved the new boosters for children as it already did on order of the American president Joe Biden, sponsored in the electoral campaign by Pfizer in a shameful and macroscopic conflict of interest.
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Similar subjection to Big Pharma has been demonstrated by the Italian Government of the new Prime Minister Giorgia Meloni who has allocated 650 million euros, more in the forecast budget for 2023 than her predecessor Mario Draghi, for the purchase of vaccines, despite the official data on the campaign of vaccination in Italy, detected by RAI News, show that for months the percentage of third doses has not dropped from 67%. Not only. As can be seen from the table, the deliveries of new doses continue to be far higher than the number of inoculated ones.
Instead, Pfizer sings victory in its statement: «As the virus evolves it remains our goal to be able to provide access to variant-adapted vaccines against COVID-19 to a broader population,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “With this authorization, the adapted vaccine based on the Omicron sublineages BA.4 and BA.5 can become an important part of the primary vaccination series for young children».
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«The amendment to the EUA is supported by clinical data from adults who received the Omicron BA.4/BA.5-adapted bivalent vaccine, post-authorization experience with this bivalent vaccine among ages 5 years and older, and post-authorization experience with the original Pfizer-BioNTech COVID-19 Vaccine as a three-dose primary series for children 6 months through 4 years of age. Additional support is provided by clinical data from the companies’ Omicron BA.1-adapted bivalent vaccine in adults as well as pre-clinical and manufacturing data from the companies’ 3-µg Omicron BA.4/BA.5-adapted bivalent vaccine. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the U.S. and European Union (EU)» adds the New York pharmaceutical company.
«An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA)» concludes the Big Pharma partner of GSK, controlled by Bill Gates, and of Goldman Sachswhere powerful Italian politicians have made a career who have played a prominent role in the management of the pandemic such as former premier Mario Draghi and WHO supervisor Mario Monti.
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Obviously, Pfizer did not mentioned the research conducted by the doctor of the Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Isabelle Wagenhäuser, together with the deputy director of the Unit Manuel Krone, who had to declare a conflict of interest having received “fees from GSK and Pfizer outside of the work presented”.
Therefore the study on the vey high risks of the bivalent booster is supported even by a scientist who in the past was paid by the same Big Pharma which today has obtained the authorizations for inoculation on children.
THE DEBATE BETWEEN EXPERTS ORGANIZED BY THE US SENATOR
The Defender, the online journal of the Health Children’s Defense association led by the lawyer Robert. F. Kennedy jr summarized the latest critical issues on vaccines that emerged during the meeting of experts organized by US Senator Johnson.
Edward Dowd, a former BlackRock analyst now with the Humanity Project, showed data from the Society of Actuaries 2021 Group Life Insurance survey that showed a jump in excess mortality among young and middle-aged adults starting around the time the vaccines began being administered.
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Several vaccines have been linked to side effects such as myocarditis, a form of heart inflammation that can turn deadly. Doctors testifying during the panel said they’ve seen an increase in patients with the inflammation. Dr. Kirk Milhoan, a pediatrician based in Hawaii, said he’s seen more cases. The studies show that the spike protein, which the vaccines cause the body to make, is “cardiotoxic and cause the heart to be inflamed,” Milhoan said. “Let that sink in, the current public health plan is asking our own body to make a cardiotoxin.”
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Dr. Harvey Risch, a professor emeritus of epidemiology at the Yale School of Public Health, presented data from the CDC that show young people face little risk from COVID-19.
McCullough, chief scientific officer of The Wellness Company, said that no randomized, double-blind, placebo-controlled trial has shown the vaccines reduce hospitalization or death. Such trials, known as RCTs, are generally considered the highest form of evidence for a drug.
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Despite this, in perfect harmony with the global immunization plan launched by Gates and the Rockefeller Foundation in 1999 in Villa Serbelloni in Bellagio (Como), the Big Pharma project for the healthcare and transhumanist dictatorship of the New World Order proceeds inexorably using also the children as guinea pigs for a new eugenicsworse than that experienced by Adolf Hitler’s Nazis: because it is legalized internationally by the WHO, the UN health agency.
Fabio Giuseppe Carlo Carisio
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Fabio is Director and Editor of Gospa News; a Christian Information Journal.
Fabio Giuseppe Carlo Carisio, born on 24/2/1967 in Borgosesia, started working as a reporter when he was only 19 years old in the alpine area of Valsesia, Piedmont, his birth region in Italy. After studying literature and history at the Catholic University of the Sacred Heart in Milan, he became director of the local newspaper Notizia Oggi Vercelli and specialized in judicial reporting.
For about 15 years he is a correspondent from Northern Italy for the Italian newspapers Libero and Il Giornale, also writing important revelations on the Ustica massacre, a report on Freemasonry and organized crime.
With independent investigations, he collaborates with Carabinieri and Guardia di Finanza in important investigations that conclude with the arrest of Camorra entrepreneurs or corrupt politicians.
In July 2018 he found the counter-information web media Gospa News focused on geopolitics, terrorism, Middle East, and military intelligence.
His articles were published on many international media and website as SouthFront, Reseau International, Sputnik Italia, United Nation Association Westminster, Global Research, Kolozeg and more…
His investigations was quoted also by The Gateway Pundit, Tasnim and others
He worked for many years for the magazine Art & Wine as an art critic and curator.
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It’s all criminal. How many vaccines are in the pipeline awaiting approval? 10? 50? 100? 500? If you answered 500 you are closer to the truth than those who answered 100. I’m 74, I am unvaccinated, and I never wore a mask. How did I survive the past 3 years, while this pandemic raged? Was I just lucky? No! I’m going from memory here so I may be off a little. Statistics show that in 2019 there were 3 million flu deaths. In 2020? Scientific American says about 700. What happened is this, the other millions were recorded as Covid19 deaths. If you look into it it’s all very transparent. COVID19, just like 911 is a psyop. After 911 all commercial flyers now have to remove their shoes. In 2020 everyone they closed borders and everyone has to wear a mask. If allowed this un-natural progression predicts limited mobility. Maybe we will be restricted to travel in just a 5-mile radius.
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