by Brian Shilhavy
Editor, Health Impact News
Pfizer and BioNTech announced today that they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.
They will also be making a submission to the European Medicines Agency (EMA) in the coming days.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.
The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision.
An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days. (Source.)
The Press Release today also reported that they have begun Phase 1/2/3 studies on babies and young children aged 6 months through 11 years of age to test “the safety, tolerability, and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.” (Source.)
The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was already authorized for adults over the age of 18 on August 31, 2022 without any human testing, so Pfizer is using babies and children as lab rats to conduct the first human tests on this new COVID-19 vaccine.
The Press Release was published on businesswire, which is owned by Warren Buffet’s Berkshire Hathaway investment firm, and who undoubtedly is heavily invested in Pfizer stock and COVID-19 vaccine development.
Some have observed and suggested that their logo has 3 numeral 6s embedded within it, which is common in many logos used by companies owned by the Globalists today, especially in the financial world. See:
Some Pro-Vaccine Heavyweights are Breaking Ranks with the FDA Over Child COVID Shots
One of the more interesting news articles to come through my newsfeed in recent days, is an interview that Dr. Paul Offit did with CNN, where he came out AGAINST giving COVID-19 booster shots to younger people.
The reason this is interesting, is because Dr. Paul Offit is perhaps one of the most militant pro-vaccine doctors in the world. He is infamous for stating that childhood vaccines are so safe, that babies could receive up to 10,000 vaccines at one time with no harmful effects.
He owns stock in one of the childhood vaccines on the CDC childhood vaccination schedule, and in the past he has called for journalists who question vaccines to be arrested and jailed. See:
A search of his name on Health Impact News will return a result of 92 articles where we have mentioned him in the past. Dr. Offit is what we have labeled in the past as an “Extremist Pro-Vaccine Doctor,” because these kind of doctors believe that ALL vaccines are good for ALL people ALL the time, by force if necessary.
He is an advisor to the FDA for new vaccine approvals, and he voted AGAINST the approval of the COVID-19 shots for young children the first time they were submitted to the FDA, but the FDA and CDC approved them anyway, against the advice of the FDA Advisory Committee that included industry insiders such as Dr. Offit.
So why would he become so vocal against the COVID-19 shots for children, as he has touted the line “the science is settled when it comes to vaccines” for decades now in his efforts to get parents to vaccinate their children?
The only logical explanation I can think of, is that he is afraid of what potential lawsuits are coming down the road against Pfizer and the FDA, and wants to abandon a burning, sinking ship, while there is still time.
Because prior to this, it is safe to say that Dr. Offit never met a vaccine for children he didn’t like.
VAERS Data – This Should End Any Discussion of Injecting Children with COVID-19 Shots
The U.S. VAERS (Vaccine Adverse Events Reporting System) government database has just added a separate category for the newly authorized COVID-19 Bivalent vaccine, which was given emergency use authorization by the FDA as a COVID-19 “booster” shot on August 31, 2022, for adults 18 years and older. (Source.)
As of the latest update to the VAERS database on 9/16/2022, there have already been 528 cases filed of adverse reactions to this newly authorized COVID-19 booster shot, including 1 death, 1 permanent disability, 39 ER visits, 5 life threatening injuries, and 9 hospitalizations. (Source.)
According to the latest statistics by the CDC, only 1.5% of those eligible for the COVID-19 Bivalent vaccine have received one so far, approximately 4.4 million people. (Source.)
These numbers in VAERS apparently include the testing currently underway among children, as 35 of these cases are among children between the ages of 3 and 17 who have already been harmed. In many of these cases the shots were reportedly given in “error,” instead of the “regular” COVID-19 shots that are already authorized for this age group. (Source.)
Two of those children had to go to the ER, and one was hospitalized. (Source.)
The White House COVID advisor Dr. Ashish Jha has even told the public that people can get BOTH the new COVID booster shots AND the Flu shot together, and that “this is why God gave us two arms.”
So in Colorado, that’s what they apparently did to one 14-year-old boy on September 9th, and this is the reaction that was recorded in VAERS:
RECEIVED FLUARIX FIRST IN LEFT ARM THEN RECEIVED PFIZER BIVALENT – START SEIZING- TWITCHING HAED BACK- NON RESPONSIVE FOR 5 SECONDS – NAUSEOUS AND LOSS OF ALL HIS COLORS- (Source.)
A similar case was reported with a 13-year-old boy in Indiana on September 15th who also received both the COVID-19 Bivalent shot and the flu shot at the same time:
Patient began feeling very warm about 4 minutes after receiving the vaccine combination. Patient was waiting in the car for the 15 minute suggested wait period. Patient”s caregiver stated that about 5 minutes after receiving the vaccines, the patient blacked out in a seizure like behavior and was out for about 25 seconds. When he became responsive, he vomited and complained of an overall numb feeling. (Source.)
In another recorded case with a 12-year-old, that is apparently part of the current trials on children since it was not noted that the shot was given in error for this age group, this 12-year-old boy now has myocarditis (heart disease).
Myocarditis Managed with ibuprofen and monitoring Sx resolved in 1 day Trponins trended down in 3 days (Source.)
As we have previously reported, this new COVID-19 Bivalent vaccine, which is already causing injuries and deaths in adults and young people and is now being tested on babies and children, was authorized by the FDA and CDC with ZERO testing on humans. See:
As for the “original” COVID-19 vaccines given to children between the ages of 6 months old through 17 years old, here are the current total injuries and deaths in VAERS as of 9/16/2022:
These are obviously “Life Threatening” shots for children. (Note: this is for data through 9/16/2022 and these numbers will change each Friday when they update the VAERS database. So depending on when you read this, the “Life Threatening” number will be different, but how interesting that number is on the day this article is being published.)
A 2011 report by Harvard Pilgrim Health Care, Inc. for the U.S. Department of Health and Human Services (HHS) stated that less than 1% of all adverse events following vaccines are ever reported to VAERS.
Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA).
Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. (Source.)
Dr. Tenpenny describes extreme danger with bivalent vaccine.
BOMBSHELL: Video Emerges Where Fauci and Others Planned for a “Universal mRNA Flu Vaccine” Which Became the “COVID-19 mRNA Vaccine” Because People were not Afraid Enough of the Flu Virus
COVID-19 “Vaccine” Casualties List
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