Source – Page 14
Posted on 11/01/2021 8:18:16 PM PDT by ransomnote
A document prepared for the FDA Advisory Committee meeting, in which members voted seventeen to zero in favour of giving emergency use authorisation for the administration of the Pfizer Covid-19 injection to children aged 5 to 11, confirms that Pfizer have modified the formulation of their injection for children to include an ingredient that reduces the acidity of blood and is used to stabilise people who have suffered a heart attack.
By Patricia Harrity
The FDA Briefing Document titled ‘EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 though 11 years of age‘ states the following on page 14 –
“Authorization is being requested for a modified formulation of the Pfizer‑BioNTech COVID-19 Vaccine. Each dose of this formulation contains 10 μg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple dose vials.”
“To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphatebuffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride”.
The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine for children aged between 5 to 11 years old on October 29th 2021. The authorisation was based on what the FDA believes was their “thorough and transparent evaluation of the data” which included input from independent advisory committee experts, and the vote was overwhelmingly in favour of making the vaccine available to all children in this age group.
However, with overwhelming evidence against the safety of the vaccine and now a change in the formula used in clinical trials EUA should never have been granted.
The Pfizer risk and benefit analysis presented to the FDA for EUA approval, states that resulting from their clinical trials they have found the COVID-19 vaccine to be 90.7% effective at preventing symptomatic disease in children ages five to 11. The UKs Joint Committee on Vaccination and Immunisation (JCVI) have said that the evidence strongly indicates that almost all children and young people are at very low risk from COVID-19.
Where symptoms are seen in children and young people, they are “typically mild, and little different from other mild respiratory viral infections which circulate each year”. Children also recover from these infections quickly and according to many studies develop a robust broad spectrum immunity.
The rates in 5 to 11 are so low that there were no “cases” of severe COVID-19 or death from either the treatment (n= 1,518) or control group (n= 750), this renders the “90% effective” claim, meaningless. This should have stopped an EUA application in its tracks, as clearly there is no emergency for this age group in particular and therefore no benefit either.
Additionally, Pfizer admit that the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination or long-term safety of COVID-19 vaccine in participants 5 to 11 years old.
The FDA had addressed this earlier in the year and asked Pfizer to expand the clinical trials, nevertheless, this had not happened., Pfizer just ignored them and instead “fudged it by importing data from a different study” according to experienced risk and benefit analyser Toby Rogers PHD.
In his article, “Ten red flags in the FDA risk benefit” Toby Rogers simplified, “if the rate of particular adverse outcome in kids as a result of the vaccine is 1 in 5,000 and the trial only enrols 1,518 in the treatment group then it is unlikely to spot this particular harm in the clinical trial”.
The study that was added “polluted data rather than clarified outcomes” as participants from cohort 1, which was 95.1% of the trial had safety follow-ups up to 2 months after Dose 2 and cohort 2 were only monitored for adverse events for a mere 17 days at the time of the September 6, 2021 data cut-off.”
According to Dr Robert Malone, inventor of mRNA technology, the harms of myocarditis from these vaccines will likely unfold over the course of years the risks of “adverse events such as cardiomyopathy will be cumulative.” 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”. Therefore, the trials did not allow nearly adequate time to analyse the long-term effects, but also the other 4.9% who did not have a safety follow up after dose 2 with no indication of whether they were in the control group or the treatment group, potentially skews the results.
Pfizer-BioNTech do admit however, that Myocarditis and Pericarditis have occurred in some people who have received the vaccine. A first dose of Pfizer’s vaccine comes with a risk of 3 to 17 cases of vaccine-induced Myocarditis and a second dose risks an additional 12 to 34 cases of myocarditis.
How can this be deemed safe? Yet through the recording of adverse events following vaccination, we have been made aware of the many other risks there have been 837,593 reports to date to the US VAERS site alone. There is a remote chance that the vaccine could cause a severe allergic reaction according to Pfizer-BioNTech . A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine.
Signs of a severe allergic reaction can include:
• Difficulty breathing • Swelling of the face and throat • A fast heartbeat • A bad rash all over the body • Dizziness and weakness
VAERS 31/10/2021If Pfizer believes that their vaccine was safe why have they changed the formulation? The authorisation for the EUA being requested is not for the formulation that had been tested in the clinical trials, what has been requested is “a modified formulation of the Pfizer‑BioNTech COVID-19 Vaccine”.
This is to provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphate buffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride.
This is similar to the Moderna COVID-19 Vaccine formulation, yet according to the Centers for Disease Control and Prevention (CDC), have also said that since April 2021, increased cases of myocarditis and pericarditis have been reported particularly in adolescents and young adults in the United States after mRNA COVID-19 vaccination from both Pfizer-BioNTech and Moderna. See here: What are the ingredients in the Moderna COVID-19 Vaccine
When the Pfizer COVID-19 vaccine was granted an EUA from the FDA, its ingredients list was published online along with other safety data. The list included the now excluded ingredients sodium chloride and potassium chloride and includes the additional ingredient Tromethamine.
Tromethamine (Tris) is a blood acid reducer which is used to stabilize people with heart attacks. Here are known side effects: Respiratory depression – local irritation- tissue inflammation – injection site infection – febrile response – chemical phlebitis – venospasm (vein spasms) – hypervolemia – IV thrombosis – extravasation (with possible necrosis and sloughing of tissues) – transient decreases in blood glucose concentrations – hypoglycemia, and Hepatic Necrosis with infusion via low-lying umbilical venous catheters.
Typically vaccines can take 10 to 15 years, before being made available to the public, up until now the fastest ever vaccine was developed for mumps in four years in the 1960s. Yet the U.S. Food and Drug Administration (FDA) has granted emergency authorization to the Pfizer, Moderna, and Johnson & Johnson vaccines in less than a year.
With so much evidence against the vaccination in general, the FDA have not had a “thorough and transparent evaluation of the data” as they say, or if they have, they are not fit for purpose, because they should never have authorised the roll out of the Pfizer BioNTech vaccine to children as young as 5 to 11 years old. Alarmingly, with the changed formulation, the clinical trials are really only just about to begin in children.
ransomnote: a few months ago the CDC specified that post Covid vaccine adverse events reports from foreign subsidiaries are included in the VAERS data.
Here's a note from Openvaers.com about the data:
If foreign subsidiaries are required to report such cases to VAERS, then it seems like they do that for all vaccines. But the CDC has now specified that the data shown in the graph includes foreign subsidiary data, and then pro vax advocates complain we shouldn't use the combination. I don't understand the reasoning. If this is normal for vaccines and people actually suffered as a result of the vaccines, and this is required reporting, why complain?
But for those who feel somethign devious is going on, I'll post the 'US & TERRITORIES ALONE' version here. It's still utterly unacceptable levels of death and suffering unlike any in VAERS 30 year history.
ransomnote: are these unprecedented levels of death acceptable with foreign subsidiary reports excluded? The chart below shows the death rate for vaccines for 30 years. Not the Covid 'vaccine' data in the sharp spike to the right? See anything wrong?
Counting the combination, 2 out of every 3 deaths post vaccine reported to VAERS in the past 30 years are for Covid 'vaccines' which were administered in the past 11 months.
If foreign subsidiary Covid 'vaccine' adverse event reports are excluded, only 48% of all deaths in VAERS history are from the Covid 'vaccines'. I don't see the point in objecting, as some strenuously do, to the CDC's method of requiring the reports to be published to VAERS. It's funny though, the CDC has been withholding reports from VAERS when it wants to, but acts like it's 'forced' to report per the rules in this instance. I think this decision came along when 'too many people' were sharing VAERS info and they want to reduce reliance on it.
THIS is how the CDC responds to the congressional mandate to share vaccine harm data?
COVID Vaccine Data (openvaers.com)
PING
Oh please. They’re just trying to keep the kids from having heart attacks while they immunize them against the deadliest, most contagious pathogen to ever rage through kindergarten classrooms.
Because they are EVIL.
Related....
Dr Peter McCullough: Early Treatment, Not Vaccine Hubris, Will Protect Kids from COVID
https://rumble.com/voebcs-early-treatment-not-vaccine-hubris-will-protect-kids-from-covid.html
Never listen to what they tell you.
Watch what they DO.
uuuuummmmmmm, because tooo many of them were getting heart attacks?
but they say it’s a child dose, not a shot made for children
17-0
its unanimous they are evil and criminal
At the least, the vaccine was flawed.
Unfreakinbelievable!
Children:
“Use with care in children. Talk with the doctor.”
https://www.drugs.com/cdi/tromethamine.html
If they are afraid of too many kids having a heart attack within a day or so of getting the vax and thus creating a panic, what does this say about how much they think the vax will effect the heart?
This medication can’t be strong enough for a vax they expect the heart so profoundly not to effect the heart at all. Thus, we are going to see a lot of heart problems in kids several days after the vax. They are just hoping they can excused it all as undiagnosed pre-existing heart problems or severe anxiety.
To be fair, I thought Tromethamine was in all the Notavaxes used for adults. It is Moderna’s I know.
Given the warnings associated with it with regards to giving it to kids, I am not so sure it is going to prevent heart attacks and/or strokes such as cause them. Or probably more likely cause digestive system bleeding.
Can’t let them die too quickly. Must get them all to get the jabs.
I know the child trials were limited and flawed, but does anyone wonder if they added this ingredient in trials to hide this particular adverse event?
Things the make you go 🤔
If the formulation has been changed how can it still be “approved” (lie, it’s still the EUA) and therefor mandated?
.
A rash of childhood hear attacks and strokes probably would even get into the MSM and would get dissemination on Facebook for a few minutes and Twitter before it could be killed off.
Why has Pfizer changed the formulation of its Covid-19 Vaccine for Children to include an ingredient that stabilises people suffering a Heart Attack?
Also: Pfizer adds ingredient to Vaccine for kids… Used to stabilize heart attacks
I have a REALLY BAD feeling about what they are doing to kids.
PARENTS SHOULD NOT ALLOW THEIR CHILDREN TO RECEIVE THIS VAX!
Every few days, on the local news, there’s another child who was given the adult dosage or given the Covid-19 jab instead of the regular flu shot.
You’d think they would want to do extensive testing rather than just injecting kids with “something” and watching to see how many they kill.
yup
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