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”.
EMERGENCY USE GRANTED
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 90% EFFECTIVE CLAIM IS MEANINGLESS
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.
TRIALS WERE TOO SMALL
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.
WHAT ARE THE OTHER RISKS OF THE VACCINE?
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
THE MODIFIED FORMULATION
If 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.
CLINICAL TRIALS NULL AND VOID
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.
Link to FDA document: https://www.fda.gov/media/153447/download