FDA

7 Pfizer COVID-19 Trade Secrets in 3.2.P.1?

There appear to be up to 7 fully redacted ingredients in Pfizer’s experimental genetic vaccine BNT162b2. In this video, I discuss a heavily redacted excerpt of Section 3.2.P.1 from a confidential Pfizer document, released by the MHRA in response to my Freedom of Information request. For further details, please visit alltherisks.com/trade-secret. I have already extensively documented #AllTheRisks across toxicology, molecular biology, virology, immunology and epidemiology in a fully independent biosecurity risk assessment at http://www.alltherisks.com.

Summary Basis for Regulatory Action – Comiranty

Source: https://www.fda.gov/media/151733/download

https://drive.google.com/file/d/1sgZYqm7vJhxEk4Zc0nbFsv69ClCZqniX/view

CRITICAL UPDATE! In response to my Freedom of Information (FOI) request, on 11 November 2021, the MHRA provided the below heavily redacted excerpt from a confidential Pfizer document. Table 3.2.P.1-1 appears to list 7 fully redacted ingredients.

Background: COMIRNATY is a trade name of Pfizer’s experimental SARS-CoV-2 genetic vaccine BNT162b2, the same experimental product deployed in the UK under Regulation 174 from the MHRA, the UK’s Medicines and Healthcare Regulatory Agency. According to the CDC, “There has been no change in the formulation of the vaccine since the name change.” The FDA’s document Summary Basis for Regulatory Action – COMIRNATY, dated 23 August 2021, outlined the full approval of COMIRNATY. As below, Table 2 protected a 0.450ml excipient from public disclosure, according to U.S.C. § 552(b)(4), in lieu of “[t]rade secrets and commercial or financial information obtained from a person and privileged or confidential”.

Without reversioning their document, as below, the FDA later spontaneously updated Table 2 to supposedly reveal this previously undisclosed excipient to simply be water for injection (UNII: 059QF0KO0R).

However, this new disclosure cannot be reconciled with Table 3 in the same FDA document.

Therefore, on 20 October 2021, I raised a Freedom of Information (FOI) request to the MHRA entitled: Exact quantity of Water for Injection pre and post dilution in BNT162b2.

On 28 October 2021, the MHRA responded with the following:

The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm whereby the information can be used by competitors to inform their own product development and overcome regulatory hurdles.

Critical questions that must immediately be addressed by the MHRA therefore include:

  1. What could possibly warrant the MHRA’s decision to not disclose the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 by invoking an absolute exemption (Section 41) and a qualified exemption (Section 43)?
  2. Why would the disclosure of the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 inflict any “commercial harm” on Pfizer, as the MHRA claim?
  3. If the only solution present in BNT162b2 in liquid or frozen state is water for injection (UNII: 059QF0KO0R) then how could confirmation that it comprises the entire solution of BNT162b2 in its pre-dilution and post-dilution state “be used by competitors to inform their own product development and overcome regulatory hurdles”?

A diagram of mine illustrating dilution and post-dilution dosing of BNT162b2 is shown below.

The FDA wants the public to wait until the year 2076 – a full 55 years – for them to release the information it relied on to deem Pfizer’s vaccine safe for usage

Source: https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf

In page 10 you will find this:

The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076.
Until the entire body of documents provided by Pfizer to the FDA are made available, an appropriate analysis by the independent scientists that are members of Plaintiff is not possible.
Would the FDA agree to review and license this product without all the documents? Of course not. These independent, world-renowned scientists should be provided the same forthwith.
The entire purpose of the FOIA is to assure government transparency. It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.

InfoWars – FDA Documents Show Pfizer Secretly Added Heart Attack Drug to Children’s COVID Vaccines

Source: https://banned.video/watch?id=618c7b9111848a41725b16e2

The Food and Drug Administration (FDA) Advisory Committee that voted 17-0 to approve the jabs for children as young as five was notified that the children’s formulation of the drug contains tromethamine (Tris), a chemical that reduces blood acidity and stabilizes people who have suffered a heart attack.

https://theexpose.uk/2021/11/01/pfizer-adds-ingredient-to-vaccine-for-kids-that-treats-heart-attacks/

Vaccines and Related Biological Products Advisory Committee Meeting
October 26, 2021
FDA Briefing Document
EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age

PDF: https://www.fda.gov/media/153447/download

Page 14, Chapter 5

Vaccine formulation
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 packaged vials for the new formulation are stored frozen at -90°C to – 60°C. The frozen vials may be thawed and stored at refrigerator at 2°C to 8°C for up to 10 weeks.

https://www.drugs.com/cdi/tromethamine.html

Uses of Tromethamine:
It is used to treat or prevent acid problems in the blood.

What do I need to tell my doctor BEFORE I take Tromethamine?
For all patients taking tromethamine:

If you have an allergy to tromethamine or any other part of tromethamine.
If you are allergic to tromethamine; any part of tromethamine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you are not able to pass urine.

Children:

This medicine is not for newborns who have any of these problems: High blood carbon dioxide levels or too much salicylate in the body.
This is not a list of all drugs or health problems that interact with tromethamine.

What are some things I need to know or do while I take Tromethamine?
For all patients taking tromethamine:

Tell all of your health care providers that you take tromethamine. This includes your doctors, nurses, pharmacists, and dentists.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
Check your blood sugar as you have been told by your doctor.
Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tromethamine while you are pregnant.
Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

Use with care in children. Talk with the doctor.
How is this medicine (Tromethamine) best taken?
Use tromethamine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as an infusion into a vein over a period of time.

https://www.drugs.com/dosage/tromethamine.html

Tromethamine Dosage
Applies to the following strengths: 3.6 g/100 mL

Usual Pediatric Dose for Metabolic Acidosis
Associated with RDS in Neonates and Infants:
1 mL/kg for each pH unit below 7.4

Dose Adjustments
Dosage should be limited to an amount sufficient to increase blood pH to normal limits (7.35 to 7.45) and to correct acid-base derangements

Estimate the IV dosage of tromethamine injection from the buffer base deficit of the extracellular fluid in mEq/liter determined by means of the Siggaard-Andersen nomogram.

Use the following formula as a general guide:
Tromethamine solution (mL of 0.3 M) required =
Body Weight (kg) X
Base Deficit (mEq/liter) X 1.1

Note: Factor of 1.1 accounts for an approximate reduction of 10% in buffering capacity due to the presence of sufficient acetic acid to lower pH of the 0.3 M solution to approximately 8.

https://www.drugs.com/sfx/tromethamine-side-effects.html

Side effects include:

Adverse effects may include respiratory depression, local irritation, tissue inflammation, injection site infection, febrile response, chemical phlebitis, venospasm, hypervolemia, IV thrombosis, extravasation (with possible necrosis and sloughing of tissues), transient decreases in blood glucose concentrations, hypoglycemia, and hepatocellular necrosis with infusion via low-lying umbilical venous catheters. (See Warnings under Cautions.)


Why has Pfizer changed the formulation of its Covid-19 Vaccine for Children to include an ingredient that stabilises people suffering a Heart Attack?
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.

Childrens Health Defense – Pfizer Asks FDA to Authorize Booster Shots for All Adults, as Vaccine Maker Puts ‘Profits’ Over ‘Public Health’

Pfizer and BioNTech said their FDA request is based on results of a study, conducted by the two companies, which has not been published or peer-reviewed.By Megan Redshaw

Store: https://childrenshealthdefense.org/defender/pfizer-profits-fda-booster-shots-adults-public-health/

Pfizer and BioNTech on Tuesday asked the U.S. Food and Drug Administration (FDA) to authorize a third dose of their COVID vaccine for all people 18 and older, even though advisory panels to the FDA and Centers for Disease Control and Prevention (CDC) in September overwhelmingly rejected a similar request.

The companies said their new request is based on the results of a study, conducted by Pfizer and BioNTech, which has not been published or peer-reviewed.

The companies said the study of more than 10,000 volunteers showed vaccine efficacy against symptomatic infection of 95% or greater for people receiving the booster.

According to the Associated Press, a median of 11 months after receiving their last Pfizer vaccine dose, trial participants were given either a third booster dose or a placebo shot. Researchers tracked any infections that occurred at least a week later.

So far, five cases of symptomatic COVID occurred among booster recipients compared to 109 cases in the placebo group.

Pfizer did not disclose how many participants experienced asymptomatic infection, or whether the clinical trial included individuals with natural immunity acquired from previous SARS-CoV-2 infection — as did Pfizer’s clinical trial for 5 to 11 years olds.

According to CDC data, about 25 million people in the U.S. have received a COVID booster. It’s not clear how many would qualify for a booster if the FDA signs off on Pfizer-BioNTech’s request.

Steve Kirsch – New VAERS analysis reveals hundreds of serious adverse events that the CDC and FDA never told us about

They missed hundreds of serious adverse events that are more elevated than myocarditis. A new VAERS analysis done by Albert Benavides blows the doors off the “safe and effective” narrative.

Source: https://stevekirsch.substack.com/p/new-vaers-analysis-reveals-hundreds

The CDC and FDA have said the vaccines are “safe and effective.” They haven’t found any serious issues with the COVID vaccines. Zero. Zip. Nada. It was the DoD that found myocarditis.

The evidence in plain sight shows that they are either lying or incompetent. Or both. But of course, the medical community is never going to call them on this.

C19 count
This is the raw number of VAERS events in 2020 and 2021 due to the COVID vaccines for that symptom. The key here is that this count should be multiplied by 41 (known as the underreporting factor or URF to estimate the absolute number of events that occurred). See this article for how that is computed.

Baseline count
The baseline rate is the # of incidents occurring in a 5 year period from 2015-2019 for all vaccines given in that time period.

X-factor
The X-factor is the (C19 count*5/Baseline count). This is because the baseline is 5 years so we compare the COVID counts in a year vs. the average count in a typical year. So an X-factor of 10 or more would mean that the symptom is very likely to be caused by the vaccine since it is highly elevated from the “normal” rate.

Now let’s tackle the tabs. There are two tabs:

match tab
On the match tab are symptoms where the baseline count !=0

no match tab
On the “no match” tab are symptoms where the baseline count=0. So these are quite extraordinary since these symptoms are not typically seen even once in 5 years. So here, even a small value in the “count” field is very significant, e.g., 2 or more would be comparable to a 10X or more on the “match tab.”

Now here are some screenshots of the first page of the two tabs:

And the no match tab:

What the data tells us

Here are a few quick observations from the complete data set (see next section for downloading):

  1. Female reproductive issues top the list. These are strongly elevated by these vaccines. Many of the top symptoms are all related to the menstrual process.
  2. There are an enormous number of cardiovascular and neurological events that are strongly elevated, many of them serious.
  3. Fibrin D dimer increased is #53 on the list, elevated by a factor of over 400x above baseline. Charles Hoffe discovered D-dimer was elevated in over 60% of the patients he measured. This is very serious as D-dimer is a lagging indicator of blood clots.
  4. Troponin increased was #130, elevated by a factor of 205. Troponin indicates heart damage and it is elevated to extreme levels (10X heart attack levels or more) and can stay elevated for months at a time (with a heart attack, the levels start returning back to normal immediately after the incident)
  5. Death as a symptom (which is pretty unusual coding since it isn’t a symptom), is #433 and elevated by 96X. Hardly a “safe” vaccine.
  6. Brain herniation at #405 is elevated by a factor of 100X over baseline. However, this is not considered a big deal at the CDC (perhaps because many people there don’t use their brain).
  7. Cardiac arrest at #450 is elevated by 93X. This is when your heart stops. This is a relatively serious condition since you don’t last for too long after that. It’s a bit surprising that the CDC missed that one. Perhaps because they don’t have a heart?
  8. Pulmonary embolism #24 is elevated by 954 times normal. How the CDC can miss that one is simply astonishing! This was the cause of death of 2 of the 14 kids that the CDC looked at in their death analysis. Mainstream press will never ask them that question as to why the CDC would not find causality here. They wrote: “CDC reviewed 14 reports of death after vaccination. Among the decedents, four were aged 12–15 years and 10 were aged 16–17 years. All death reports were reviewed by CDC physicians; impressions regarding cause of death were pulmonary embolism (two), …” 954 times normal is hard to explain, isn’t it? So no causality? That’s hard to explain, so they didn’t. They just moved on as if there is nothing to see.
  9. Intracranial haemorrhage (their spelling) is at #604 and is elevated by 79X. Two of the 14 kids from the CDC analysis died from that. How could that not be causal? They never explained that.
  10. Tinnitus at #362 is elevated by 105X. This can be so bad that people can kill themselves from this alone. One of the people who work at Vaccine Safety Research Foundation (VSRF) had to talk a friend out of suicide.
  11. There are many many more issues to be concerned with, but I wanted to get the list out quickly so there can be more eyes on this.
  12. For months, I’ve offered to discuss our data and analyses to both the FDA and CDC outside committees as well as the CDC and FDA themselves, but nobody wanted to see it. Most hit delete on my emails. A few told me to wait for the public comment period and submit it then (which I’ve done). Nobody followed up.