WARNING - FDA Report Shows Proof New Pfizer COMIRNATY Covid Vaccine They Approved Is Different And It's Potential Dangers

I found the FDA Report for the "approved" Covid Pfizer vaccine from Pfizer. Warning, it is a different vaccine than the current one available. It's called Comirnaty and they have yet to release it! Do not be fooled by mainstream media or other people that do not do the research. Here is the link from the FDA for the report. I have listed some of the concerns that I noticed as I read through it and posted it here. You might find other details I may have missed that are concerning as well.

FDA Report - Approval For Pfizer COMIRNATY Vaccine (Summary Basis for Regulatory Action)
[link to www.fda.gov (secure)]

**Nonclinical Toxicology** (page 14 - Proof Pfizer Comirnaty and the currently available Pfizer BioNTech BNT162b2 vaccine are TWO DIFFERENT VACCINES - THIS IS WHY THE CURRENT PFIZER VACCINE IS NOT FDA APPROVED AND NOT RELEASED YET)
The repeat dose toxicity evaluations were conducted on COMIRNATY and a similar vaccine termed BNT162b2 (V8). COMIRNATY and BNT162b2 (V8) have identical amino acid sequences of the encoded antigens but COMIRNATY includes the presence of optimized codons to improve antigen expression.

**Myocarditis/Pericarditis** (page 23)
Post-EUA safety surveillance reports received by FDA and CDC identified serious risks for myocarditis and pericarditis following administration of COMIRNATY. Reporting rates for medical chart-confirmed myocarditis/pericarditis in VAERS have been higher among males under 40 years of age than among females and older males and have been highest in males 12-17 years of age (65 cases per million doses administered as per CDC communication on August 20, 2021), particularly following the second dose, and onset of symptoms within 7 days following vaccination. Although some cases of vaccine- associated myocarditis/pericarditis required intensive care support, available data from short-term follow up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae and outcomes in affected individuals. A mechanism of action by which the vaccine could cause myocarditis and pericarditis has not been established.
These safety findings of increased risk for myocarditis/pericarditis led to warning in section 5.2 Warning and Precautions of the PI.. Moreover, since vaccine-associated myocarditis/pericarditis is the most clinically significant identified risk, FDA undertook a quantitative benefit-risk assessment to model the excess risk of myocarditis/pericarditis vs. the expected benefits of preventing COVID- 19 and associated hospitalizations, ICU admissions, and deaths.

**Advisory Committee Meetings** (page 26)
Vaccines and Related Biological Products Committee (VRBPAC) meetings were convened on October 22, 2020 to discuss, in general, development for EUA and licensure of vaccines to prevent COVID-19 and on December 10, 2020, to discuss BioNTech Manufacturing GmbH/Pfizer’s EUA request for the Pfizer-BioNTech COVID-19 Vaccine.

The VRPBAC voted on one question:
1. Based on the totality of scientific evidence available, do the benefits of the Pfizer- BioNTech COVID-19 Vaccine outweigh its risks[u/] for use in individuals 16 years of age and older?
The results of the vote were as follows:
Yes = 17 No = 4 Abstain = 1

**Post-Marketing Requirements Under Section 505(o)** (page 33)
Study C4591009, entitled “A Non-Interventiona lPost-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
Final Protocol Submission: August 31, 2021
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion: June 30, 2025
Final Report Submission: October 31, 2025
The FDA will not get the final Safety Report on the occurrence of myocarditis and pericarditis for 4 more years!

Post-Marketing Commitments Subject To Reporting Requirements Under Section 506B (page 29)
Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/Mother To Baby Pregnancy Registry”
Final Protocol Submission: July 1, 2021
Study Completion: June 1, 2025
Final Report Submission: December 1, 2025
The FDA will not get the final Safety Report For Pregnancy and Infant Outcomes for 4 more years!

What is the document redacted???

What is the document redacted???

No, the link takes you to their 30 page report. I just copied and pasted some items I found that may be concerning. I'm sure you might find more.

Here's my question.. How can they approve a drug that's not even been produced yet? Aren't these things supposed to go through years of trials and testing pending FDA approval?

They say the original jab's ingredients are the same as COMIRNATY and are interchangeable.

Then why come up with this drug that they say is the same as the old drug under a different name?

Doesn't make sense, unless this is some type of legal fuckduggery to confuse the hapless masses.

Here's my question.. How can they approve a drug that's not even been produced yet? Aren't these things supposed to go through years of trials and testing pending FDA approval?

They say the original jab's ingredients are the same as COMIRNATY and are interchangeable.

Then why come up with this drug that they say is the same as the old drug under a different name?

Doesn't make sense, unless this is some type of legal fuckduggery to confuse the hapless masses.

Here's my question.. How can they approve a drug that's not even been produced yet? Aren't these things supposed to go through years of trials and testing pending FDA approval?

They say the original jab's ingredients are the same as COMIRNATY and are interchangeable.

Then why come up with this drug that they say is the same as the old drug under a different name?

Doesn't make sense, unless this is some type of legal fuckduggery to confuse the hapless masses.

It's a slightly different vaccine. On page 14 under Nonclinical Toxicoligy they quote, "COMIRNATY and BNT162b2 (V8) have identical amino acid sequences of the encoded antigens but COMIRNATY includes the presence of optimized codons to improve antigen expression."

Who knows what else they changed and might not be telling us. It looks like they used the tests and studies from the original vaccine and just said they changed a couple of thing for the new one. Something stinks on this that's for sure. One thing we know for certain, they are trying to confuse everyone in thinking the current one available has been approved when it clearly states in here they have two vaccines and only one has been approved. The current one will remain EAU which they extended the time to use as such. When a drug or vaccine has been approved they have to list most of the ingredients on the insert. The EAU does not and that's why the inserts are blank. The news, doctors, and businesses have it all wrong and just assume it's the same thing. So people are going out and getting the same EAU and not the approved one. That's because they haven't made it available and are not saying when it will be.

Pg5:

The mRNA in COMIRNATY is a single-stranded, 5’-capped mRNA encoding the full-
length SARS-CoV-2 spike glycoprotein derived from the Wuhan-Hu-1 isolate (GenBank
MN908947.3 and GenBank QHD43416.1).



So it has been isolated? From GenBank:

[link to www.ncbi.nlm.nih.gov (secure)]

[link to www.ncbi.nlm.nih.gov (secure)]

I found the FDA Report for the "approved" Covid Pfizer vaccine from Pfizer. Warning, it is a different vaccine than the current one available. It's called Comirnaty and they have yet to release it! Do not be fooled by mainstream media or other people that do not do the research. Here is the link from the FDA for the report.

FDA Report - Approval For Pfizer COMIRNATY Vaccine (Summary Basis for Regulatory Action)
[link to www.fda.gov (secure)]

(The report is 33 pages long! I copied some of the details I found that may be concerning and listed them here.)

**Nonclinical Toxicology** (page 14 - Proof Pfizer Comirnaty and the currently available Pfizer BioNTech BNT162b2 vaccine are TWO DIFFERENT VACCINES - THIS IS WHY THE CURRENT PFIZER VACCINE IS NOT FDA APPROVED AND NOT RELEASED YET)
The repeat dose toxicity evaluations were conducted on COMIRNATY and a similar vaccine termed BNT162b2 (V8). COMIRNATY and BNT162b2 (V8) have identical amino acid sequences of the encoded antigens but COMIRNATY includes the presence of optimized codons to improve antigen expression.

**Myocarditis/Pericarditis** (page 23)
Post-EUA safety surveillance reports received by FDA and CDC identified serious risks for myocarditis and pericarditis following administration of COMIRNATY. Reporting rates for medical chart-confirmed myocarditis/pericarditis in VAERS have been higher among males under 40 years of age than among females and older males and have been highest in males 12-17 years of age (65 cases per million doses administered as per CDC communication on August 20, 2021), particularly following the second dose, and onset of symptoms within 7 days following vaccination. Although some cases of vaccine- associated myocarditis/pericarditis required intensive care support, available data from short-term follow up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae and outcomes in affected individuals. A mechanism of action by which the vaccine could cause myocarditis and pericarditis has not been established.
These safety findings of increased risk for myocarditis/pericarditis led to warning in section 5.2 Warning and Precautions of the PI.. Moreover, since vaccine-associated myocarditis/pericarditis is the most clinically significant identified risk, FDA undertook a quantitative benefit-risk assessment to model the excess risk of myocarditis/pericarditis vs. the expected benefits of preventing COVID- 19 and associated hospitalizations, ICU admissions, and deaths.

**Advisory Committee Meetings** (page 26)
Vaccines and Related Biological Products Committee (VRBPAC) meetings were convened on October 22, 2020 to discuss, in general, development for EUA and licensure of vaccines to prevent COVID-19 and on December 10, 2020, to discuss BioNTech Manufacturing GmbH/Pfizer’s EUA request for the Pfizer-BioNTech COVID-19 Vaccine.

The VRPBAC voted on one question:
1. Based on the totality of scientific evidence available, do the benefits of the Pfizer- BioNTech COVID-19 Vaccine outweigh its risks[u/] for use in individuals 16 years of age and older?
The results of the vote were as follows:
Yes = 17 No = 4 Abstain = 1

**Post-Marketing Requirements Under Section 505(o)** (page 33)
Study C4591009, entitled “A Non-Interventiona lPost-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
Final Protocol Submission: August 31, 2021
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion: June 30, 2025
Final Report Submission: October 31, 2025
The FDA will not get the final Safety Report on the occurrence of myocarditis and pericarditis for 4 more years!

Post-Marketing Commitments Subject To Reporting Requirements Under Section 506B (page 29)
Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/Mother To Baby Pregnancy Registry”
Final Protocol Submission: July 1, 2021
Study Completion: June 1, 2025
Final Report Submission: December 1, 2025
The FDA will not get the final Safety Report For Pregnancy and Infant Outcomes for 4 more years!

I found the FDA Report for the "approved" Covid Pfizer vaccine from Pfizer. Warning, it is a different vaccine than the current one available. It's called Comirnaty and they have yet to release it! Do not be fooled by mainstream media or other people that do not do the research. Here is the link from the FDA for the report.
SNIP

I just went through it and it seems it was approved.

Isn't the whole document the "approval"?

I just went through it and it seems it was approved.

Isn't the whole document the "approval"?

"Recommended Action: The Review Committee recommends approval of this product."

Here's my question.. How can they approve a drug that's not even been produced yet? Aren't these things supposed to go through years of trials and testing pending FDA approval?

They say the original jab's ingredients are the same as COMIRNATY and are interchangeable.

Then why come up with this drug that they say is the same as the old drug under a different name?

Doesn't make sense, unless this is some type of legal fuckduggery to confuse the hapless masses.

Here's my question.. How can they approve a drug that's not even been produced yet? Aren't these things supposed to go through years of trials and testing pending FDA approval?

They say the original jab's ingredients are the same as COMIRNATY and are interchangeable.

Then why come up with this drug that they say is the same as the old drug under a different name?

Doesn't make sense, unless this is some type of legal fuckduggery to confuse the hapless masses.

Here's my question.. How can they approve a drug that's not even been produced yet? Aren't these things supposed to go through years of trials and testing pending FDA approval?

They say the original jab's ingredients are the same as COMIRNATY and are interchangeable.

Then why come up with this drug that they say is the same as the old drug under a different name?

Doesn't make sense, unless this is some type of legal fuckduggery to confuse the hapless masses.