As I was analyzing some of the letters from the FDA regarding Comirnaty I have some questions..
Summary Basis for Regulatory Action - Comirnaty (prior to approval) https://www.fda.gov/media/151733/download Page 26 - Advisory Commitee results 17(Y) 4(N) 1(A)
Page 27 - VRBPAC commented on the need to "further assess vaccine effect on asymptomatic infection and VIRAL SHEDDING, and further evaluation of safety and effectiveness in subpopulations such as HIV infected individuals, and individuals with prior exposure to SARS 2 (Covid)
”FDA did not refer this application to the VRBPAC because our review of the information submitted to this BLA did not raise concerns or controversial issues that would have benefited from an advisory committee discussion”
BLA definition? The Biologics License Application (BLA) is a request for permission to** introduce**, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA.
Approval Letter - https://www.fda.gov/media/151710/download
"We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards"
It does not say it was authorized to be administered? Do any of the other approval letters for vaccines state this or is this specifically written to avoid legal actions?
Page 2 of the Approval letter states below...
“We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”
However on the FDA website it under steps to vaccine approval it stated After phase 3.. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
"After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission"
"While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use."
This step was skipped as you can see in the approval letter.
The Reporting Schedule on the Approval letter is on page 7 from August 21,2021.
Study completion date: Dec 31, 2026
How is this not experimental if the study completion date is 5 years out? How does this not violate Nuremberg Code of 1947?
Elisa Harkins name shows up on every page of the Approval letter. Who is she?
Notable names to also look into for conspiring or criminal activity would be:
Mary A. Malarkey - Director for Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research
Marion F. Gruber, PhD - Director of Office of Vaccines Research and Review Center for Biologics Evaluation and Research
After Approving the letter Gruber suddenly resigns? https://www.biopharmadive.com/news/marion-gruber-phil-krause-leaving-fda/605859/
Does anybody have more info about this?
As I was analyzing some of the letters from the FDA regarding Comirnaty I have some questions..
Summary Basis for Regulatory Action - Comirnaty (prior to approval) https://www.fda.gov/media/151733/download Page 26 - Advisory Commitee results 17(Y) 4(N) 1(A)
Page 27 - VRBPAC commented on the need to "further assess vaccine effect on asymptomatic infection and VIRAL SHEDDING, and further evaluation of safety and effectiveness in subpopulations such as HIV infected individuals, and individuals with prior exposure to SARS 2 (Covid)
”FDA did not refer this application to the VRBPAC because our review of the information submitted to this BLA did not raise concerns or controversial issues that would have benefited from an advisory committee discussion”
BLA definition? The Biologics License Application (BLA) is a request for permission to** introduce**, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA.
Approval Letter - https://www.fda.gov/media/151710/download
"We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards"
It does not say it was authorized to be administered? Do any of the other approval letters for vaccines state this or is this specifically written to avoid legal actions?
Page 2 of the Approval letter states below...
“We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”
However on the FDA website it under steps to vaccine approval it stated After phase 3.. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
"After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission"
"While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use."
This step was skipped as you can see in the approval letter.
The Reporting Schedule on the Approval letter is on page 7 from August 21,2021.
Study completion date: Dec 31, 2026
How is this not experimental if the study completion date is 5 years out? How does this not violate Nuremberg Code of 1947?
Elisa Harkins name shows up on every page of the Approval letter. Who is she?
Notable names to also look into for conspiring or criminal activity would be:
Mary A. Malarkey - Director for Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research
Marion F. Gruber, PhD - Director of Office of Vaccines Research and Review Center for Biologics Evaluation and Research
Does anybody have more info about this?