[SaneVax: This document is for the serious researcher. Whether you are a vaccine safety advocate, medical professional or scientist, you will want to look at the concerns expressed during the last Vaccines and Related Products Advisory Committee (VRBPAC) meeting on 9 Sept 2012. The FDA briefing document table of contents is printed below for your convenience. Access the entire document here. Please, take a few minutes to at least scan through this important information. The time for relying on pharmaceutical manufacturers to provide the truth is long past.]
Table of Contents
Cell Lines Derived from Human Tumors for Vaccine Manufacture
1. Introduction……………………………………………………………………………..……………………………4
2. Background………………………………………………………….………………………………………………..4
2.1 History of Cell Substrates for Viral Vaccine Manufacture in the U.S.: Primary,
Diploid, and Tumorigenic Cells……………………………….…………………………………………………5
2.2 Cell Substrates Derived from Human Tumors Proposed for Manufacture of
Viral vaccines……………………………………………………………………………………………………………6
3. Considerations Regarding the Use of Tumor-derived Cell Lines……..…………………………8
3.1 Mechanism of Tumorigenesis and Considerations for Characterization of Cell
Substrates…………………………………………………………………………………………….……………..……8
3.1.1 Oncogenic Viruses…………..…………………………………….………………………………………….9
3.1.2 Somatic Mutations………………………………………………………………..………………………….9
3.1.3 Epigenetic Changes……………………………………….………………………………..………………10
3.2 Metastatic Potential……………………………………………….…………………………………………11
4. Recommendations for Testing of Cell Substrates and Vaccines……………………………….12
4.1 Adventitious Agents……………………………………………………………….………………….……….12
4.1.1 Background………………………………………………………………………………………………………12
4.1.2 Current Recommendations for Characterization and Testing of Cell Substrates………………………………………………………….……………….……………………….…………..13
4.1.3 Emerging Technologies for Viral Detection……..……………….………………………..….…14
4.1.4 Viral Clearance by the Manufacturing Process..……………….………………..…………….…15
4.2 Residual Cell-substrate DNA………………………………………………………………………….…….15
4.2.1 Background: DNA Oncogenicity, DNA Infectivity, and DNA Integration…………..15
4.2.2 Current Recommendations for Control of Whole Cells and Host-cell DNA Content in Vaccines……………………………………….………………………………………………………………….…17
5. Summary…………………………………………………………….…………………………………………..……18
Appendix 1: Prior VRBPAC Discussions and other Meetings on Cell Substrates……………19
Appendix 2: Cell Substrate Recommended Testing from “Guidance for Industry:
Characterization and Qualification of Cell Substrates and Other Biological Materials Used in
the Production of Viral Vaccines for Infectious Disease Indications”……………..….…………22
Appendix 3: Summary of Selected Emerging Technologies for Virus Detection…………………………………………………………………………….……………………………………24
Appendix 4: WHO Deliberations: Issues Associated with the Presence of Residual
Cell-substrate DNA in Vaccines…………………………………………..……………………………….……25
References…………………………………………………………………………………………………………..…..26
Attachments:
1. Guidance for Industry (February 2010): “Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications”
2. Review Article (Anal. Chem. 83, 4327-4341; May 25, 2011): “Landscape of Next Generation Sequencing Technologies” by Thomas P. Niedringhaus, Denitsa Milanova, Matthew B. Kerby, Michael P. Snyder, and Annelise E. Barron
Terrible news.
FDA has now approved for trials involving the use of cell lines derived from human tumors for vaccine manufacture.
The meeting of the Advisory Committee is accessible in a webcast (link below) of several hours’ duration.
The entire webcast is given in the link below, (might be difficult to open). The last session, (third link when the link below is opened) is illustrative of FDA’s attitude:
Cell lines derived from human tumors for vaccine manufacture have been approved by FDA for trials although it is certainly not convincing (to me at least) that these vaccines will not induce tumors in the recipients, nor that the vaccines will be free from advantageous agents from the substrates.
The committee was openly concerned about presenting propaganda to doctors regarding safety issues and that information in package inserts should not be formulated so as to give rise to public anxiety.
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm321441.htm
here is the link to the FDA BRIEFING DOCUMENT’ advisory ‘ TO USING ‘ CELL LINES’ LIKE human cancerous tumors’ for vaccine manufacture’
( BUT YOU SEE THEM GOING ON ABOUT’ public opinion etc, IT’S DISGUSTING’ and’ immoral for them to even consider this’ but they do anyway, and my problem with it as well? IF YOU GO ‘ to a majority of the’ vaccine inserts out there – many many of them ADMIT OUTRIGHT’ they are NOT ‘ tested for carcinogenic, mutagenic, or impairment of fertility ‘ AND I FIND THAT ‘ rather reckless don’t you all? WITH ALL THE INFERTILITY in the world? with them using cell lines’ like human cancerous tumors’ insect cell lines’ ,
THE VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM326830.pdf