Walter S. Kyle, Esquire
Vaccine & Related Biological Product
Advisory Committee – May 7, 2010 –
PUBLIC COMMENT
GOOD AFTERNOON - I AM WALTER KYLE - AN ATTORNEY WHO HAS REPRESENTED VACCINE VICTIMS IN CLAIMS AGAINST THE UNITED STATES REGULATORY AGENCIES AND MANUFACTURERS. (1)
MY COMMENTS FLOW FROM REVIEW OF THOUSANDS OF INTERNAL MEMOS AND DOCUMENTS OBTAINED IN LITIGATION
I QUESTION THE “GUIDANCE FOR INDUSTRY” EXHIBIT (2) FROM A LEGAL PERPECTIVE, AND HAVE OBJECTIONS TO ITS PROVISIONS RE: “CELL CULTURE SAFETY TESTS FOR MONKEY CELL LINES”.
HISTORICALLY - THE FDA SHOWED NO CONCERNS ABOUT RELEASING LIVE POLIO VACCINE GROWN IN SUBSTRATE CONTAMINATED BY AFRICAN GREEN MONKEY HERPESVIRUSES.
A 1972 DBS STUDY FOUND 100% OF LEDERLE’S AGM VACCINE SUBSTRATE CONTAMINATED WITH CMV – A HERPES VIRUS
LEDERLE’S RESPONSE - THE "CYTOMEGALOVIRUS CONTINGENCY PLAN" (3) OUTLINED LEDERLE'S PLOT TO BLOCK REGULATIONS THAT MIGHT ELIMINATE AGM-CMV FROM ITS VACCINE.
AND NO REGULATIONS WERE EVER ENACTED - THE FDA AND CHAIRMAN OF THE AAPIDC APPARENTLY AGREED WITH LEDERLE'S POSITION THAT CYTOMEGALOVIRUS COULD NOT JUMP SPECIES FROM AGM'S TO HUMANS. (4)
BUT BY 1978, THE COLBURN STRAIN OF AGM CYTOMEGALOVIRUS, BIOPSIED FROM THE BRAIN OF A NORTH CAROLINA CHILD WITH ENCEPHOLOPATHY - PUT THE LIE TO THAT POSITION. (5) WHICH SHOULD SURPRISE NO ONE BECAUSE IN 1971 (13) AGM-CMV WAS FOUND TO REPLICATE IN HUMAN CELLS AND BE THE LEAST SPECIES SPECIFIC CYTOMEGALOVIRUS
THE FDA NEVER REQUIRED ANY WARNINGS ON LEDERLE'S PACKAGE INSERTS TO ALERT DOCTORS ABOUT ENCEPALOPATHIES OR OTHER HERPES RELATED DISEASES. (6)
A 1976 FDA ASSESMENT ESTIMATED OPV CAUSED 6-10 DEATHS PER YEAR AND 500 HOSPITALIZATIONS (7) WHILE THE PACKAGE INSERT ONLY “WARNED” OF “1 IN A MILLION CHANCE” OF "VACCINE ASSOCIATED POLIO” - ABOUT 10 PER YEAR. (6).
IT WAS NOT A WARNING - IT WAS A WARRANTY - AND DEFLECTED ATTENTION AWAY FROM THE LIVE VACCINE’S LATENT VIRUS ISSUE
CMV IS JUST ONE OF THE HERPES VIRUSES FOUND IN THE PRIMATES USED TO MAKE LIVE ORAL POLIO VACCINE... (AGM’s RHESUS & CHIMPANZEES) WERE ALL USED TO CREATE IT. (8)
IN 2001 GAMMA-2 HERPESVIRUSES – CALLED RHADINOVIRUSES -DISCOVERED IN THESE MONKEYS INCLUDED KAPOSI'S SARCOMA HERPES VIRUS (HHV-8), AND EBV ALONG WITH HTLV.(9)
SABIN’S LIVE VACCINE VIRUSES HAVE PROVEN TO BE EXCELLENT CARRIERS OF OTHER VIRUSES GENETIC SEQUENCES. (10) HENCE OPV VIRUSES COULD BE VECTORS FOR GENETIC SEQUENCES OF THE HERPES AND IMMUNODEFICIENCY VIRUSES WITHIN THE PRIMATES USED TO MAKE THE VACCINE.
“INTERDIGITATION” WAS THE TERM DBS COINED TO DESCRIBE THE CAPABILITY – IN 1964.
THESE PRIMATE MONKEY VIRUSES RELATE TO AUTO IMMUNE DISEASES IN HUMANS AND COULD HAVE BEEN TRANSMITTED FROM MONKEYS TO HUMANS WITHIN LIVE OPV VIRUSES (ACTING AS VECTORS) OR IN THE VACCINE ITSELF –
A NON STERILE PRODUCT. SPEAKING OF WHICH -
IN 1976 THE FDA DISCOVERED UNKNOWN RETROVIRUSES CONTAMINATING POLIO VACCINE (11) BUT RELEASED THE CONTAMINATED VACCINE IN 1978.
IN 1980 FDA JUSTIFIED ITS ACTIONS BY STATING, IN ESSENCE, THAT THE REGULATIONS DID NOT REQUIRE REMOVAL OF TYPE C RNA CONTAINING RETROVIRUSES FROM LIVE POLIO VACCINE BECAUSE THE RT TESTS, THAT WON BALTIMORE AND TEMIN THE 1975 NOBEL PRIZE, WERE NOT REQUIRED BY THE 1962 REGULATIONS GOVERNING POLIO VACCINE - (12).
BY 1982 AN EPIDEMIC PRESENTATION OF MONKEY VIRUSES AROSE WHEN EBV WAS FOUND ASSOCIATED WITH ORAL HAIRY LEUKOPLAKIA AND KSHV SIMULTANEOUSLY CAUSED KAPOSI'S SARCOMA IN THOUSANDS OF HOMOSEXUAL MEN WHO ALSO PRESENTED WITH HUMAN CYTOMEGALOVIRUS DISEASE.
THE EPIDEMIC WAS AIDS - AND IT HAS BEEN SUGGESTED THAT IT WAS A COMBINED EPIDEMIC OF HIV AND KSHV. (13)
AUTO IMMUNE DISEASE ASSOCIATED WITH CMV AND THE RHADINOVIRUSES INCLUDE MULTIPLE SCLEROSIS, LUPUS, CHRONIC FATIGUE SYNDROM, INFECTIOUS MONONUCLEOSIS, BURKITT’S LYMPHOMA AND AIDS. (14)
I QUESTION IF THE 4 WEEK OBSERVATION PERIOD FOR CELL CULTURE ASSAYS, AS SUGGESTED IN GUIDANCE (2) OF (2010) IS SUFFICIENT TO ELIMINATE SLOW GROWING VIRUSES IN VACCINE SUBSTRATES. (15) DETAILS A 10 FOLD INCREASE IN LATENT VIRUS DETECTION IN 4-8 WEEKS OVER 2-3 WEEK STUDIES – THE MINIMUM OBSERVATION PERIOD SHOULD BE 8 WEEKS.
I SUGGEST THAT MANDATORY REGULATIONS, VERSES NON-BINDING GUIDELINES, REQUIRE ELIMINATION OF ANY VACCINE OR VACCINE VIRUS CONTAMINATES NOT ACTUALLY PROVEN SAFE FOR HUMANS EVEN IF THE TESTING TECHNIQUES WERE NOT AVAILABLE WHEN THE REGULATIONS WERE WRITTEN.
I BELIEVE THAT THE “GUIDANCE FOR INDUSTRY” (2) IS A SHAM.
IT IS WRITTEN TO INSULATE THE FDA FROM LIABILITY UNDER THE TORT CLAIMS ACT WHERE DISCRETIONARY DECISIONS CAN NOT BE THE BASIS OF A LAWSUIT -
I FEEL ITS RELAXED APPROACH TO CONTROLLING THE ISSUES DIRECTLY VIOLATES THE MANDATE 42 USC 262 THAT REQUIRES THE FDA TO INSURE THE SAFETY AND PURITY OF VACCINES.
Walter S. Kyle, Esq.
May 4, 2010
I certify that I have no financial ties to or interest in any pharmaceutical company and that I have not been paid or compensated for preparation or presentation of this paper.
Walter S. Kyle
REFERENCES
JULIE GREENSILL, JULIE A. SHELDON, NEIL M. RENWICK, BRIGITTE E. BEER
Both KSHV and STLV (a/k/ATLV) naturally infected captive African Green Monkeys.
b. Georg-Fries B, Mueller-Lantzsch N, “ Epstein-Barr virus induced proteins V: comparison of EBV-specific polypeptides from different virus strains”, Med Microbiol Immunology, 1982; 171(1): 11-21
c. Characterization of African green monkey B-cell lines releasing an adult T-cell leukemia-virus-related agent. Yamamoto N, Kobayashi N Takeuchi K, Koyanagi Y Hatanaka M Hinuma Y Chosa T Schneider J Hunsmann G, Int J Cancer. 1984 Jul 15;34(1):77-82.
Eight lymphoblastoid cell lines were established from the peripheral blood of individual African green monkeys (AGM). The AGM-2206 line grew out spontaneously. The others - AGM-6, 7, 8, 10, 12, 13, and 16 - were obtained after infection of peripheral AGM lymphocytes with cell-free culture supernatant of AGM-2206. All lines contained, and were probably transformed by, AGM-EBV.
d. “Data suggests that HHV-6 infects African green monkeys…”
Safak Yalcin, et.al ”Experimental infection of cynomolgus and African green monkeys with human herpesvirus 6” Journal of General Virology (1992), 73, 1673-1677
Poliovirus is an attractive live viral vector for several reasons. The Sabin live poliovirus vaccine is one of the best human vaccines in the world. It produces long-lasting immunity (59, 75) and herd immunity (75); it is very safe and easy to experimentally manipulate (47); it has a proven safety and efficacy record in over 1 billion vaccinees (75); it is inexpensive to produce and to distribute in developing countries (29); and, most importantly, it produces a potent mucosal immune response (51, 56, 79). The capacity of poliovirus to generate a strong mucosal immune response is particularly important given that more than 90% of HIV type 1 (HIV-1) infections worldwide have occurred via sexual transmission (77). Any strategy to control the AIDS pandemic must include a vaccine that prevents sexual transmission of HIV-1.
b) SHENBEI TANG, RONALD VAN RIJ, DEBORAH SILVERA, AND RAUL ANDINO, “Toward a Poliovirus-Based Simian Immunodeficiency Virus Vaccine: Correlation between Genetic Stability and Immunogenicity” JOURNAL OF VIROLOGY, Oct. 1997, p. 7841–7850 Vol. 71
11) 1976 FDA Laboratory report: “Cell Culture Assays for Adventitious Virus in Polio Vaccine” shows Lederle polio vaccine monopool 3-444 contains unknown retrovirus capable of infecting Human, rhesus and African Green monkey embryonic lung tissue, [1000-100,000 per ml]
(@25673…The regulations prescribe reasonable and generally appropriate measures to exclude unwanted microbial agents {except perhaps Type C RNA containing retroviruses} that might be in the substrate initially or might be acquired by contamination during manufacture. @25665…concerns have been expressed about potential oncogenic effects due to presence in the vaccine of unknown viral contaminants, or to genetic fragments of oncogenic viruses somehow incorporated into the genome of the vaccine virus…
such a theoretical risk should be given little or no weight when estimating the benefit-risk ratio.
Merck's AIDS Vaccine failure requires review of AIDS strategies and re-evaluating the Origin of AIDS issues, WSKYLE, bioinfo.net
Vaccine & Related Biological Product
Advisory Committee – May 7, 2010 –
PUBLIC COMMENT
GOOD AFTERNOON - I AM WALTER KYLE - AN ATTORNEY WHO HAS REPRESENTED VACCINE VICTIMS IN CLAIMS AGAINST THE UNITED STATES REGULATORY AGENCIES AND MANUFACTURERS. (1)
MY COMMENTS FLOW FROM REVIEW OF THOUSANDS OF INTERNAL MEMOS AND DOCUMENTS OBTAINED IN LITIGATION
I QUESTION THE “GUIDANCE FOR INDUSTRY” EXHIBIT (2) FROM A LEGAL PERPECTIVE, AND HAVE OBJECTIONS TO ITS PROVISIONS RE: “CELL CULTURE SAFETY TESTS FOR MONKEY CELL LINES”.
HISTORICALLY - THE FDA SHOWED NO CONCERNS ABOUT RELEASING LIVE POLIO VACCINE GROWN IN SUBSTRATE CONTAMINATED BY AFRICAN GREEN MONKEY HERPESVIRUSES.
A 1972 DBS STUDY FOUND 100% OF LEDERLE’S AGM VACCINE SUBSTRATE CONTAMINATED WITH CMV – A HERPES VIRUS
LEDERLE’S RESPONSE - THE "CYTOMEGALOVIRUS CONTINGENCY PLAN" (3) OUTLINED LEDERLE'S PLOT TO BLOCK REGULATIONS THAT MIGHT ELIMINATE AGM-CMV FROM ITS VACCINE.
AND NO REGULATIONS WERE EVER ENACTED - THE FDA AND CHAIRMAN OF THE AAPIDC APPARENTLY AGREED WITH LEDERLE'S POSITION THAT CYTOMEGALOVIRUS COULD NOT JUMP SPECIES FROM AGM'S TO HUMANS. (4)
BUT BY 1978, THE COLBURN STRAIN OF AGM CYTOMEGALOVIRUS, BIOPSIED FROM THE BRAIN OF A NORTH CAROLINA CHILD WITH ENCEPHOLOPATHY - PUT THE LIE TO THAT POSITION. (5) WHICH SHOULD SURPRISE NO ONE BECAUSE IN 1971 (13) AGM-CMV WAS FOUND TO REPLICATE IN HUMAN CELLS AND BE THE LEAST SPECIES SPECIFIC CYTOMEGALOVIRUS
THE FDA NEVER REQUIRED ANY WARNINGS ON LEDERLE'S PACKAGE INSERTS TO ALERT DOCTORS ABOUT ENCEPALOPATHIES OR OTHER HERPES RELATED DISEASES. (6)
A 1976 FDA ASSESMENT ESTIMATED OPV CAUSED 6-10 DEATHS PER YEAR AND 500 HOSPITALIZATIONS (7) WHILE THE PACKAGE INSERT ONLY “WARNED” OF “1 IN A MILLION CHANCE” OF "VACCINE ASSOCIATED POLIO” - ABOUT 10 PER YEAR. (6).
IT WAS NOT A WARNING - IT WAS A WARRANTY - AND DEFLECTED ATTENTION AWAY FROM THE LIVE VACCINE’S LATENT VIRUS ISSUE
CMV IS JUST ONE OF THE HERPES VIRUSES FOUND IN THE PRIMATES USED TO MAKE LIVE ORAL POLIO VACCINE... (AGM’s RHESUS & CHIMPANZEES) WERE ALL USED TO CREATE IT. (8)
IN 2001 GAMMA-2 HERPESVIRUSES – CALLED RHADINOVIRUSES -DISCOVERED IN THESE MONKEYS INCLUDED KAPOSI'S SARCOMA HERPES VIRUS (HHV-8), AND EBV ALONG WITH HTLV.(9)
SABIN’S LIVE VACCINE VIRUSES HAVE PROVEN TO BE EXCELLENT CARRIERS OF OTHER VIRUSES GENETIC SEQUENCES. (10) HENCE OPV VIRUSES COULD BE VECTORS FOR GENETIC SEQUENCES OF THE HERPES AND IMMUNODEFICIENCY VIRUSES WITHIN THE PRIMATES USED TO MAKE THE VACCINE.
“INTERDIGITATION” WAS THE TERM DBS COINED TO DESCRIBE THE CAPABILITY – IN 1964.
THESE PRIMATE MONKEY VIRUSES RELATE TO AUTO IMMUNE DISEASES IN HUMANS AND COULD HAVE BEEN TRANSMITTED FROM MONKEYS TO HUMANS WITHIN LIVE OPV VIRUSES (ACTING AS VECTORS) OR IN THE VACCINE ITSELF –
A NON STERILE PRODUCT. SPEAKING OF WHICH -
IN 1976 THE FDA DISCOVERED UNKNOWN RETROVIRUSES CONTAMINATING POLIO VACCINE (11) BUT RELEASED THE CONTAMINATED VACCINE IN 1978.
IN 1980 FDA JUSTIFIED ITS ACTIONS BY STATING, IN ESSENCE, THAT THE REGULATIONS DID NOT REQUIRE REMOVAL OF TYPE C RNA CONTAINING RETROVIRUSES FROM LIVE POLIO VACCINE BECAUSE THE RT TESTS, THAT WON BALTIMORE AND TEMIN THE 1975 NOBEL PRIZE, WERE NOT REQUIRED BY THE 1962 REGULATIONS GOVERNING POLIO VACCINE - (12).
BY 1982 AN EPIDEMIC PRESENTATION OF MONKEY VIRUSES AROSE WHEN EBV WAS FOUND ASSOCIATED WITH ORAL HAIRY LEUKOPLAKIA AND KSHV SIMULTANEOUSLY CAUSED KAPOSI'S SARCOMA IN THOUSANDS OF HOMOSEXUAL MEN WHO ALSO PRESENTED WITH HUMAN CYTOMEGALOVIRUS DISEASE.
THE EPIDEMIC WAS AIDS - AND IT HAS BEEN SUGGESTED THAT IT WAS A COMBINED EPIDEMIC OF HIV AND KSHV. (13)
AUTO IMMUNE DISEASE ASSOCIATED WITH CMV AND THE RHADINOVIRUSES INCLUDE MULTIPLE SCLEROSIS, LUPUS, CHRONIC FATIGUE SYNDROM, INFECTIOUS MONONUCLEOSIS, BURKITT’S LYMPHOMA AND AIDS. (14)
I QUESTION IF THE 4 WEEK OBSERVATION PERIOD FOR CELL CULTURE ASSAYS, AS SUGGESTED IN GUIDANCE (2) OF (2010) IS SUFFICIENT TO ELIMINATE SLOW GROWING VIRUSES IN VACCINE SUBSTRATES. (15) DETAILS A 10 FOLD INCREASE IN LATENT VIRUS DETECTION IN 4-8 WEEKS OVER 2-3 WEEK STUDIES – THE MINIMUM OBSERVATION PERIOD SHOULD BE 8 WEEKS.
I SUGGEST THAT MANDATORY REGULATIONS, VERSES NON-BINDING GUIDELINES, REQUIRE ELIMINATION OF ANY VACCINE OR VACCINE VIRUS CONTAMINATES NOT ACTUALLY PROVEN SAFE FOR HUMANS EVEN IF THE TESTING TECHNIQUES WERE NOT AVAILABLE WHEN THE REGULATIONS WERE WRITTEN.
I BELIEVE THAT THE “GUIDANCE FOR INDUSTRY” (2) IS A SHAM.
IT IS WRITTEN TO INSULATE THE FDA FROM LIABILITY UNDER THE TORT CLAIMS ACT WHERE DISCRETIONARY DECISIONS CAN NOT BE THE BASIS OF A LAWSUIT -
I FEEL ITS RELAXED APPROACH TO CONTROLLING THE ISSUES DIRECTLY VIOLATES THE MANDATE 42 USC 262 THAT REQUIRES THE FDA TO INSURE THE SAFETY AND PURITY OF VACCINES.
Walter S. Kyle, Esq.
May 4, 2010
I certify that I have no financial ties to or interest in any pharmaceutical company and that I have not been paid or compensated for preparation or presentation of this paper.
Walter S. Kyle
REFERENCES
- Loge v. United States, 662 F.2d 1268 (8th Cir. 1981), Schafer v. American Cyanamid, 20 F.3d 1, (1st Cir. 1993)
- Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications
- CYTOMEGALOVIRUS CONTINGENCY PLAN, Lederle Laboratories Internal Memorandum by R.J. Vallancourt, Responsible Head for Biologicals Production, to David Carroll, President, Lederle Laboratories, Aug. 4, 1972
- Deposition of R.J. Vallancourt, Chatigny v. Lederle Laboratories, USCD So. Dist. Calif. 1990, Lederle Internal Memorandums and press release entitled “CORRECTION” related to opposing switch from primary monkey kidney tissue after 100% of OPV vaccine substrate [AGM-MKC] was found contaminated with CMV.
- Huang, E.S., et. al. “Genetic Analysis of a Cytomegalovirus-Like Agent Isolated from a Human Brain”, JOURNAL OF VIROLOGY, June 1978, p. 718-723, Vol. 26 No. 3
- ORIMUNE – Product Package Insert for Lederle’s Sabin Trivalent Oral Poliovirus Vaccine – 1971-1979
- HEW letter from Robert C Wetherell, Director, Office of Legislative Services, to HEW Commissioner January 29, 1976
- Sabin, AB “ PROPERTIES AND BEHAVIOR OF ORALLY ADMINISTERED ATTENUATED POLIOVIRUS VACCINE”, JAMA, July 13, 1957 (1216-1223) @1219, “The type 2, single plaque strain that was ultimately selected was derived from a stool culture of a chimpanzee that had been fed the optimum single plaque virus segregated from the P 712 strain”. [( P 712, Ch, 2 ab) was the identifier of the Sabin Type 2 seed viruses used worldwide. “Ch” stands for Chimpanzee derived.]
- a. Two Distinct Gamma-2 Herpesviruses in African Green
JULIE GREENSILL, JULIE A. SHELDON, NEIL M. RENWICK, BRIGITTE E. BEER
Both KSHV and STLV (a/k/ATLV) naturally infected captive African Green Monkeys.
b. Georg-Fries B, Mueller-Lantzsch N, “ Epstein-Barr virus induced proteins V: comparison of EBV-specific polypeptides from different virus strains”, Med Microbiol Immunology, 1982; 171(1): 11-21
c. Characterization of African green monkey B-cell lines releasing an adult T-cell leukemia-virus-related agent. Yamamoto N, Kobayashi N Takeuchi K, Koyanagi Y Hatanaka M Hinuma Y Chosa T Schneider J Hunsmann G, Int J Cancer. 1984 Jul 15;34(1):77-82.
Eight lymphoblastoid cell lines were established from the peripheral blood of individual African green monkeys (AGM). The AGM-2206 line grew out spontaneously. The others - AGM-6, 7, 8, 10, 12, 13, and 16 - were obtained after infection of peripheral AGM lymphocytes with cell-free culture supernatant of AGM-2206. All lines contained, and were probably transformed by, AGM-EBV.
d. “Data suggests that HHV-6 infects African green monkeys…”
Safak Yalcin, et.al ”Experimental infection of cynomolgus and African green monkeys with human herpesvirus 6” Journal of General Virology (1992), 73, 1673-1677
- S. Crotty, C. J. Miller, B. L. Lohman, M. R. Neagu, L. Compton, D. Lu, Protection against Simian Immunodeficiency Virus Vaginal Challenge by Using Sabin Poliovirus Vectors Journal of Virology, August 2001, p. 7435-7452, Vol. 75, No. 16
Poliovirus is an attractive live viral vector for several reasons. The Sabin live poliovirus vaccine is one of the best human vaccines in the world. It produces long-lasting immunity (59, 75) and herd immunity (75); it is very safe and easy to experimentally manipulate (47); it has a proven safety and efficacy record in over 1 billion vaccinees (75); it is inexpensive to produce and to distribute in developing countries (29); and, most importantly, it produces a potent mucosal immune response (51, 56, 79). The capacity of poliovirus to generate a strong mucosal immune response is particularly important given that more than 90% of HIV type 1 (HIV-1) infections worldwide have occurred via sexual transmission (77). Any strategy to control the AIDS pandemic must include a vaccine that prevents sexual transmission of HIV-1.
b) SHENBEI TANG, RONALD VAN RIJ, DEBORAH SILVERA, AND RAUL ANDINO, “Toward a Poliovirus-Based Simian Immunodeficiency Virus Vaccine: Correlation between Genetic Stability and Immunogenicity” JOURNAL OF VIROLOGY, Oct. 1997, p. 7841–7850 Vol. 71
11) 1976 FDA Laboratory report: “Cell Culture Assays for Adventitious Virus in Polio Vaccine” shows Lederle polio vaccine monopool 3-444 contains unknown retrovirus capable of infecting Human, rhesus and African Green monkey embryonic lung tissue, [1000-100,000 per ml]
- FDA electron micrograph of unknown retrovirus contaminant.
- NCI evaluation of EM’s
- Lab notes from EM lab.
- FOIA requests and responses from 1993 through 2001 showing FDA disinformation campaign in blocking access to scientific evaluation of contaminated vaccine monopools identified in 1992 in “Simian retroviruses polio vaccines and the origin of AIDS” The Lancet, 339:600-601, Mar. 7 1992
- HEW - APRIL 15, 1980 – FEDERAL REGISTER – Vol. 45 No. 74
(@25673…The regulations prescribe reasonable and generally appropriate measures to exclude unwanted microbial agents {except perhaps Type C RNA containing retroviruses} that might be in the substrate initially or might be acquired by contamination during manufacture. @25665…concerns have been expressed about potential oncogenic effects due to presence in the vaccine of unknown viral contaminants, or to genetic fragments of oncogenic viruses somehow incorporated into the genome of the vaccine virus…
such a theoretical risk should be given little or no weight when estimating the benefit-risk ratio.
- YOICHI MINAMISHIMA, BElTIE J. GRAHAM, MATILDA BENYESH-MELNICK, “Neutralizing Antibodies to Cytomegaloviruses in Normal Simian and Human Sera” INFECTION AND IMMUNITY, Oct. 1971, p. 368-373, Vol. 4, No.4 “CMV isolated from African green monkeys appears to be less species-specific (3, 4, 9) than any of the known cytomegaloviruses (10). The virus replicates in cells of human origin (3, 4, 9)…”
- O’Brien, TR, et.al “Evidence for Concurrent Epidemics of Human Herpesvirus 8 and Human Immunodeficiency Virus Type 1 in US Homosexual Men: Rates, Risk Factors, and Relationship to Kaposi’s Sarcoma” Jour.Inf.Dis. 1999:180:1010-1017
Merck's AIDS Vaccine failure requires review of AIDS strategies and re-evaluating the Origin of AIDS issues, WSKYLE, bioinfo.net
- HSIUNG, GD, “Latent Virus Infections in Primate Tissues with Special Reference to Simian Viruses”, Bacteriological Reviews, Vol.32, No.1, p.185-205 Sep. 1968
- @194 “Of the 120 lots of (primary monkey) cultures examined, about 3% showed virus infections when examined 2 to 3 weeks after the cells were planted, the usual duration of most virological studies.. However, when the same lots were examined after prolonged cultivation, i.e., 4 to 8 weeks after the cells were planted, it was noted that the percentage of isolations increased 10-fold. Thus the longer the cultures were kept, the higher the percentage of virus isolations obtained.
