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Posts Tagged ‘WHO approves Galaxo’

World AIDS Day is today December 1, 2oo9.   It is also the day that the World Health Organization, WHO approved Glaxo’s version of the H1N1 Swine Flu Vaccine that can give a false positive reading for HIV.

12/1/09 LONDON — Drug giant GlaxoSmithKline says one of its swine flu vaccines has been certified by the World Health Organization, making it available for donors to buy for developing countries.   In a statement issued Tuesday, GlaxoSmithKline PLC said WHO had approved its Canadian vaccine after examining its quality and safety data. The vaccine contains an adjuvant, a chemical compound to boost the immune system http://www.washingtonexaminer.com/economy/ap/who-approves-glaxos-swine-flu-shot-donor-agencies-now-free-to-buy-vaccine-for-poor-countries-78208832.html

Free HIV testing centres around Nairobi reported impressive turn-outs as Kenyans took time to check their status.  With numerous AIDS cases there, if they are also the recipients of Glaxo’s vaccine we may be seeing a huge increase in patients testing false positive.  And what of the rest of the world? 

Glaxo’s Pandemrix vaccine contains a who who’s list of toxic ingredients as highlights from The Summary of Product Characteristics or patient information sheet via  http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/emea-combined-h832en.pdf says that Pandemrix contains:

AS03 adjuvant composed of squalene (10.69 milligrams), DL-polysorbate 80 (4.86 milligrams) tocopherol (11.86 milligrams), The vaccine contains 5 micrograms thiomersal.   6.1 List of excipients:  Polysorbate 80,  Octoxynol 10, Thiomersal, Sodium chloride (NaCl), Disodium hydrogen phosphate, Potassium dihydrogen phosphate,  Potassium chloride,  Magnesium chloride, Water for injections, Sodium chloride, Disodium hydrogen phosphate.

In clinical studies of efficacy they tested the vaccine in ferrets where all of the ferrets died and exhibited viral shedding. 

Following influenza vaccination, false-positive serology test results may be obtained by the method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially  HTLV-1. In such cases, the Western blot method is negative. These transitory false-positive results may be due to IgM production in response to the vaccine.

Via WIKI http://en.wikipedia.org/wiki/HIV_test#cite_note-pmid7539579-16 Rare false positive results due to factors unrelated to HIV exposure are found more often with the ELISA test than with the Western Blot. False positives may be associated with medical conditions such as recent acute illnesses and allergies. A rash of false positive tests in the fall of 1991 was initially blamed on the influenza vaccines used during that flu season, but further investigation traced the cross-reactivity to several relatively non-specific test kits.[17] A false positive result does not indicate a condition of significant risk to health. When the ELISA test is combined with Western Blot, the rate of false positives is extremely low, and diagnostic accuracy is very high (see below).

HIV antibody tests are highly sensitive, meaning they react preferentially with HIV antibodies, but not all positive or inconclusive HIV ELISA tests mean the person is infected by HIV. Risk history, and clinical judgement should be included in the assessment, and a confirmation test (Western blot) should be administered. An individual with an inconclusive test should be re-tested at a later date.

Reference 17- Am J Epidemiol. 1995 Jun 1;141(11):1089-96.

Multiple false reactions in viral antibody screening assays after influenza vaccination.

Simonsen L, Buffington J, Shapiro CN, Holman RC, Strine TW, Grossman BJ, Williams AE, Schonberger LB.  Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

In December 1991, US blood centers reported an unusual increase in donations that tested falsely reactive for antibodies to two or more (multiple false positive) of the following viruses: human immunodeficiency virus type 1 (HIV-1), human T-cell lymphotrophic virus type I (HTLV-I), and hepatitis C virus. Many of these donations were from people who had recently received the 1991-1992 influenza vaccine, raising the possibility that this vaccine had somehow specifically caused the problem of multiple false reactivity. A case-control study of 101 affected donors and 191 matched controls found that recent receipt of any brand of influenza vaccine was significantly associated with testing multiple false positive (p < 0.05), as was a history of recent acute illness (p < 0.05) and of allergies (p < 0.05). Surveillance for monthly rates of multiple reactive donations from May 1990 through December 1992 linked the seasonal cluster of multiple false-positive donations to the use of viral screening test kits thought to react nonspecifically to donor immunoglobulin M. There was no similar increase in multiple false-positive donations during the 1992-1993 influenza vaccination season after the HIV-1 and hepatitis C virus tests were replaced; however, the number of donations that were falsely reactive for only HTLV-I almost doubled, indicating that false reactivity was not specifically associated with the 1991-1992 influenza vaccine. Retesting of affected donors found that the duration of HTLV-I and hepatitis C virus false reactivity was 3-6 months. The cluster of multiple false-positive donations in 1991 was most likely caused by the test kits used, rather than by the influenza vaccine.    PMID: 7539579 [PubMed – indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/pubmed/7539579

Basically these brilliant scientists blamed the viral scrrening kits in 1991 for the false positive results.  Almost 20 years later, do you believe it the kits are still at fault?  

Wake up and never roll up your sleeve.  Happy World AIDS Day.

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