Vaxelis Endotoxin content a Dark TGA Secret
TGA has a dedicated Batch release webpage for Endotoxin testing of Covid19 jabs, but why don't they provide one for Child jab Vaxelis? Whistleblowers invited to tell all.
Looking for any information at all on the Endotoxin of Vaxelis jabs approved by the TGA in March 2022.1 I know it is in there.
I searched TGA website for Vaxelis + Endotoxin and this was the result on 23 Oct 2023.
Vaxelis contains numerous nasty ingredients:
Polysorbate 80, Formaldehyde, Glutaraldehyde, Bovine Serum Albumin, Neomycin, Streptomycin Sulfate, Polymyxin B Sulfate, Ammonium Thiocyanate, Yeast Protein, Aluminium.
But today I am chasing just the Endotoxin.
So I went off to the US FDA and see they too are very concerned about Endotoxin in Vaxelis and are doing all in their powere to hide the levels, as shown in this Memo from 24 June 2015.
So then I went hunting and found a Patent, now expired, describing the manufacture of the Aventis product.2
Vaccine for protecting humans against Bordetella pertussis infection comprises pertussis toxoid (I), filamentous haemagglutinin (II), pertactin (III) and agglutinogens (IV) of B. pertussis in relative amts. able to confer protection to >= 70% of an at-risk population. A single dose is 5-30 mu g (I) and (II), 3-15 mu g (III) and 1-10 mu g (IV), all expressed as nitrogen contents, esp. 10 mu g (I) and 5 mu g (II) or 20 mu g each of these, plus 5 mu g (III) and 3 mu g (IV). Vaccines are administered by subcutaneous or intramuscular injection. (IV) comprises fimbrial agglutinogens (Agg) 2 and 3 (pref. at ratio 1.5-2:1) but is free of Agg 1. These may also include diphtheria toxoid, pref. at 15 Lfs, and tetanus toxoid, pref. at 5 Lf, opt. also other non-Bordetella antigens. They can also include an adjuvant, specifically alum.
Here mu g = microgram of Nitrogen content. Unusual ?
There they reveal that Endotoxin is present and they apply a crude method to reduce the level described in another patent from Chinese inventors.3
The invention relates to the technical field of biological pharmacy, and discloses a method for removing endotoxin of pertussis component pilin 2/3. After fermentation culture of bordetella pertussis, centrifugally collecting thalli, and extracting the thalli by using a urea phosphate buffer solution; centrifuging to collect supernatant, and precipitating with PEG-8000 and ammonium sulfate; the precipitate was extracted with phosphate buffer, then centrifuged to collect the supernatant, which was then treated with a Q-Sepharose column and eluted with sodium chloride-containing phosphate buffer to remove the Fim2/3 fraction. The invention combines three operations of PEG8000 precipitation, ammonium sulfate precipitation and Q-Sepharose chromatographic column treatment, removes endotoxin in pilin Fim2/3 by multiple means, can keep the bioactivity and recovery rate of active ingredient Fim2/3 without adding exogenous substances, and simultaneously removes the endotoxin in Fim2/3 to be below 10 EU/mg.
10 EU/mg is a very large amount to Endotoxin in one of the components. How much is in the finished product and variation Batch to Batch is a matter that every parent has a Right to Know!
Vaxelis is described as one brand of “generic” Hexavalent jabs.45
The present manufacturer of Vaxelis is Sanofi Pasteur, marketed in Australia by Maxx Pharma Pty Ltd6 - a most interesting company!
Related information
VAXELIS DTPa5-HB-IPV-Hib vaccine suspension for injection in 0.5 mL pre-filled syringe (2021-22)
2021-22
Annual charge exemption
Exempt from annual charge in 2021-22 due to Maxx Pharma Pty Ltd declaring $0 turnover in that period.
The EMA does not shed much light on my question.7
Polysorbate 80 is known to Mask Endotoxin
The incompetence of the BigPharma TGA is increasingly being exposed on a daily basis. I think I know why they have not reported any masurements of Endotoxin in Vaxelis - Polysorbate 80 is known to almost completely mask Endotoxin.8
Note these researchers used EndoZyme to detect Endotoxin, but strangely9 this is NOT AVAILABLE IN AUSTRALIA!
So please let me know if you can tell us what Endotoxin measurements have been done by TGA and what they found.
We need some smart Senators to ask Questions about Endotoxin.
https://www.tga.gov.au/resources/auspmd/vaxelis
Raafat E. F. Fahim, John R. Vose, John Thipphawong, Luis Barreto, Gail E. D. Jackson, Larry U. L. Tan, Andrew Herbert, Michel H. Klein. Acellular pertussis vaccines and methods of preparation thereof. EP0826001B1. https://patents.google.com/patent/EP0826001B1/en
王长永, 王梦舒, 徐艳艳, 梁洪野, 闫慧, 原秀娟. 2019. Method for removing pertussis component fimbrin 2/3 endotoxin. CN110358802B. https://patents.google.com/patent/CN110358802B/en
https://en.wikipedia.org/wiki/Hexavalent_vaccine
Yahiya Y. Syed. 2017. DTaP5-HB-IPV-Hib Vaccine (Vaxelis®): A Review of its Use in Primary and Booster Vaccination. https://link.springer.com/article/10.1007/s40272-016-0208-y
https://www.tga.gov.au/resources/artg/363251
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis
Reich J. 2019. Low Endotoxin Recovery - Masking of Naturally Occurring Endotoxin. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6412962/
https://www.biovendor.com/endonext-endozyme-ii-go--fast-recombinant-factor-c-rfc-endotoxin-detection-assay?utm_source=google&utm_medium=organic