Vaccines containing Tween 80 (Polysorbate 80):
DTaP-all brands
DTaP/HepB/IPV (Pediarix)
HPV-Gardasil
Influenza-Fluarix
Japanese Encephalitis-JE-Vax
A study published in December, 2005 discovered that Tween80 can cause anaphylaxis, a sometimes fatal reaction characterized by a sharp drop in blood pressure, hives, and breathing difficulties. Researchers concluded that the severe reaction was not a typical allergic response characterized by the combination of IgE antibodies and the release of histamines; it was caused by a serious disruption that had occurred within the immune system.
(Coors, Esther A., Seybold, Heidi, Merk, Hans, Mahler, Vera. “Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions,” Annals of Allergy, Asthma and Immunology 95 (2005): 593–599.)
The study also included a pregnant woman who suffered anaphylactic shock after being given an IV drip of multi-vitamins containing polysorbate 80. There have been numerous studies which show that the stabilizer causes infertility. Source:
(Gajdova M, Jakubovsky J, Valky J.Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. Food Chem Toxicol. 1993 Mar;31(3):183-90. PMID: 8473002.)
Infant female rats were injected with polysorbate 80 at days 4-7 after birth. It accelerated the maturing of the rats and caused changes to the vagina and womb lining, hormonal changes, ovary deformities and degenerative follicles.
According to the World Intellectual Property Organization, which is part of the United Nations, scientists from the organization are developing vaccines specifically to damage fertility as a method of contraception. A suggested ingredient for the vaccine is tween 80 (polysorbate 80):
“In a preferred embodiment the vaccine comprises oil, preferably a biodegradable oil such as squalene oil. Typically, the vaccine is prepared using an adjuvant concentrate which contains lecithin in squalene oil. The aqueous solution glycoprotein is typically a phosphate-buffered saline (PBS) solution, and additionally preferably contains Tween 80.”
(Fertility Impairing Vaccine And Methods of Use’ This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998.)
Gardasil contains Polysorbate 80, which is linked to infertility in mice,” noted Dee Nicholson, National Communications Director for Freedom in Canadian Health Care. It is stated clearly in the manufacturer’s information sheet that comes with the vaccine.
Vaccine adjuvants: The dream becomes real
After about 70 years two new adjuvants have been approved for human vaccines. The first is MF59 developed by the ex-Chiron now Novartis Vaccines and it consists in an oil-in-water emulsion, comprising a low content of biodegradable squalene oil (4.3%) as the dispersed phase, which is stabilized by two non-ionic surfactants (Tween 80 and Span 85), and a low ionic strength citrate buffer as the continuous phase. The second defined as AS04 it has been developed by GSK Biologics it consists in 3-0-descyl-4’-monophosporyl lipid A (MPL) that comes from the cell wall LPS of Gram-negative Salmonella minnesota R595 and is detoxified by mild hydrolytic treatment and purification. It is absorbed on aluminum hydroxide or aluminum phosphate. Thus, new molecules are available to improve the immune response to vaccine also in humans: this is the beginning of a new era in vaccinology.
The current research on the stabilizer Tween 80 reveals the following:
“Neonatal female rats were injected ip (0.1 ml/rat) with Tween 80 in 1, 5 or 10 percent aqueous solution on days 4-7 after birth. Treatment with Tween 80 accelerated maturation, prolonged the oestrus cycle, and induced persistent vaginal oestrus. The relative weight of the uterus and ovaries was decreased relative to the untreated controls. Squamous cell metaplasia of the epithelial lining of the uterus and cytological changes in the uterus were indicative of chronic oestrogenic stimulation. Ovaries were without corpora lutea, and had degenerative follicles.” ~ PMID: 8473002
Female lab rats injected with Tween 80 developed impaired sexual organs as well as premature development of their sexual organs.
Adjuvants–a classification and review of their modes of action
Water-in-oil emulsions
These are microdroplets of water, stabilized by surfactant (typically mannide monooleate) in a continuous oil phase (typically mineral oil, squalene or squalane). Freund’s incomplete adjuvant (FIA) has been used for human and veterinary vaccines, but is now largely discredited (perhaps unjustly) due to a low incidence of site reactivity. Emulsions based on metabolizable oils have a superior safety profile.
They are poorly immunomodulatory (in absence of local irritant effect), provide good short term depots, are inexpensive, relatively simple to formulate and induce good antibody responses especially for hydrophilic immunogens. W/o emulsions provide an excellent formulation into which soluble immunomodulators can be incorporated. Emulsions can be unstable.
Oil-in-water (o/w) emulsions
These are microdroplets of oil (typically squalene or squalane, size about 290 nm), stabilized by surfactants (typically Tween 80 and/or Span 85) in a continuous water phase and are under development as human vaccine adjuvants, frequently in association with soluble immunomodulators [e.g., muramyl dipeptide (MDP) derivatives or block copolymers]. O/w emulsions result in excellent antigen presentation and moderate targeting.
They are inexpensive, safe and excellent basic formulations into which lipophilic immunomodulators can be incorporated: in addition they are highly suited for amphipathic molecules where presentation is important. It is important to incorporate immunogen into the oil phase.
Filed under: Vaccine Excipients | Tagged: polysorbate 80, tween80, Vaccine Excipients | 2 Comments »
Exploring Vaccines 