Polysorbate 80 in Vaccines: Is it safe?

Vaccines are loaded with ingredients that the average person doesn’t know much, if anything, about. We don’t know why any particular ingredient is needed in a vaccine, how that ingredient interacts with other vaccine ingredients, or how that ingredient will affect our bodies when it is injected. We assume that scientists who create vaccines know the answer to these important questions prior to licensing for public use. We assume our doctors have read all the scientific studies exhibiting the safety of the various vaccine ingredients prior to assuring us that any given vaccine is safe for us or our children. But, have the studies been done? Can these scientists and our doctors definitively answer these basic, yet necessary, questions about the safety of each ingredient?

We’ll talk about one such ingredient today- polysorbate 80. The CDC Vaccine Excipient and Media Summary lists Polysorbate 80 as an ingredient in the following vaccines:

• • DTaP (Infanrix)
  • DTaP – IPV (Kinrix and Quadracel)
  • DTaP- HepB- IPV (Pediarix)
  • DTaP- IPV- Hib (Pentacel)
  • HPV (Gardasil and Gardasil 9)
  • Influenza (Agriflu and Fluarix)
  • Meningococcal (MenB- Trumenba)
  • Pneumococcal (PCV13 – Prevnar 13)
  • Rotavirus (Rotateq)
  • TdaP (Boosterix)

What is polysorbate 80?

Polysorbate 80 is used as an emulsifier/stabilizer in vaccines, but you won’t find any safety information from CDC documents. It’s not listed on the CDC Ingredients of Vaccines Fact Sheet.

The Drugs.com definition states: “Polysorbate 80 is a common excipient and solubilizing agent used in the pharmaceutical industry. Polysorbate 80 (also known as polyoxyethylene-sorbitan-20 mono-oleate, or Tween 80) is used in the pharmaceutical and cosmetic industry in lotions, medical preparations (eg vitamin oils, vaccines, and intravenous preparations) and as an excipient in tablets. A solubilizing agent acts as a surfactant and increases the solubility of one agent into another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent.”

In other words, it allows the vaccine ingredients that normally behave like oil and water, to mix.

Children’s Hospital of Philadelphia (CHOP), the soapbox for vaccine apologist, Dr. Paul Offit, (if you’ve never heard of Offit, he’s the chief of infectious disease at CHOP who famously said that babies could tolerate “10,000 vaccines at once” and who holds a $1.5 million research chair funded by Merck) lists the only “pediatrician” information I could find regarding the safety of polysorbate 80 in vaccines:

“The HPV vaccine contains polysorbate 80 as a stabilizer. Some stories on the internet have suggested that polysorbate 80 in this vaccine causes infertility. First, it is important to know that the HPV vaccine does not cause infertility. Second, polysorbate 80 has been used for years as an emulsifier to make ice cream smooth and to slow melting. A typical serving of ice cream (½ cup) may contain 170,000 micrograms of polysorbate 80. On the other hand, the amount of polysorbate 80 in each dose of the HPV vaccine- 50 micrograms- is very small. Therefore, polysorbate 80 isn’t contained in vaccines at quantities that could possibly do harm.”

Frankly, if the pediatrician has to appeal to the old “you eat it in your food and it hasn’t killed you, so you shouldn’t be worried about injecting it into your body” spiel, instead of offering up safety studies- it’s a red flag. The amount of polysorbate 80 in vaccines can’t possibly harm me? Cool- show me the studies that identify “safe” injectable levels. I’ll be waiting…

Is polysorbate 80 safe in our food?

It depends on what you consider “safe.” If by safe you merely mean that you don’t drop dead immediately from ingesting it, then polysorbate 80 fits that description. However, if you broaden your definition to include the long-term and cumulative risk of ingesting polysorbate 80, you may be interested in these studies:

1. This study published in the American Academy of Cancer Research found that a diet including regular consumption of emulsifiers experienced exacerbated tumor development and chronic low-level inflammation. This chronic inflammation was also associated with inflammatory bowel diseases like Crohn’s and is observed in colorectal cancers. The study also points out that occurrence of colorectal cancers “have been markedly increasing since the mid-20^th century.”

2. This 2015 study also linked polysorbate 80 to gut inflammation, negatively altered gut bacteria (we now know that a healthy gut biome is necessary for immune function), obesity and metabolic syndromes.

If ingested polysorbate 80 is causing inflammation in the gut, is it a stretch to question if injected polysorbate 80 is causing inflammation (a hallmark of autoimmune disease) elsewhere in the body?

There is no shortage of troubling information about polysorbate 80 in vaccines:

1. They don’t have enough data to answer basic safety questions.

   – The Science Lab Material Data Sheet for polysorbate 80 highlights my point. Section 3 of this report lists the potential chronic health effects. Carcinogenic, mutagenic, and teratogenic effects as well as the developmental toxicity are all “unavailable.” (Synonym for “unknown”?) However, section 11 states these special remarks on the chronic effects on humans:

   “May cause adverse reproductive effects based on animal test data. No human data found. May cause cancer based on animal test data. No human data found. May affect genetic material (mutagenic).” Under the special remarks on other toxic effects on humans is stated, “Animal studies have shown it to cause cardiac changes, changes in behavior (altered sleep time) and weight loss (upon repeated or prolonged ingestion.) However, no similar human data has been reported.”

   – Of course, injected polysorbate 80 isn’t discussed in this report at all. If you’re like me, there are way too many statements of “no human data found” for comfort.

2. Polysorbate 80 may allow other vaccine ingredients to cross the blood brain barrier.

• • This is huge- as in a total game changer. In fact, it is used in other medications for that very purpose. Dr. Lawrence Palevsky points out:

    “Polysorbate 80 is used as an emulsifier by the pharmaceutical industry to enhance the delivery of chemicals/drugs from the blood into the brain across the blood brain barrier (BBB). Being that the BBB is impermeable to many things in the bloodstream, researchers needed to find a way to deliver chemicals/drugs into the brain from the bloodstream in order to treat hard-to-reach brain infections/lesions/tumors, etc. Polysorbate 80 is one such chemical that helps in this delivery.”

  • This Science Direct link discusses the role of polysorbate 80 in crossing the BBB: http://www.sciencedirect.com/science/article/pii/S014296120300855X Could polysorbate 80 be allowing other vaccine ingredients (some of which are known neurotoxins) such as aluminum, mercury, bacterial/viral/yeast protein antigens which would be harmful to the brain, to cross the BBB?

3. Injected polysorbate 80 metabolizes into chemicals that are much more toxic than the original chemical.

• • • These studies show that after injection polysorbate 80 breaks down into sorbitol and ethylene oxide. The NIH toxicology network states that sorbitol is “not to be injected,” and that ethylene oxide is a “known carcinogen,” among other concerning toxicity information.

4. Polysorbate 80 has been linked to infertility.

• • In this study, baby female rates were injected with polysorbate 80 at days 4-7 after birth which resulted in their accelerated maturation, caused changes to the vagina and womb lining, hormonal changes, ovary deformities and degenerative follicles.

• • This study researching the link between the HPV vaccine and infertility cited the findings of the rat study above and notes insufficient and poorly designed research on fertility effects in clinical trials for the HPV vaccine. If you’ll recall, the Children’s Hospital of Philadelphia (CHOP) quote above claims that there is no link between the HPV vaccine and infertility. However, this study states unequivocally that this claim cannot be asserted:

    “The relevance of polysorbate 80 ovarian damage to the cases presented here is unresearched and unknown and assurances of ‘no biologically plausible’ link between HPV4 vaccine and ovarian effects cannot be given.” (emphasis mine)

  • If you’ll recall, CHOP also drew a comparison to ingested polysorbate 80. This study also addresses fertility effects of ingested polysorbate 80:

    “The chemical is present in orally ingested medicines and foods, but did not affect rat reproduction when subject to digestive processes at up to 5% of their oral intake. It did decrease rat reproduction at 20% of their oral intake.”

  • Sounds like CHOP is comfortable making claims that actual scientists researching the HPV vaccine will not make.

• • As an interesting and possibly relevant side note, a patent for a vaccine that would decrease animal fertility has been submitted by the University of Georgia Research Foundation. This patent lists polysorbate 80 as a preferable ingredient: “and additionally preferably contains Tween 80 (polysorbate 80).” According to the patent “Background of the Invention” section, this vaccine is an effort to controlling dog overpopulation. Another quote from the patent:

    “Collegenase treatment of zona pellucida proteins known to alter the proteins in a way that can be demonstrated immunocytochemically. Abnormal estrus cycles, characterized by constant or prolonged estrus, and other deleterious side effects, such as ovarian cyst formation, were found to be associated with the vaccinations (C. Mahi-Brown, Am. J. Reprod. Immunol. Microbiol..18,94-103 (1988)), and were never satisfactorily explained.” (emphasis mine)

• • • Those phrases in bold echo findings in the polysorbate 80 rat study linked above.

5. Injected polysorbate 80 has been identified as the cause of anaphylaxis.

• • The study, Anaphylaxis Due to the Excipient Polysorbate 80, appeared in the Annals of Allergy, Asthma and Immunology in December of 2005. (page 21 on the pdf linked above) “In our conclusion, based on our results and the literature reviewed, we believe that polysorbate 80 should be included in the test battery for allergy to medications such as corticosteroids, since it could be a cause of anaphylaxis of unknown etiology.”

• • The NIH link for this study notes, “Polysorbate 80 is a ubiquitously used solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions.”

6. Can injected polysorbate 80 negatively affect our immune system?

• • In addition to its role as an emulsifier/stabilizer, polysorbate 80 also functions as a vaccine detergent. Detergents are used in killed virus vaccines (such as the flu vaccine) to split or disrupt the virus particles. Detergents cause cells to leak or explode by weakening their cell walls. The danger is that this process mimics our bodies’ membrane attack complex, or MAC. This link explains in detail why this is so dangerous: http://www.sailhome.org/Concerns/Vaccines/MAC.html

• • • A “cliff’s notes” version of the article above:
      • “The Complement system is a chain-reaction of biochemical events that help remove pathogens from the body…The Membrane Attack Complex (MAC) is part of the Complement system- and it is one of the immune system’s ultimate weapons…Killing cells by punching holes into them makes the MAC extremely potent- and also extremely destructive if it runs out of control. For this reason the MAC (and the Complement system in general) is tightly regulated by additional proteins.”

• • • “When activated, the Complement system triggers such events as: increased arachidonic acid metabolism leading to acute inflammation and damage to nearby tissue; histamine release with its effects on allergic response, digestion, and neurotransmitter function; pyrogen release and the onset of fever.”

• • • “Detergents represent the worst kind of autoimmune dysfunction- they randomly destroy any kind of host cell with no mechanism for regulating destructive activity.”

• • • A troubling comparison of the characteristics of MAC vs vaccine detergents:

1. 1. 1. 1. 1. 1. 1. Both cause cells to leak or explode.
                  2. MAC is “regulated by proteins”, whereas detergents are completely unregulated. “like the MAC out of control.”
                  3. MAC “targets foreign cells and avoids self-cells”, while detergents “hit cells randomly”.
                  4. MAC “responds to signals calling off the attack”, but detergents “continue to destroy cells.”
                  5. MAC is “integrated into complex (and sensitive) signaling and feedback relationships”, however detergents are both “foreign” and “disruptive” to these systems.

Should we be comfortable with polysorbate 80 as a vaccine ingredient?

For me, the answer is an emphatic no- until scientists can adequately exhibit favorable answers to Dr. Palevsky’s following questions:

1. What vaccine materials get across the BBB, with the help of polysorbate 80, into the brain of children? And
2. What effect do they have once they get into the brain? Do they contribute to inflammation, toxicity, encephalitis?

Since polysorbate 80 works as an emulsifier, and will also enhance delivery of vaccine materials into the rest of the cells of the body,

3. What vaccine materials enter the cells of our bodies?
4. Do they remain in the cells once they get there?
5. Do they impair any parts of the cells, its mitochondrial DNA, nuclear DNA, or other cellular apparatuses- endoplasmic reticulum, golgi apparatus?
6. Do they become part of the DNA of the cells since there are whole DNA strands from live viruses in the vaccines, along with foreign animal DNA and bacterial/viral/yeast protein antigens?
7. If they do become part of the DNA, how does this change the function and/or regulatory systems in the cells?
8. Do the materials from vaccines (eg aluminum, mercury, formaldehyde) entering through the cell membranes at the hands of polysorbate 80 do anything to impair the electrical charge of the cell membrane, or impair/alter the way materials enter or exit the cell through the cell membrane (nutrients, cellular wastes, manufactured proteins, or enzymes?)

Since babies have a poorly developed BBB, which may not solidify for at least the first 6 months, or maybe longer if they have a brewing inflammatory condition yet to be determined that has delayed the full development of the BBB, then questions 3-8 apply to their brains as well.

Until we have studies providing answers to these questions, don’t let anyone tell you “Well, your polysorbate 80 loaded ice cream hasn’t killed you yet, so the small amount in these vaccines is probably ok too.” If you’re like me, you believe our children require proof- not a “probably.”