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Polysorbate 80, Vaccines and Federal Allergen Regulation

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Polysorbate 80 contains oleic acid derived from vegetable oils. So it is not possible to guarantee that it is free of allergen proteins.

 

For example, NOF Corporation claims "number one quality product in the world" for its "injectable grade" Polysorbate 80 HX2 product but it is not allergen free.

http://polysorbate.jp/

 

Federal regulations below prohibit the addition of extraneous protein known to be capable of producing allergenic effects into injectable vaccines.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.15

 

Title 21 of the Code of Federal Regulations (CFR) Section 610.15 Constituent materials.

These regulations state "(a) Ingredients, preservatives, diluents, adjuvants.

All ingredients used in a licensed product, and any diluent provided as
an aid in the administration of the product, shall meet generally
accepted standards of purity and quality (b)Extraneous protein; cell
culture produced vaccines. Extraneous protein known to be capable of
producing allergenic effects in human subjects shall not be added to a
final virus medium of cell culture produced vaccines intended for
injection.
"

 

However, the FDA has approved numerous vaccines containing Polysorbate 80.

 

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

 

Anyone have an explanation?

 

 

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So, what you are asking about is the presence of something tested for allergens and not found to contain them

"ultra-pure Polysorbate 80(HX2)TM for injectable grade, which has outstanding features as follows;

...
Low Allergic Reaction (Low Degranulation)"

 

What's the problem?

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If it does not contain allergens, there should be NO allergic reaction, not low allergic reaction.

Federal regulations do not specify a safe level for allergens.

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If it does not contain allergens, there should be NO allergic reaction, not low allergic reaction.

Federal regulations do not specify a safe level for allergens.

How, exactly, do you plan to check that there's not a single allergenic molecule present?

The FDA realise that's not a valid goal to pursue, so they define a lower limit.

The product meets that limit.

What's the problem?

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Could you please point to FDA's definition of the lower limit? I have not been able to find one.

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My best guess would be "below the limit of detection".

That;s certainly the practical limit for some regulations.

You set a legal limit of "zero" but there's obviously no way you can measure down to that limit (As I said, you can't measure a single molecule).

So the enforcement limit is practically the detection limit of the test.

 

 

Do you have any evidence that it matters, i.e that the limit is set too high?

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First of all, almost anything of sufficient size has a potential (if very low) to elucidate allergic effects. If all potential allergens were banned, we would only be able to inject saline.

That being said, note that the guideline mentions specifically extraneous proteins from cell culture produced vaccines. What is meant is that if you derive a vaccine from cell cultures you have to ensure that during the process no additional protein is added, or sufficiently diluted if it is necessary component (the mentioned serum is often a constituent of medium).

None of which really applies to polysorbate 80.

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As you know, when any protein is injected into the body for the first time, it causes immune system sensitization. Subsequent exposure to the protein by any route will eliciit an allergic reaction.

We also know that the amount of protein required for sensitization is much much smaller than the amount required to elicit an allergic reaction.

Measles, mumps and rubella vaccine (MMR) has 10000x more gelatin than DTaP.

http://www.chop.edu/service/vaccine-education-center/vaccine-safety/vaccine-ingredients/gelatin-allergies.html

Development of food allergy requires only trace quantities of food protein as Nakayama et al., have
found.

Nakayama T, Aizawa C, Kuno-Sakai H. A clinical analysis of gelatin allergy and determination of its causal relationship to the previous administration of gelatin-containing acellular pertussis vaccine combined with diphtheria and tetanus toxoids. J Allergy Clin Immunol 1999;103:321–5.

DTaP causes the development of gelatin allergy (sensitization) and subsequent MMR administration results in anaphylaxis. When MMR is administered first, one would expect that it is more likely to cause the
development of gelatin allergy. Subsequent DTaP administration however does not result in
anaphylaxis, most likely due to the small quantity of gelatin present in DTaP. This is probably the
reason people who are allergic to egg can still get flu shots without eliciting an anaphylactic reaction. However, the flu shot could have enough egg protein to cause the development of egg allergy (sensitization).

That team subsequently concluded that removal of gelatin from vaccines was the ultimate solution to avoid sensitization to gelatin.

Kuno-Sakai H, Kimura M. Removal of gelatin from live vaccines and DTaP-an ultimate solution for vaccine-related gelatin allergy.Biologicals 2003;31:245-9. [PubMed]

Logically, one would expect that following the above findings/conclusions that research would have been performed to establish safe levels for ALL food proteins in vaccines such that they do not cause sensitization. One would also expect that federal regulations would codify/specify and enforce such limits.

Since NOF Corporation's Polysorbate 80 has enough allergen to elicit an allergic reaction, that level of allergens can easily cause sensitization.

On the one hand there seems to be federal regulations prohibiting the addition of allergens.
On the other hand, the FDA seems to be approving vaccines that contain enough food allergens to cause sensitization. Given this, how can we confidently assert that the food allergy epidemic is not being caused by food allergens in vaccines or injections resulting in sensitization?

If we argue that vaccines causing food allergies is a well known side effect then one would expect that vaccine package inserts would document that sensitization and development of food allergies as an expected side effect. Today vaccine package inserts do not list food allergy development/sensitization as a side effect.

Why this disconnect?

Edited by vinucube

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As you know, when any protein is injected into the body for the first time, it causes immune system sensitization. Subsequent exposure to the protein by any route will eliciit an allergic reaction.

 

Nope. in both cases there is a risk of it happening. It does not happen automatically and is trivially countered by the number of people without allergies. The biggest issue is typically that people who are already allergic to gelatin could react badly to vaccines containing it.

 

That being said, why would you think there are proteins in polysorbates? You may want to look up what compounds you are talking about. Also, a quick check did not reveal that polysorbates themselves elicit allergic reaction (though there are a few cases nonimmunologic anaphylactoid reactions). So before you ask the question why companies and FDA allow certain things or not, it may be useful to get the facts straight first and then draw conclusions (rather than the other way round).

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CharonY,

 

"Nope. in both cases there is a risk of it happening. It does not happen automatically and is trivially countered by the number of people without allergies."

Agreed, I should perhaps have stated "... any protein is injected into the body for the first time in sufficient quantity ...".

 

"The biggest issue is typically that people who are already allergic to gelatin could react badly to vaccines containing it."

No, the biggest issue is why do people become sensitized to gelatin in the first place. Kunio-Sakai et al., have proved beyond doubt that vaccines caused the sensitization.

Following this finding, common sense would dictate that every food protein in every vaccine should be a suspect in the food allergy epidemic.

 

Kuno-Sakai H, Kimura M. Removal of gelatin from live vaccines and DTaP-an ultimate solution for vaccine-related gelatin allergy.Biologicals 2003;31:245-9. [PubMed]
"why would you think there are proteins in polysorbates?"
Polysorbate 80 is derived from vegetable oils and it is therefore impossible to remove food proteins completely from it. If it is peanut, hazelnut or sesame oil then those food proteins would be present, risking the development of peanut, treenut or sesame allergy in the vaccine/injection recipient.
As I wrote in the OP, in http://polysorbate.jp/ NOF Corporation who claim to manufacture some of the world's highest injection quality Polysorbate 80 also show that their product does elicit allergic reactions.
Edited by vinucube

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We had this discussion already. There was only one study that showed a possible (weak) link, which, incidentally, is not the paper you cited (which describes the case I mentioned, i.e. detection of allergic reaction after injection, meaning patient was sensitive to begin with). In either case this is far from beyond any doubt.

The concentration is indeed an issue, but those are typically low in vaccines. Guess where the biggest source in infants is? The intestine. The epithelial barrier in infants are often immature at birth and food can relatively easily enter the bloodstream at vastly higher concentrations then presented in vaccines. It is one of the reasons that some do not recommend early peanut or other allergen exposure (though some food has to be presented, obviously). Yet there is newer lit that kind of recommends the opposite approach, showing that the question is far from being resolved. Saying that there is doubt left in this processes (vaccines or not) is beyond disingenuous.

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"Polysorbate 80 is derived from vegetable oils and it is therefore impossible to remove food proteins completely from it."

Well, for a start, most proteins don't dissolve ewell in oil so filtering it would remove a lot of the protein.

Adding a filter aid/ sorbent like fuller's earth would strip out practically all the rest.

 

But it still doesn't matter if there are traces left.

You claim "... any protein is injected into the body for the first time in sufficient quantity ...".

Well, that may be true, but since it's trivially easy to strip out very nearly all the protein from vegetable oil, it's easy to ensure that the "sufficient quantity" isn't resent.

 

Then there's the fact that we are not injecting the oil.

The oil is chemically converted to oleic acid by treatment with either superheated steam, caustic or oiling acid.

Those will denature and/ or hydrolyse any proteins still present.

Then the oleic acid will be purified again to remove any impurities introduced by the hydrolysis process.

And then, it is reacted with the other component- the sorbitol derivative- to male polysorbate.

Proteins probably won't survive that process either.

So, between the olive and the vial there have been at least 5 processes that would remove proteins.

 

Please learn something about chemistry- it will save you from worrying about this sort of non-existent risk.

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CharonY,

Kuno-Sakai H, Kimura M. Removal of gelatin from live vaccines and DTaP-an ultimate solution for vaccine-related gelatin allergy.Biologicals 2003;31:245-9. [PubMed]

Kuno-Sakai et al. have indeed proved beyond doubt that vaccines were the cause for gelatin allergy.
As I wrote, the logical next step after this finding would be to examine ALL food proteins in all vaccines, establish and enforce a safe level for food proteins in vaccines/injections if they cannot be eliminated. The FDA has done nothing.

Of course there are other food allergy development mechanisms that are possible. You have to look at all mechanisms for which strong evidence exists.
The intestine protein absorption hypothesis has flaws:

1. In healthy humans, proteins are denatured by stomach acid and therefore there is not enough protein absorption in the intestine to cause sensitization. The paper below shows that if proton pump inhibitors (PPI) are prescribed to reduce stomach acid, patients develop food allergy.

Untersmayr E, Bakos N, Schöll I, Kundi M, Roth-Walter F, Szalai K, Riemer AB, Ankersmit HJ,
Scheiner O, Boltz-Nitulescu G, Jensen-Jarolim E. Anti-ulcer drugs promote IgE formation toward
dietary antigens in adult patients . FASEB J. 2005;19:656–658.

So yes, the mechanism of intestinal protein absorption and sensitization is possible but unless we are feeding PPI to our infants, it does not explain the food allergy epidemic.

2. The most reliable way to induce sensitization and food allergy in laboratory animals is to inject them with food proteins along with adjuvants, the same as human vaccines. They don't use the oral/intestinal route.

Birmingham N., Thanesvorakul S., Gangur V. Relative immunogenicity of commonly allergenic
food versus rarely allergenic and non-allergenic foods in mice. J. Food Prot. 2002;65:1988–1991.

3. What changed in the intestines of infants in the last few decades? Food allergy was not common before that.

4. All infants are not fed the same type of foods. There are a wide range of food proteins fed to infants.
Why only milk, egg, peanuts/treenut are the top food allergies? If the intestinal route was the cause, one would expect widely varying food allergies potentially along ethnic lines.

5. My son is allergic to milk, egg and peanuts/tree nuts including hazel nuts. We never fed him hazel nuts. How did it get to his intestine? The first time in his life that he was fed cow's milk, he developed an allergic reaction. How was sensitization through the intestinal route possible?

6. As you wrote, doctors made one recommendation and then they changed their minds and made the opposite one proves they are looking at a flawed hypothesis.

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You seem to have rather ignored the fact that the proteins will be destroyed before they get to the vaccine.

 

Now, I accept that for allergies to eggs, gelatine and other things that are actually present in the vaccine, there may be a problem.

But they don't seem to have much to do with this thread.

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John,

 

I was not ignoring your comments, I was working on a reponse ...

As we have discussed, the FDA has not established safe limits for food proteins in vaccines. If there were safety limits and the Polysorbate 80 production process resulted in safe levels of food proteins, I would of course have nothing to complain about. NOF Corporation's ultra pure injection grade process results in enough allergen concentration to elicit allergic reactions. I don't see how that can be considered safe.

One would expect by now that vaccine making is a mature engineering discipline with clear specifications, clear test methods and clear enforcement of specifications. However, the FDA's approach to vaccine safety seems more like tinkering than engineering to me and it is putting millions of lives at risk for life-threatening food allergies.

It looks like experts who understood the danger of allergens in vaccines ensured that Federal regulations were written to prohibit them. The FDA seems to have decided to ignore those regulations.

While we have been discussing food allergies, injecting oleic acid is also known to cause lung injury. Perhaps Polysorbate 80 in vaccines/injections may even be linked to the asthma epidemic in kids.
http://www.ncbi.nlm.nih.gov/pubmed/3949648

Looks like the FDA has a lot of work to do ...

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Sorry, I must have missed it.

What's the evidence for this bit

"Corporation's ultra pure injection grade process results in enough allergen concentration to elicit allergic reactions."

 

Also re.

"injecting oleic acid is also known to cause lung injury."

Granted, I'm not injecting it, but every time I eat anything with ft in I end up with oleic acid in my bloodstream and gets to the lungs, just the same as if I injected it.

How come I'm still breathing?

Could it be because I'm not a sheep?

Edited by John Cuthber

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"What's the evidence for this bit

"Corporation's ultra pure injection grade process results in enough allergen concentration to elicit allergic reactions.""

 

Please see http://polysorbate.jp/

 

I am not an expert in fat metabolism. If as you said, you end up with oleic acid naturally, another possibility is that there are also other chemicals released into the bloodstream simultaneously which may have a protective effect perhaps?

 

For example, taking calcium and oxalate separately increases the risk of calcium oxalate kidney stones. Taken together, calcium and oxalate absorption is reduced, cutting the risk of calcium oxalate kidney stones.

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That page indicates that it does not cause an allergic reaction.

There's certainly no evidence f protein being present.

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http://polysorbate.jp/

 

Says "Low Allergic Reaction". To me, that is not "does not cause an allergic reaction".

 

In 2003:

Kuno-Sakai H, Kimura M. Removal of gelatin from live vaccines and DTaP-an ultimate solution for vaccine-related gelatin allergy.Biologicals 2003;31:245-9. [PubMed]

 

I was told US vaccines contain hydrolyzed gelatin which is free of proteins that can cause allergy.

 

In 2013:

http://www.acaai.org/allergist/news/New/Pages/AllergictoGummyBearsBeCautiousGettingtheFluShot.aspx

 

Looks like we are being too careless about what goes into our vaccines even after all the evidence about the dangers.

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Can we leave the gelatin discussion out of this please? It's just going to add confusion.

 

What they say is "Low Allergic Reaction (Low Degranulation)"..

I may be wrong but I still think that means below detection, which is a surrogate zero.

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They are reporting mast cell degranulation that releases histamine. If there was no allergic reaction detected in the animals, I assume the company would have been more than happy to report that.

 

You wrote that the Polysorbate 80 process which includes hydrolysis would remove proteins.

The FDA said the same thing about hydrolyzed gelatin in vaccines.

 

The FDA has been proven wrong by the ACAAI report:

http://www.acaai.org...theFluShot.aspx

 

Assuming trace quantities of protein in vaccines are safe is costing people their lives. Is it not time for the FDA to study the issue thoroughly and establish safe limits or eliminate food proteins from vaccines/injections? Sorry for bringing up gelatin again but it helps make my point that the FDA seems to be (wittingly or unwittingly) violating federal allergen regulation and endangering people's lives.

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"They are reporting mast cell degranulation that releases histamine. If there was no allergic reaction detected in the animals, I assume the company would have been more than happy to report that."

I suspect that injecting distilled water would induce some reaction.

In fact there are papers that show this- albeit ones that sought to show something else.*

If the polysorbate produces the same level of reaction do you lie and say there's no reaction?

Or do you say that it's a low reaction?

 

I wrote that filtering will remove insoluble stuff.

Are you arguing about that?

 

*

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1375241/

The famous multicenter study, led by J. Benveniste and involving four other laboratories, reported that human basophils undergo ‘degranulation’ (metachromasia) not only at usual anti-IgE antibody doses (10−3 mg/ml) but also at extremely high dilutions (10^60 or 10^120 times lower than the concentrations usually leading to a molecular interaction)

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According to my calculations, if a person weighing 100 kg were made of hydrogen atoms, they would have 6x10^28 atoms. Please verify my calculations ...

Since we are of course made of heavier molecules, the number is smaller. So, I don't know how anyone talking about dilutions of 10^60 or 10^120 can be taken seriously.

I read that by some estimates, the number of atoms in the universe is ~10^80 ...

If Nature published this work, may be it is a serious candidate for retraction?

Edited by vinucube

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Your calculation is right (or, at least, it is close enough- I didn't bother to check because it doesn't matter)

The whole point is that the numbers are absurd.

It is perfectly clear that the "solutions" that Benveniste and his collaborators used were plain water.

And yet it raised a "response".

 

It did so because, sometimes, the mast cells just decide to degranulate (more realistically, their degranulation is provoked by something, but we don't know what).

So, if they test polysorbate and the cells degranulate but they also degranulate with water, it is impossible to be sure that the polysorbate isn't having a small effect.

So, they can't say "it has no effect" (much as they might wish to do).

 

All they can ever say it that the effect is low.

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As I wrote http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1375241/ and the J. Benveniste work are fundamentally flawed. No one has been able to replicate it.

 

http://www.ncbi.nlm.nih.gov/pubmed/8255290

 

The papers should have been retracted. So it is best to ignore those results.

 

If basophils degranulate when exposed to distilled water in a lab, they will also degranulate when you drink a glass of water. So every mammal sporting such basophils would have gone extinct by now. Natural selection would have eliminated such basophils. If a test produced the same result whether you used water or a chemical, why would the laboratories continue to perform that test at all?

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