Claim: Flu vaccine from multi-dose vials Use Too Much Mercury

[Brighten Tompkins]

The claim that multi-dose vaccines contain more ethylmercury than is safe.

A single Thimerosal-preserved flu vaccine contains 25 micrograms of ethylmercury. If the EPA RfD for ingested methylmercury is applied to this injected ethylmercury figure, an individual would have to weigh more than 250 kilograms (551 pounds) for the 25 microgram exposure to be considered safe.

https://worldmercuryproject.org/mer...ble-dangers-of-ethylmercury-and-methylmercury

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The reference dose (RfD) for methylmercury according to the EPA is 1 microgram per kilogram per day.

The RfD derived in this assessment is 0.1 ug/kg per day. This is the same as the RfD derived by EPA in 1995 based on an earlier study of a poisoning episode in Iraq, in which data on adverse neurological effects in infants was used as the point of departure for derivation of the RfD.

https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=20873&CFID=86940110&CFTOKEN=22545478

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The only vaccines containing more than trace amounts of mercury are multi-dose vials. One of these thimerosal-perserved multi-dose vaccines is the Fluzone® Quadrivalent vaccine. Of this vaccine 0.25 mL, containing 12.5 mcg of mercury, are injected intramuscularly.




https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm356094.pdf

A baby girl and boy weighs 7 kg each.

According to the Centers for Disease Control, the median weight, or 50th percentile weight for a 6-month-old baby girl is approximately 16 pounds. The weight for a baby boy is approximately 17 1/2 pounds.

http://www.livestrong.com/article/233753-how-much-should-a-6-month-old-baby-weigh

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The article making the claim appears to have the math wrong. For 25 mcg you would need to be 55 pounds (25 kg). But I don't understand how a 7 kg 6-month old is safe receiving 12.5 mcg of mercury in a dose.

 

[Z.W. Wolf]

https://worldmercuryproject.org/mer...ble-dangers-of-ethylmercury-and-methylmercury

A single Thimerosal-preserved flu vaccine contains 25 micrograms of ethylmercury. If the EPA RfD for ingested methylmercury is applied to this injected ethylmercury figure, an individual would have to weigh more than 250 kilograms (551 pounds) for the 25 microgram exposure to be considered safe.

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The first thing that jumps out at you is comparing two different molecules as if they are exactly the same thing, just because the same element is in both. Watch for that M.

Is hydrogen cyanide exactly the same as carbon dioxide? They both have carbon.

Or maybe better, is hydrogen cyanide exactly the same as water? They both have hydrogen.

In this case mercury is a "goblin word." Anything with the word mercury in it carries an emotional weight.

Let's change some words:
A single Thimerosal-preserved flu vaccine contains 25 micrograms of dihydrogen monoxide. If the EPA RfD for ingested hydrogen cyanide is applied to this injected dihydrogen monoxide figure, an individual would have to weigh more than 250 kilograms (551 pounds) for the 25 microgram exposure to be considered safe.

 

[deirdre]

The only vaccines containing more than trace amounts of mercury are multi-dose vials. One of these thimerosal-perserved multi-dose vaccines is the Fluzone® Quadrivalent vaccine. Of this vaccine 0.25 mL, containing 12.5 mcg of mercury, are injected intramuscularly.

https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm356094.pdf

Just fyi, even if a child needs 2 doses that does not make it a "multi-dose vaccine presentation". A child, esp. in America, would get 2 doses from 2 separate 1 dose vials.

I did change your thread title to reflect this. There is a big difference between multi-dose vaccines and multi-dose vaccine VIALS.

Thimerosal is used in multi-dose vials to prevent bacteria from growing in the vaccine between shots.

Thimerosal is an ethyl mercury-based preservative used in vials that contain more than one dose of a vaccine (multi-dose vials) to prevent germs, bacteria and/or fungi from contaminating the vaccine
...
Flu vaccines in multi-dose vials contain thimerosal to safeguard against contamination of the vial. Most single-dose vials and pre-filled syringes of flu shot and the nasal spray flu vaccine do not contain a preservative because they are intended to be only used once.

A list of available flu vaccines and their thimerosal content is available.

https://www.cdc.gov/flu/protect/vaccine/thimerosal.htm

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[Brighten Tompkins]

https://worldmercuryproject.org/mer...ble-dangers-of-ethylmercury-and-methylmercury

A single Thimerosal-preserved flu vaccine contains 25 micrograms of ethylmercury. If the EPA RfD for ingested methylmercury is applied to this injected ethylmercury figure, an individual would have to weigh more than 250 kilograms (551 pounds) for the 25 microgram exposure to be considered safe.

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The first thing that jumps out at you is comparing two different molecules as if they are exactly the same thing, just because the same element is in both. Watch for that M.

Is hydrogen cyanide exactly the same as carbon dioxide? They both have carbon.

In this case mercury is a "goblin word." Anything with the word mercury in it carries an emotional weight.

I would agree with you but the FDA uses methylmercury data for ethylmercury.

[T]he FDA evaluated the amount of mercury an infant might receive in the form of ethylmercury from vaccines under the U.S. recommended childhood immunization schedule and compared these levels with existing guidelines for exposure to methylmercury, as there are no existing guidelines for ethylmercury, the metabolite of thimerosal.

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

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[deirdre]

The article making the claim appears to have the math wrong. For 25 mcg you would need to be 55 pounds (25 kg). But I don't understand how a 7 kg 6-month old is safe receiving 12.5 mcg of mercury in a dose

That recommendation is per day, a cumulative effect. But I'm going to call @Dan Wilson to address that because the review where they came up with the rdf for METHYLmercury is horribly long
[wrong link sorry..PDF attached}

 

[Z.W. Wolf]

I would agree with you but the FDA uses methylmercury data for ethylmercury.

[T]he FDA evaluated the amount of mercury an infant might receive in the form of ethylmercury from vaccines under the U.S. recommended childhood immunization schedule and compared these levels with existing guidelines for exposure to methylmercury, as there are no existing guidelines for ethylmercury, the metabolite of thimerosal.

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

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That was in 1999 and appears to be hyper caution from a government agency because there were no established guidelines at the time. The FDA is a bureaucratic organization and bureaucrats work within guidelines. They had no guideline so they used another one that was most similar.

I'll have to go with sources like this on the actual science:

https://www.ncbi.nlm.nih.gov/pubmed/23401210

Ethylmercury (etHg) is derived from the metabolism of thimerosal (o-carboxyphenyl-thio-ethyl-sodium salt), which is the most widely used form of organic mercury. Because of its application as a vaccine preservative, almost every human and animal (domestic and farmed) that has been immunized with thimerosal-containing vaccines has been exposed to etHg. Although methylmercury (meHg) is considered a hazardous substance that is to be avoided even at small levels when consumed in foods such as seafood and rice (in Asia), the World Health Organization considers small doses of thimerosal safe regardless of multiple/repetitive exposures to vaccines that are predominantly taken during pregnancy or infancy. We have reviewed in vitro and in vivo studies that compare the toxicological parameters among etHg and other forms of mercury (predominantly meHg) to assess their relative toxicities and potential to cause cumulative insults. In vitro studies comparing etHg with meHg demonstrate equivalent measured outcomes for cardiovascular, neural and immune cells. However, under in vivo conditions, evidence indicates a distinct toxicokinetic profile between meHg and etHg, favoring a shorter blood half-life, attendant compartment distribution and the elimination of etHg compared with meHg. EtHg's toxicity profile is different from that of meHg, leading to different exposure and toxicity risks. Therefore, in real-life scenarios, a simultaneous exposure to both etHg and meHg might result in enhanced neurotoxic effects in developing mammals. However, our knowledge on this subject is still incomplete, and studies are required to address the predictability of the additive or synergic toxicological effects of etHg and meHg (or other neurotoxicants).

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Yes, there's still some uncertainty.

 

[deirdre]

Yes, there's still some uncertainty.

agree.

and while this doesn't address the specific 'safety' question of OP, I would just like to stress again that at least in the United States, currently all vaccines are available thimerosal free.

Ethylmercury is an organomercurial that should be distinguished from methylmercury, a related substance that has been the focus of considerable study. Methylmercury is the type of mercury found in certain kinds of fish. At high exposure levels methylmercury can be toxic to people. In the United States, federal guidelines keep as much methylmercury as possible out of the environment and food, but over a lifetime, everyone is exposed to some methylmercury.
....
A vaccine containing 0.01% thimerosal as a preservative contains 50 micrograms of thimerosal per 0.5 mL dose or approximately 25 micrograms of mercury per 0.5 mL dose. For comparison, this is roughly the same amount of elemental mercury contained in a 3 ounce can of tuna fish.
...
All vaccines routinely recommended for children 6 years of age and younger in the U.S. are available in formulations that do not contain thimerosal. In addition, vaccines that do not contain thimerosal as a preservative are available for adolescents and adults.

From list of vaccines:




https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

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[Brighten Tompkins]

I would just like to stress again that at least in the United States, currently all vaccines are available thimerosal free.

I disagree. All vaccines available in the United States are not thimerosal free. Every vaccine routinely administered is available as a single-dose thimerosal-free vaccine but that doesn't mean multi-dose ones aren't available. In fact, the CDC created the One & Only Campaign, a public health effort, in order to combat multi-dose vial misuse because of it's prevalence in the states.

In case you weren't sure this is a United States effort, here are the only partner states listed on their website.

http://www.oneandonlycampaign.org

 

[deirdre]

Every vaccine routinely administered is available as a single-dose thimerosal-free vaccine

that's what I said. Although I should have specified I am only speaking of pediatric vaccines, I never bothered researching adult vaccines.

CDC created the One & Only Campaign, a public health effort, in order to combat multi-dose vial misuse because of it's prevalence in the states

I'm not seeing that on their website. The few pages I clicked on are talking about improper practices with both single and multiple dose vials. Can you, as per posting guidelines, quote the prevalence of multiple-dose vials in the states? (amongst children, since this thread is about pediatric vaccines.)

 

[Trailblazer]

The important part in all this is that the reference dose is for cumulative daily exposure. If a small child had a vaccine shot containing more than the RfD every day for an extended period of time then yes, they could risk harmful effects from mercury build-up.

That is the reason that multiple shots of thimerosal-containing vaccines are given with a wide separation, as seen in the table posted at the start of the thread:





Here is a reminder of what the reference dose means, as defined by the EPA:

A reference dose is the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance. Reference doses are most commonly determined for pesticides. The EPA defines an oral reference dose (abbreviated RfD) as:

[A]n estimate, with uncertainty spanning perhaps an order of magnitude, of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime.

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(my emphasis added).

That is a quote from Wikipedia, with the original source here: https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS Glossary


A reference daily dose does not mean that you risk toxic effects if you exceed it on one particular day. It's designed to provide safe limits for continued exposure. And, as mentioned above, the safe limit for ethylmercury is likely significantly higher than for methylmercury.

 

[Brighten Tompkins]

I'm not seeing that on their website. The few pages I clicked on are talking about improper practices with both single and multiple dose vials. Can you, as per posting guidelines, quote the prevalence of multiple-dose vials in the states?

I was referring to the prevalence of multi-dose vial misuse.

Since 2001, at least 50 outbreaks involving unsafe injection practices were reported to CDC.

http://www.oneandonlycampaign.org/single-dose-multi-dose-vial-infographic

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I'll have to go with sources like this on the actual science:

[…]

Yes, there's still some uncertainty.

The CDC appears to have it sorted out.

When learning about thimerosal and mercury it is important to understand the difference between two different compounds that contain mercury: ethylmercury and methylmercury. They are totally different materials. Methylmercury is formed in the environment when mercury metal is present. If this material is found in the body, it is usually the result of eating some types of fish or other food. High amounts of methylmercury can harm the nervous system. This has been found in studies of some populations that have long-term exposure to methylmercury in foods at levels that are far higher than the U.S. population. In the United States, federal guidelines keep as much methylmercury as possible out of the environment and food, but over a lifetime, everyone is exposed to some methylmercury. Ethylmercury is formed when the body breaks down thimerosal. Low-level ethylmercury exposures from vaccines are very different from long-term methylmercury exposures because ethylmercury is broken down by the body differently and clears out of the blood more quickly.

https://www.cdc.gov/vaccines/hcp/pa...downloads/vacsafe-thimerosal-color-office.pdf

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If a small child had a vaccine shot containing more than the RfD every day for an extended period of time then yes, they could risk harmful effects from mercury build-up.

Okay. So I think the EPA paper on mercury compounds, specifically the section on health hazard information, establishes a minimal lethal dose of 20 to 60 milligrams per kilogram.

It has been estimated that the minimum lethal dose of methyl mercury for a 70-kg person ranges from 20 to 60 mg/kg.

https://www.epa.gov/sites/production/files/2016-09/documents/mercury-compounds.pdf

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This would suggest the safe dose of 1 mcg could be pushed up to even 1 mg without adverse effects.

That is the reason that multiple shots of thimerosal-containing vaccines are given with a wide separation, as seen in the table posted at the start of the thread:

That would make sense with ethylmercury being safer than methylmercury and the RfD not being the dose you will have serious adverse reactions at. Going back to what deirdre said about the multi-dose vials not being for pediatric use in the states, from Fluzone being allowed for ages 6 months and up and the CDC mentioning its usage for the "entire country", that does appear to be the case.

To produce enough flu vaccine for the entire country, some of it must be put into multi-dose vials.

https://www.cdc.gov/vaccines/hcp/pa...downloads/vacsafe-thimerosal-color-office.pdf

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Further, a list of vaccines and their respective thimerosal contents is hosted on the CDC website where the multi-dose vials of Fluzone is indeed used in the United States on children.

 

[deirdre]

I was referring to the prevalence of multi-dose vial misuse.

your link says

Dozens of recent outbreaks have been associated with reuse of single-dose vials and misuse of multiple-dose vials

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I see NO prevalence statistics of multi-dose vial use in infants (6 months to 36 months).


also your link does not differentiate anywhere between adult doses and infants. Since your thread topic claim is meant to spread fear amongst parents regarding vaccines for 6mos-36mos year olds please keep on topic.

I do imagine that adults often get multi-dose vials, for example in those pharmacies that hand out flu shots or medical personnel who travel to large corporations and give out flu shots at work. So I am in no way saying that multi-dose vials aren't used in the United stated.

Again the topic of your thread is safety to infants and toddlers (6mos-36mos). And the bottom line parents need to know is that you can TELL your pediatrician you want a single-dose vial of vaccine for your child.

It has been estimated that the minimum lethal dose of methyl mercury for a 70-kg person ranges from 20 to 60 mg/kg.

https://www.epa.gov/sites/production/files/2016-09/documents/mercury-compounds.pdf

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This would suggest the safe dose of 1 mcg could be pushed up to even 1 mg without adverse effects.

I don't see where you are getting that assumption. Lethal dose means could cause death. "Adverse effects" could mean anything from nausea to permanent CNS damage. You cant just pull a number out of thin air and tell people that is a safe number.

 

[deirdre]

Going back to what deirdre said about the multi-dose vials not being for pediatric use in the states, from Fluzone being allowed for ages 6 months and up and the CDC mentioning its usage for the "entire country", that does appear to be the case.

I never said multi-dose vials can not be used. please stop paraphrasing me incorrectly.

disclaimer. pediatrician CAN use a multidose vial for infants/toddlers. There is no law I can find preventing it, in fact there is documentation explaining to doctors how to properly monitor the multi-dose vials they use for different age groups. SO PARENTS MUST INFORM PEDIATRICIANS THEY ONLY WANT SINGLE DOSE VIALS/or prefilled syringes. (if they are scared of thimerosal, which there really is no reason to be based on reams of scientific data)

 

[Brighten Tompkins]

I never said multi-dose vials can not be used. please stop paraphrasing me incorrectly.

disclaimer. pediatrician CAN use a multidose vial for infants/toddlers. There is no law I can find preventing it, in fact there is documentation explaining to doctors how to properly monitor the multi-dose vials they use for different age groups. SO PARENTS MUST INFORM PEDIATRICIANS THEY ONLY WANT SINGLE DOSE VIALS/or prefilled syringes. (if they are scared of thimerosal, which there really is no reason to be based on reams of scientific data)

Okay. Perfect. I'm glad that was cleared up. Sorry for misunderstanding you.

So, in conclusion, the RfD is the safe dose for oral consumption as established by the EPA at 1 microgram per kilogram per day of methylmercury. Ethylmercury is safer and studies have, according to the CDC, established no harm done to children when thimerosal is used. And if you are concerned for your baby, the thimerosal-free or trace amount vaccines fall perfectly within EPA standards for methylmercury and can be requested in place of a multi-dose vial. Am I summing everything up so far correctly?

 

[deirdre]

Okay. Perfect. I'm glad that was cleared up. Sorry for misunderstanding you.

So, in conclusion, the RfD is the safe dose for oral consumption as established by the EPA at 1 microgram per kilogram per day of methylmercury. Ethylmercury is safer and studies have, according to the CDC, established no harm done to children when thimerosal is used. And if you are concerned for your baby, the thimerosal-free or trace amount vaccines fall perfectly within EPA standards for methylmercury and can be requested in place of a multi-dose vial. Did I get everything right in summing everything up so far?

um, sorta right.
-I didn't read "oral consumption" anywhere.
-Ethylmercury: I'm not personally sure about "safer" (which is why I tagged @Dan ) but according to resources already listed above in this thread, it leaves the body faster ie. doesnt accumulate the same way.
-Studies have shown/linked no major adverse effects with thimerosal. I wouldn't use "no harm done" when speaking to parents because there can be side effects with everything.

-Yes, parents can request single dose vials or a prefilled syringe. In the rare case your pediatrician says no or gives you a hard time, I strongly recommend leaving his office and getting another pediatrician. Not because I personal have any issues with thimerosal, (all my kids and kids friends got saturated with thimerosal back in the day and they are all absolutely healthy and fine) but because parents need an understanding pediatrician they trust and are comfortable with, in my opinion.

 

[Brighten Tompkins]

um, sorta right.
-I didn't read "oral consumption" anywhere.

A reference dose is the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance.

https://en.wikipedia.org/wiki/Reference_dose

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-Ethylmercury: I'm not personally sure about "safer" (which is why I tagged @Dan ) but according to resources already listed above in this thread, it leaves the body faster ie. doesnt accumulate the same way.
-Studies have shown/linked no major adverse effects with thimerosal. I wouldn't use "no harm done" when speaking to parents because there can be side effects with everything.

Yeah, alright.

-Yes, parents can request single dose vials or a prefilled syringe. In the rare case your pediatrician says no or gives you a hard time, I strongly recommend leaving his office and getting another pediatrician. Not because I personal have any issues with thimerosal, (all my kids and kids friends got saturated with thimerosal back in the day and they are all absolutely healthy and fine) but because parents need an understanding pediatrician they trust and are comfortable with, in my opinion.

I agree.

 

[deirdre]

A reference dose is the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance.

https://en.wikipedia.org/wiki/Reference_dose

ah. then you might want to ask what the difference is between an oral dose and an injection into muscle tissue.

 

[Brighten Tompkins]

ah. then you might want to ask what the difference is between an oral dose and an injection into muscle tissue.

Well the FDA doesn't seem to see a difference, at least not when defining exposure limits. They count their own, the ATSDRs, and WHOs exposure levels in the same category as the EPAs RfD as to whether or not they were within guidelines. It could be worth looking into though. I mean, it does enter the blood stream that way.

At the time of [a] review in 1999, the maximum cumulative exposure to mercury from vaccines in the recommended childhood immunization schedule was within acceptable limits for the methylmercury exposure guidelines set by FDA, the Agency for Toxic Substances and Disease Registry, and the World Health Organization. However, depending on the vaccine formulations used and the weight of the infant, some infants could have been exposed to cumulative levels of mercury during the first six months of life that exceeded Environmental Protection Agency (EPA) recommended guidelines for safe intake of methylmercury.

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

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[deirdre]

Well the FDA doesn't seem to see a difference.

your quote there doesn't really cut it for me. That is cumulative exposure. Doesn't really answer the question of 12.5mcg in one day for a 7kg kid.

I mean, you said 1mcg per kg a day is within safety guidelines. So that isn't much more really.


Intuitively I think since the shot is given in the thigh, they should be about the same. But bioavailability is a complicated thing for me and since I (refuse to read the Methylmercury Rfd determination review) really know nothing about Methylmercury, other than eat less tuna fish, I would personally need more info*.



*Not that it matters as I'd just get my kid the single-dose vaccines. But I'm not sure they are available in all countries yet.

 

[Dan Wilson]

some infants could have been exposed to cumulative levels of mercury during the first six months of life that exceeded Environmental Protection Agency (EPA) recommended guidelines for safe intake of methylmercury.

Despite this, no harm has been associated with thimerosal in vaccines. Some recent papers all by the same author are claiming that thimerosal in vaccines is neurotoxic. There are, however, well done studies from respected journals sowing no evidence of harm.
http://pediatrics.aappublications.org/content/107/5/1147.long?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR:+No+local+token

Our review revealed no evidence of harm caused by doses of thimerosal in vaccines, except for local hypersensitivity reactions. However, some infants may be exposed to cumulative levels of mercury during the first 6 months of life that exceed EPA recommendations. Exposure of infants to mercury in vaccines can be reduced or eliminated by using products formulated without thimerosal as a preservative.

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http://pediatrics.aappublications.org/content/early/2010/09/13/peds.2010-0309

There were no findings of increased risk for any of the 3 ASD outcomes.

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I think the take home message so far is that there is little cause for concern, especially now with the absence of thimerosal in most vaccines. Ethyl mercury is broken down and cleared by the body rather quickly and is unlikely to cause adverse long term health effects. There may be some uncertainty but the evidence in favor of its safety is much stronger than the alternative.