Aluminum Information from The Vaccine Book
Aluminum is added to a number of vaccines to help them work better. Normally one wouldn’t consider aluminum to be a problem. It’s present everywhere in our environment. It’s in food, water, air, and soil. It’s also a main ingredient in over-the-counter antacids. Aluminum is harmless when swallowed since it isn’t absorbed into the body.
I didn’t think much about aluminum when I first started researching vaccines 13 years ago. In fact, my early seminars on vaccine education included a brief statement that aluminum was nothing to worry about. So why am I writing about it here? As I read each product insert and looked at the micrograms of aluminum in several of the vaccines, I wondered, “Has anyone determined what a safe level of injected aluminum is?” I didn’t have to wonder for long, because I found the answer quite easily. You can find it as well; just go to www.fda.gov and search “aluminum toxicity.” You’ll see several documents about aluminum.
The first document (see Resource 1) I came across discusses labeling of aluminum content in injected dextrose solutions (a sugar solution added to IVs in the hospital). On page 2, section 3.a., you will read the following: “Aluminum may reach toxic levels with prolonged parenteral administration [this means injected into the body] if kidney function is impaired . . . Research indicates that patients with impaired kidney function, including premature neonates [babies], who received parenteral levels of aluminum at greater than 4 to 5 micrograms per kilogram of body weight per day, accumulate aluminum at levels associated with central nervous system and bone toxicity [for a tiny newborn, this toxic dose would be 10 to 20 micrograms, and for an adult it would be about 350 micrograms]. Tissue loading may occur at even lower rates of administration.” Wow, that was a mouthful. I had to read it three times to understand it, so feel free to do the same.
The second document (see Resource 2) discusses aluminum content in IV feeding solutions (called TPN). The FDA requires these solutions to have no more than 25 micrograms of aluminum in each liter of solution. A typical adult in the hospital would get around 1 liter of TPN solution each day, thus about 25 micrograms of aluminum. The document also states on page 2, “Aluminum content in parenteral drug products could result in a toxic accumulation of aluminum in individuals receiving TPN therapy. Research indicates that neonates [newborns] and patient populations with impaired kidney function may be at high risk of exposure to unsafe amounts of aluminum. Studies show that aluminum may accumulate in the bone, urine, and plasma of infants receiving TPN. Many drug products used in parenteral therapy [injections] may contain levels of aluminum sufficiently high to cause clinical manifestations [symptoms] . . . parenteral aluminum bypasses the protective mechanism of the GI tract and aluminum circulates and is deposited in human tissues. Aluminum toxicity is difficult to identify in infants because few reliable techniques are available to evaluate bone metabolism in . . . infants . . . Although aluminum toxicity is not commonly detected clinically, it can be serious in selected patient populations, such as neonates [newborns], and may be more common than is recognized.”
OK, that was another mouthful . . . or a syringe full if you prefer. So what does all this mean? Here’s your translation. According to the first document, if premature babies get more than 10 micrograms of aluminum per day in their IV solution, this aluminum may accumulate in their bones and their brain in toxic levels. According to the second document, aluminum toxicity isn’t rare in newborns and other patients receiving injectable medications and IV solutions containing aluminum. They also warn that toxicity is difficult to detect just by observing symptoms.
There is another paper I found from A.S.P.E.N. (the American Society for Parenteral and Enteral Nutrition, not the ski resort), a group that monitors for safety and side effects of oral and injectible nutritional products. Their statement on aluminum safety, published in Nutrition in Clinical Practice in 2004 (See Resource 3), states that aluminum accumulation in body tissues can occur in newborns receiving IV solutions containing aluminum for prolonged periods. They state that the significance of this is not known. They also reiterate the FDA’s recommendations that IV nutritional solutions contain no more than 25 micrograms of aluminum per liter. Other injectible products aren’t required to limit aluminum, but they are required to have a warning label that says, “This product contains aluminum that may be toxic . . . .” The label goes on to specify the worries about aluminum in patients with kidney problems and premature babies and the limit of 5 micrograms per kilogram of body weight per day. A.S.P.E.N. recommends that doctors “may want to purchase equivalent products with the lowest aluminum content when possible and should monitor changes in the pharmaceutical market that may affect aluminum concentrations.”
Where does the 4 to 5 mcg per kilogram per day safety limit come from? I found a very interesting study from the New England Journal of Medicine 1997 (See Resource 4) that compared the neurologic development of about 100 premature babies who were fed a standard intravenous feeding solution that contained aluminum with 100 premature babies who were feed the same solution, but with almost all the aluminum purposefully filtered out. What prompted this study (as discussed in the study’s introduction) was the knowledge that aluminum can build up to toxic levels in the bloodstream, bones, and brain when injected, that preemies have decreased kidney function and have a higher risk of toxicity, that one preemie with sudden, unexplained death had high aluminum concentrations in the brain on autopsy, and that toxicity can cause progressive dementia. So these researchers sought to prove that aluminum may be harmful to preemie babies. They turned out to be right. The infants who were given IV solutions with aluminum showed impaired neurologic and mental development at 18 months, compared to the babies who were fed much lower amounts of aluminum. Those who got aluminum received an average of about 500 mcg of aluminum spread out over an average of 10 days. This comes out to about 50 micrograms per day. The babies who got the solution with aluminum filtered out received about 10 mcg daily, or 4 to 5 mcg per kilogram of body weight per day. This seems to be where this safety level originated from.
Now, none of these documents or studies mention vaccines. They only look at IV solutions and injectible medications. I’m not sure why that is. Nor is it clear why the FDA does not require aluminum warning labels on vaccines when they do require it on all other injectible medications. Vaccines apparently have some sort of exemption.
All these warnings seem to apply mainly to premature babies and kidney patients. What about larger, full-term babies with healthy kidneys? Using the 5 mcg/kg/day criterion from the first document as a minimum amount we know a healthy baby could handle, a 12-pound 2-month-old baby could safely get at least 30 micrograms of aluminum in one day. A 22 pound one-year-old could get at least 50 micrograms safely. Babies with healthy kidneys could probably handle a lot more than this, but we at least know they could handle this amount. However, these documents don’t tell us what the maximum safe dose would be for a health baby or child. And I can’t find such information anywhere. This is probably why the A.S.P.E.N. group suggests, and the FDA requires, that all injectable solutions have the 25 mcg limit, since we at least know that is safe.
But wait. You are probably thumbing back through the book right now to see exactly how much aluminum was in each vaccine. Put your thumb away. At the risk of being repetitive I’ll just list it right here again:
- Hib (PedVaxHib brand only) – 225 micrograms per shot.
- Hepatitis B – 250 micrograms.
- DTaP – depending on the manufacturer, ranges from 170 to 625 micrograms.
- Pneumococcus – 125 micrograms.
- Hepatitis A – 250 micrograms.
- HPV – 225 micrograms.
- Pentacel (DTaP, HIB and Polio combo vaccine) – 330 micrograms.
- Pediarix (DTaP, Hep B and Polio combo vaccine) – 850 micrograms.
OK, I’ll do the math for you. A newborn who gets a Hepatitis B injection on day one of life would get 250 micrograms of aluminum. This would be repeated at one month of age with the next Hep B shot. When a baby gets the first big round of shots at 2 months, the total dose of aluminum can vary from 295 micrograms (if a non-aluminum HIB and the lowest aluminum brand of DTaP is used) to a whopping 1225 micrograms if the highest aluminum brands are used and Hep B vaccine is also given. These doses are repeated at 4 and 6 months. A child would continue to get some aluminum throughout the first 2 years with most rounds of shots.
Just to remind you, the FDA feels that premature babies and any patient with impaired kidney function shouldn’t get more than 10 to 25 micrograms of injected aluminum at any one time.
As a medical doctor, my first instinct is to worry that these aluminum levels far exceed what may be safe for young babies. But then my second instinct is to assume that this issue has been researched and that studies have been done on healthy infants to determine their ability to excrete aluminum rapidly. My third instinct is to go looking for these studies, and so far I have not been able to find any. It is likely that the FDA feels the kidneys of healthy infants work well enough to excrete this aluminum rapidly before it can circulate through the body, accumulate in the brain, and cause toxic effects. However, I can’t find any references in the FDA documents that show that using aluminum in vaccines has been tested in human infants and found to be safe.
So I did what any pediatrician would do. I turned to the American Academy of Pediatrics. They published a policy in 1996 called Aluminum Toxicity in Infants and Children (See Resource 5). Here are several keys items I found in this paper:
- Aluminum can cause neurologic harm.
- A study from 30 years ago showed that human adults will increase their urine excretion of aluminum when exposed to higher levels (suggesting adults can clear out excess aluminum).
- Adults taking aluminum-containing antacids don’t build up high levels in their body.
- There have been reports of infants with healthy kidneys showing elevated blood levels of aluminum from taking antacids.
- The AAP found that people with kidney disease who build up levels of aluminum greater than 100 micrograms per liter in their bloodstream are at risk of toxicity.
- The AAP also states that the toxic threshold may be lower than this.
- The paper states that aluminum loading (meaning tissue build up) has been seen even in patients with healthy kidneys who receive IV solutions containing aluminum over extended periods.
Completely absent from this paper was any mention whatsoever of aluminum in vaccines.
To put this in perspective, an average adult has about 5 liters of blood. So having more than 500 micrograms in the bloodstream all at once would be toxic if their kidneys weren’t working well. Toxicity has also been seen in patients with healthy kidneys. A newborn has a blood volume of about 1/3 liter, or 300 mL. So having more than 30 micrograms floating around in their bloodstream at once could be toxic if the baby’s kidneys weren’t working well. A child has about 1 liter of blood, so more than 100 micrograms in his system could be toxic. I’ve already stated that babies can get more than 1000 micrograms injected at one time. Fortunately, this amount doesn’t all go into the bloodstream at once. It would be slowly diffused into the bloodstream over a period of time from the muscle or skin where it is injected.
But that is the main point of this entire section. No one has ever measured the levels of aluminum absorption into the bloodstream, then excretion into the urine and out of the body, when it is injected into the skin and muscle of human infants. All the FDA and AAP documents say is it may be a problem, but we haven’t studied it yet, so we should limit aluminum in injectible solutions. But no one is talking about the levels in vaccines.
What I think may have happened is that aluminum used to be in only one vaccine (DTP), so no one thought much about it. Then along came PedVaxHib brand of HIB vaccine in the 80s with aluminum, but the other brands of HIB did not have aluminum, so no one thought much about it. Then we started using Hep B vaccine in the 90s, Pc vaccine in the 2000s, and recently Hep A vaccine. Giving one aluminum vaccine at a time doesn’t amount to much aluminum, but giving four all together really adds up. It seems this issue has simply escaped everyone’s attention. Or has it?
Some researchers from the Cochrane Collaboration (a group that looks at healthcare issues around the world) investigated aluminum in vaccines and published their findings in The Lancet Infectious Diseases in 2004 (see Resource 6). This group reviewed all the side effect testing for one particular aluminum-containing vaccine (DTP) and looked for any evidence that an aluminum-containing vaccine caused more side effects than non-aluminum vaccines. Other than more redness, swelling and pain at the injection site, they didn’t find any indications that an aluminum-containing vaccine caused any problems. What prompted their investigation? According to the Lancet journal, there have been suspected cases of aluminum causing various neurologic and degenerative problems. The Cochrane Collaboration wanted to look at a very large study group to see if there was a real correlation. They didn’t find any problems with aluminum in vaccines and concluded that no further research should be undertaken on this topic. That’s a pretty bold statement. Most researchers will make a conclusion on research findings, but it’s unusual to go so far as to say that no one else should do any more research into the matter.
This is especially surprising because the Cochrane group didn’t actually study aluminum metabolism itself. They didn’t test aluminum levels in kids after vaccination. They didn’t explore whether or not the amount of aluminum in vaccines builds up in the brain or bone tissues. They just looked for evidence of visible symptoms of toxicity without even looking for internal aluminum effects. And they didn’t even do their own research. They simply reviewed all available studies done by other people. Also, they only looked at one aluminum-containing vaccine instead of testing all four at once. The Cochrane group essentially closed the book on aluminum without ever really opening it.
In 2002 a group of doctors and researchers met for a workshop conference to discuss aluminum in vaccines (see Resource 7). You can read the conclusions of this conference online, but in a nutshell they describe the importance and usefulness of using aluminum in vaccines, and the lack of evidence that the amounts used causes any harm, but they acknowledge that more research needs to be done to verify the pharmacokinetics and toxicology of aluminum in human children.
In addition, the Global Advisory Committee on Vaccine Safety for the World Health Organization just met in 2008 and determined there is no evidence of a health risk from aluminum-containing vaccines or any justification for changing current vaccination practices. I just wish they could have included at least one study on live human infant aluminum pharmacokinetics to prove this for sure. “No evidence of a health risk” is not as good as saying “Aluminum has been proven to be safe.”
The most obvious way to study this matter would be to inject various amounts of aluminum into kids and see what happens to it internally. We know from the FDA documents that aluminum toxicity does occur from other types of injectible treatments in those with impaired kidneys, that it can accumulate in the brain and bones in toxic amounts, that this may occur more commonly than is recognized, and that aluminum toxicity is hard to detect just by observing for symptoms. So what happens when the amount of aluminum in vaccines is injected? I’m not sure it would be ethical to inject human infants with aluminum for no good reason, but perhaps we could study it with vaccines that are already being given anyway?
I think vaccine manufacturers may have started wondering the same thing, because I found some interesting research in the product insert of the brand new HPV vaccine. The Merck Company actually added a little extra step to their safety research. They injected aluminum into a separate group of test subjects to use as a safety control group. They studied some of the side effects of their new vaccine compared to a saline placebo as well as the aluminum placebo. They found that the placebo with aluminum was a lot more painful than the saline placebo, and just about as painful as the full HPV shot. The aluminum placebo also caused a lot more redness, swelling, and itching than the saline placebo, but not quite as much as the full HPV shot. Unfortunately, they only looked at aluminum effects right at the injection site. They didn’t state in the product insert what role the aluminum placebo played in all the other standard side effects like fever and flu-like symptoms, although they probably have this data somewhere. And they didn’t study internal aluminum metabolism. But this research did show how reactive aluminum can be when injected into the muscles, and it was a good first step. I’m hoping that someone who is research minded and curious about this issue will explore it in complete detail so I can put it behind me, and you can feel more confident about vaccine safety. I will post any new developments about aluminum on www.TheVaccineBook.com to keep you updated.
Since aluminum may be toxic, why not just take it out of the vaccines as was done with mercury? The problem is, aluminum is an adjuvant. This means that it helps the vaccines work better. By mixing aluminum with the vaccine components, the body’s immune system recognizes the vaccines better. So to take it out would decrease the vaccine’s effectiveness. The Cochrane group also pointed out that taking aluminum out of vaccines would be a huge undertaking, requiring extensive trials on re-formulated vaccines. Mercury was easy to take out, since it had nothing to do with helping the vaccine work. But the pharmaceutical companies would need to have some good evidence that aluminum is harmful before it would be able to invest in reformulating vaccines without aluminum.
What exactly does aluminum do in the brain when it builds up in toxic amounts? While no one has studied healthy babies to see how much, if any, aluminum builds up in the brain from the amount used in vaccines, the study on IV feeding solutions in premature babies I discussed previously found that aluminum impaired their neurologic and mental development (see Resource 4). But that was in premature babies, not full-term healthy ones. I found several animal studies involving aluminum and/or aluminum-containing vaccines that did show neurologic harm (see Resources 8 – 12). Not only did the aluminum build up in the brain and cause damage, some of this damage looked similar to what is seen in the brains of Alzheimer’s patients. But it’s hard to correlate these findings precisely into human terms. What we need are more human infant studies.
Parents who wish to be extra cautious and limit their baby’s exposure to aluminum can do the following:
- Ask your doctor to order the brand of HIB vaccine that does not contain aluminum.
- Ask your doctor to avoid the brand of DTaP with the most amount of aluminum. However, you should be aware that the DTaP with the lowest aluminum also has a trace of mercury and uses cow tissue in manufacturing. The brand of DTaP with a moderate amount of aluminum does not contain mercury and does not use cow tissues.
- As for Hep B, Pc, Hep A, and HPV, all available brands have the same amount of aluminum. Parents can limit the number of aluminum-containing vaccines given at any one time, but this would mean coming in for extra “shot only” visits in between check ups. In Chapter 19, What Should You Now Do?, I will detail a vaccine schedule that allows you to get every vaccine in a timely manner, while only getting one aluminum-containing vaccine at a time.
- Avoid any combo vaccines that have more aluminum than the individual shots do.
If I could sum up the aluminum controversy in three sentences, it would be this. There is good evidence that large amounts of aluminum are harmful to humans. There is no solid evidence that the amount of aluminum in vaccines is harmful to infants and children. No one has actually studied vaccine amounts of aluminum in healthy human infants to make sure it is safe. Should we now stop and research this matter? Or should we just go on and continue to hope that it is safe?
I’m sure as soon as this book is published, vaccine policy makers and advocates will get word of it and read my concerns over aluminum. This will probably initiate several research studies to explore the risks of aluminum. I would ask a favor of those of you who undertake such research. Please don’t simply conduct a retrospective review of all the old vaccine safety studies and journal articles to look for aluminum side effects. Because you won’t find any. Aluminum toxicity, as the FDA, AAP, and others have stated, can’t be noticed just by external observation. It would really be a shame to have several such reports show up in the medical literature just to try to put a lid on this issue. The only way the aluminum safety issue can be put to rest is for someone to conduct several real-time studies on thousands of human infants and measure aluminum levels after vaccination. And they should not just look at blood levels. They should find out where aluminum accumulates in the body, if at all, and how it is eliminated from the body and at what rate. Once I see such research, and it is determined to my satisfaction that aluminum has been proven safe, then I will post an update on www.TheVaccineBook.com and change this section in the next revision of this book. If we find that aluminum may not be safe, then I would expect a new vaccine schedule to be adopted that spaces out the aluminum vaccines. I would also expect vaccine manufacturers to begin finding ways to reduce or remove aluminum from vaccines without compromising their effectiveness. One brand of HIB vaccine requires aluminum to make it work, but another brand doesn’t. Why is that? One brand of DTaP has 4 times as much aluminum as another brand. Why?
As doctors, we can choose certain vaccine brands that have less or no aluminum. We can be careful about giving only one aluminum-containing vaccine at a time. And we can talk about it instead of brushing the issue under the carpet. I pray to God that my fears on aluminum are unfounded, and that several unbiased, objective studies done by completely independent groups who have no ties to vaccine manufacturers or political organizations show that aluminum is safe. If not, I would hope that vaccine manufacturers would start to reduce aluminum and look for new adjuvants as soon as possible. I know this won’t be an easy task, but our children are worth it.
- Department of Health and Human Services, Food and Drug Administration, Document NDA 19-626/S-019, Federal Food, Drug and Cosmetic Act for Dextrose Injections. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19626scs019ltr.pdf
- Department of Health and Human Services, Food and Drug Administration, Document 02N-0496, Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition. Available online at http://www.fda.gov/ohrms/dockets/98fr/oc0367.pdf
- A.S.P.E.N. Statement on Aluminum in Parenteral Nutrition Solutions, Charney P, Aluminum Task Force, Nutrition in Clinical Practice 19;416-17, August 2004.
- Aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions. Bishop NJ, Morley R, Day JP, Lucas A.,N Engl J Med. 1997 May 29;336(22):1557-61.
- Aluminum Toxicity in Infants and Children, Committee on Nutrition, American Academy of Pediatrics, Pediatrics Volume 97, Number 3 March, 1996, pp. 413-416.
- Adverse events after immunization with aluminum-containing DTP vaccines: systematic review of the evidence, Jefferson T, et al; The Lancet Infectious Diseases 2004; 4:84-90
- Workshop summary: aluminum in vaccines, Eickhoff TC, Myers M., Vaccine 2002:20 (suppl):S1-S4.
- Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of beta-amyloid protein, Kawahara M et al., Brain Res. Bull. 2001; 55, 211-217.
- Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue, Redhead K, Quinlan GJ, Das RG, Gutteridge JM. Pharmacol.Toxico. 1992; 70;278-280.
- Aluminum impairs the glutamate-nitric oxide-cGMP pathway in cultured neurons and in rat brain in vivo: molecular mechanisms and implications for neuropathology, Canales JJ et al, Journal of Inorganic Biochemistry, 2001; Nov;87(1-2):63-69.
- Effects of aluminum exposure on brain glutamate and GABA systems: an experimental study in rats, Nayak P, Chatterjee, AK, Food Chem Toxicology, 2001, Dec:39(12):1285-9.
- Neuropathology of aluminum toxicity in rats (glutamate and GABA impairment), El-Rhaman SS. Pharmacol. Res. 2003 March:47(3):189-94.