Two New Combination Vaccines Now Available Friday, August 22, 2008 With 12 separate vaccines on the childhood schedule, and as many as 6 separate injections at any one visit, parents and doctors love to be able to combine vaccines into fewer injections. There are several combination vaccines that do just that. These include: Chickenpox and MMR – combined as ProQuad (Merck). DTaP, Hep B, and Polio – combined as Pediarix (GlaxoSmithKline). HIB and Hep B – combined as Comvax (Merck). DTaP and HIB – combined as TriHibit (Sanofi-Pasteur). This can only be combined for the 18 month dose. It isn’t combined for the first three doses. Hep A and Hep B – combined as Twinrix (GlaxoSmithKline). This is only for adults 18 and older. Using some of these combinations instead of the separate shots certainly cuts down on the pain. There are now two new combinations available for doctors and parents to choose from: DTaP, HIB, Polio – combined as Pentacel. DTaP, Polio – combined as Kinrix. Here is what you need to know about these two new products: Pentacel (made by Sanofi-Pasteur). This is a fairly useful option for infants to get at 2 months, 4 months, 6 months and/or 18 months of age. It turns three injections into just one at each of these visits. You would only use this combo for 3 out of 4 of these vaccine rounds, because a baby should only get 3 polio shots during infancy. The total chemicals and ingredients in this combined shot are similar to what would be given in the three separate injections, except that the amount of pertussis germs (from the DTaP part of the shot) is greater in Pentacel than in the corresponding DTaP made by Sanofi, called Daptacel. Infants who have begun their vaccines using separate injections can change to this combined form at any time, with their doctor’s guidance. You can read full details on this vaccine in The Vaccine Book (even though this shot just came out, I knew about it ahead of time and was able to include full details on it in the book). Dr. Bob comments: This looks like a good idea. However, those patients following my Alternative Vaccine will notice that getting this vaccine gives the Polio component months earlier than my suggested schedule. I think this is fine for any patients who believe the decrease in injections is worth it. Kinrix (made by Glaxo). This combination is only approved for use at the 5 year booster dose of DTaP and Polio. Instead of getting these two shots separately at that age, you can now get them combined together in one shot. Here’s the catch though: You have to have gotten a Glaxo brand of the DTaP vaccine as your infant rounds of DTaP (either the Glaxo brand Infanrix or Pediarix). Dr. Bob comments: I’m not a fan of the Glaxo DTaPs due to their high aluminum content. So this isn’t a combo vax that I’ll be using. Labels: Vaccine News posted by Dr. Bob Sears @ 2:49 PM   25 Comments: At August 23, 2008 8:57 AM ,  Science Mom said... Dr. Sears, Are you aware of the current AAP recommendation against MMR-V (ProQuad) in favour of MMR and Varicella separately? Due to increased risk of febrile seizures and production problems.   At August 23, 2008 9:35 AM ,  Dr. Bob said... Yes. I think I did a blog on that a few months ago. I agree with it.   At August 25, 2008 5:03 AM ,  Anonymous said... Dr. Sears don't you think that the larger multiple Vaccines can put a big assault on a baby's immune system? I was reading your passage in the book about these last night and I can't figure out what would be the right course of action for us. I am not sure which is more problematic the large pertussis or the one that has over 600 micrograms of aluminum. Thanks!   At August 25, 2008 11:06 AM ,  Dr. C said... Hey Doc, How about a citation about how much Aluminum is in vaccines and a controlled trial as to why it is harmful. I'd appreciate it because you scar the living daylights out of my patients. Dr. C.   At August 25, 2008 11:07 AM ,  Dr. C said... excuse me, "scare" instead of "scar", but perhaps it was a Freudian slip   At August 25, 2008 1:37 PM ,  Dr. Bob said... I don't use the combo vaccines in my office. Dr. C. I put a large number of citations in the back of the book, and within the aluminum section of the book, that demonstrate the neurotoxicity of aluminum IN GENERAL. However, I can't show you a single controlled trial in human infants that shows the amount of aluminum in vaccines is either safe or harmful. No such study has been done. And that is the crux of the issue. No one has demonstrated it is safe.   At August 25, 2008 2:56 PM ,  Dr. C said... Well, Dr. Bob, thanks for the plug for your book but I found this excellent WebMD reference: http://www.webmd.com/parenting/news/20040129/aluminum-in-vaccines-poses-no-harm Further looking shows that: Typical adults ingest 7 to 9 milligrams of aluminum per day whereas a typical vaccine has about 0.125mg of aluminum http://www.chop.edu/consumer/jsp/division/generic.jsp?id=88655 Aluminum has been used since the 1920's (I certainly got it in my baby shots in the 40's). You are still making my life harder and causing parents to put their children at risk for potentially fatal disease without any true science to back it up.   At August 26, 2008 6:14 PM ,  Dr. Bob said... Key word in the webmd reference is INGEST. Ingesting AL is very different than injecting. So again, I pose the challenge. Show me a study that examines INJECTIBLE AL and proves it's safety. Plus, only one vaccine has 0.125 mg of AL. Most have more.   At August 27, 2008 12:14 PM ,  Dr. C said... Dr. Bob, I am doing the literature search as we speak. I will back to you on this subject here in the next day or so. Dr. C.   At August 29, 2008 9:09 AM ,  Dr. C said... Dr. Bob, There is a wealth of information available on the Web and via PubMed concerning Aluminum used as an adjuvant in vaccines. You are correct, the amount used in some vaccines is higher than the 0.125 mg that I mentioned above. http://www.autismhelpforyou.com/Simpsonwood_And_Puerto%20%20Rico.htm (Transcript On Aluminum in Vaccines Part 1).Here are some quotes (it was a conference) From Puerto Rico conference Page 150; Dr. Stanley Hem, Absorption and Elimination of Aluminum Containing Adjuvents “….aluminum adjuvents are dissolved by the citrate in the interstitial fluids and that they leave the body.” “…alum precipitatin adjuvant to refer to the adjuvant that is produced from alum.” “…interstitial fluid contains some alpha hydroxy carboxylic acid. It contains citric acid, lactic acid and malic acid. Alpha hydroxy caboxylic acids are chelating solubilizing agents for aluminum.” “…aluminum phosphate adjuvants dissolve in citrate solution similar to the citrate at the same concentration that citrate is in human interstitial fluid.” Page 160. “ …we generally get about 10mg of Aluminum a day..” Page 161: (aluminum concentration) “…..five micrograms of aluminum per liter.” “In terms of tissue concentration it ranges from one to 100 milligrams per kilogram of tissue. And in comparison then the maximum dose of aluminum that is allowed in a human vaccine is 0.85 milligrams. That will give you a little bit of perspective. We are not talking about very much aluminum compared to what we are exposed to in our daily life in our daily contacts.” Page 164: Injected 0.850 mg labelled Al into rabbits. Within an hour the labelled Al appeared in the blood stream. “So the body has a very powerful mechanism for processing and eliminating these adjuvants.” Page 165: For aluminum hydroxide adjuvant about 17% appeared in the urine after 28 days. For aluminum phosphat, about 51%. Page 167: “…and the distribution here is the same as you normally see aluminum in these different organs. So the aluminum 26 was not going to a special place and the aluminum from the adjuvant was not going to a special place in the body.” Page 168: “…I do not think there is any doubt that the body has a way to eliminate the adjuvants, the citrate, the alpha hydroxy, carboxylic acids in the interstitial fluid chelate, dissolve them, they go throught the lymph, into the blood, to the tissues, and out, and out in the urine.” The bottom line is that the amount of aluminum in vaccinations is negligible. However, it is an important adjunct which has been in use for 60-80 years with probabaly over a billion injections. The toxicity seen from aluminum in children has mainly been in premature infants with or without renal failure who are exposed to high doese in TPN. Most importantly, there have been no trials to test your hypothesis that it is dangerous because it is not a provable hypothesis. The numbers of children that would need to be tested to prove your point would be astronomical. Furthermore, it would be unethical to remove the adjuvant since the risk of harm from not having the adjuvant (markedly decrease immunity) far outweights any hypothetical risk from the miniscule amount of injected aluminum. Consequently, I would ask you to reconsider your stance re this issue since, again, you are contributing to the hysteria that now surrounds vaccines leading, as you are well aware, to increased incidence of preventable disease, particularly measles. Dr. C. (I am more than willing to send you my entire literature search and documents if you wish)   At September 1, 2008 10:55 PM ,  Dr. Bob said... Thanks for the very thorough information. Others have shown me this info as well. Here are my thoughts: To say that AL adjuvants dissolve into the bloodstream doesn't make the AL harmless, does it? It's still AL. It's not like it disappears. I do, however, understand your point that it may then be chelated by the alpha hydroxy acids. Yes, I agree. In regards to pages 164 and 165, I do agree our body can "process" the AL, but I don't see any proof that we have "powerful mechanisms to eliminate it." If only 17% of the ALOH comes out by 28 days, that means MOST of it is hanging around by the time the NEXT round of shots is given 2 months later. With the ALPO4, it does seem a bit better. BUT only 50% comes out by 28 days. How much is left by the time the next round of shots is given? What comes out in the next 28 days? You make good points. And I must say that I ultimately only have ONE MAJOR objection. The science that you refer to in that paper is based on animal research. I really would be more comfortable if such elimination research were done on a small group of human infants to see WHERE the AL goes in the body, see if any tissue-loading occurs (namely, in the brain),and quantify how quickly it's eliminated in the urine. A radio-labeled AL study, like the one you refer to. I know it would be tricky, but it wouldn't have to be a large study as you suggest. Hey, even simply doing urine elimination studies would be a start. That wouldn't be invasive. Let's PROVE that it is chelated and eliminated quickly. Adding blood level testing for a few days after the shots would also yield some interesting results. To set this issue aside based on some limited animal research doesn't seem good enough to me. If we are going to be doing this for decades more, we should prove it's safe NOW. Finally, as far as I know, all babies with renal failure (not a lot of them, fortunately) get vaccinated the same as all other babies, without a second thought to choosing a non-AL brand or a brand with lower AL. That would be a nice AAP policy to have. Thanks for your very useful participation. I'm going to keep hoping for a bit more human infant research though. Dr. Bob   At September 3, 2008 6:36 PM ,  Anonymous said... Dr. Bob and Dr. C. -- A genuine thanks to both of you for discussing the aluminum issue here. It was one that caught my attention when I read the Vaccine Book, and when I brought it up with two pediatricians in my practice, I was very disappointed in the response. Both pediatricians misunderstood the concern and were not interested in figuring out their own answer (besides "AAP's schedule is fine, don't ask questions."). As a result, I was left feeling unheard and with more questions than answers. I appreciate the frank discussion, and Dr. C., I very much appreciate that you are willing to go the extra mile for your patients by looking into this yourself. --- Chicago Mom   At September 4, 2008 2:19 PM ,  Dr. C said... Dear Dr. Bob and Anon, Thank you for your replies. I think that there is little chance that we will ever do trials in humans with and without the Al adjuvants since: a) the dose is trivial; b) obtaining levels would be almost impossible, particularly brain levels. It would also not be possible to use the radioactive isotope in children. It would be unethical. So, I guess the bottom line is that we are where we are. My honest opinion is that Al Adjuvants do not pose more than an trivial and minimal risk to a child and it is far less a risk than that of the diseases we are vaccinating against. (George Washington died of quinsy, which is now known as peritonsillar abscess. It is still possible that it was diptheria.) Dr. C.   At September 4, 2008 3:53 PM ,  Dr. Bob said... Thanks Dr. C. One last thing though. The dose isn't trivial at all. You should find my discussion on AL in the book very enlightening (not in terms of vaccine safety, BUT in terms of how many micrograms of AL are considered safe). I agree that most chemicals in vaccines ARE in trivial doses. BUT, due to the neurotoxicity of AL, the FDA limits the amount of parenteral AL in IV solutions to 25 micrograms per liter. AND the FDA, AAP, and ASPEN all state that no one should get more than 5 micrograms per kilogram per day of parenteral AL. They make this limit because more than that can be bad for anyone with renal disease. But they impose the limit on ALL hospitalized patients, even those with good kidneys, so that no one is harmed. So - 5mcg/kg/day is only about 20 mcg for an infant, and 350 mcg for an adult. That's for parenteral AL in a hospitalized patient. I think they really mean Intravenous, but Intramuscular and subcutaneous are also parenteral routes. Here's my problem - infants get as much as 1200 micrograms of AL at 2 months, 4 months, and 6 months. That's 60 times the FDA limit. So, I'm saying that's dangerous, because we don't know it's dangerous. But, please don't think the the AL amount is TRIVIAL. It is not. Like to hear your thought on that. I provide all the citations from the FDA and AAP on this in the book. Bob And hey, how about that new Autism MMR study? Good news!   At September 7, 2008 6:47 AM ,  Catherina said... Dr Bob, what about Twinrix junior? Is that not licenced in the US and would that not be a viable alternative for those parents who do not do the hepB in year 1?   At September 8, 2008 12:37 PM ,  Dr. Bob said... Have not yet heard of Twinrix Junior in the U.S.   At September 9, 2008 12:40 PM ,  Anonymous said... Folks may want to read the NY Times article failing to show Measles vaccine virus link to autism in the fashion first promoted by Wakefield. Cut and paste into browser. Dr L. http://www.nytimes.com/2008/09/09/opinion/09tue3.html?_r=1&ei=5070&emc=eta1&oref=slogin   At September 9, 2008 3:03 PM ,  Anonymous said... Dr. Bob, is it true that if an infant get Hep B vaccine at birth, 2, and 4 month, he needs to get another one at 6 months because the 3rd one didn't count because he is too young? We're so confused. We thought 3 was all he needed. Thanks so much - Kim   At September 13, 2008 12:08 PM ,  estherar said... Dr. Sears, I know Science Mom has directed you to my blogposts regarding aluminum in vaccines, starting here at Part I. Thank you for considering them "well done". I would appreciate your response (here or in the comments of my blog) why, when all of what is currently known regarding the toxicological data on aluminum, not to mention the empirical data, points to the fact that children are not being aluminum poisoned en masse by the current vaccine schedule. Aluminum may be a neurotoxin, but so is water; the dose makes the poison, always. I'll reiterate what I said in the other comment I made on your blog: Most of what we know about the effects of medicines in pregnancy and lactation are derived from empirical evidence (accidental exposure or just long experience with the specific meds) and animal studies. Using your 'perfect knowledge' criteria, I could almost never give a pregnant or lactating patient of mine any antibiotic. I'm not even sure I could, in good conscience, advise her to take a Tylenol for her headaches (and let's not even think about unregulated herbal preparations). While it's a good idea to have human studies and this would probably help define just how many aluminum-containing vaccines given simultaneously would be safe, the preponderance of evidence makes it clear that the current vaccine schedule does not contain aluminum in any hazardous amount. Hence my contention that aluminum in the current vaccine schedule should be considered innocent until proven guilty...which I very much doubt it will be. Looking forward to your response - Esther Mainstream Parenting Resources (http://mainstreamparenting.wordpress.com)   At September 17, 2008 10:36 AM ,  Anonymous said... Dr. Sears, if one's pediatrician is unable to offer the MMR split into separate doses, do you recommend delaying the MMR? didn't it used to be given at 18 months instead of 1 year? how do you recommend finding a doctor who will split the doses? Thank you, Andrea   At August 17, 2009 7:59 PM ,  Anonymous said... I am not a medical doctor, I am a Ph.D. with about 2 decades worth of biomedical research experience. I am just giving my interpretation of the literature as I read it. I'll attempt to explain my take on the topic from the perspective of being a parent wanting the best for my child. Vaccinations are a very powerful weapon to use in our arsenal to fight disease. With the current vaccination schedule and population herd immunity it has created, many common diseases have become rare and rare ones are near extinction. For some of these it does require continued vaccinations of new arrivals to keep it that way. What is in it for the new arrivals? The vaccines are given with many shots to begin with, because the baby is not very good at making his/her own immune defenses and it takes more for him/her to do so. Thus more shots and longer time than for an equivalent adult. Were we able to place newborns in a germfree cocoon for the first 2 years and then vaccinate, it may lead to better immune responses and least disease but it is not realistic. So we have a choice, prick them often, and hope they won't have to rely on their own immunity too soon. In regards to aluminium. Bioavalability is a word that describes how much of a substance when present in the body is actually active and doing something, be it bad as in a toxin or good as in a medicine. First, the nature of aluminium has to be understood before making a judgment as to whether it is bad. Everyone is familiar with aluminium as a metal, it is what foil and airplanes are made of. Aluminium that is used in vaccines is in a different form, that of a salt (aluminium ions). Taking an example from popular media, in an old Star Trek episode, Kirk and his crew come across a crystalline organism who refers to humans as ugly bags of mostly water. Well, from a biochemistry perspective the bags of mostly water part holds true. Now everyone is familiar with table salt (sodium chloride), and knows it is soluble in water. However when first placed in water it can take a while to dissolve. Not many are familiar with aluminium salts and their solubility. The aluminium salt used in most vaccines is in the form of KAl(SO4)2.12H2O. This is able to dissolve in pure water readily. The human body being mostly water, however has lots of other potential molecules for aluminium ions to interact with. As it turns out, most aluminium salts are very insoluble. A lot of the aluminium ions are already attached to the vaccine components and insolubilized that way when injected. Plus when alum comes into contact with other dissolved salt components such as phosphate, carbonate and organic molecules, inside the injection site of the muscle tissue most of the aluminium becomes insoluble. This is in part how we understand the aluminium functions to help activate the immune system. It causes a foreign object to formed at the location of injection that is very hard to remove by the immune system. To make aluminium soluble again can take a very long time, sometimes months or even years. Aluminium ions can clearly be bad when in the human blood stream or deposited in human organs. The FDA is clear about it as well and set clear levels. In vaccines most of the aluminium has very low bioavailability, i.e. release of the aluminium from the muscle into the bloodstream is very slow, as supported by several papers. Knowing all this, where does this leave me as a parent. I know the limitations of vaccines in individuals, especially in babies. When weighing the risks versus benefits, I choose vaccinations. I will remain vigilant and try to choose based on what is known in the field, it is the best I feel I can do for my child. C, Ph.D.   At August 29, 2009 8:19 PM ,  Anonymous said... I just found out about The Vaccine Book. Although I wish I had a month ago; before my 4 mo old received Pentacel. I am very upset that our pediatrician posed it as "less pricks" and did not inform me about Aluminum levels. Not to mention, she charged me 5x as much for it. This is the only time my daughter has had that shot. Otherwise, her shots have not exceeded 250 micrograms of aluminum in one visit (which still seems high). Now that I know about Dr. Sears' vaccine schedule, this will not happen again. However, I am filled with worry that I harmed my baby with the Pentacel shot. Any thoughts on the repercussions of one dose of Pentacel on a 4 mo old body? Plus a Hep B vaccine at that same visit. Thank you for your time in responding to my concern. Thank you for your invaluable work and that of your family. I have been enlightened from your collective books. Fondly, Dr. D   At September 1, 2009 7:36 PM ,  Jaime said... Dr Sears, I need help. My pediatrician is giving my 8 week old son Pediarix in 2 days and I just found this out. I have never heard of it. Can you tell me about the aluminum levels and how long it has been around and if you feel it is safe to give all those vaccines at once? Thank you in advance.   At October 3, 2009 2:36 PM ,  Anonymous said... Dr. Sears- In the book you say that there is 1500 micrograms on aluminum in the Pentacel vaccine which my doctor's office uses. On this website it seems like you say that it is fine to use. Did the amount of aluminum change? Can you please clarify? Thank you- Brooklyn Mom   At October 13, 2009 9:35 AM ,  COmom said... My second son is now 2.5 months old and while I feel it is important for him to be immunized, the current # of vaccinations being given to infants is a significant concern. I got Dr. Sears' book after his first shot at 2 mo. My peds office gives Pediarix and I only had him get that one shot at his 2 mo visit. Now that I see it has 850mcg of aluminum (to answer the Q above about how much aluminum it contains - pulled from Dr. Sears' book), I need to speak with his ped about changing to a different shot.   Post a Comment << Home   The 12 Childhood Vaccines Vaccine-preventable Diseases Boost Your Child's Immune System FAQs Parents Who Choose not to Vaccinate Current Outbreaks and Epidemics Vaccine Discussion Forum Read Dr. Bob's Online Interviews Updates & Corrections to The Vaccine Book Find a vaccine-friendly doctor near you Alternative Vaccine Schedule American Academy of Pediatrics 2007 Vaccine Schedule Vaccine News Vaccines and Autism Vaccines and their diseases

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