New HIB Vaccine Now Available to Ease the HIB Vaccine Shortage Friday, August 21, 2009 Over the past year and a half there has been a shortage of HIB vaccine. Normally given at 2, 4, 6, and 15 months of age to prevent HIB meningitis, there had been a temporary halt on giving that last dose in order to allow all babies to get at least the first three doses. In June of this year the CDC announced the shortage was over and reinstated that 4th dose again. In order to help ease the supply burden, the FDA has granted GlaxoSmithKline an accelerated approval of their Hiberix brand of HIB vaccine (see FDA announcement regarding their accelerated approval guidelines and other details at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm179527.htm). This vaccine has been used in other countries since 1996. This new vaccine is NOT yet approved for the entire vaccine series; it only has approval to be given as a booster from 15 months through 4 years of age (prior to the fifth birthday). It is only approved to be used after an infant has received the first three doses of ActHIB or Pentacel brands of HIB, or the first two doses of PedVaxHIB or Combivax brands of HIB vaccine. In The Vaccine Book I provide details on how all other HIB vaccines are made and what the ingredients are. Here are the details on this new vaccine: How it is made and what the ingredients are: The HIB germs are grown in what they term a “synthetic medium,” then the germs are taken out and broken up. Some sugars from the outer covering of the germ are filtered out, and the rest of the germ is discarded. Tetanus germs are grown in a separate “semi-synthetic medium.” The toxin produced by the tetanus germs is filtered out and inactivated by adding formaldehyde. This toxin is then combined with the HIB sugars, most of the formaldehyde is filtered out, some lactose sugar is added, and the final product is mixed with saline. The ingredients in the final product are the HIB sugars, the tetanus toxin (this is used to help the vaccine work better by stimulating the immune response), lactose sugars, saline (salt water), and less that 0.5 micrograms of formaldehyde. There is NO mercury and NO aluminum. This product seems to be made in a very similar manner as the ActHIB brand in The Vaccine Book. I don’t know the details about the “media” in which the germs are grown. I may be able to track this down in the future. So I don’t know exactly what types of minute ingredients may transfer from those media into the vaccine solution. Side effects: Side effects were mainly studied when this vaccine was given at the same time as Pediarix (a combo of DTaP, IPV, and Hep B), and the standard reactions (fever, fussiness, redness) were about the same as with Pediarix, occurring in about 25% of children. There is no research listed in the Hiberix or the Pediarix Product Inserts that discusses the rate of these reactions in babies getting Pediarix alone versus those who get Pediarix at the same time as Hiberix. So, I can’t give any clear indication on whether or not this vaccine is MORE reactive that other vaccines in general, but there is no indication that it IS more reactive. A major drawback of the research discussed in the Product Insert is that they only studied this vaccine in 1000 infants. This is probably the smallest study I have ever seen in the past 15 years. Post-marketing reported reactions (since the vaccine has been in use in other countries since 1996) has revealed reactions that are similar to other very rare but serious vaccine reactions. Nothing has shown up with any more frequency than other vaccines. My recommendations: I am always leery of any new vaccine. As my office has been able to maintain a good supply of ActHIB, I won’t be using this new vaccine (unless I run into supply problems). I worry that this was only tested on a very small group of children so far. As part of the accelerated approval process, the FDA is requiring GlaxoSmithKline to perform ongoing safety and efficacy testing in the U.S. in order to meet the regular testing guidelines. Once I’ve review that information (6 to 12 months from now? I don’t know how long that will take), I’ll be able to offer a more research-guided recommendation. But because of Hiberix’s similarity to ActHIB brand, both in its ingredients and how it is manufactured, overall I don’t see any problem with using this vaccine when the alternative is to go without it. If this is the only option your doctor has for you, I recommend you follow your doctor’s advice on this. This vaccine can be given along with any other vaccines at any time within my alternative vaccine schedule, as long as it meets the age guidelines above. Dr. Bob Labels: Vaccine News posted by Dr. Bob Sears @ 1:37 PM   16 Comments: At August 30, 2009 6:13 AM ,  Anonymous said... How funny..... Not one comment after a week.. Where are all the critics when Dr Bob is actually showing he is indeed pro vaccinations?..   At September 1, 2009 10:02 AM ,  Dr. Bob said... Ha Ha - well, this is more of just an FYI blog. NOt really interesting. so, I didn't expect any responses.   At September 2, 2009 7:56 PM ,  Anonymous said... Is the H1N1 vaccine already in safety trials now? When will you reach a verdict Dr. Bob?   At September 2, 2009 10:44 PM ,  Dr. Bob said... Yes it is. As soon as I can see product inserts - probably at least another month from now   At September 9, 2009 12:35 PM ,  Anonymous said... Dr. Bob, thanks for keeping us up todate on then new H1N1. My question is... how important is it to get the vaccine? I am hearing all these news reports about outbreaks on campuses all across the country and no one is dieing. Getting sick for a few days and needing to stay home. Doesn't seem like a big deal to me. Is it? thanks Jen ( mom of 10 month old twins)   At September 14, 2009 5:46 PM ,  Anonymous said... Dr. Bob I have a 15month baby boy, and I have been following your Alternative Plan minus the Mumps Vaccine, I am considering not giving him his last HIB an PC vaccinations, because he is at the age where parents with Autistic children see diffrences, I want to wait until he is out of this age group before introducing any more vaccines, what is your take on this?   At September 16, 2009 9:30 AM ,  Krista said... What is the correlation of Type I diabetes with this new HIB vaccine? My husband has Type I diabetes and we want to avoid it in our children. The correlation between the original HIB vaccine and the occurrence of Type I is disturbing to us.   At September 30, 2009 10:35 PM ,  Katharine said... Dr. Bob , just read your article...my 18 mo old son just received the new Hib and the reguLar flu today. How ling should I wait if I want him to be vaccinated with the swine flu vaccine? Also, according to our drs office the only thing going around is the H1N1 virus, infact a 12 yr old girl just died with the virus here, we live in Texas, two days ago. What are your recommendations about getting my 6 mo old daunted vaccinated as well. Did I moe. Mistake by getting the regular flu vaccine. I am very worried.   At October 5, 2009 1:20 PM ,  Rose said... Dr. Bob, I am leaning toward not getting the H1N1 flu shot for my 10 mo. old son. My question is would there be any potential benefit to him if I got the flu shot since I'm breastfeeding him still? Thanks!   At October 10, 2009 10:15 AM ,  brenda said... I sincerely cannot believe that Pregnant women and some Moms will be so foolish to fall for the Swine Flu Vaccine. Studies stating that there is no link between Autism and Vaccines were ALL FUNDED BY Pharmaceutical Companies. 1 in 58 boys in this country has Autism. Pharmaceutical Comps do as they please because they give $$$s to our congressmen and politiicians. Vaccines DO CAUSE AUTISM but just as long as Pharmaceutical Comps are funding the studies and giving money to our polticians, they can do as they please http://www.opensecrets.org/lobby/induscode.php?l name=H4300&year=2009   At October 11, 2009 8:51 AM ,  AM said... I have a 5 month old who received his first ActHIB on July 20th (born May 17th). He is overdue for his 2nd dose because we moved to Mexico during that time and ActHIB is not available here. I'm really concerned about the aluminum content in the other HIB vaccines so I have postponed his second shot until I can get back to the States. My question is: How long is the window between the two HIB shots before the 1st shot is rendered useless? (I plan on being in the States for Thanksgiving.) Also, is this window standard for all the vaccines or do the windows vary according to the particular vaccine? (I've got an issue with Tripedia coming up.) Please advise. Thanks so much!   At October 12, 2009 10:52 PM ,  Anonymous said... Hi Dr. Bob! I have a 3 year old, super healthy, has had some vaccinations in the past, BUT - is very allergic to egg protein (we carry epipens). I'd like to get him the H1N1 vaccine or nasal mist, but all are made with egg protein. What's the right approach? How dangerous could this be? Would I have the shot/mist in his allergists office and then wait a few hours to be safe? Thank you, Ryan's Dad   At October 22, 2009 5:09 AM ,  Anonymous said... Dr. Bob, Do you know when they will start to care about the seasonal flu vax supply again? My 8 month old got her first dose in September, and less than a month later, they are out and have no clue when a shipment will come. AND, is she protected at all, or did she get a shot that will not even help her? We do preservative-free, and I'm even more concerned about availability with that particular shot, too. Thanks!   At October 22, 2009 9:16 AM ,  Jennifer said... Your claim that "The product inserts make it VERY clear that the “swine” flu versions of these vaccines have NOT undergone any testing to demonstrate whether or not they are safe and whether or not they even work" makes me doubt whether you know anything about what you're talking about. I work at a pharmaceutical research company that HAS been testing the H1N1 vaccine for safety (and some efficacy). The FDA will not approve anything that hasn't at least been safety tested.   At October 27, 2009 5:43 PM ,  Anonymous said... What parents have to understand is that even though this site may list a bunch of vaccine manufacturers and the products they make, your doctor's office may not carry the particular vaccine you want your child to receive. As far a seasonal flu vaccine supply, I doubt that Dr. Bob will be able to shed more light than what your pediatrician has already told you...there is a delay in shipment because manufacturers have been concentrated on the H1N1 The same thing happened at my pediatrician's office.   At October 29, 2009 9:01 AM ,  Candide said... Dear Dr. Bob, I was on the fence about the H1N1 vaccine, but when my 15-month-old nephew became very sick for a week it was scary enough to make me want to avoid this in my 8.5 month old son. So when the H1N1 vaccine became available for babies we went to the health department to get one. They wouldn't answer my questions about whether there was mercury in the vaccine until I had waited and was with the nurse. It was then that I learned that the only vaccine they were given had the full dose of mercury in it. I'm bad at making decisions on the fly and the nurse's recommendation was to go ahead and get it anyway, so I did. Since then I have been worried that I made the wrong decision, and have been constantly watching my son to make sure I don't see any changes in his personality. I called his pediatrician and they too said I had made the right choice. But no one will discuss seriously with me what the risks are. Other than this shot, I have been following your alternate vaccination schedule, so my son has received essentially no mercury up until now. Will we probably be ok if it's just this one shot and we go back to avoiding mercury from this point on? Thanks so much for your time, Amalia (Nolan's mom)   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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