|
HIB Vaccine Shortage Over, but Don’t Rush in to Catch Up
For almost a year now there has been a shortage of HIB vaccine, due to a production snag for one manufacturer last year (Merck, the makers of PedVaxHIB brand). Due to the shortage, doctors have been withholding the final dose of the vaccine (normally given at 15 months of age). HIB vaccine is designed to prevent HIB meningitis, a severe disease that only affects about 25 U.S. infants and young children each year (it used to run rampant back in the 1980s, but has now all but been eliminated).
Sanofi-Pasteur, the maker of ActHIB brand, has been trying to pick up the slack until Merck’s product becomes available again. While it is still unknown when the Merck brand will be ready, the CDC has now determined that there is enough ActHIB brand to go around, so toddlers can begin receiving their 15 month booster. This dose can be given at any time between 15 months and 60 months (5 years) of age. Any child who didn’t get their 15 mo booster can get the dose at any age up until 60 months.
There are two ways to get the 15 month booster: 1. get the ActHIB brand, or 2. Get Pentacel combination vaccine (which contains DTaP, ActHIB, and Polio) at 18 months. These are both made by Sanofi Pasteur. I think it is fine to go with Pentacel combo if your doctor doesn’t carry (or doesn’t have enough) separate ActHIB. Getting Pentacel may give a child an extra polio dose unnecessarily, but I think that’s ok if that’s your only choice. Talk to your doctor about that.
Parents may wonder if they should even bother with catching up on the missing HIB dose. Virtually all cases of HIB occur in children younger than 2 years. A few cases occur in kids 2 to 5 years each year. One 4 year old child died of HIB last year in Minnesota (unvaccinated). So, I think it is worthwhile for any child missing that last dose to go ahead and get it at their next check up, as long as it is before their 5th birthday. This vaccine can be given along with any other vaccines.
Any parent who wants to skip that dose because they feel this risk of HIB is minimal can choose to do so. In general, though, I feel it is important to finish. The 3 infant doses don’t provide lasting protection. Without the 4th dose, an infant is considered not very well protected.
There is ONE situation in which a child would not need a 4th dose, and that is if a baby’s 3rd dose was given at 15 months or later. In those cases, that 3rd dose works well enough that you don’t need a fourth.
One other situation in which only 3 doses are needed is if the Merck brand (PedVaxHIB) was used (prior to its recall in 2008) and 3 doses were given. With that brand, there is no 4th dose. With the ActHIB brand (Sanofi-Pasteur, whether single ActHIB or combo Pentacel), it’s 4 doses.
The CDC is recommending that children NOT rush in to the doctor to get caught up (unless it’s going to be a while until your next checkup – 6 months or more). If everyone rushes in, doctors are going to run out again. The CDC recommends that doctors resume giving any 15 month olds the shot on time, and any toddlers who come in for a check up after that (18 mo, 2 years, etc) should get the shot at that check up.
If your child is already scheduled to get two shots at a check up, I would come in on a separate month for the HIB.
Dr. BobLabels: Vaccine News
Return of Separate Measles, Mumps, Rubella Vaccines Planned for 2011
I received official word from a Merck representative that the company plans to resume production of the separate M-M-R component vaccines. They anticipate these becoming available in 2011 (no actual month specified). This is good news for those parents who want the vaccines separated, but the two year wait will leave some kids unprotected. In my MMR blog from January (http://www.askdrsears.com/thevaccinebook/archives/2009_01_01_archive.asp) I discuss all the ins and outs of deciding whether or not to do the full MMR. Delaying it definitely puts children at risk of catching these diseases. Parents have to weigh all the information and decide what to do. The good news is that it looks like the separate shots will be back. I will certainly let you know as soon as they become available in 2011.
Dr. BobLabels: Vaccine News
U.S. News and World Report February Issue Features Dr. Bob’s Alternative Vaccine Schedule
The vaccine debate rages on, and Deborah Kotz’s feature in the February issue provided a very well done summary of many of the current issues. She included many quotes from various medical experts from around the country about parents’ growing fears over vaccines side effects and where we should go with research. Here are some of the highlights that I found interesting:
Pediatrician Catherine DeAngelis, editor in chief of the Journal of the American Medical Association (now that’s a credential!), was quoted as saying, “I certainly think it’s wrong to give [Gardasil] to young teenage girls. What are the risks? We won’t know until it’s given to millions of women.” It’s interesting that the chief editor of JAMA would make such a statement, but it does echo what many parents across the country are saying about Gardasil.
“According to the CDC, if every American child followed the schedule, 33,000 lives would be saved every year.” I find this very hard to believe. Vaccine-preventable diseases only kill about 500 children each year (a rough estimate, but it’s still very tragic). Where does the CDC get such a high number? I think they are probably including all the elderly people that die of the flu, Hepatitis B, and cervical cancer. That may be true, but this number gives the false impression that 33,000 children are dying each year of what should be vaccine-preventable diseases. That’s just not true.
Deborah discusses how the AAP and CDC are approaching the issue of vaccine safety. In my opinion, there is a significant disparity between the two institutions in how they are handling the public’s worries over vaccines. The AAP’s answer: form an “immunization alliance” to create a publicity campaign (not research!) to push for all kids to get all recommended vaccines on time, lead by vaccine patent-holder Dr. Paul Offit. But the CDC, while also encouraging the same policy, is willing to admit that more research needs to be done. Deborah quotes Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (which is a key partner in new research initiatives on vaccines) as saying “If we can show that individuals of a certain genetic profile have a greater propensity for developing adverse events, we may want to screen everyone prior to vaccination.” It seems to me that the AAP just wants to keep doing business as usual, and the CDC wants to do more research (while continuing to do business as usual for now).
In regards to the Hannah Poling case (whose autism was ruled by the U.S. Vaccine Court to be triggered by vaccines because she had a mitochondrial disorder), Deborah quotes neurologist Dr. Bruce Cohen (a mitochondrial disease expert at the Cleveland Clinic) as saying, “Mitochondrial disease often occurs in the later stages of a viral illness, and it’s proper reasoning to think that vaccines could do what viruses do” in terms of immune reactions.
John Iskander, the CDC’s associate director for immunization safety, is quoted as saying, “Vaccines are extraordinarily safe medical products.” He also comments on the issue of unknown safety risks of two new vaccines, Menactra and Gardasil, which only need to be tested on several thousand people in order to receive FDA approval: “These trials simply aren’t big enough to detect rare events that only come to light after 1 million or more doses are distributed.”
Dr. Bernadine Healy, former director of the National Institutes of Health, adds her two cents (or rather, her couple of bucks) to the article with a discussion of where the NIH is headed with its vaccine safety research efforts to learn “how to use them more safely and effectively.” They plan to study how vaccines can affect the immune in ways we don’t yet know, learn how to identify susceptible groups who may respond poorly to vaccines, to study various vaccine schedules, and to learn more about the infant immune system.
Deborah reminds us that “the original vaccine against rotavirus . . . was tested on fewer than 1300 American infants before it was approved in 1998; a year later, after being given to 1.5 million babies, Rotashield was pulled from the market because 13 reported cases of severe intestinal blockages were attributed to the vaccine. The meningitis vaccine Menactra was studied in just over 7500 people before it was approved in 2005 . . . It wasn’t until . . . after 15 million doses had been administered that the CDC announced a “small increased risk” of Guillain-Barre [a paralyzing disease] that needs to be studied further.”
Deborah points out the drawbacks of the VAERS system and discusses the CDC’s Vaccine Safety Datalink, a better monitoring system for studying adverse reactions. Dr. Richard Platt from Harvard is expected to release the results of this system’s monitoring of Menactra side effects (namely Guillain-Barre) later this year.
Deborah reminds us that avoiding immunizations altogether isn’t a good solution for families because certain serious diseases could rise sharply and cause more fatalities if vaccination rates drop too sharply. “Parents who choose not to vaccinate had better hope that other parents aren’t following their lead. Certain approaches (referring to my alternative vaccine schedule), though, can help minimize risks without leaving children unprotected.
She ends the article with a layout of my alternative vaccine schedule. This is the first national publication to do so in a neutral/positive light (Yay!). You can find an online version of this part of her article here. If you click on the vaccine chart on the left side, you’ll see my alternative schedule laid out next to the AAP/CDC schedule.
This is the first vaccine article that I’ve read in a mainstream news magazine or newspaper that didn’t end with, “So vaccines are perfectly safe, parents have nothing to worry about, and everyone needs to vaccinate their babies according to the standard vaccine schedule.” But it didn’t end with “vaccines are dangerous and everyone needs to beware” either. The article summarized what seems to be a shift within the CDC, NIH and the government toward more research into making sure what we are doing with vaccines is safe, how we can improve upon it, how we can screen out that very small number of infants who may not react well, and how we can gain a better understanding of how vaccines affect the immune and nervous system.
The party line used to be “vaccines are perfectly safe, we know everything we need to know about their side effects and how they affect the immune and nervous system, and that’s that.” I can’t tell you how many AAP medical meetings I’ve been to where doctors just sit around and laugh at anyone who even thinks about saying anything negative about vaccines. They literally laugh. I think that arrogant mindset is changing. How can anyone pretend that we know everything? We need more research. I’m not saying we should stop vaccinating, neither is Deborah Kotz in this article, and neither are any of the doctors whom she quoted. But it seems that the call for more research and understanding has been heard. I look forward to seeing it all (in ten years or so, unfortunately).
What will happen to the vaccine industry if research finds that a small, but significant, percentage of children truly are susceptible to suffering some harmful neurologic or immunologic effects? I predict that this will NOT lead to a change in our overall vaccine policy. The fear over what would happen with diseases is too powerful of a concern in the medical community. I think that in most doctors’ minds, disease prevention takes precedence over the occasional developmental challenges that vaccines may trigger in a small subset of our population. I’m not saying that’s right, I’m just saying that’s the way I think the medical community would view this issue if research proves there’s a concern for a small percentage of children. Of course, the financial and emotional burdens of autism on each individual family and our nation as a whole is huge, and it’s climbing. What is going to happen with these 1 in 150 kids in 20 years?
What I think will happen as more research comes out is that we will learn how to screen newborns to determine who is susceptible, then we will learn how to vaccinate them differently in a way that doesn’t cause harm to that small subset. Or we may not vaccinate them at all. But I don’t think that this research is going to lead to a sudden revelation that vaccines are dangerous to all children and that we should stop. In order for something like that to overcome the momentum that vaccine policy has, the research would have to be very clear that vaccines can harm many or most children. Labels: Vaccine News
Separate Measles, Mumps, and Rubella Vaccines No Longer Available? What Can Parents Do?
One of the most challenging and controversial parts of the alternative vaccine schedule is splitting up the MMR into three separate shots, spread out over a few years. The reasoning behind this idea is to expose a child to only one live viral vaccine at a time to allow the child’s immune system to better handle each vaccine and possibly experience fewer side effects. Although there is no medical evidence that this precaution is necessary or even useful, some parents, long before my book came out, have been skipping the MMR over fear of side effects. Some of these parents are more open to getting the separated vaccines. I present this option as a way to allow such families to vaccinate for these diseases. I don’t claim that it is the best way to go. I simply acknowledge it as an option.
Now, however, it seems that this option has been taken away from these families. The official word on Merck’s website is that these vaccines are not available for order. I’ve called Merck to ask if they are planning to start making more, but I can’t get anyone from the company to call me back. I have heard from numerous people and some news reports that Merck isn’t currently making the vaccine. I haven’t heard that they’ve decided to stop permanently, just that they aren’t producing any at this time. So, it’s pretty clear that, at least for the time being, there is no more to be had. It is probably safe to say that there won’t be any more for at least 6 months to 1 year. It is also possible that they won’t ever make the separate vaccines again.
This puts many parents in a difficult position. Some children have already received part of the series and are now left without a way to finish it without getting the entire MMR (and thus accepting extra doses of some components). Part of me wonders if Merck has stopped production as a way to force parents into an all-or-nothing decision. The AAP and CDC continue to insist on a “one size fits all” approach to vaccinating, without offering any suggested alternatives. Is this their way of forcing parents into the full MMR? I don’t know. The official word from Merck is that they need to devote all of the manufacturing capabilities to the full MMR and Chickenpox. They also state that the demand for the separate vaccines is so low that it doesn’t justify its production. One news story stated that the separate components only make up about 2% of the total MMR demand. Well, with 5 million babies being born each year in the U.S., that could be as many as 100,000 families searching for the separate vaccines each year. That would be a lot of unvaccinated children if these parents refused the full MMR.
One issue that I don’t understand is that the separate rubella vaccine is routinely used for adult women after they have a baby. Any new mom who doesn’t have rubella immunity is given the vaccine. If Merck stops making it, such women will have to get the full MMR, even if they still have good measles and mumps immunity.
The separate mumps vaccine also has its usefulness. During the outbreak of 2005/2006, many teens and adults needed a mumps booster to help contain the disease. If separate mumps vaccine isn’t made available for such events, the full MMR will have to be used. The same would be true if a measles epidemic occurs.
So, what can parents do? Parents hate to give their children an extra dose of a vaccine if it isn’t needed. You’ve gone to all the trouble to try to split it up, and now you are faced with having to give it all together anyway. I know it’s frustrating. One note of encouragement is that there is no known harm in getting an extra dose, other than the fact that you are taking the small risk of a side effect an extra time and the frustration of knowing the separate shot you gave earlier was all for naught. If a child already has some immunity to one of the diseases from a previous vaccine, I’ve never seen any research that shows a child is any more likely to react to a second dose compared to anyone just getting their first dose. I’ve seen no evidence that getting an extra dose is dangerous. I know it’s very small consolation, but I just mention this so that parents aren’t afraid to get any extra components of the MMR if they decide to.
Part of me wants to rally the nation’s parents in a campaign to insist that Merck begin making the shots again. Write your Senators, email Merck (politely!), refuse to get the full MMR! But that just isn’t responsible. Skipping the shots altogether leaves children at risk, the riskiest disease being measles. Of course, parents do have the option to skip the vaccine altogether. Even in states with mandatory vaccines laws, parents can still exercise a religious exemption (except for West Virginia and Mississippi).
But for those of you (which is most of you) who do want MMR protection, I will offer you some choices. There isn’t one right choice here. When it comes to MMR there is so much controversy that I don’t believe there is one clear option. So, I will lay out all the choices so you can think it through. Most people who are very pro-vaccine feel my MMR recommendations should more closely reflect the standard American vaccine schedule. Now that the separate M-M-R vaccines are no longer available, most such vaccine advocates are hoping that I will now begin recommending the MMR at the standard ages of 1 and 5 years. To these people I would like to point out that I don’t make absolute recommendations. I present options. That’s what I’m going to do here.
Here are all the options, depending on whether or not your child has received some of the separate components:
CHILDREN WHO HAVE NEVER HAD ANY MMR COMPONENTS
- Parents who feel confident in the safety of the MMR vaccine should go ahead and vaccinate at the recommended age of 1 and 5 years.
- Parents who were planning to do it separately because they have some worry about side effects should wait until a later age to get the full MMR. I suggest waiting until a child is either 4 years of age or enters school, whichever comes first. The reason for the 4-year recommendation is two-fold: 1. Many kids don’t enter school until age 4, so their risk of catching measles, mumps, or rubella is very low, and the risk that they would expose other kids if they got sick is very low, and 2. Most states only require one dose of mumps and rubella if that one dose is given at age 4 or older, because the vaccine works much better for older kids like this. Some states do require a second dose of measles, however. See the State Requirements section below.
- Parents who don’t feel comfortable leaving their children susceptible to these three diseases until age four, but want to delay it for at least a little while, can get the MMR at whatever age you feel most comfortable. If your toddler or young child is entering early preschool at age 2 or 3, you may want him to have the disease protection. If you get the MMR before age 4, your child would need a second dose around age 5 according to the regular vaccine schedule. This second dose is given because a small percentage of kids lose their immunity from the first dose and need a booster. From a health care cost perspective, it isn’t economical to test every child’s blood at age 5 to see which kids need a booster, then only give those kids a booster. So, the routine practice is to just give the two doses to everybody. If you don’t want to simply follow this routine 2-dose schedule, and instead want to try to get by with just one dose, you can do the one dose at any age, then get a blood test around age 5 to check immunity, then repeat the MMR if needed.
- When you do get the MMR, I would suggest getting it alone, without any other shots. You can pick any time in the vaccine schedule to do it. There is no exact time that I would place it into my Alternative Vaccine Schedule. It’s an individual choice for each parent. If you get the shot at 1, 2, or 3 years of age, you can then either get the booster at 5, or do blood testing to confirm immunity and skip the booster if your child is still immune to all 3 diseases. There is also the possibility that in a few years we will have separate M, M, R component vaccines again, and you can give a booster shot for only those diseases your child needs a booster for, based on the blood immunity results. If the separate shots are not available, and 1 or 2 parts of the first shot (but not all three) have worn off, it’s okay to get the full MMR again. Or, you could just leave your child susceptible to a disease. The choice is yours.
The risk of skipping or delaying the MMR
Although these diseases are rare, outbreaks can occur. I encourage you to re-read the MMR chapter to refresh your memory on these diseases. The riskiest disease is probably measles. While most kids weather the disease without problems, occasional complications do occur. The risk of suffering a fatality from measles is about 1 in 1000 to 1 in 3000 cases. The risk of suffering a non-fatal complication that requires hospitalization (such as pneumonia, dehydration, and a variety of others) is unclear, but is probably 1 in 100 to 1 in 300 cases. Many years have gone by in the U.S. without a measles fatality. I pray it stays that way.
CHILDREN WHO HAVE ALREADY HAD ONE DOSE OF ALL THREE MMR COMPONENTS EITHER SEPARATELY OR TOGETHER
This decision is easy. Either get the 5 year booster of MMR, or do a blood test around age 5 to check immunity and don’t get any more MMR if immune to all three diseases. If your child is only immune to 1 or 2 diseases, but not all, it’s OK to get a full MMR. Or you can wait for the separate vaccines to come out again.
CHILDREN WHO HAVE ALREADY HAD 1 OR 2 COMPONENTS OF THE SEPARATED MMR VACCINES
Those of you who have already begun the process of separated MMR vaccines, you probably did so with two things in mind: You at least had some concern about MMR safety, and you felt comfortable to some degree with leaving your child susceptible to some of these diseases during the early years until all three doses were given. But now what do you do?
- If your child has already received 1 dose of rubella (but no mumps or measles yet), you either have to get the full MMR now or wait until 4 years of age and get it then. It all depends on how comfortable you are with leaving your child susceptible to mumps and measles. You can review the book information on mumps and measles to refresh your memory. Leaving a child open to measles is probably the riskiest of the three diseases. If you get the MMR at 4, you can verify mumps and measles immunity with a blood test about 6 to 12 months later if your state requires it, since your child only received one dose. If your state doesn’t require it, I wouldn’t bother with an immunity check since most kids get full immunity after just one dose given this late. See State Requirements below.
- If your child has already received 1 dose of mumps (but no rubella or measles), the same information applies as the previous paragraph. Rubella is extremely rare, and harmless to young children. Review the disease information in the book to remind yourself of the risk to pregnant women.
- If your child has received 1 dose of measles, but not mumps or rubella, then I suggest you wait until age 4 to do the full MMR. That will give your child the required 1 dose of mumps and rubella, and 2 doses of measles. I wouldn’t bother checking blood immunity levels in this instance – you are pretty well covered. Since rubella is harmless to young children, and mumps is virtually always harmless, it is generally safe to remain susceptible to these until 4, especially if not in school yet. However, you should fully inform yourself about the personal and public health risks of delaying these shots by reviewing those pages in the book.
- If your child has received 2 out of the 3 components already, it is not worth getting a full MMR prior to age four just to get protection from the third disease now, only to have to get another booster dose at age 5. Just wait until age 4 or 5 to get the full MMR, as long as you feel comfortable with the disease risk for a couple years for whichever vaccine hasn’t been given yet. See State Requirements below if you worry that your state laws may require you to get the shot sooner. If the third disease that you haven’t gotten the shot for yet is measles, I would just wait until 4 to get the full MMR dose.
- Technically you can get the full MMR as close as only 1 month after any doses of the separate vaccines. However, as a precaution I would suggest putting at least a few months between them if you move on to the full MMR
MEETING STATE REQUIREMENTS
If you live in one of the 20 free states (these are listed on page 218 of the book) that allows parents to skip a vaccine for personal beliefs, and you chose to skip the MMR during infancy, I would suggest getting the MMR around age 4 or 5 when your child is going to have more exposure to other children and the general public. I wouldn’t bother with immunity blood testing – this one shot works very well in virtually all kids who get it late. If you want to skip the shot until the pre-teen years, it may be useful to check blood immunity around age 10 prior to the shot, since by that time your child will have been around many kids for many years and might have acquired some natural immunity. If your child does not have immunity to one or more diseases, you can either get the full MMR or separate components if they are available at that time.
If you live in one of the 30 states that have mandatory vaccine laws, and you don’t want to claim religious exemption, realize that this doesn’t mean you absolutely have to get the MMR at age 1 and 5 years. You only have to meet the state requirements by the time a daycare, preschool, or kindergarten is going to enforce it. So, this means that if you are worried about the MMR, you can delay it for a year or two (or more) until your child enters school. Most states only require one dose of mumps and rubella if given at age 4 or older (since getting the shot at this later age works much better). Most states, however, will require either 2 measles vaccines, or a blood test to verify immunity from just the one dose. I suggest getting a blood test 6 to 12 months after the shot to prove this immunity. If not immune to measles, a second dose may be required by your state. This may mean another full MMR if the separate shots aren’t being made yet. If you do need (or want) to get the full MMR at an earlier age (between age 1 and 3 years), I suggest you do it alone, without any other shots.
SUMMARY
In the vaccine book I clearly state that vaccines are important, and that I believe the benefits outweigh the risks. Each vaccine can have a serious side effect, but in most cases this is rare. The MMR, however, is unique in that it is a triple live virus vaccine, and therefore has a more extensive list of possible reactions. These reactions mimic what the actual disease complications can be. Some of these reactions are very serious. Yes, the serious reactions are extremely rare, but it is a risk nonetheless. However, vaccinating for the MMR diseases is also a very important individual and public health concern. Measles will continue to increase if parents don’t vaccinate. Rubella may come back. The more people that don’t vaccinate, the more likely this is to happen.
I have presented the options here. It’s not based on what the right or wrong decision is. It all comes down to what you as a parent and individual believe about the safety of the MMR and the risks of the three diseases. Remember, my alternative vaccine schedule isn’t a reflection of what I believe all parents should do. It is a suggestion for parents who are more worried about vaccines than the average person, and want to vaccinate their child more carefully. Splitting the MMR was part of that approach, but now it’s not an option for the foreseeable future. If I was to have written my alternative vaccine schedule without the separate vaccines, it would probably look something like this: MMR at age one and five, with an asterisk that says if you are worried about a reaction to the MMR, wait until age 4 to get the first (and only) dose, or get it sooner if your child will be entering early preschool (and possibly need a booster dose around age 5 or 6).
LOOKING INTO THE FUTURE – WILL WE HAVE SEPARATED DOSES AGAIN?
I think that one of two things are going to happen:
1. Many angry parents are going to delay or skip the MMR vaccine (either out of protest against Merck or out of worry over side effects), and once the government notices this (as measles increases or reports on non-compliance grow) they will ask Merck to begin producing the separate doses again. Post-partum moms who need a Rubella shot, but refuse the full MMR, may add to this campaign. When outbreaks of measles and mumps do occur (and they will!), and the parents of any unvaccinated children refuse the full MMR (but make it known they would happily accept the single component vaccines), the government might take notice.
OR
2. Only a small minority will skip the full MMR. Most parents who wanted the separate shots will go ahead with the MMR at the recommended age of 1 year, and enough children will be vaccinated so we don’t see any appreciable rise in measles, mumps and rubella. Merck won’t begin making the separate shots again.
Labels: Vaccine News
HIB Vaccine Shortage Continues – Pentacel Combo Vaccine is an Acceptable Alternative for Now
With Merck’s PedVaxHIB vaccine still unavailable (and not anticipated to return until mid-2009), the country has been relying solely on Sanofi Pasteur’s ActHIB brand (which happens to be my preferred brand since it is aluminum-free). While most doctors, including myself, have been able to remain stocked with ActHIB (given at 2, 4, and 6 months of age), we aren’t yet able to offer the 4th and final dose of HIB vaccine at 15 months (current recommendations state to skip this last dose until the shortage is over). Some areas of the country may have already run out and are unable to provide any doses of plain HIB. Some doctors have instead begun offering Pentacel (a combo vaccine from Sanofi Pasteur that contains DTaP, Polio, and HIB). The HIB component is identical to ActHIB. The polio and DTaP components vary slightly from the regular plain polio and DTaP vaccines, but not in any way this is significant (read more about this under the Vaccine News Blogs). The amount of aluminum in Pentacel is the same as what is in Sanofi Pasteur’s plain DTaP (330 mcg).
I believe that Pentacel is an acceptable alternative during this shortage. Although it does give polio vaccine earlier than where I have it on my Alternative Schedule (which has polio at 9, 12, and 24 months), using Pentacel at 2, 4, and 6 months provides all three vaccines (DTaP, HIB, and Polio) at the usual ages recommended on the regular vaccine schedule. I wouldn’t recommend using Pentacel for all four infant doses of DTaP and HIB (2, 4, 6, and 18 months) because that means an extra Polio dose (only 3 are needed during these first 2 years). Feel free to use Pentacel for any 3 or the 4 doses at 2, 4, 6, or 18 months.
How this would look on my Alternative Schedule would be something like this:
2 mo – Pentacel
3 mo – PC, Rota
4 mo – Pentacel
5 mo – PC, Rota
6 mo – Pentacel
7 mo – PC, Rota
6 to 12 mo – flu shot at start of flu season, whenever you can work it in.
Then continue on according to my schedule, just without the 9, 12, and 24 mo polio shots.
You can also do the opposite – PC, Rota on the even months, and Pentacel on the odd months.
If you begin Pentacel, you can switch back to the individual components at any time if the HIB supply returns.
Dr. Bob Labels: Vaccine News
A Response to Dr. Offit’s Misleading and Inaccurate Review of The Vaccine Book in Pediatrics, January 2009
On December 29, 2008, Dr. Paul Offit published a special article entitled “The Problem With Dr. Bob’s Alternative Vaccine Schedule” in Pediatrics (www.pediatrics.org/cgi/doi/10.1542/peds.2008-2189). Affiliated with the Vaccine Education Center at Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine, as well as the co-inventor and co-patent holder of the RotaTeq vaccine, Dr. Offit has long been recognized as a prominent and respected leader in vaccine education and research. He has been one of the primary spokesmen for the American Academy of Pediatrics’ recent campaign to improve the public trust in our nation’s vaccination policy. I appreciate Dr. Offit taking the time to review The Vaccine Book and offer his constructive criticisms on it. Dr. Offit and I agree on many things, including the opinion that vaccines are extremely important and have been one of the most valuable public health endeavors in the past several decades.
I would like to take this opportunity to clear the record regarding The Vaccine Book and my own professional opinions on vaccines. I believe that Dr. Offit has greatly misrepresented the overall message of the book as being ‘anti-vaccine.’ In fact, the book encourages parents to vaccinate their children. In order to give parents a complete educational experience, while presenting all the ‘pros’ of vaccines I felt it was important to list the ‘cons’ as well by discussing the potential side effects from the vaccine product inserts (while emphasizing how rare any severe reactions are). I also discuss the reasons why some parents choose not to vaccinate so that the readers can understand what these parents’ issues are. I believe that vaccine books that only show one side of the issue aren’t an effective educational tool. That’s why I present both sides.
However, I believe that Dr. Offit has misconstrued the book’s overall message by selectively extracting various phrases and sentences that discuss anti-vaccine ideas and worries that parents have and portraying those ideas as my own. He quotes various areas of the book that sound anti-vaccine without offering the pro-vaccine conclusions that I offer on the subject. I would expect colleagues within the AAP to have more respect for each other and double and triple check to make sure something printed in Pediatrics wasn’t so riddled with selective, misleading, and inaccurate quotes. I will point out such areas in my discussion below. I will say that there are a couple of small items in the book that Dr. Offit points out are in error, and I appreciate that clarification he has been able to offer. I will discuss these areas, and the changes that I will make in the next edition of the book.
I will admit that the book does offer one major controversial idea; my alternative vaccine schedule. However, it is important to note the context in which I offer that advice. At the end of the book, I encourage parents to vaccinate their children according to the CDC schedule if they feel confident in our nation’s vaccine system. For those parents who, after reading all the reasons why vaccines are important in my book, still believe vaccines aren’t safe and plan to not vaccinate, I at least ask them to consider getting the most important infant vaccines so their babies have protection from the life-threatening illnesses (HIB, PC, DTaP, and Rota). Where my alternative schedule comes into play is for those parents who are still unsure about vaccines, but they do want to fully vaccinate. I offer them an optional schedule that gets their child fully vaccinated, but at a slower pace. It doesn’t delay any of the most important shots, but it slightly delays some shots that are for lower-risk diseases. This option is really for parents who would otherwise leave a doctor’s office unvaccinated – parents who are too torn to make a decision, and therefore often don’t make any decision to vaccinate at all.
It is my belief that many families go unvaccinated simply because they aren’t offered a more gradual option. If they were, many would vaccinate. I believe this approach would actually increase vaccination rates, not decrease them as Dr. Offit suggests. I think that is our main area of disagreement.
The rest of this article will take a look at each of Dr. Offit’s statements and offer my own view. This isn’t going to be any sort of “great debate over vaccines” because we agree on most things. I will point out the parts of his article that I agree with, and parts that I accept his correction on something that I wrote in error.
Open debate and discussion is healthy in the field of medicine. I welcome it, and I’m sure Dr. Offit does as well. However, I must take issue when a person very clearly misrepresents information in my book, selectively quotes certain sections out of context, and attributes statements and ideas to the book and to myself that I never even wrote. Some of these errors are so erroneous, it’s almost as if Dr. Offit was reading some other anti-vaccine book instead of mine. The purpose of my response is not to determine who’s right and who’s wrong. It’s simply a clarification of some false claims made against me.
Doctors Do Not Understand Vaccines
I agree with what Dr. Offit says here, except that I think parents want their own personal doctor to have a more thorough understanding of vaccines. Parents are much more likely to accept their doctor’s advice if the doctor has a complete understanding (or nearly so) of all the vaccine issues, side effects, ingredients, safety research, and possible drawbacks to a vaccine. If a doctor can look a patient in the eye and say, “I’ve spent weeks investigating all these issues personally and reviewing all the research myself, and, along with the expert backing of the AAP, CDC, and ACIP, I believe that the vaccines are safe and should be given according to the CDC schedule,” that has much more weight than a doctor simply saying, “I agree with the AAP, CDC, and ACIP that vaccines are safe.” Parents aren’t automatically going to trust such organizations the way we doctors do. They want us to do our own homework. Back in the old days when most patients simply trusted what doctors said, maybe that wasn’t necessary. But today’s parents want more from us. They are asking questions that we, as doctors, should be prepared to answer. If we are caught off guard by a parent’s question, because we aren’t familiar with a particular anti-vaccine argument or a certain vaccine ingredient or side effect, the parent will lose trust in us.
Public Health Agencies and Pharmaceutical Companies Are Not Trustworthy
Dr. Offit’s words, not mine. I never make this statement, nor do I try to imply it. Most vaccine books are ripe with anti-pharmaceutical company conspiracies. In fact, I tried to steer clear of any conspiracy theories in this book. Now, when reading the quote he offers from the Hep B chapter of the book, in the context of first reading the above heading, I can see how one could read some “mistrust of the system” into my words. But this wasn’t my intent, nor is this impression given when read within the context of my book. In fact, on the next page I state, “These researchers were part of a very well-respected group – the leaders in their field.”
Now, two of the researchers involved in studying Hep B rates in children and helping to create neonatal Hep B vaccine policies did work for Merck and GSK. Anti-vaccine books love to jump all over any researcher who has ties to vaccine manufacturers. But I didn’t. But now that Dr. Offit has questioned this, I will comment. The doctors who worked with Merck and GSK and were part of the research that recommended Hep B vaccination in infants could be the most honorable, dedicated, unbiased doctors in the world. I’ve never met them. But in medical school we are taught to at least briefly raise an eyebrow at research funded by a pharmaceutical company, instead of simply taking it for granted. I will emphasize that while I did that, I didn’t do so based on their pharmaceutical ties. I simply wondered about the findings in the research. While some people might question the motives of and advice given by any doctor with financial ties to the vaccine industry, I refrain from doing so in my book.
Parents look at Hep B vaccination for their newborn and wonder, “Why?” Many pediatricians that I’ve talked to do as well. If Hep B is a potential risk to children through non-sexual casual contact, then vaccination would be a no-brainer. While writing my book I tried to find proof that non-sexual spread of Hep B is a significant risk to babies so that I could advise parents to vaccinate right away. But as a pediatrician, I’ve never seen it occur. And I’ve only heard of one case publicized in the media – an infected child sneezed on a teacher’s hand, and the teacher contracted Hep B through a cut on her hand. I’m sure there are many more such cases. But really, 16,000 kids each year less than 10 year old? Am I the only doctor that wonders whether or not that’s true?
I went straight to the source of disease data – the MMWR 2002 – to see what the actual reported cases of Hep B used to be in children younger than 10 years of age (Reference 1) and found that during the late 80s and early 90s, prior to introducing Hep B vaccine to infants, there was only 1 case of Hep B per 100,000 children age 0 to 9 in the U.S. (see chart at the end of the MMWR report). With 36,000,000 children in the U.S. in that age range, that only comes out to about 360 cases per year. The chart doesn’t differentiate between the perinatal exposures and accidental exposures. I know that some childhood Hep B infections will go unrecognized for many years, but I just can’t believe with such a low number of reported cases that the estimates of 16,000 cases per year can even be close.
The study that Dr. Offit refers to, as well as every other study done during the late 80s and 90s that looked at Hep B in young children, doesn’t actually determine the rate of Hep B by direct study or by reported cases (References 2 – 5). These studies provide estimates using population statistics. They look at adult cases, and estimate what percentage of those may have come from non-sexual contact during childhood, and make a logical guess at what the rate in children might be. Well, in order to really determine the rate of Hep B in children (to see if infant vaccination is warranted), all one would have to do is screen several thousand children for the disease and see how often it shows up. Then repeat the study again with a larger group. That’s what should have been done decades ago prior to introduction of the vaccine. The study could be done today on children who have skipped the vaccine. Why hasn’t anyone simply done that?
I have no doubt that Hep B vaccination is important, especially for pre-teens. And because there may be some small risk of non-sexual exposure to the disease during childhood, vaccinating during childhood may be important as well. I state this very clearly in the book. But does it have to be given right away during the neonatal period? For any family with a Hep B positive family member, yes – each baby should be vaccinated. But for the other 99% of American families, I don’t believe the vaccine needs to be given to young infants, especially in the hospital. Why give a less-than-necessary vaccine to a newborn and risk creating sepsis-like side effects (Reference 6 and 7)? Any family that asks to delay this vaccine shouldn’t be treated like they are crazy. They simply want to give their newborn a break for the first few weeks.
As for the issue regarding parents’ trust in the vaccine manufacturers, that trust was severely shaken when it was revealed in the Los Angeles Times on February 8, 2005, that way back in 1991 a researcher at Merck sent a memo to the president of Merck’s vaccine division stating that they had just realized that the cumulative amount of mercury in vaccines given to infants by six months of age was about 87 times the safety limits set by the FDA. And that information was not revealed to the public until 8 years later. Now I realize that pharmaceutical companies do so much good for our health and the field of medicine, and that such negative occurrences are rare. As a pediatrician I put my trust in them everyday by prescribing their products, including Merck vaccines, to my patients. But I find it surprising that any doctors can fault a parent for not completely trusting Merck after that, or the FDA and CDC departments that were supposed to be overseeing this type of issue.
Vaccine Mandates Should Be Eliminated
I don’t make any claim that unvaccinated children have been taken away from the home. I state that I have heard “rumors” of such, but that I don’t believe them. I do believe, however, that some states may actually have that power by law, but I doubt it has ever been exercised. You may recall the recent court battle this year on the East Coast in which parents were refusing the Hep B vaccine for their teenagers. The parents were threatened with jail time if they didn’t either sign the religious waiver or comply with vaccinations. I don’t know if anyone was ever jailed, but that is a really scary thing to have occurred in our free country. I agree with Dr. Offit that in the event of an outbreak that significantly puts the public health at risk, the state should have some authority to step in. But during the normal course of life, I believe that parents should have the right to decline vaccines.
Vaccine-Preventable Diseases Are Not That Bad
This is a prime example in which Dr. Offit has taken one statement out of the book and portrayed my viewpoint inaccurately. I clearly state how bad each disease can get as well as the number of yearly fatalities. At the very beginning of the PC chapter I share how serious PC disease is. I also state at the very end of that chapter that I consider PC “a fairly important vaccine.” At the end of each chapter I share any personal experiences I have had as a pediatrician with each disease, and this was the only one I’ve had for invasive PC. At the end of the book I strongly urge parents who are thinking of skipping vaccines to at least consider PC vaccine (as well as a few others). On my website, I dispel a myth that’s been going around that the PC vaccine is no longer important, and is causing other emerging strains, and I urge parents to continue getting the current PC vaccine until an expanded one comes available.
A word of thanks to Dr. Offit on this issue for pointing out that I could perhaps improve on my disease descriptions in the book. In the next edition I am planning to add a section on each disease that paints a picture of “a typical course of this disease”, then a “worst case scenario of the disease.” Dr. Offit is absolutely correct. Parents should know how bad each disease can be.
Hide in the Herd
I agree with Dr. Offit here. Herd immunity is very important. I state the argument in the book that “the good of the many outweighs the good of the few.” Nowhere in the book do I encourage parents to “hide in the herd.” Again, Dr. Offit’s words, not mine. I clearly state (as Dr. Offit quoted) the danger to our country if too many people don’t vaccinate. My comment on “not sharing your fears with your neighbors” was an attempt at humor, while trying to teach a very important point.
Natural Infection Is Better Than Vaccination
Again, what book is Dr. Offit reading? Not mine. I describe chickenpox parties in the book, but I certainly don’t recommend them. Notice the “. . .” in Dr. Offit’s quote here. The entire quote is “Some parents actually want their kids to catch chickenpox. They may purposely get their child exposed to get the disease over with.” I’m simply stating what some parents do. Not what I think they should do. As for the risk of acquiring natural immunity to a disease, I agree with Dr. Offit. It is a risk. And I clearly state what that risk is for each disease.
A very popular anti-vaccine argument is that childhood diseases are healthy. They exercise the immune system. Other authors encourage parents to allow their kids to catch many of these diseases. I couldn’t disagree more. My book tries to dispel that myth. No one wants to exercise their baby’s immune system with meningitis or hep B, or most of the other vaccine-preventable diseases.
Vaccination Has Eliminated Infectious Diseases at the Price of Causing Chronic Diseases
I never even come close to saying any such thing I my book. Allow me to quote from page 178: “Critics [of vaccines] worry that many chronic diseases and other physical and mental problems like ADHD, chronic fatigue, diabetes, allergies, asthma, learning disorders, and autism are triggered by vaccines. I haven’t found any solid research to support this contention.” Interestingly, this is the very sentence that precedes Dr. Offit’s quote here. As Dr. Offit points out, I go on to say I found studies that show a “possible link,” but that’s it. I actually go out of my way to debunk the myth described in the heading above. By the way, the peer-reviewed journals that discuss “possible links” include Revue Neurologigue, Rheumatology, British Journal of Rheumatology, Journal of Rheumatology (that’s a lot of rheumatology!), Lancet, Neurological Science, Scandinavian Journal of Rheumatology, Acto Dermato-venereologica, Autoimmunity, Journal of the American Academy of Dermatology, and Clinical Rheumatology, Journal of Allergy and Clinical Immunology. See References 8 through 19.
Vaccine Safety Testing Is Insufficient
I don’t say that safety testing is insufficient. Again, Dr. Offit left out some of the words in his quote. I start this particular chapter with a discussion of the extensive short-term research that is done with each new vaccine, describing the research in a similar way that Dr. Offit states here in his article. As for his quote from my book, the entire text reads: “A new medication goes through many years of trials in a select group of people to make sure it is safe. These subjects undergo extensive blood testing and physical evaluations over many years. If nothing severe or common shows up, the medication is then released for general use. Vaccines, on the other hand, don’t receive that same type of in-depth short-term testing or long-term safety research . . . Their blood isn’t tested to check for internal toxic effects. Doctors don’t do physical exams to look for problems.” My point here is that the short-term research could be more hands-on, instead of simply by parent questionnaires.
I agree that vaccine safety testing is very extensive, and in my mind it is very adequate. What we could improve is the long-term safety research. Dr. Offit points out how VAERS and VSDP are model systems for detecting rare adverse events. A few paragraphs down, however, under “Risks From Vaccines,” he states (somewhat contradictorily, if that’s a word) “VAERS is a passive surveillance system and cannot be used to determine the true incidence of adverse events, which can be determined only by using control groups.” I couldn’t agree more. We need a large placebo group of voluntarily unvaccinated kids to compare to the vaccinated population. I think that we will see that in the upcoming National Children’s Health Study.
But back to “insufficiency” of safety research. In the book I refer to a statement made by the Cochrane Collaboration in Vaccine 2003 (Reference 20) regarding a review of 22 studies on MMR vaccine safety: “the design and reporting of safety outcomes in MMR vaccine studies, both pre-and post-marketing, are largely inadequate.” Their words, not mine.
Public Health Officials Make Recommendations for the Public and Not for Individuals
I’m pouring through the book right now trying to find where I may have made such a statement, and I just can’t find it. Hmmm. What I do believe is that Public Health Officials view vaccine issues from two sides – the risk to individuals as well as the risk to our nation as a whole. Parents, on the other hand, tend to make decisions based on their own individual child, without considering the public’s benefit. I also state in the book that such a decision is perhaps “selfish.”
As for the polio vaccine, Dr. Offit fails to include other quotes from the book that state the importance of the polio vaccine: “I consider this vaccine very important from a public health viewpoint. Until the whole world is polio free, ongoing vaccination will help keep our nation protected . . . (page 79).” Because there haven’t been any cases of polio in the U.S. for decades, I do believe it is correct to say that we don’t use this vaccine to protect each particular child from catching the disease (as compared to every other vaccine we use). Rather, we use it for herd immunity. I agree with Dr. Offit that “every individual benefits from receiving polio vaccine.” There is no “flaw in logic” here. We are both saying the same thing.
Decision-Making
You know, I do suppose it was a little presumptuous of me to state that “I have offered you all the information you need to make this decision.” That would imply by book is 100% complete. No book is. I should have said, “I have given you almost all the information . . .” As for misinformation, I’m still waiting for some here.
Distinguishing Good Science From Bad Science
Because the science on vaccine safety is not complete, and never can be, I didn’t undertake the very tedious task of detailing every scientific study there is. Who would read such a book? This is a book for the general public. Where I state “Reasons some people choose not to get the vaccine,” I clearly state the risks that such parents are taking.
I will take this opportunity for the second time to state my appreciation for an oversight pointed out by Dr. Offit. I really should have delineated which studies come from a peer-reviewed (mainstream) journal and which do not. This is very important, so parents can decide whether or not a particular study holds any weight. This will be corrected in the next edition of the book.
Risks From Vaccines
Once again, I am respectfully thankful for this constructive criticism. Dr. Offit is right. We shouldn’t view reported reactions in VAERS as actual vaccine reactions, and I shouldn’t have used such numbers to determine statistical risks. I do, however, point out in the book that we don’t know that VAERS reports are actual vaccine reactions. The problem is, that’s the only system I have to try to determine what the risk of a vaccine reaction might be. I think parents deserve to know that. Until we have an active surveillance system, instead of a passive one, we won’t know what that risk is. I could also add that VAERS only contains reactions that are reported. Many reactions go unreported. So, even if only some of the VAERS reactions can be attributed to the vaccine, not all such reactions are actually reported. So, my numbers may reflect something close to reality. But that’s not scientific. We really need to take a better look at this.
Risks From Vaccine-Preventable Diseases
Wow. I am now convinced that we are not talking about the same book here. I not only make it very clear what the risks are from each disease, allow me to quote from the meningococcal vaccine chapter’s list of reasons to get this vaccine: “Obviously, meningitis is devastating. Getting the shot during the early teens protects a child . . . the chance that a college freshman in a dorm could catch it is something to consider. In the chapter’s conclusion: “No one can argue that MC disease isn’t a horrible thing to see, much less to actually catch.” That sentence precedes the one quoted by Dr. Offit here. Yes, I do comment on the GBS issue, as that was brand new information when the book came out. I state “If experts can determine that the risk of GBS is negligible, the shot will likely become more widely accepted.” I also predicted that it will become approved for two-year-olds, and state “this will become a very important vaccine, since the disease is more common in younger children.” I comment on GSK’s combo of HIB and MC vaccine for 2, 4 and 6 month olds (currently undergoing trials) and state “this vaccine will provide much-needed protection during infancy, when MC disease is most common.” I also describe MC disease (page 137) as “. . . extremely serious. This is probably the single most serious and potentially deadly of all vaccine-preventable diseases.” I go on to describe in detail the likely ICU course, with organ failure and likely permanent disability. Even though I fortunately don’t get to “see much of this evil”, I certainly describe it in the book.
Animal Products
I didn’t raise the specter of Mad Cow Disease. That’s a ploy found in many anti-vaccine books, and I state that this is an issue the critics often bring up. Dr. Offit is right, I should have mentioned that we don’t use “mad cows” in the U.S., but I though everyone already knew that.
Dr. Offit failed to mention the one time when a viral disease did contaminate a vaccine. And this was no small deal either. I open Ch. 16 with this info. In August of 2002 and February of 2003, the pediatric newspaper Infectious Diseases in Children published reports of SV-40 viral contamination of millions of doses of polio vaccine due to the use of monkey kidney tissues used to make the vaccine. It was estimated that almost 30 million people were injected with vaccines containing this virus between 1955 and 1963. Also, in 1980, 150 newborns were given an experimental Hep A vaccine that was contaminated with SV-40 virus. This virus has been linked to several human cancers, although fortunately the people injected with this virus haven’t been found to have higher than expected rates of cancer. Now we know to screen for this virus.
I find it peculiar that Dr. Offit portrays my book as raising the specter of mad cow, but completely leaves out the SV-40 virus problem. It’s not a problem anymore, but I use it as an example of what happened in the past. I state that vaccine critics worry that “unknown infectious particles or . . . foreign DNA in [human and animal] tissues may cause problems . . .” I end the section with “At this time, I can’t offer any good evidence to support these worries . . .”
Thimerosal
Actually, the whole point of my two-page discussion on thimerosal is that it has been removed from virtually all vaccines, so you really don’t have to spend hours researching whether or not it is harmful. I save the parents’ time by making it a non-issue. Going back and reviewing all the research is a moot point for parents deciding about vaccines today. I actually thought that I was doing a great service by dispelling this myth. I guess not?
Aluminum
Ok. Aluminum is a very complicated issue. It really deserves its own article. In order to provide you with a full discussion on aluminum, I have posted that section from the book on my website in the FAQ section on the right, click here to read. I ask you to not pass judgment until you’ve read the whole thing. I don’t use the 2002 Vaccine study in my book. Instead I use the 2004 Lancet study from the Cochrane Collaboration for a thorough review of aluminum (Reference 21). For those of you who don’t read the entire aluminum section of the book, here is the bottom line. We know aluminum is a neurotoxin. We also know that humans can ingest huge amounts without harm, since 99% of it passes out through the stools. I’m sure Dr. Offit knows that, so I’m curious as to why he’d use the “babies ingest tons of aluminum anyway” argument. I would also point out that the conclusion of the study that Dr. Offit refers to doesn’t say anything about proving that aluminum is safe. It simply concludes that the amount in vaccines didn’t warrant changing the schedule. Those are two completely different statements.
I’ve been searching and searching for human infant studies that determine what a safe level of injected aluminum is, including looking at all the studies used in the article quoted by Dr. Offit, and I can’t find a single one. There is a lot of animal research, a lot of studies that use theoretical mathematical models, and one human adult study, but not a single human infant study (see Resources 22-30). As a precaution, I show worried parents how to take precautions to limit their baby’s aluminum dosing during vaccinations. This allows these parents to vaccinate, instead of declining them all.
Other Vaccine Ingredients
Up until December 2007, the albumin used as a growth medium for the MMR viruses was human albumin filtered out of human blood. The PI described how the human albumin is screened for the absence of adventitious agents, and processed using the Cohn cold ethanol fractionation procedure. In December 2007, the MMR PI changes its description of the albumin to recombinant. Dr. Offit makes it sound as if I’m misleading my readers and printing false information, when in fact my information was correct in October 2007. I appreciate him highlighting this change, however. It’s good to see Merck moving away from using a human blood product. Not that this was a problem – the albumin was carefully screened and filtered. Reference 31.
MMR Vaccine and Autism
Actually, in the book I describe in detail six studies that showed no link between MMR and autism (References 32-37). As for the MMR vaccine/intestinal inflammation/autism theory being debunked, I would now agree with Dr. Offit. At the writing of my book, however, no one had yet repeated Dr. Wakefield’s work to prove him wrong. As of this year, a very well done study by Harvard, Columbia, Mass General, CDC, and the AAP has (Reference 38). I have written an update to this effect on my website. My initial worries about the MMR and intestinal inflammation are probably unfounded.
Coincidence Versus Causality
Again, it sounds like myself and Dr. Offit mostly agree here, although for some reason my agreement with him would be viewed as “poorly reasoned or illogical.” One can’t simply group all reported reactions into two groups: either proven to be caused by a vaccine or proven to not be cause by a vaccine. There are so many reported reactions that haven’t been proven one way or the other through scientific study. This is a third category, and as further research is done we will place each reaction in one of the first two categories. But until that is done, parents can only view these reports as somewhere between coincidence and causality.
Scientific Proofs
I agree. This is not a sound scientific argument. I just really wish we could prove a vaccine doesn’t cause a particular reaction. Parents could then worry a lot less. Although we can’t prove a negative, we can improve the long term safety research of vaccines so parents can be more confident.
Context
We’ve already covered this. As for the flu shot, here’s my opinion. Because mercury is a known neurotoxin, all the science in the world won’t convince many parents to give their baby a mercury-containing flu shot, especially when they have the option to get a non-mercury version. I completely agree with Dr. Offit’s statement that the science shows no evidence that the amount of mercury in a flu shot causes any harm. But I just don’t think that parents believe it.
Understanding Risk
I understand the risk of MC disease as well as any doctor, and I very clearly recommend this vaccine in my book: “Obviously, meningitis is devastating. Getting the shot during the teen years protects a child through high school and college . . . There are about 250 teen and college-age cases each year. The ingredients are among the purest and simplest of all vaccines . . .” I do discuss how the reported GBS reactions may worry some parents, and may cause dome parents to delay the vaccine. But never do I say not to get the vaccine: “. . . this vaccine is an important step in eliminating or at least minimizing the disease among our nation’s teens . . .” I also give a very strong recommendation in favor of its use in younger children if it becomes approved for that age group. I don’t understand how Dr. Offit could misconstrue my statements to say that I don’t recommend this vaccine. I agree that the risk of GBS is much smaller than the disease risk.
The Harm
In my selective schedule, I don’t tell parents not to get the MMR, VZ, Hep A, Polio, and Flu shots. That’s their decision. This schedule is designed to encourage non-vaccinating families to at least get their baby the DTaP, Rota, PC, and HIB vaccines, and their teens the HPV and Hep B vaccines.
Dr. Offit makes an incorrect statement regarding my alternative schedule. He says that children using this schedule won’t be getting a flu shot until age 5. On page 236, the flu is very clearly listed as a recommended vaccine starting at 6 months and continuing through to age five, so I’m not sure exactly what book Dr. Offit was looking at. Not mine.
My alternative schedule isn’t necessarily what I recommend parents do. In the book (page 235), I encourage parents who trust in our country’s vaccine system and safety, as recommended by our nation’s top medical experts and almost every doctor, to go ahead with the regular vaccine schedule. “I recommend that you trust your doctor’s advice, and your own intuition, and go ahead with vaccination.”
The alternative schedule is designed for parents who are worried about grouping so many shots together. That is the single most common worry I’ve heard from parents over the years. They want to fully vaccinate, they just want to do it at a slower pace. But up until now such parents haven’t had any guidance on how to do this. These are parents who otherwise may not be vaccinating, or if they do they are cringing and scared about doing it. Parents should feel secure and confident in their vaccine choices. Yes, this schedule is a lot more time consuming and more work for the parents and the doctor’s office. It certainly wouldn’t be a reasonable or practical vaccine schedule for our country as a whole. Babies would fall behind on their shots, compliance would wane, and some could be susceptible to what should be a vaccine-preventable disease. I agree with Dr. Offit there. My alternative schedule is simply an option for parents who want to take the extra time and effort. It’s just an option. I worry that if doctors don’t offer an option like this, some patients will go unvaccinated, and that’s not good. I believe this schedule will increase vaccination rates among non-vaccinating families.
The only vaccines that my alternative schedule delays to any extent are polio (until 9 months of age), Hep B (until 2 ½ years) and Measles (until age 3). This is virtually no risk involved in delaying the first two, but I agree with Dr. Offit that delaying measles vaccine is a risk, especially for a child in daycare or with older siblings. On my website, I encourage such families, and any family who is worried about measles exposure, to vaccinate for measles sooner.
Conclusion
The manner in which Dr. Offit has portrayed my book is erroneous and misleading. A more accurate discussion of the book would have been much more constructive. As a fellow pro-vaccine doctor, if my book had been portrayed correctly, we would find very little to debate about. I would expect colleagues within the AAP to have more respect for each other and double and triple check to make sure something printed in Pediatrics wasn’t so riddled with selective, misleading, and inaccurate quotes. The number one area that we don’t agree on is whether or not we should offer non-compliant parents some selective or alternative options. By doing so, do we increase or decrease vaccination rates among such families? That’s the main question. There is so much to talk about when it comes to vaccines and how to regain the nation’s trust in the system. This type of article further damages that trust.
You can find this article posted online tonight at www.TheVaccineBook.com
References:
1. Achievements in Public Health: Hepatitis B Vaccination, United States, 1982 to 2002. Morbidity and Mortality Weekly, June 28, 2002; 51(25):549-552, 563. Available online at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5125a3.htm
2. The changing epidemiology of hepatitis B in the United States. Need for alternative vaccination strategies, Alter MJ, Hadler SC, Margolis HS, et al, JAMA 1990;263:1218-22.
3. Prevention of hepatitis B virus infection in the United States: a pediatric perspective, West DJ, Margolis HS, Pediatric Infectious Disease Journal, 1992; 11:866-874.
4. Hepatitis B: Evolving Epidemiology and Implications for Control, Margolis HS, Alter MJ, and Hadler SC, Seminars in Liver Disease 1991, Vol. 11, No. 2.
5. Estimated and reported cases of Hepatitis B infection in children, Sepkowitz S, The Pediatric Infectious Disease Journal, Vol. 12, No. 6, June 1993.
6. Hep B vaccine Product Inserts list of report reactions, Merck and GlaxoSmithKline.
7. Unexplained fevers in neonates may be associated with hepatitis B vaccine, Linder N. et al, Archives of Disease in Childhood: Fetal and Neonatal Edition 1999; 81(3);206-207.
8. Vaccinations and multiple sclerosis, Gout O, Federation of Neurology, Paris France, Neurological Science 2001, Apr; 22(2): 151-154.
9. Arthritis after hepatitis B vaccination. Report of three cases, Gross K, et al, Scandinavian Journal of Rheumatology, 24 (1), 1995.
10. Atopic dermatitis is increased following vaccination for measles, mumps and rubella or measles infection, Olesen AB, et al, Acta Derm Venereol. 2003;83(6): 445-450.
11. Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM, Classen JB, Classen DC, Autoimmunity 2003, May;36(3):123.
12. Vaccination-induced cutaneous pseudolymphoma, Maubec E, et al, Journal of the American Academy of Dermatology, April 2005; 52(4):623-629.
13. Vaccine-induced autoimmunity, Cohen AD, Journal of Autoimmunity, 1996 Dec;9(6):699-703.
14. Kawasaki disease in an infant following immunization with hepatitis B vaccine. Miron D, Clinical Rheumatology, 2003 Dec;22(6):461-3.
15. Vaccination and autoimmunity-'vaccinosis': a dangerous liaison? Shoenfeld Y, Aron-Maor A, Journal of Autoimmunity, 2000 Feb;14(1):1-10.
16. Macrophagaic myofasciitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle, Gherardi M et al. 2001, Brain, Vol 124, No. 9, 1821-1831.
17. Adverse Events Following Pertussis and Rubella Vaccines, Howson C and Fineberg H, The Institute of Medicine, Journal of the American Medical Association, Vol. 267, No. 3, Jan. 15, 1992.
18. Persistent Rubella Infection and Rubella-Associated Arthritis, Chantler J, et al, The Lancet, June 12, 1982.
19. Is RA27/3 Rubella Immunization a Cause of Chronic Fatigue? Allen, Medical Hypotheses, 27: 217-220, 1988
20. Unintended events following immunization with MMR: a systematic review, Jefferson T, et al, Vaccine 2003, Sept. 8, 21(25-26):3954-3960.
21. 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 \
22. Aluminum Toxicity in Infants and Children, Committee on Nutrition, American Academy of Pediatrics, Pediatrics Volume 97, Number 3 March, 1996, pp. 413-416.
23. 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.
23 a. 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 http://www.fda.gov/cder/foi/appletter/2004/19626scs019ltr.pdf
24. 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
25. 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.
26. 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.
27. 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.
28. 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.
29. 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.
30. Neuropathology of aluminum toxicity in rats (glutamate and GABA impairment), El-Rhaman SS. Pharmacol. Res. 2003 March:47(3):189-94.
31. MMR vaccine Product Insert, Merck, 2003 and 2007.
32. Vaccines for measles, mumps, and rubella in children, The Cochrane Database of Systematic Reviews 2005, Issue 4.
33. No evidence for links between autism, MMR and measles virus, Chen W et al, Psychology Medicine 2004, Apr; 34(3): 543-553.
34. Immunization Safety Review: Vaccines and Autism, from the Immunization Safety Review Committee of The Institute of Medicine, 2004.
35. MMR vaccine and autism: an update of the scientific evidence. DeStefano F; Thompson WW, the Centers for Disease Control, Expert Rev Vaccines. 2004; 3(1):19-22 (ISSN: 1476-0584)
36. Epidemiology and Possible Causes of Autism, Hershel Jick, M.D.; James A. Kaye, M.D., D.P.H. Pharmacotherapy, Dec 2003
37. Unintended events following immunization with MMR: a systematic review, Jefferson T, et al, Vaccine 2003, Sept. 8, 21(25-26):3954-3960
38. Lack of Association Between Measles Virus Vaccine and Autism with Enteropathy, Hornig, et al., Public Library of Science, One 3(9): e3140
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140 Labels: Vaccine News
Flu Vaccine Update for the 2008/2009 Season
It’s flu season again, and people are already lining up for their flu shot. Each year, however, the flu shots change to cover what experts predict will be the “going” strains for the coming year. Last year they guessed wrong, and the flu shot wasn’t very effective. Let’s hope they get it right this year (as they did for the few years prior to last year). The available brands are virtually identical to what they were last year as far as manufacturing and ingredients go (including mercury).
The most important thing for infants, children, and pregnant women is to MAKE SURE YOU ARE GETTING A MERCURY-FREE FLU VACCINE. Here are all the flu vaccines for the 2008/2009 flu season:
FLUZONE Shot
This is the only brand approved for all age ranges, from young infants to adults. It comes in four different formulations:
Pre-filled syringe for infants 6 through 35 months – NO mercury.
Pre-filled syringe for children 3 years and older and adults – NO mercury.
Single-dose vial for children 3 years and older and adults – NO mercury.
Multi-dose vial for infants 6 months and older, children and adults – contains the full dose of mercury.
FLUZONE is the only brand of flu shot approved for young infants and toddlers. BEWARE – the multi-dose vial has the full dose of mercury. You have to make sure you are getting a single-dose pre-filled syringe or vial, NOT the multi-dose vial.
FLUMIST Nasal Spray
An alternative to the flu SHOT for young children is the FLUMIST nasal spray. There is no mercury in this formulation. It is approved for children 2 years and older and adults through age 49.
FLUVIRIN Shot
This shot is approved for children 4 years and older and adults. It comes in two formulations:
Pre-filled syringe – has a trace of mercury (see below)
Multi-dose vial – has the full dose of mercury
FLUARIX Shot
This is only for adults 18 years and older. It only comes as a pre-filled syringe with a trace amount of mercury.
FLULAVAL Shot
This is only for adults 18 years and older. It only comes as a multi-dose vial with the full dose of mercury.
AFLURIA Shot
This is only for adults 18 years and older. It has two formulations:
Pre-filled syringe with no mercury
Multi-dose vial with the full dose of mercury
Nasal Spray Versus the Shot?
Overall I have no preference between the two. The nasal spray is a great alternative for anyone who wanted the shot, but can’t find a mercury-free version. It seems that the nasal spray works a little better, but causes flu-like side effects more often. It also shouldn’t be used in anyone with asthma or a history of wheezing. The shot seems to not quite work as well, but may cause fewer side effects.
What is the Difference Between Trace and Full-Dose Mercury?
In trace mercury vaccines, mercury is added to the manufacturing process as a preservative, but is then filtered out at the end before being put into single-dose syringes or vials. A full preservative isn’t needed because this vial or syringe is only opened and used once, and then discarded. The amount of mercury in vaccines that are labeled “trace” is less than 1 microgram. I believe that this amount is completely harmless (as opposed to the full dose).
In full-dose mercury vaccines, the mercury is not filtered out. The preservative is needed for these large 10-dose vials because many doses are drawn out, and the solution needs to stay sterile during that process. The amount of mercury in these large vials is 25 micrograms per dose (any infants through age 3 getting a Fluzone shot from the multi-dose vial with mercury would only be getting a half dose, so each shot would be 12.g micrograms).
Why Not Just Make All Flu Shots Without Mercury?
The challenge is space and money. The five different companies that make the flu shot have to scramble every year to make enough. It costs more money and takes up more manufacturing time and space to put single doses of the flu shot into syringes or single-dose vials, compared to putting 10 doses into larger vials. In order to accommodate the demand, manufacturers have to make most of their product “in bulk” this way. In the future I hope that more companies will change over to mercury-free formulations, or the almost-as-good trace mercury formulations.
Infants and Pregnant Women – Just Say No To Mercury
The debate over whether or not mercury in the flu shot is enough to cause harm continues to rage on, with no clear resolution yet. I believe it is prudent in the mean time to avoid giving any full-dose mercury shots to children under 3 and to pregnant women. What should you do if all you can find is a full-dose version? Just say no, and tell your doctor why. Maybe if enough patients do this, doctors will order and demand more of the mercury-free version for next year. For kids 2 years and older, get the nasal spray instead (this can’t be given to pregnant women).
New Flu Shot Recommendations for This Year?
The ACIP, AAP and CDC have decided that it would be beneficial for all children to get a flu shot every year until age 18. Previously the recommendation was for all children until age 5. They don’t know whether or not to push this new policy for THIS year, or wait until next year, because they don’t know if there will be enough flu vaccine to go around to cover all children and teenagers. They don’t want to make a new policy unless they have enough vaccine to cover it. But whether it goes into effect this year or next, it is now believed by medical experts that it’s best to get a flu vaccine for all children and teens every year.
ALL OF THE INFORMATION IN THE VACCINE BOOK REGARDING FLU SHOTS FOR LAST YEAR IS STILL THE SAME FOR THIS YEAR (with the one exception that in the book I state that Fluvirin brand only has trace mercury, and this they also make a full-dose mercury version). FOR MORE INFORMATION ON DECIDING WHETHER OR NOT TO GET A FLU VACCINE, VISIT www.TheVaccineBook.com
YOU CAN VIEW THE PRODUCT INSERTS FOR THIS YEAR’S FLU VACCINES YOURSELF AT www.fda.gov/cber/flu/flu2008.htm
Labels: Vaccine News
Two New Combination Vaccines Now Available
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
Plain Mumps Vaccine Shortage - Should Babies Just Get the Full MMR?
Some parents are choosing to split the 1 year MMR vaccine into three separate shots. Although we don't know if this precaution is necessary, some worried parents prefer the choice of getting plain Mumps vaccine at 1 year, Rubella at 2 years, and Measles at 3 years.
With a shortage of the plain Mumps vaccine expected to last the rest of 2008, parents may not be able to get the Mumps vaccine for their babies for a while. I would suggest getting a rubella vaccine at 1 year, and then Mumps at 2 years (by the time any current one-year-olds are two, the shortage will hopefully be over).
Some parents are wondering if they should get the full MMR vaccine at age 1, not just to get coverage for mumps now, but also to get measles coverage in light of the recent increase in measles outbreaks. I think that this is a very valid choice to consider, especially for infants who are entering childcare or early preschool. For children who are not going to be in daycare or school until age 3 or 4, delaying the measles vaccine is less of a worry. Labels: Vaccine News
Dr. Bob Sears Offers Advice in March 21st New York Times Health Section on Vaccine Choices Parents Make
The recent measles outbreak (if you can call it that) in San Diego last month, in which twelve children came down with the illness after an unvaccinated family brought the disease back with them from Switzerland, raises awareness of a growing trend among families to decline certain vaccines.
This article raises the question, should parents have the right to decline vaccines when doing so may put the health and safety of other children at risk? In twenty states of our free nation, parents are allowed to decline vaccine for personal reasons. But in 28 states they must have a religious reason, and two states (West Virginia and Mississippi) don’t allow parents to decline them for any reason.
I believe our nation can tolerate a certain percentage of unvaccinated children without risking the overall public health in any significant way. Since most children are vaccinated, our nation has enough “herd immunity” to contain outbreaks like this one. However, in the San Diego case, some infants caught measles before they were old enough to even be vaccinated. Fortunately, all cases passed without complications, as is usually the case with measles.
So the question is, are unvaccinated parents putting the rest of our children at risk? Maybe a little. But in my opinion parents SHOULD have the right to make health care choices for their children. They should not be forced into vaccinating if they feel strongly against it.
Click here to read the whole New York Times story.
Dr. BobLabels: Vaccine News
Merck Vaccine Recall
Merck Recalls 1.2 Million Doses of HIB and HIB/Hep B Vaccines Due to Possible Contamination
This week Merck announced a recall of over a million doses of their PedVaxHIB brand of HIB vaccine that protects against a now rare form of infant meningitis as well as their ComVax brand of HIB/Hepatitis B combination vaccine. Routine testing of their manufacturing facility found some equipment was contaminated with a bacterium called Bacillus Cereus. Under normal conditions, the manufacturing process is sterile to avoid contaminant bacterial growth within the vaccine product. Bacillus Cereus is a common cause of diarrhea food poisoning when consumed in contaminated food. If any of these bacteria happened to contaminate any of the batches of vaccines and was injected into a baby, the possible effects are unknown, although it is thought that it may only result in a rash around the injection site. It is not yet known if any of the bacteria actually made it into the vaccine bottles. The problem is expected to shut down Merck’s production of these two vaccines for about 9 months.
What can parents do? The first thing is to find out if your doctor even uses the Merck brand of these two vaccines. Many doctors use another brand of HIB vaccine called ActHIB, and don’t use the combination HIB/Hep B vaccine. IF your doctor uses the Merck brands, ask the office manager if your child received any doses from the recalled batches. The nurse will have written the batch numbers your child received in the chart. If your child did not receive a recalled batch, then you have nothing to worry about. If your child DID receive a possibly contaminated vaccine, and shows no unusual rash or signs of skin or muscle infection around the injection site, then there is most likely nothing you need to do or worry about. Granted, the effects of injecting these bacteria into the body may be unknown, but theoretically the body’s immune system should be able to kill the germs. And keep in mind, we don’t even know if any of the germs made their way into any of the vaccine bottles.
The bottom line is that there is no treatment and nothing to do right now as long as you don’t see any problems. You can be concerned, even angry, and I’m sure you’ll worry, like any parent would. But there’s nothing you really need to do as long as the injection site seems fine and your baby did not show any bothersome reactions to the vaccine. Labels: Vaccine News
Should Goverment have the Right to Make Vaccines Mandatory?
In an exclusive interview with Newsweek.com, Dr. Bob addresses the question “Should state governments have the right to make vaccines mandatory?” The state of Maryland sued a couple thousand parents and students who had declined chickenpox and hepatitis B vaccines, literally forcing the parents to decide between having their pre-teens vaccinated for these diseases or face stiff fines. Maryland state law dictates that vaccines are mandatory, unless a family has religious objections. 29 other states have similar laws, while 20 states allow parents to decline vaccines simply for personal reasons. This case raises the question, should states have the right to force vaccination? Personally, I say no. Vaccines should be a personal medical decision that every family living in a free country should have the right to make. Having said that, I must admit that if there were a very serious and contagious disease spreading through the country killing a considerable amount of people, I might agree that in this situation it might be a good idea for the government to insist on vaccinations for the public good, IF the public good is threatened. In the case of hepatitis B and chickenpox, however, I can’t really say that these two diseases threaten public safety. Sure, hep B is bad, but it’s a sexually transmitted disease. So there are ways to prevent it and protect yourself, OR choose vaccination. And since chickenpox only kills about 1 in 65,000 people who catch it, you can’t really say that’s a threat to public safety either. Hopefully more and more states will follow the example of us Californians (and 19 other states) and allow parents free choice in this matter. Click here to read Dr. Bob’s exclusive interview with Newsweek.com.Labels: Vaccine News
Dr. Bob Sears Featured in the NY Times
Dr. Bob Sears Featured in the NY Times Review of a New CDC Study Demonstrating the Effectiveness of Vaccines Over the Twentieth Century
A CDC study published today, Nov 14, 2007, in the Journal of the American Medical Association discussed how vaccines are responsible for a 90% drop in fatalities from some diseases and a 100% elimination of fatalities from other diseases. The same also applies to the actual number of cases of the diseases as well. Now, I know what you’re thinking if you are part of the anti-vaccine crowd – this study is just more propaganda launched by the CDC to quell the opposition. Pretty much every anti-vaccine book or website I’ve read discusses how diseases were already declining before its vaccine was ever introduced. They say that measles was already on the way out, and we didn’t need the vaccine. Polio was on the decline and would have gone away without the vaccine. And the list goes on. They even show statistical flow charts of the disease trends to back up their point. As you know, I’m typically quite sensitive and sympathetic toward the worries and issues that parents have about vaccines. And in The Vaccine Book I’ve tried to help parents get better informed about these issues so they can understand how to more safely vaccinate their children. But I must say, when it comes to the question of whether or not vaccines work and have eliminated or decreased disease, it’s pretty clear to me that the CDC and the American Medical Association have it right. Now I don’t just say this because I believe the medical establishment. I’ve looked at all the data myself. I’ve reviewed disease statistics and trends over the twentieth century, seen when each vaccine was introduced, and to me it’s obvious that as soon a vaccine began, the disease sharply declined and in same cases eventually disappeared. Cases in point: Pertussis – this vaccine was introduced in the 1940s, and there was an immediate decrease in the disease. Polio – this vaccine was introduced in the 1950s with an immediate impact, and eventual eradication of the disease from the entire western hemisphere. Measles and Rubella – these two diseases decreased significantly with the vaccine and are now extremely rare. HIB meningitis – this severe disease used to kill babies left and right, but as soon as the vaccine began in the 1980s there was a sharp decline and it is now almost unheard of. Chickenpox – this shot became universally used in the 1990s, and we’ve seen a dramatic decline ever since. With this clear association between disease trends and vaccines, why are vaccine opponents still skeptical of the vaccines’ effectiveness? Why do they claim the diseases would probably just have gone away anyway, or at least decreased dramatically? It’s because some of the above diseases were beginning to decline before the shot was started, due to improved sanitary conditions and better healthcare. But I don’t believe the diseases would have gone away completely (like polio and smallpox) without the vaccines. And we wouldn’t have seen the diseases decrease to the point they are today. Take chickenpox, for example. This disease has been around for centuries, and everyone used to get it. If sanitation and quality healthcare were going to help decrease chickenpox, we should have seen a decline by the 1970s or 80s. But we didn’t, until we began using the shot in the mid 1990s. And the same can be said of HIB. In fact, MOST vaccine-preventable diseases aren’t even related to poor sanitation, poor living conditions, or healthcare access. Virtually all these diseases occur equally among the rich and the poor, the clean and the dirty, those who have good access to healthcare and those that don’t. Another factor to consider is that many vaccine-preventable diseases aren’t actually treatable. These include measles, mumps, rubella, polio, rotavirus, hepatitis A, and human papillomavirus. Some diseases can improve with treatment, but sometimes don’t respond well to current treatment options, including chickenpox, pertussis, tetanus, hepatitis B, and the flu. Therefore, the quality of healthcare doesn’t have a significant effect on preventing fatalities in many of these diseases. Victims can still die even with the best care in the world. The best way to prevent the deaths is to prevent the diseases from occurring in the first place. So, in my opinion, vaccines have played a tremendous role in eliminating or limiting the diseases in our country. I also know there is much more than just this one issue that goes into deciding whether or not to vaccinate, and how to vaccinate in the safest manner possible. There is so much that parents need to know and think about. I encourage all parents to become informed and educated as they begin their baby’s vaccinations. Click here to view the New York Times ArticleLabels: Vaccine News
Nasal Spray Flu Vaccine Now Approved for Kids as Young as Two Years of Age
FluMist, the nasal spray form of the flu vaccine, has been used as an alternative to getting an injected flu shot for many years for ages 5 years through 50 years. This week, FluMist was just approved for use down to age 2 years. Does the nasal spray have any advantages over the shot, besides being pain-free? It has been shown to be more than 50% effective than the flu shot. However, the nasal spray also has a slightly higher rate of flu-like side effects. A major advantage of the nasal spray is that it is mercury free. Many brands of the flu shot still contain mercury. The single-dose vials of the Fluzone brand of the flu shot are the only flu shots that are completely mercury free. Labels: Vaccine News
How to Make Sure Your Baby's Flu Vaccine is Mercury-free
Almost 10 years ago the American medical community was rocked by the realization that millions of infants were being overloaded with mercury from childhood vaccinations. Medical policy-makers and vaccine manufacturers scrambled to remove mercury from vaccines, and by the end of 2002 mercury was a thing of the past. Or was it? Mercury has now been removed from all vaccines except for some formulations of the flu vaccine (and some diphtheria-tetanus shots). But when you take your child in to the doctor's office for the flu shot this year, there may not be any mercury-free flu shots left. For the upcoming flu season, here are the brands your doctor can choose from: - Fluvirin brand is approved for kids 4 years and older and adults. Mercury is used in manufacturing, but then filtered out.
- Fluarix and FluLaval are for adults only. Fluarix filters out the mercury too, but FluLaval contains the full dose of mercury (25 micrograms).
- Fluzone is the only brand that is used in infants age 6 to 35 months. The half-dose infant and toddler sindle-dose vials are mercury-free, but there isn't enough to go around.
- Fluzone also makes a very small supply of mercury-free flu shots for older children and adults, so only the first kids in line will get one.
- Fluzone devotes most of their manufacturing facilities to making the full-dose mercury-containing large bottles of flu shots for all age groups.
Ask the nurse to physically show you the bottle as she prepares the shot. If it is Fluzone brand, and it is a small single-dose vial or a pre-filled single-dose syringe, then you can be sure it is mercury-free. If it is Fluvirin or Fluarix brand, then there is only a tiny, barely detectable, insignificant amount of mercury. If it is FluLaval brand, or the large 10-dose bottle of Fluzone, then just say no! What should you do if the only thing your doctor has left are shots with the full dose of mercury? First, healthy kids 5 years and older don't need a flu vaccine, but if you want one anyway, the nasal spray flu vaccine is mercury-free and was just approved for use down to age 2 years. Second, you can search elsewhere for any left-over mercury-free shots at other offices or clinics. Or you can simply decide to do without the flu vaccine for that year. This is especially true for pregnant women and young children. No one wants their developing fetus or infant to be exposed to mercury while their brain is developing. Do you even have to worry about mercury in the first place? The debate rages on. Researchers battle back and forth over this issue. We've known for decades that mercury is toxic to the brain and body tissues. But whether or not the amount in vaccines is enough to cause damage is still up in the air. Some research shows there is enough evidence of harm; other studies have determined there is not enough proof that the mercury in vaccines is dangerous. No study, however, has yet to prove for certain that this mercury is safe. Labels: Vaccine News
Vaccine Shortages September 2007
From time to time vaccine shortages occur for a variety of problems. Here are the current shortages that may affect the vaccine supplies at your doctor's office: ProQuad - The current supply of this combination of MMR and Chickenpox vaccine (by Merck) has run out, due to a variety of manufacturing factors. It is unclear how long it will remain unavailable. The shortage may continue into 2008. This vaccine is given at age 1 year and 5 years. However, the MMR and the Chickenpox vaccine can also be given separately. So this shortage won't disrupt the actual vaccine schedule. It simply means that the convenient combined shot won't be available. Mumps Vaccine - Some families choose to separate the MMR into its separate components. Well, the separate Mumps vaccine by Merck is in short supply and may not be available until October. If you are planning to get this vaccine, don't worry. There's no rush. Simply wait until your doctor has it back in. Chickenpox Vaccine - This is also in short supply, although we haven't run out completely. But doctors may run out for a week or two from time to time for the rest of the year. But don't worry - it can be given at any time after age 1. Hepatitis A Vaccine - the Merck brand of this shot (Vaqta) has run out. It's not expected to become available until early 2008. There is another brand, Havrix (by GlaxoSmithKline) which IS available for now Labels: Vaccine News
|
|
