The Vaccine Book

Separate Measles, Mumps, and Rubella Vaccines No Longer Available? What Can Parents Do?

2009-10-30T11:33:00.000-07:00

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.

Four Swine Flu Vaccines Approved by FDA

2009-09-18T10:38:00.000-07:00

The FDA just approved four versions of the pandemic H1N1 (or “swine” flu) vaccine. Expected to become available as early as the first week of October, here is the run down on each of these four vaccines:

Sanofi Pasteur’s injected vaccine: Approved for ALL age groups (infants 6 months of age through adulthood and the elderly). It comes in several forms:

Prefilled single ½ dose syringe with NO mercury – for infants 6 thru 35 months of age. Prefilled single full dose syringe with NO mercury – for anyone 3 years and older.
Single-dose (full-dose) vial with NO mercury – for anyone 3 years and older.
Multidose bottle (contains ten full doses or twenty ½ doses) WITH 25 mcg of mercury per full dose – for anyone 6 months and older (infants 6 to 35 months would get a half dose (0.25 ml), 3 years and older would get the full 0.5 ml dose).

Other ingredients include: the viral proteins, egg proteins, gelatin, formaldehyde, polyethylene glycol p-isooctyphenyl ether, sucrose.

CSL’s injected vaccine: Approved for anyone 18 years and older. It comes in two forms:

Prefilled single-dose syringe with NO mercury.
Multidose bottle with ten doses WITH 24.5 mcg of mercury per dose.

Other ingredients include: the viral proteins, sodium chloride, sodium phosphate, potassium phosphate, calcium, taurodeoxycholate, egg protein, 2 antibiotics, and beta-propiolactone.

Novartis’s injected vaccine: Approved for anyone 4 years and older. It comes in two forms:

Prefilled single-dose syringes with a trace amount of mercury (less than 1 mcg because 99% of it is filtered out).
Multidose bottle with ten doses WITH 25 mcg of mercury per dose.

Other ingredients include: the viral proteins, sodium chloride, phosphate, egg proteins, two antibiotics, betapropiolactone, nonylphenol ethoxylate.

MedImmune’s live virus nasal spray vaccine: Approved for anyone 2 years through 49 years of age. There is no mercury.

Other ingredients include: the live viruses, egg protein, MSG, pig gelatin, arginine, sucrose, potassium phosphate, an antibiotic,

How are these vaccines manufactured?

Here is the interesting part. Everyone has been worrying and theorizing about how these BRAND NEW vaccines are going to be made and what new and dangerous ingredients they might contain. Well, what has ended up happening is that these four companies have made their “swine” flu vaccines using the exact same process and ingredients that they’ve used for their regular flu vaccines. All they’ve changed is the strain of the flu germs that go into the vaccine. Not to say that these vaccines are completely chemical free and 100% safe. But we aren’t dealing with brand new flu vaccines here. We are dealing with the same thing we face with flu shots every year: same chemical ingredients, new flu vaccine strains. You can find out more details on how regular flu shots are made in the flu chapter of the vaccine book, and apply that same process to the “swine” flu vaccines.

Sanofi Pasteur’s pandemic H1N1 vaccine is analogous to their regular flu vaccine Fluzone, a brand that has been in use for several years.
CSL’s pandemic H1N1 vaccine is analogous to their regular flu vaccine Afluria, a newer player in the flu vaccine market that was first made last year for the 2008/2009 flu season.
Novartis’s pandemic H1N1 vaccine is analogous to their regular flu vaccine Fluvirin, which has been around for a few years (previously made by Chiron).
MedImmune’s live nasal spray pandemic H1N1 vaccine is analogous to their regular nasal spray Flumist.

Which one do I recommend?

At this time I have absolutely no preference whatsoever.

How many doses are needed?

All infants and children from 6 months through 9 years of age are supposed to get two doses of this vaccine, one month apart (no matter what brand you are using, and you probably shouldn’t switch brands between the two doses). This is needed to generate an adequate immune response. Anyone who is 10 years and older only needs ONE dose.

Can doses be given along with other vaccines?

The product inserts make it very clear that no testing has yet been done on these versions of the flu vaccine to determine if they can be given along with other vaccines. The government is operating under the assumption that these vaccines should behave the same way as their regular seasonal flu vaccine counterparts. So, the unofficial word is that you can give them with any vaccines, or apart from any other vaccines in any time intervals you want.

Technically you can get them together (both flu shots together) or with any other vaccine. But my advice? Get them alone, as far apart as you can from another flu shot or any other shots. More on this below.

What safety and efficacy testing has been done on these vaccines?

Here is where we are flying by the seat of our pants, so to speak. The product inserts make it VERY clear that the “swine” flu versions of these vaccines have NOT undergone any testing to demonstrate whether or not they are safe and whether or not they even work. They are relying on the fact that they are so similar to the regular flu shots that they should work just as well.

Although I don’t like that approach, I must admit that they may be right. I don’t see any reason to doubt that our immune systems won’t respond to this vaccine the same way they respond to regular flu shots. And I don’t expect that the side effects would be any different either. In The Vaccine Book, I give a lot of detail about flu vaccine ingredients and side effects that you should be aware of before getting this shot.

I’ve heard that the last swine flu vaccine caused a really bad reaction called GBS? What about THIS swine flu vaccine?

Every product insert for this new vaccine discusses this issue from 1976 in which the old swine flu vaccine caused a higher rate of GBS (weakness and paralysis reaction) than expected, so they stopped using it. That was a completely different strain of the swine flu than what we have today. Plus, that vaccine was made much differently than how they are made today. So, I see no correlation between the risk of GBS from that old vaccine and the current one.

Having said that, everyone needs to be aware that ANY flu vaccine poses a very small risk of a GBS reaction. Although I don’t think this new vaccine has an increased risk, what I DO worry about is that infants will be getting FOUR (count them, FOUR) flu vaccines this year – two doses of the regular one, and two doses of the swine flu vaccine. That’s unprecedented. We’ve never given anyone four doses of a flu vaccine in one year. There is no way to predict what the side effects might be.

What about pregnant and/or nursing mothers?

This is a little scary. The flu shots are ALREADY recommended for pregnant and nursing moms, BUT (and this is a really huge but) the vaccine product inserts make it very clear that the regular flu vaccines have never been tested on pregnant or nursing women to determine if there is any harm to fetuses or young babies (with one exception – the Flumist nasal spray brand did have some testing in this area, BUT not enough, as is stated in the product insert).

Despite this complete lack of research, it is recommended for these moms anyway. Anyone see a problem with that?

If you do get a flu shot, at least make sure it is mercury free (or at least only TRACE mercury).

What should I get first, regular or swine flu shots, and how do I space them out?

My basic advice for anyone is to only get one flu shot at a time, spaced out one month apart. So, it would take 3 months to work in all four doses (2 regular flu and 2 swine flu). I have no preference on how you go about doing this. Do get 2 regular, THEN two swine? Or the other way around? Or do you alternate between the two? Take your pick.

The seasonal flu causes about 20 infant and 100 total pediatric deaths each year in the U.S. The swine flu has so far caused 112 pediatric deaths. So, that’s about the same as the regular flu. From April through the end of July, there were about 43,000 confirmed swine flu cases, with 5000 hospitalizations and about 300 deaths in all ages according to the CDC website. More deaths have occurred since then. This is no different from the regular flu. They’ve stopped officially counting the number of cases because it’s now too widespread to keep track of. But the bottom line is that the swine flu is about the same level of seriousness as the regular flu. So, take your pick which to do first. You may want to start with the regular flu shot since it’s available right now.

What about other routine childhood vaccines that are also needed during this time?

I would advise parents to delay any vaccines for diseases that don’t pose an immediate danger to a baby’s or child’s life and catch up on those vaccines in Feb or March, a couple months after finishing the flu vaccines. Diseases that aren’t usually life-threatening (keeping in mind that ANY disease can be fatal, but the following are less likely to be) include measles, mumps, rubella, chickenpox, and Hep A. Diseases that don’t exist in the U.S. or that don’t occur during infancy in the U.S. (so even though they can be very severe, a child has almost no risk of catching it in the U.S.) that could be safely delayed are polio, Hep B, tetanus, and diphtheria (although to get a pertussis vaccine, tetanus and diphtheria have to come along with it).

Diseases that DO pose an immediate danger to babies and children are HIB and PC meningitis, Rotavitus, and Pertussis. So, I would rather children stay on time with those four vaccines and delay the flu shots (if you feel comfortable delaying flu shots).

If you want to make sure your child has flu coverage and stays up to date on these other shots, you can stagger them by two weeks.
For teens, I would follow the same guidelines – don’t get flu shot around any of the other routine teen shots like HPV, meningococcal, or Tdap. The only disease here that would be more severe than flu would be meningococcal, so that’s more of a priority.

Should people even get any flu shots?

I don’t have a recommendation one way or another. There hasn’t been a lot of research on safety and efficacy of flu shots (just read through the product inserts – the sizes of the research studies are very small compared to all other childhood vaccines), and the product inserts are very clear about where the research is lacking (almost seems like a disclaimer in there).

BUT, the flu can and does kill people every year. I do believe the flu shot helps protect against the flu and lowers this risk. I go over many of the pros and cons in The Vaccine Book. Everyone has to make their own choice on this. I’m not going to make a suggestion one way or the other.

You can review all the product inserts yourself from the homepage of

www.FDA.gov

Flu Vaccine Update for the 2009/2010 Season

2009-09-10T11:45:00.001-07:00

With the threat of H1N1 flu, the government is recommending everyone begin their regular flu shots earlier this year, as in right now. The available brands are virtually identical to what they were last year (and the year before) as far as manufacturing and ingredients go (including mercury). Full details on how each flu vaccine is made, what the ingredients are, and the possible side effects are available in The Vaccine Book, although published in 2007, the flu vaccine info my book has changed very little, you can click here for any updates to The Vaccine Book.

The most important thing for infants, children, and pregnant women is to MAKE SURE YOU ARE GETTING A MERCURY-FREE FLU VACCINE. Here is a list of this year’s available flu vaccines with updated info on mercury content:

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 (contains ½ dose) – 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 (25 mcg of thimerosal). Infants 6 thru 35 months would get a ½ dose of this form, all others would get a full dose.

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 to avoid mercury.

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 NO mercury (this is new this year: in past years, there was a trace 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

WHAT ABOUT THE H1N1 VACCINE THAT’S COMING OUT IN OCTOBER?

Click here to view my previous blog on this. I will be writing an updated H1N1 vaccine blog when the safety research is finished and I see what the vaccine ingredients are.

TIMING THE FLU VACCINE WITH OTHER VACCINES

Because the flu vaccine is so reactive (likely to cause fever and flu-like side effects), I prefer to avoid giving it with other reactive shots (like MMR, Hep B, Chickenpox, or the H1N1 vaccine). I recommend at least one month between the flu shot and any of these. I would place the priority on the flu shot over the MMR, Hep B or Chickenpox; delay any of those until it’s been at least a month after the flu shot. I do think it’s ok to get the flu shot with any other vaccine on the same day. The teenage vaccines (Tdap, Meningococcal, and HPV) are also fairly reactive, so it would be better to get any flu shots at least one month apart from any of those as well.

As for the H1N1 vaccine, I won’t be recommending that anyone get it at the same time as the regular flu vaccine. So, if you anticipate that you or your child will likely be getting an H1N1 vaccine in October or November, I would get the flu vaccine now (if you are going to get it). Another option, wait until November or December, 1 month after you’ve gotten the H1N1. The flu is unlikely to hit until that time anyway.

Keep in mind that infants and children 8 years or younger need 2 doses of the flu shot the first year they ever get it. So, if this is your child’s first year of flu shots, you need to plan ahead and not get any other reactive shots during those two months.

NASAL SPRAY VERSUS THE SHOT?

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. I have a slight preference for the nasal spray, because it’s a more natural form of vaccination (it is given nasally, which is how the flu is naturally contracted).

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, 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 thimerosal 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 12.5 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”. In the future I hope that more companies will change 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 the 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 immunize every child and teenager. 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.

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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm162050.htm

New HIB Vaccine Now Available to Ease the HIB Vaccine Shortage

2009-08-21T13:37:00.000-07:00

Over the past year and a half there has been a shortage of HIB vaccine. Normally given at 2, 4, 6, and 15 months of age to prevent HIB meningitis, there had been a temporary halt on giving that last dose in order to allow all babies to get at least the first three doses. In June of this year the CDC announced the shortage was over and reinstated that 4th dose again. In order to help ease the supply burden, the FDA has granted GlaxoSmithKline an accelerated approval of their Hiberix brand of HIB vaccine (see FDA announcement regarding their accelerated approval guidelines and other details at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm179527.htm). This vaccine has been used in other countries since 1996. This new vaccine is NOT yet approved for the entire vaccine series; it only has approval to be given as a booster from 15 months through 4 years of age (prior to the fifth birthday). It is only approved to be used after an infant has received the first three doses of ActHIB or Pentacel brands of HIB, or the first two doses of PedVaxHIB or Combivax brands of HIB vaccine. In The Vaccine Book I provide details on how all other HIB vaccines are made and what the ingredients are. Here are the details on this new vaccine:

How it is made and what the ingredients are:
The HIB germs are grown in what they term a “synthetic medium,” then the germs are taken out and broken up. Some sugars from the outer covering of the germ are filtered out, and the rest of the germ is discarded. Tetanus germs are grown in a separate “semi-synthetic medium.” The toxin produced by the tetanus germs is filtered out and inactivated by adding formaldehyde. This toxin is then combined with the HIB sugars, most of the formaldehyde is filtered out, some lactose sugar is added, and the final product is mixed with saline. The ingredients in the final product are the HIB sugars, the tetanus toxin (this is used to help the vaccine work better by stimulating the immune response), lactose sugars, saline (salt water), and less that 0.5 micrograms of formaldehyde. There is NO mercury and NO aluminum. This product seems to be made in a very similar manner as the ActHIB brand in The Vaccine Book.

I don’t know the details about the “media” in which the germs are grown. I may be able to track this down in the future. So I don’t know exactly what types of minute ingredients may transfer from those media into the vaccine solution.

Side effects:
Side effects were mainly studied when this vaccine was given at the same time as Pediarix (a combo of DTaP, IPV, and Hep B), and the standard reactions (fever, fussiness, redness) were about the same as with Pediarix, occurring in about 25% of children. There is no research listed in the Hiberix or the Pediarix Product Inserts that discusses the rate of these reactions in babies getting Pediarix alone versus those who get Pediarix at the same time as Hiberix. So, I can’t give any clear indication on whether or not this vaccine is MORE reactive that other vaccines in general, but there is no indication that it IS more reactive. A major drawback of the research discussed in the Product Insert is that they only studied this vaccine in 1000 infants. This is probably the smallest study I have ever seen in the past 15 years. Post-marketing reported reactions (since the vaccine has been in use in other countries since 1996) has revealed reactions that are similar to other very rare but serious vaccine reactions. Nothing has shown up with any more frequency than other vaccines.

My recommendations:
I am always leery of any new vaccine. As my office has been able to maintain a good supply of ActHIB, I won’t be using this new vaccine (unless I run into supply problems). I worry that this was only tested on a very small group of children so far. As part of the accelerated approval process, the FDA is requiring GlaxoSmithKline to perform ongoing safety and efficacy testing in the U.S. in order to meet the regular testing guidelines. Once I’ve review that information (6 to 12 months from now? I don’t know how long that will take), I’ll be able to offer a more research-guided recommendation.

But because of Hiberix’s similarity to ActHIB brand, both in its ingredients and how it is manufactured, overall I don’t see any problem with using this vaccine when the alternative is to go without it. If this is the only option your doctor has for you, I recommend you follow your doctor’s advice on this. This vaccine can be given along with any other vaccines at any time within my alternative vaccine schedule, as long as it meets the age guidelines above.

Dr. Bob

H1N1 Flu Vaccine is on it's Way. What Should Parents Do?

2009-07-30T13:46:00.000-07:00

Ever since the H1N1 flu hit the U.S., everyone has been wondering if and when a vaccine is going to come out, and whether or not the vaccine is going to be mandatory. Everyone seems to be in a panic over what to do. I haven’t really jumped in on this debate yet, as I was waiting for the dust to settle a bit and see what the government and health care policymakers decided to do. Well, the decision is very clear now. Yes, an H1N1 flu vaccine is due to be available in October. And it looks like there will be a choice between a nasal spray and a shot. This will be a separate vaccine from the regular seasonal flu vaccine. What should parents do?

My first piece of advice is to not even put any thought into this decision yet. We know nothing about the H1N1 flu vaccine ingredients. Will it contain mercury? What else will be in there? I can’t make a recommendation until I have that information. We also don’t know what the side effects will be. Will they be similar to the regular flu vaccine? Will they be more severe or less? There has been much worry over this issue because of reports that the last time the country had to produce a swine flu vaccine in the 1970s to thwart an expected outbreak (which ended up not happening), rates of Guillain-Barre reactions (GBS: temporary muscle weakness and/or paralysis) went through the roof that year. This is a known (but rare) side effect of the regular flu vaccine as well, but the reactions in the 1970s were reportedly much more than expected. So, will that be a worry with this H1N1 vaccine? We don’t know. This vaccine is different, but how different?

So, the bottom line is that I am going to reserve judgment on this issue until I see what the ingredients are and what the initial safety trials show. At that point, I still will probably not act. I will wait until the second round of safety trials are done, and wait at least a month or more for it to be used in the general population to see if GBS reactions are a worry. I definitely will not be the first office to offer the vaccine. If the safety pans out, I will then make a recommendation. But that won’t be expected until at least November. So, until then, I wouldn’t waste time and energy fretting about it.

Now, what you can fret about is whether or not the government will make the vaccine mandatory. Not “mandatory” in the sense that all vaccines are “required,” but parents can sign a waiver. I’m talking about mandatory in that Child Protective Services will take your kids away, or hold you back while they force the shot on your child. Yeah, that would be something to worry about. So, write your senator now and put in your two cents. OR, don’t even worry about it until they decide whether or not it’s mandatory, but by then it will be too late to make your voice heard.

Having put that conspiracy on the table, I will offer one piece of reassuring news. The latest report I just got from the AAP discusses their anticipation that not everyone who is recommended to get the flu shot will go out and get it. That tells me they aren’t thinking “mandatory” yet. However, I’ve also seen reports that the government is thinking about making it absolutely mandatory. I don’t know whom to believe yet.

Although they will be recommending the shot for everyone, they only plan to have about 120 million doses, so the CDC just announced a priority list for those at highest risk of suffering a severe case of the H1N1 flu (or those most likely to spread it to others): Pregnant women, health care workers, and children 6 months and older. Parents and anyone caring for infants, anyone with high-risk medical conditions (such as heart, lung, or immune diseases), and young adults ages 19-24 (not sure why) should also be given priority.

Just how bad is the H1N1 flu? Our experience so far indicates that it is a little worse than the regular flu, but it is not the rampaging epidemic that will sweep through the country and kill everybody. So why is the government so worried? It’s because the evil drug companies are paying them to act worried and create hype over the H1N1 flu so that the drug companies can make billions of dollars selling a vaccine that everyone will be scrambling for. The companies can then hand some of that money back to the government officials who helped them out.

I jest, but that is the worry many people have. Is this all just about money and not health? I have to believe that our government isn’t crooked enough to go that far. Am I just being naive? Some would say so. I don’t know.

What I hear from medical policy makers is that they are not so worried about what the H1N1 flu is like now, but about what it could become if it mutates and starts creating more severe disease. That’s why they are acting preemptively to try to stop it. Is that a good idea? I guess.

So, stay tuned for my November report. In the meantime, worry, or don’t worry. It’s up to you.

Dr. Bob

HIB Vaccine Shortage Over, but Don’t Rush in to Catch Up

2009-06-29T11:51:00.000-07:00

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. Bob

Government and CDC Finally Agree to do Extensive Research into Vaccine Safety . . . Maybe

2009-06-10T16:11:00.000-07:00

For over a decade now most doctors, researchers, and government officials have denied that there could be any link between vaccines and autism. They’ve denied it so vehemently that they’ve refused to adequately study the very idea. Until now. The federal government’s vaccine advisory panel (the National Vaccine Advisory Committee or NVAC) just voted to recommend to the US Dept of Health and Human Services that they and the Centers for Disease Control and Prevention conduct large-scale prospective research trials in groups of vaccinated versus unvaccinated children to determine various theoretical risk factors and possible severe reactions to vaccines, including autism.

For those of you who are saying, “Wait – they HAVE researched it extensively and have proven there is NO link between vaccines and autism.” Well, that’s not exactly accurate. To date, no study has “proven” there is no link. Many studies have “failed to demonstrate a causative relationship between vaccines and autism” – in essence, showing there probably is no link, or even there is almost definitely no link. But that is a very far cry from “proving for sure that there is no link.” What they HAVE done so far is use population-based statistical analyses (epidemiological studies) to determine that vaccines probably don’t cause autism. But no large prospective study has yet to be done using unvaccinated children as a large control group to have something to compare the vaccinated children to. This is really the gold standard for coming as close as we can to proving something is safe. And that’s the type of research the government had, up until now, refused to do. And we are not just talking about autism. There are so many other theoretical reactions to vaccines that have never been adequately studied. We’ve just written them off as so rare we won’t worry about them. Finally, after years of public pressure, the government has agreed to do the research.

Maybe.

What they FIRST have to do is do a study to determine if such research is even feasible and figure out how exactly to go about doing it. The government is going to select a neutral third-party research organization (The Institute of Medicine, possibly) to study how to do the study. Such an organization may or may not find such research feasible. If they determine it is feasible, then the research will begin. If not, then we’re back to square . . . whatever square we are on right now, which is “vaccines probably don’t cause problems, but we haven’t really proven it for sure.” This is also going to take time – a couple years to study the feasibility of the study, then a few more years before results start to roll in. But at least the ball is now (probably) rolling. The only thing that could stop it is a roll of red tape. That’s no obstacle at all, right?

Here are a few highlights of what the NVAC recommended the CDC begin doing research on (if it is found to be feasible):

Identifying subsets of our population that may be at higher risk of suffering a severe vaccine reaction, such as those with mitochondrial dysfunction, autoimmune diseases, autoimmune family histories, and genetic predispositions

Accurately determine the statistical incidences of various reported severe reactions like encephalitis, encephalopathy, seizures, autoimmune reactions, demyelinating disorders, and autism

The risks of reactions for babies with a prior reaction or with a family history of reactions in the parents

Study various alternative vaccine schedules, including comparing reactions with multiple vaccinations to fewer vaccinations

Study specific and individual vaccine chemical ingredients, including animal toxicology research (hey, I thought they would have already studied each and every vaccine ingredient in animals before they started giving them to us?)

These issues have always sat in the back of my mind as unanswered questions. And the absence of unvaccinated control groups in vaccine research has probably been the one single factor that has always weighed heavily in my mind regarding vaccines. To date, such control groups have always been infants receiving the current vaccine schedule minus the new vaccine that is being studied. But now there are just way too many vaccines to consider such a group as a placebo control.

FINALLY, the government is paying attention to what parents really want to know regarding vaccines. Let’s just hope they pull through with these plans so we can all feel safer about vaccines.

A more extensive discussion regarding this development can be found here: http://www.huffingtonpost.com/david-kirby/top-us-panel-some-vaccine_b_211843.html , David Kirby’s analysis of the NVAC’s findings. David also provides a link to the NVAC’s 90-page document at the bottom of his blog so you can read the document yourself.

Dr. Bob

Do Doctors Have a Financial Incentive to Get Their Patients Fully Vaccinated?

2009-05-29T16:20:00.000-07:00

I get a lot of emails from people who wonder if doctors have any sort of financial incentive to get their patients vaccinated. Do we get any sort of bonus from the insurance companies that pay us? I’ve always thought that the answer to this question was no. I recently found out otherwise.

Now, if you count the fact that part of the income for a doctor’s office comes from providing vaccines themselves, and the checkups that go along with the vaccines, you could argue that that’s a financial incentive. Yes, doctors’ offices do make a little money on vaccines. But I don’t really count that as an actual incentive to try to talk any patients into getting vaccines or as a reason to kick a patient out of a practice if they don’t vaccinate. I don’t think any doctor would kick someone out just because the doctor isn’t going to be able to make as much money on an individual patient who doesn’t get vaccines.

But I recently talked with two physicians in different states that told me the HMO plans that they contract with do chart reviews and patient surveys at the end of each year. If their office scores high enough on these reviews, the HMO plan gives them a several thousand dollar bonus. This bonus varies depending on the number of patients the doctor sees. One of the requirements for a patient’s chart to pass the test is that they are fully vaccinated.

Now, I can somewhat understand the logic behind this. The insurance wants to make sure all their clients are fully vaccinated so they don’t catch any particularly severe disease that might result in an expensive hospitalization or disability that would cost the insurance company a lot of money. Oh, and they probably also care about their clients overall health and wellbeing too. So, why not give their doctors a bonus for meeting this goal?

Here’s why. This policy gives any doctor who contracts with such HMO plans an incentive to NOT want any unvaccinating families in their practice. Maybe a few such families wouldn’t make them fail the chart reviews, but if they have too many, there goes their year-end bonus. One colleague here in southern California told me that he happily gives up this bonus because he wants to serve these families. Good for him! But I bet that many doctor across the U.S. refuse care to these families solely because they don’t want to lose this bonus. They make so little from the HMO plan as it is that losing this bonus could make them actually lose money caring for these families. In fact, this bonus isn’t actually a bonus at all. It is actually money that should be paid to the practice anyway month by month, but it is held back until the year-end surveys are done. I don’t know of any PPO plans that do this, fortunately.

I’ve always wondered by so many doctors are so adamantly hardcore about demanding all their patients fully vaccinate, and why they kick patients out of their office who refuse. I’d always just assumed it was because the doctors felt that the vaccine protection was so important that they don’t want any children to be at risk, so they draw a line in the sand for the good of the child (in their minds). BUT some doctors, especially those large groups who rely heavily on large HMO contracts, may actually be doing this because of money. Do they have the right to do so? Of course. But is it right? I don’t know. The American Academy of Pediatrics Committee on Bioethics makes it very clear that the official AAP policy is that doctors NOT kick patients out of their office over this issue. But when money talks, some people don’t listen.

So, knowing this information doesn’t really help parents one way or another. But I thought you’d find it interesting to know why you might be having a hard time finding a vaccine-friendly doctor. If you’ve never checked out my vaccine-friendly doctors list, click here to find one near you (he’ll be the one driving the Honda instead of the Lexus).

Return of Separate Measles, Mumps, Rubella Vaccines Planned for 2011

2009-05-15T19:45:00.000-07:00

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. Bob

Swine Flu Outbreak – Is It Time to Panic?

2009-04-27T16:26:00.000-07:00

No, it’s not. But people should be aware of what’s going on and how to lower their risk of catching or spreading this unusual strain of the flu.

Instead of writing my own details on the swine flu in this blog, I am simply going to refer everyone to the Centers for Disease Control and Prevention’s website on the swine flu. Because this information is changing on an almost daily basis, it doesn’t make much sense for me to try to write a new blog every few days.

The CDC’s website is www.CDC.gov/swineflu/ . There you can read all sorts of timely and useful information about what it is, where it is, how to prevent it, and how to seek care if you suspect it.

In a nutshell, here are a few highlights:
• There is currently no vaccine for humans for the swine flu. There is one for pigs.

• The current common flu vaccine used in humans does NOT protect against the swine flu.

• There are anti-viral medications for anyone with a confirmed case available for children age 1 year and older, and adults.

• The symptoms are the same as the regular flu. It isn’t clear why there have been more fatalities than expected in the Mexico outbreak.

• This particular strain of the swine flu seems to be a naturally-occurring cross breed of the human flu, an avian flu, and 2 types of the swine flu.

EVERYONE NEEDS TO DO THEIR PART AND STAY HOME IF YOU ARE ILL WITH FLU-LIKE SYMPTOMS, COVER YOUR MOUTH IF YOU SNEEZE OR COUGH, WASH YOUR HANDS FREQUENTLY, AND CONTACT YOUR DOCTOR AND ASK ABOUT BEING TESTED FOR THE SWINE FLU IN THEIR OFFICE WITHOUT INFECTING EVERYONE ELSE THERE.

As of right now, only people who have knowingly been in contact with a swine flu-infected person, or people who are part of a large flu outbreak in a certain area, are recommended to get tested with a nasal swab. If you have flu symptoms, but haven’t been knowingly exposed and aren’t part of a large outbreak (such as your workplace, school, etc), then you probably just have the regular flu. The CDC website has up-to-date information.
If a vaccine becomes available and necessary, I will post the info on this blog.

Dr. Bob

U.S. News and World Report February Issue Features Dr. Bob’s Alternative Vaccine Schedule

2009-03-20T11:17:00.000-07:00

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.

Separate Measles, Mumps, and Rubella Vaccines No Longer Available? What Can Parents Do?

2009-01-22T13:29:00.000-08:00

HIB Vaccine Shortage Continues – Pentacel Combo Vaccine is an Acceptable Alternative for Now

2009-01-13T14:41:00.000-08:00

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

A Response to Dr. Offit’s Misleading and Inaccurate Review of The Vaccine Book in Pediatrics, January 2009

2008-12-29T19:27:00.000-08:00

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

Should Parents Continue to Give Their Infants the Pneumococcal Vaccine (Prevnar) in Light of Current Controversies Over it?

2008-10-22T09:09:00.000-07:00

The NY Times published a very interesting article summarizing the challenges with the PC vaccine. http://www.nytimes.com/2008/10/14/health/14vacc.html?_r=1&em&oref=slogin

Since the vaccine came out in 2000/2001, the number of total cases of severe PC disease has declined dramatically (from about 100 cases for every 100,000 children under 5 years of age down to about 20 per 100,000). This occurred because the PC vaccine protected infants and children against the 7 most common PC strains. While these strains are still circulating among the general population, they are no longer causing many severe infections in young children since kids are now protected. Plus, kids aren’t spreading these strains to the elderly, another at-risk age group for severe PC disease. Almost everyone has a variety of strains of the PC bacteria living within their nose and throat. For the most part, the germs are harmless. But occasionally they invade into the body and cause severe internal infections like meningitis, pneumonia, bloodstream infections, and severe ear infections. This vaccine prevents those 7 strains from doing this anymore.

However, there are dozens of OTHER strains of PC bacteria that are not covered by the vaccine, and one particularly nasty strain is now jumping in and replacing some of the vanishing strains. It is called strain 19A. Since the PC vaccine’s use began, 19A has increased from about 3 cases per 100,000 children under 5 to about 11 cases per 100,000. Plus, some areas of the country are reporting that this strain in their area is resistant to most antibiotics (New York and Texas, for example). But in most areas, the strain is likely still susceptible to most antibiotics. Overall, the number of total cases of severe PC disease from all strains combined is much lower than it used to be.

The logical next step would be to update the current PC vaccine to include 19A and other emerging strains, and that’s exactly what vaccine makers Wyeth and Glaxo Smith Kline are doing. However, these vaccines are about 1 to 2 years away. Wyeth has developed one, but safety and efficacy approval testing is a long process. Wyeth hopes to apply to the FDA for review and approval some time next year. I don’t know how far along the GSK company is with their version.

There are now two main questions parents are asking: Should parents stop giving their kids the current PC vaccine since those strains aren’t causing as much severe disease? NO. My opinion is that since those strains ARE still around, living in older kids and adults, any unvaccinated child could catch it and come down with a severe case. I recommend that parents continue with the vaccine for now.

The other question is this: Does getting the current PC vaccine (and therefore preventing those 7 strains from living within that child) make that child more likely to have other strains of PC (namely the 19A strain) set up shop in their nose and throat and possibly cause a severe internal infection that may be antibiotic resistant? I don’t think so. Or rather, I hope not. We just don’t know yet. Someone will have to do the following research: compare the rates of severe PC disease in vaccinated versus unvaccinated kids (I think they’ll find it lower in vaxed kids). But IF the rates are higher in vaxed kids (which I don’t think they’ll find), what strains are they finding and are they antibiotic resistant? If they find that vaxed kids are catching more severe and antibiotic resistant PC diseases compared to unvaxed kids, then the current vaccine would NOT be a good idea. But I just don’t think that they will find that to be true in a research study.

I feel the benefits of the current PC vaccine are still valid and parents should continue to vaccinate with it until an updated version of the vaccine becomes available. Should parents skip the current one and wait for the new one? No – it is at least one, maybe two, years away.

Dr. Bob

Flu Vaccine Update for the 2008/2009 Season

2008-10-15T11:18:00.000-07:00

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

Second Rotavirus Vaccine Now Available and the Timing of the Doses has been Expanded

2008-10-07T14:23:00.000-07:00

Rotateq was the first rotavirus vaccine to come onto the market (2006). I provided full details on how this vaccine is made in The Vaccine Book. Now there is a competitor, Rotarix (GlaxoSmithKline), licensed in April 2008. At the time The Vaccine Book was written I wasn’t able to provide you with the precise details on how its manufacturing process may differ from Rotateq. Here’s how it is made:

The viruses used in this vaccine are a single strain that was originally taken from infected humans. They are grown in a culture of monkey kidney cells to allow the virus to multiply. Batches of the virus are removed from the kidney cells and mixed into a solution of amino acids, sugars, and minerals (see details in The Vaccine Book).

As for the ingredients, I provided most of these in The Vaccine Book, except I couldn’t give details on what was in the solution that the viruses are grown in, called DMEM (Dulbecco’s Medium). DMEM contains numerous vitamins, minerals, sugars, amino acids, and phenol red.

Here is how the new Rotarix differs from the Rotateq:
Single strain of the virus (the most common one that infects humans), so it may be less protective against all strains of the virus compared to Rotateq (which uses 5 strains).
Virus comes from humans and is not “cross-bred”. The 5 strains in Rotateq are a mix of human and cow strains, and the viruses are cross bred to increase their effectiveness in the vaccine.
The PI for Rotarix makes no mention of using fetal cow serum to nourish the viruses as it does in Rotateq.
Rotarix only has TWO DOSES, compared to the three doses of Rotateq.

So, which one is better?

I have no preference between the two brands right now. I’ve been using the 3-dose Rotateq, since that’s what came out first. Once Rotarix has been out for a year or more, and no problems are found with it, I may switch over since it’s only two doses.

The timing of when you can give Rotavirus vaccine has expanded.

When Rotateq first came out, it was advised to be given around 2, 4, and 6 months. It could be started are early as 6 weeks, but the first dose needed to be started by 12 weeks of age. The last dose couldn’t be given later than 32 weeks of age.

NOW, you can start the vaccine at the slightly older age of 14 weeks and 6 days. And the last dose needs to be completed by 8 months, 0 days. These guidelines apply to both the 2-dose and the 3-dose brands. You are NOT supposed to go back and forth between the two brands.

Reported Side Effects of HPV Vaccine Has Parents, and Teens, Worried

2008-09-24T19:04:00.000-07:00

The HPV was licensed in 2006, and since that time over 16 million doses have been distributed across the United States (although, it isn’t known how many of these have yet been administered to patients). There have been about 10,000 reports of adverse reactions to the vaccine. 6% of these reports (or 600) were considered serious, either causing an ER visit, a hospitalization, a fatality, or permanent disability. If all 16 million doses were given, that would mean about 1 in every 26,000 patients would have a severe reaction. If 12 million doses, about 1 in every 20,000.

What about the reported fatal reactions? So far there have been about 20 reported fatalities. This obviously has parents very concerned. But the question is, are these fatalities caused by the vaccine? I was able to review the VAERS reports on 17 of these cases. Here is what I found:

17 year old girl – sudden death due a suspected heart arrhythmia 2 days after the shot.
12 year old girl – a history of seizure disorder and prolonged QT syndrome (a type of heart arrhythmia), on seizure meds. After 2nd dose of the vaccine began having seizures again (hadn’t had any seizures for a couple years). She died 56 days after 2nd dose of the vaccine from a heart arrhythmia and complications of a seizure.
17 year old girl with a previously diagnosed seizure disorder died 15 days after the vaccine was given. No other details were provided.
15 year old obese girl – 2 days after the vaccine was found to have an enlarged heart and heart failure and died.
21 year old girl – 17 days after 2nd dose of the vaccine was found dead in dorm room. She died of unknown causes. There was a trace of alcohol in her bloodstream.
14 year old girl – developed a new seizure disorder after 2nd dose of the vaccine. Then, 2 weeks after the 3rd dose she was rushed to ER for unknown reasons. She died in the ambulance.
21 year old – developed viral myocarditis (a heart infection) after the 3rd dose of the vaccine and died. Details as to how many days after the vaccine weren’t provided.
12 year old - 6 days after a dose of the vaccine died suddenly of myocarditis.
19 year old - Sudden death from a pulmonary embolism 14 days after first dose of the vaccine.
15 year old - Died of staphylococcus (a bacteria) bloodstream infection and the flu 2 months after the vaccine (not clear how many doses she received).
11 year old - 3 days after the 1st dose of the vaccine had a severe allergic reaction (anaphylaxis), cardiac arrest and died.
22 year old - 2 days after the vaccine suddenly died. No other data were given on this case.
17 year old with diabetes – 50 days after 2nd dose of the vaccine, died of complications of diabetes (life-threateningly high sugar and acid levels in the bloodstream).
18 year old - 5 months after getting the meningococcal vaccine and HPV vaccine, died of meningitis.
12 year old – 21 days after getting the vaccine, died in her sleep. No other details provided.
26 year old - between 1 and 21 days after the first dose of the vaccine, developed blood clots in her legs, which traveled to her heart and lungs. She was found dead in her car.
20 year old - 4 days after first dose, suddenly died. Autopsy was normal. No drugs were found in her system. Cause of death, unknown.
I couldn’t find info on 3 of the deaths.

I count about 4 cases in which the death was sudden due to heart problems – arrhythmia, heart inflammation, heart failure, and severe allergic reaction and cardiac arrest. I count one case that was sudden and unexplained with a normal autopsy. There was one case in which a seizure problem may have been caused by the vaccine, then on the third dose a fatal seizure or heart complication was triggered. These six deaths were sudden, without any warning, in seemingly healthy young women, and could have conceivably been triggered by a cardiac or neurologic reaction to the vaccine.

The remaining deaths are less likely to be related to the vaccine. There were two cases with prior seizure problems who suddenly died, seemingly from complications of their seizures. There were two cases of sudden death, but no details are given to know if their deaths were mysterious (and maybe from the vaccine) or some natural explanation. Two developed blood clots that traveled to their heart and lungs, causing sudden death. A few died a long time after the vaccine, so it would be unlikely to be related. These deaths seem to be more related to a pre-existing medical condition or a known sudden condition that is known to happen (like blood clots).

Overall, it does seem like a few of these very tragic deaths could be caused by the vaccine, but certainly not all of them. If you consider that perhaps six of these deaths were due to the vaccine, out of approximately 12 million doses given, that would put the risk at about 1 in every 2 million doses.

Now what about other severe reactions that did NOT result in death, but were nevertheless very serious? I searched VAERS for all reactions that resulted in a hospitalization and were considered life-threatening. I came up with 59 results. Many of them seemed to occur too far away from the shot to have been related, or occurred in women with pre-existing medical problems that were probably responsible for their hospitalization, or were hospitalized for reasons probably unrelated to a vaccine reaction. However, some reactions occurred close to the vaccine and may have been related. 25 reactions occurred within 2 weeks of the vaccine in a perfectly healthy person who had no underlying reasons for suddenly becoming seriously ill. Such reactions included severe neurologic problems (nerve and muscle weakness, partial paralysis, and various nerve dysfunctions), severe bleeding disorders (sudden anemia or bleeding problems), blood clotting problems, sudden onset of diabetes within a few days after the shot, and a few serious allergic reactions.

WHAT SHOULD PARENTS DO WITH THIS INFORMATION?
Such reports of deaths and severe reactions would naturally scare any parent, and these events are very tragic for the families involved. But overall, the risk of a fatal reaction is very, very small. The risk of a severe reaction (not fatal) is also fairly small, but may give parents pause. I think that if a teen is going to be sexually active, the risk of HPV disease is very real, and getting the vaccine is worth the small risk. Any teens who are committed to abstinence may not need to take the small risk of the shot. Any teen who has a seizure disorder (or other neurologic disorder), a problem with blood clotting (or other hematologic disorder), or any heart problems (especially heart arrythmias) may be at a higher risk of suffering a severe reaction to the HPV vaccine.

New Study Shows No Link Between MMR Vaccine and Autism – Should Parents STILL Delay and Split Up the MMR Shot?

2008-09-09T15:48:00.000-07:00

A multicenter study (Harvard, Columbia, Mass General, CDC, and the AAP) involving 38 children (25 with Autism and 13 without) was released today, Sept 3, 2008. Its purpose was to duplicate the original research done by Dr. Wakefield in 1998 that raised questions about a link between MMR vaccine and autism. Dr. Wakefield had found measles virus infecting the intestines of children with autism and chronic diarrhea and proposed that further research be done to see if the measles virus in the vaccine could be a trigger for intestinal inflammation, chronic diarrhea, and autism. Dr. Thompson had published a study in the Lancet medical journal in 1995 (three years before Wakefield) showing a strong association between inflammatory bowel disease and Measles vaccine in adults. Wakefield tried to study this association in children with autism.

Thousands of parents across the U.S. have described how their developmentally normal infant developed diarrhea and then regressed into autism between age 1 and 2 years. I have personally heard this same story from about 300 families in my own office. While many things in an infant’s life can trigger chronic diarrhea (like antibiotic overuse and milk/wheat allergies), because of Wakefield’s work many parents have suspected that the measles virus in the MMR vaccine (given at age 1) could be a trigger. In the last 10 years, many doctors have tried to discredit Wakefield’s research, without simply repeating his work to try to prove him wrong.

This new study is the first to try to do just that. Doctors from some of the most reputable medical institutions did intestinal biopsies on 25 children with autism and 13 children without, and found only one child in each group with measles virus in their intestinal lining. Wakefield, on the other hand, had found measles in most of his 12 autistic patients and only a small percentage of his non-autistic control patients. The authors of this new study conclude that their results provide “strong evidence against an association of autism with persistent Measles Virus RNA in the GI tract or MMR vaccine exposure.”

While the authors of this study don’t go so far as to conclude that their results completely prove that there can be no link between MMR vaccine and autism, their findings should allow parents to feel more comfortable giving the MMR vaccine.

What should parents do with this information?

It has been my practice to delay the measles part of the MMR vaccine until age 3 years (to bypass any possible connection between that vaccine virus and the susceptible age of regressive autism), and provide the mumps vaccine and rubella vaccine in separate doses at ages 1 and 2. This is one of the most controversial parts of my Alternative Vaccine Schedule. This recommendation was made based on Wakefield’s findings, and the fact that no other study had yet repeated his work and proved him wrong. In fact, Uhlmann published findings similar to Wakefield’s in Molecular Pathology in 2002, but in a much larger group of 91 kids with autism. His study was also discredited by most doctors and researchers.

Now, in light of this new and seemingly credible study, the need to delay the Measles vaccine and split up the MMR has come into question. I have always known that my MMR vaccine precautions were not based on any solid proof of a connection with autism. But I felt that until someone proved Wakefield wrong, delaying the Measles vaccine was a legitimate precaution.

So the question is, does this new study prove Wakefield wrong? Does it prove there is no connection between Measles vaccine and autism? The authors of the study put it this way: “This study provides strong evidence against an association of autism with persistent Measles Virus RNA in the GI tract or MMR vaccine exposure.” It isn’t absolute proof, but it certainly is a giant step in that direction.

I am not yet ready to throw out the precaution of delaying the measles vaccine and splitting the MMR. There may not be any good scientific evidence that is necessary to delay Measles vaccine or split the MMR in regards to autism prevention (in light of this new study), but in my mind there are other potential benefits to getting only one live-virus vaccine at a time. Live-virus vaccines (MMR, Chickenpox) mimic the natural infection. Since children don’t catch all 4 of these infections simultaneously in nature, why induce them all together with vaccines if we don’t have to? I know the immune system can handle exposure to many simultaneous diseases, but when it comes to major diseases of childhood, like Measles, Mumps, Rubella, and Chickenpox, I feel it’s safer to expose infants and children to just one of these at a time. I believe the vaccines may work better this way, and may create fewer side effects when separated.

What should parents do? Finding a doctor who is willing to split the MMR up is very difficult, and the separate Mumps and Measles vaccines are in short supply. Because we don’t really have any good evidence that the Measles vaccine should be delayed in order to bypass the age of regressive autism, I think it is fine to get the full MMR at age one if a parent can’t find the separate vaccines or can’t find a doctor to split them up. Parents should feel more confident giving their infant this shot at age one in light of this new study’s findings that the MMR or plain Measles vaccine probably does not have any relationship to autism.

However, any parent who has access to the separate MMR component vaccines and wants their infant to get the shots split up according to my schedule should continue to feel free to do so. I will continue to offer this service in my office. I will continue to take the position that parents should have the freedom to choose a vaccine schedule that they are comfortable with, even if it goes outside the customary government and medical recommendations.

Click here for a link to the new study:
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140

Dr. Bob

Two New Combination Vaccines Now Available

2008-08-22T14:49:00.000-07:00

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.

New Flu Vaccine Recommendations for Older Children

2008-08-11T15:26:00.000-07:00

The American Academy of Pediatric announced a new policy for the flu vaccine. They will now recommend a flu shot for every child age 6 months through 18 years of age at the start of flu season each year. For the past few years the flu vaccine had only been recommended for all kids 6 months to 5 years. Prior to that, the flu vaccine was only used for select children with certain chronic medical conditions that would make the flu more dangerous to them.

The new policy is hoped to go into effect for this coming flu season (2008/2009), but officials aren’t sure if supplies of the flu vaccine will be adequate. It will definitely be in effect for the 2009/2010 flu season. Parents who have been giving their young children a flu shot every year will probably just continue this practice throughout childhood without putting much thought into it. However, parents with older children who aren’t used to this routine will now be faced with deciding whether or not to get the shot each year.

The flu shot has always been controversial because the disease has a very low fatality or complication rate for healthy children and young adults and the shot has a high rate of flu-like side effects. People wonder if they even need it. Each year there are about 100 fatalities in infants, children, and teens combined, and a few thousand fatalities in the elderly. So getting the flu shot certainly can help minimize these tragic deaths. The problem is, the flu shot doesn’t always work. Each year officials have to predict which strains to put into the vaccine for the next year. If they guess wrong and different flu strains circulate (as in 2007/2008), the flu shot doesn’t help much.

There’s really no right or wrong answer, in my opinion. You either get the shot or you don’t. The most critical part of this decision is to make sure you are getting a mercury-free version. As flu season approaches, I will post an update on how to tell which flu shots don’t contain mercury for this coming year.

CNN.com and Dr. Bob help parents answer the question, “Should I vaccinate my baby?”

2008-06-25T09:44:00.000-07:00

CNN correspondent Elizabeth Cohen explores how parents attempt to answer this question, and how various doctors across the nation are responding to parents’ concerns, in her weekly column on www.CNN.com

I believe vaccines are very important and have played a tremendous role in limiting many serious diseases in our country, as do all of the doctors interviewed by Elizabeth for her column. However, more and more parents are concerned and want to take an approach that varies from the regular CDC schedule. I believe that if more and more doctors offer parents such options, we will have better vaccination rates than we are seeing now.

Here are just a few of the options that Elizabeth presented in her column:

Don’t give the Hepatitis B vaccine to newborns in the hospital. Because this shot can cause fever, lethargy, and poor feeding (problems you don’t want to see in a newborn), it’s better to delay this shot for the first two months of life, especially since the disease doesn’t even occur in newborns (it’s a sexually-transmitted disease).
Checking “titers” (blood immunity levels) for various shots before doing boosters. Some kids don’t need some of the booster shots at age 5 years because their original infant series may still be working just fine. While this is a costly and time-consuming approach, some parents prefer it instead of automatically getting all the boosters.
Getting fewer shots at each infant checkup and spreading the shots out over more time. This is the hallmark of Dr. Bob’s Alternative Vaccine Schedule.
Limiting large combination shots. Some parents prefer to split some of the combo shots into separate components to decrease the chance of a reaction. While we don’t know if this precaution even helps, it is an option that some doctors like to provide for concerned parents.

The bottom line is that more and more parents want options. If we don’t provide them with options they are comfortable with, more parents will opt out of vaccines altogether. We will then see more and more disease fatalities and complications.

Dr. Bob

Plain Mumps Vaccine Shortage - Should Babies Just Get the Full MMR?

2008-06-20T12:12:00.000-07:00

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.

New Study Shows Possible Link Between Environmental Mercury and Autism – What About Vaccine Mercury?

2008-04-29T16:53:00.000-07:00

Researchers at the University of Texas showed that the closer a family lives to a power plant or industrial facility, the higher the risk of autism. Autism rates decreased by 1 to 2 percent for every 10 miles that a child lives away from such mercury sources. They also found that for every 1000 pounds of mercury released by such facilities, autism rates in the surrounding area increased by 2.6 to 3.7 percent.

Many researchers believe that the most likely reason for the increase in autism is some sort of combination of genetic susceptibility and environmental chemical exposure. This study adds credibility to that theory.

Even though mercury was removed from virtually all vaccines in 2002, parents who had their children vaccinated prior to 2003 are worried if vaccine mercury could have harmed their child. Many studies have shown that no harm was done from vaccine mercury. Some studies do show a possible link between the mercury and autism and other problems (See Resources in The Vaccine Book).

What does this issue mean for parents who are vaccinating their infants and children now? First, make sure your doctor is using 100% mercury-free vaccines. The only place mercury is still found in large quantities is in some brands of the flu shot and some older versions of the plain tetanus and diphtheria/tetanus shots. A few shots use mercury in manufacturing, then go through a filtering process that removes 99% of it, leaving a tiny little trace amount of mercury. These shots include one brand of the DTaP vaccine, some brands of the flu shot, and the newer plain tetanus or diphtheria/tetanus shots.

As long as a parent knows to avoid these sources of mercury, you can get the entire routine childhood vaccine schedule 100% mercury-free. There is a flu shot that is 100% mercury-free. Two brands of DTaP don’t contain any mercury. And the plain tetanus and diphtheria/tetanus shots that do contain mercury aren’t part of the normal vaccine schedule. So, when it comes to making vaccine decisions, you can take any fears of mercury out of the equation.

Click here to read more on this story out of the University of Texas.

Larry King Show Continues to Raise Questions About Vaccines and Autism

2008-04-03T14:40:00.000-07:00

Last night’s show was a great mix of pro-vaccine doctors, doctors who have some concerns about vaccines, and parents who are demanding a different vaccine schedule. While everyone on both sides had good things to say, as expected there really was no conclusion reached and most parents are still probably just as confused as ever.

I’ve looked at all the research, and I’m still confused as well. There is no clear answer on whether or not vaccines contribute to autism. But there is one thing that is very clear – more research needs to be done. Well, make that two things – more and more parents are going to decline vaccines unless they are offered an alternative vaccine schedule.

So, while the scientists, doctors, government officials, and parents battle it out over the next couple of decades, here’s what YOU, the concerned and confused parent with a little baby waiting for vaccines, can do NOW. Educate yourself about all the pros and cons of vaccines, understand the risk of diseases versus the rare risk of a vaccine side effect, look at all the research that does exist so far, and when you do decide you are comfortable beginning shots, vaccinate according to my Alternative Vaccine Schedule or my Selective Vaccine Schedule.

I do believe change is in the wind, but it may be a very gentle breeze that takes many years to fill the sails (nice metaphor, huh? Or is that a simile? Never could get that straight. Maybe it’s an analogy). For now, I encourage parents to follow one of my suggested vaccine schedules.