FDA Asks that One of Two Rotavirus Vaccines Not be Used

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One of Two Rotavirus Vaccines 
Now Off the Market


Advanced Pediatrics has just been alerted that the FDA has advised all doctors
to stop use of the Rotarix vaccine, one of two on the market for use in preventing
stomach flu caused by the rotavirus.


Here is the official notice:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm

This notice brings several points to mind:

• Your child is not at risk at Advanced Pediatrics from this vaccine, we have never given this brand to anyone at this office
• Rotavirus is the main type of stomach flu in February.
• All stomach flus tend to be quite mild illnesses in nearly everyone who has them
• By mild, we mean that you recover and you recover with no lasting harm
• By that definition, nearly everyone who gets the stomach flu has a mild illness
• This being the case, any vaccine that would propose to prevent rotavirus infection had better be incredibly safe.  Otherwise, getting the vaccine would prove more dangerous than having the mild illness.

These points leave us confirmed in our recommendation at Advanced Pediatrics

that rotavirus immunization is not yet established as the safe enough to prevent 

this very mild illness, and so we do not recommend immunization with it.

This most recent advisory from the FDA confirms the reasonableness

of our policy to hold on the rotavirus vaccine program at Advanced Pediatrics

until we can be sure this vaccine is far safer than having a bout of mild stomach flu.

In extremely sharp contrast to the typically mild nature of rotavirus, the 
deadly illnesses of tetanus, meningitis, polio, and diphtheria make the urgency of 
being protected against these diseases a very convincing argument for immunization

against these illnesses.

Dr. Arthur Lavin

*Disclaimer*
The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.

The Second Chickenpox Vaccine- A New Recommendation

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The Two Dose Program of the 
Chickenpox (Varicella) Vaccine:
Advanced Pediatrics Now Supports
This Recommendation


Recently, the state of Ohio has changed its recommendations for 
chickenpox (varicella) vaccine from a one dose to a two dose requirement.


This means, by Ohio law, that a child must have two doses of 
varicella vaccine before they can go to school, unless an exemption
is signed be a clergy, doctor, or parent.


Specifically, at this time, one must have two doses of varicella vaccine
before you can enter an Ohio kindergarten, one dose to enter Grades 1-4, 
but no requirement for any chickenpox vaccine to enter Grade 5 or up.
Again, no varicella vaccine is necessary if you are exempted by a signed
statement from clergy, doctor, or parent.


We have studied the varicella vaccine for many years, and some 
issues do remain, even after careful consideration.  What follows 
is a report of our findings to date, and our current recommendations.


Let us emphasize at the beginning of this discussion that our findings 
and recommendations represent a careful due diligence that has attempted
to be free of influence- either from the marketing of pharmaceutical 
companies, or the lobbying of anti-immunization groups.  Rather, we
have tried to simply stick to the facts as good studies of the facts reveal.


Here are the salient points regarding chickenpox and its vaccine:


Chickenpox in childhood tends to be a mild illness.
This is a rather obvious point, but an important one.  What this 
fact means, however, is that any vaccine used to prevent childhood
chickenpox had better be awfully safe if it can claim to improve our health.
Even relatively unusual or uncommon serious side effects could make the 
vaccine a worse proposition than the disease.


Chickenpox is not always a mild disease
Prior to universal immunization for chickenpox, some healthy children
did die from chickenpox.  It is of course a very dangerous disease
for children with weak or compromised immune systems.  And, as mother's 
antibody weans over the years, adults face quite serious risks from 
more serious chickenpox disease than children, particularly from 
chickenpox pneumonia.


The first dose of chickenpox vaccine works very well
It turns out that if someone gets one dose of chickenpox or varicella
vaccine, it works very well.  About 90% of these children will be 
completely immune for many, many years, perhaps life.  That means
if an immunized child is even heavily exposed to a chickenpox outbreak, they
have a 90% chance of not getting infected.
Further, if they do get infected, essentially all the cases will be quite mild.
For nearly all chickenpox cases in those with one shot, the disease will
be limited to just a handful, sometimes 1-4 chickenpox red dots, with little
discomfort, fever, or distress.


Given that 10% of those with one shot, who are exposed, will
come down with chickenpox a second dose has been 
advised by the public health authorities
Clearly, if you get a second dose, the chance of getting even a mild case
of chickenpox nearly disappears, and that is why this new Ohio statute
requiring two doses to enter Kindergaren was recently enacted by the 
Ohio General Assembly.


Why worry about the chickenpox vaccine?
It turns out the safety record of this vaccine is very good.
Very few serious events have been reported in children that can be
ascribed to this vaccine.  


Before we can recommend the use of this vaccine at all, 
we do feel obligated to make sure you know all the risks.


One issue, more than others, presents an interesting, if theoretical, concern.


It turns out that chickenpox is one of those viruses whose DNA stays in you
the rest of your life.


Any of you who have had chickenpox still have that virus' DNA in you today.
What happens is that as you heal from your chickenpox illness, the virus retreats into 
the insides of the nerve cells that line your spinal cord.  There, the viral DNA forms a 
cozy ring, right next to your cells' DNA.  Every now and then the viral DNA is
woken from its dormancy, and explodes down the nerve cell, causing an itchy 
painful rash in the skin at that nerve's end fibers. That's how anyone gets shingles.
Now it turns out the same thing happens when you get the varicella vaccine, only this
time the viral DNA that lands in your cells is not exactly the same as the chickenpox
DNA that has been circulating across humanity for many thousands of years.
I have personally spoken to Dr. Anne Gerson of Columbia, a leader in the 
development of varicella vaccine, and she confirms that the DNA of the 
chickenpox virus in the vaccine is indeed different from the naturally occurring 
chickenpox viral DNA, and that it does settle for life next to your DNA after immunization.


Has anyone come to any harm having novel DNA lodged in their cells
after varicella vaccination?
No.  Not even after 40 years.


So why worry?
The reason we even bring this concern to your attention, is that no one has ever 
done this on a large scale before.  We have never introduced novel DNA inside millions
of people's cells, and so no one knows for sure what will happen over the course of 80-100 
years.  Further, remember we started the discussion by observing that chickenpox tends 
to be a mild disease?  Now that fact comes into play, for if the illness tends to be mild,
then even unusual, but serious, side effects from a preventive measure like the 
chickenpox vaccine can tip the argument against vaccination.


So what to do?
1.  The First Dose of Chickenpox Vaccine
Advanced Pediatrics urges everyone to have their child immunized against varicella
or chickenpox, at least once.  This is because enough children have been 
immunized that the option of getting immunity by getting chickenpox has nearly
vanished, making those unimmunized likely to be susceptible to potentially fatal
adult chickenpox.  So get the one dose.


2.  The Second Dose of Chickenpox Vaccine
The theoretical risk of introducing a novel DNA is already taken with the first dose
of chickenpox vaccine.  Even though the second dose of chickenpox vaccine likely 
presents little benefit, it also likely presents little risk.


What will we do?
At Advanced Pediatrics, we always honor the family's decisions.  Varicella or 
chickenpox vaccine is clearly one of the least urgently required protections, and 
so we are happy to follow the family's decisions.
Our recommendation at this time is to get the first chickenpox vaccine sometime 
before adulthood, since adult chickenpox is a truly dangerous illness, and that the
second vaccine is fine to get since most of the risk come with the first dose.


Of course, our goal remains clear and simple- to provide the 
very best health care we can to the infants, children, and youth
of your family.  We at Advanced Pediatrics remain greatly honored
by your trust, and will continue to work hard to earn it.


Of course, feel free to call us with any questions.


Dr. Arthur Lavin

*Disclaimer*
The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.