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Second Rotavirus Vaccine Now Available and the Timing of the Doses has been Expanded
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.
Labels: Vaccines and their diseases
Reported Side Effects of HPV Vaccine Has Parents, and Teens, Worried
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. Labels: Vaccines and their diseases
New Study Shows No Link Between MMR Vaccine and Autism – Should Parents STILL Delay and Split Up the MMR Shot?
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
Labels: Vaccines and Autism
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