What can you tell me about the rotavirus vaccine? - Page 3 - Mothering Forums

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#61 of 112 Old 02-05-2008, 10:08 PM
 
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Originally Posted by delphiniumpansy View Post
How is 2 children out of 72,000 any kind of a big deal at all? That is statistically insignificant.
it's not the statistics, dp.

the question is not HOW MANY?

the question is...HOW THE F DID THAT HAPPEN?



no matter if it happened once or thousands of times, don't you think it's...i dunno...ODD that the VACCINE STRAIN was found in the (supposedly) PLACEBO group?
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#62 of 112 Old 02-05-2008, 10:53 PM
 
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I doubt they were at all concerned about that - that's sort of something they'd consider a bonus.
Like this?
http://www.springerlink.com/content/k32084k779x75k84/

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The similarity between the Finnish isolates and the bovine isolate NCDV suggests that they have diverged recently and that these human G 8 rotaviruses may be derived from a zoonotic infection, or alternatively, from the live rotavirus vaccine of bovine origin which has been used to vaccinate Finnish children.
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#63 of 112 Old 02-06-2008, 01:40 AM
 
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Don't have full text of that one so no idea. But definitely like with OPV - it;s sort of considered a bonus if it spreads to unvaxed people in the community. And like with the conjugate vaxes- it's considered a bonus if it has community effect.
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#64 of 112 Old 02-06-2008, 01:42 AM
 
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Don't have full text of that one so no idea. But definitely like with OPV - it;s sort of considered a bonus if it spreads to unvaxed people in the community. And like with the conjugate vaxes- it's considered a bonus if it has community effect.
Hence the reason I kept DD away from recently vaxed kiddos when she was little!!

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#65 of 112 Old 02-06-2008, 02:05 AM
 
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Don't have full text of that one so no idea. But definitely like with OPV - it;s sort of considered a bonus if it spreads to unvaxed people in the community. And like with the conjugate vaxes- it's considered a bonus if it has community effect.
diarrhea as a "bonus"?

shitoculation.
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#66 of 112 Old 02-06-2008, 02:12 AM
 
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We get a nasty stomach bug every year. I don't know if we've ever had rotavirus. I have ended up in the ER three times in my life from dehydration with them. My dd has a tendency to get very, very sick when she gets a stomach bug. She throws up for days (I think because of her reflux) and has diarrhea and loses weight. She only weighs 22 lbs and is 2 yrs old.

I would not even consider this vax (not that it's available at her age anyway). She never gets even close to dehydrated--we just keep nursing, nursing, nursing. And anyway, I never hear about anyone getting rota, so I guess I'd be more afraid of the other bugs that circulate every year (I think noroviruses?).
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#67 of 112 Old 02-06-2008, 02:29 AM
 
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shitoculation.
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#68 of 112 Old 02-06-2008, 12:28 PM
 
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Originally Posted by delphiniumpansy View Post
intussception is naturally occurring. It is nothing in the placebo but just that a certain portion of the population will get it and it is not really any different than those who got rotateq. Hence, nothing to worry about as your chances of it happening are just as great even if you do not vax.

Gitti, why do you keep discussing as if the old vax and the new one are the same? Just as many unvaxed babies are dying of intussception or having complications from it as those who got rotateq. Your children who are not vaxed could experience intussception.
What are the rates of intussception in the group of infants that did not get the vaccine OR the placebo?
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#69 of 112 Old 02-06-2008, 06:42 PM
 
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What are the rates of intussception in the group of infants that did not get the vaccine OR the placebo?
Go back in this thread and you will find the rates of intussception for the two groups. Are you asking what the rate of intussception is in the general public, outside of the study group?

http://www.kidshealth.org/parent/sys...usception.html


This site says it affects between one and four out of 1000 children.
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#70 of 112 Old 02-07-2008, 01:26 PM
 
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So where is the study that took 3 groups of 1000 children, 1st group no vaccine or placebo, 2nd group the placebo, and the 3rd group the vaccine, what were the rates in those children?
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#71 of 112 Old 02-07-2008, 02:44 PM
 
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Is the hypothesis that the placebo causes the intussception? (in this case, that would be:

Ingredients in the placebo: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.)

I am assuming above that the placebo was the vaccine minus the virus portion.

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#72 of 112 Old 02-07-2008, 02:53 PM
 
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Originally Posted by delphiniumpansy View Post
Go back in this thread and you will find the rates of intussception for the two groups. Are you asking what the rate of intussception is in the general public, outside of the study group?

http://www.kidshealth.org/parent/sys...usception.html


This site says it affects between one and four out of 1000 children.
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Originally Posted by carriebft View Post
Is the hypothesis that the placebo causes the intussception? (in this case, that would be:

Ingredients in the placebo: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.)

I am assuming above that the placebo was the vaccine minus the virus portion.

It seems thata is the hypothesis, but the link above says the rate is still quite similar, between 1 and 4 in every 1,000. But with the vast majority of kids probably getting this vaccine (not sure how many states require/push it) it still doesn't make me feel better, as the general population studies are going to be conducted on kids getting this vax.
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#73 of 112 Old 02-07-2008, 02:59 PM
 
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Originally Posted by carriebft View Post
Is the hypothesis that the placebo causes the intussception? (in this case, that would be:

Ingredients in the placebo: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.)

I am assuming above that the placebo was the vaccine minus the virus portion.
A bovine virus in the FBS might be responsible. I don't think it is, but it's possible.
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#74 of 112 Old 02-07-2008, 03:20 PM
 
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Is the hypothesis that the placebo causes the intussception?
No, I don't think so. I think there's concern that the placebo and the vaccine were mixed up, at least a bit, because two of the placebo kids had the vaccine strain rota in their poop.
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#75 of 112 Old 02-07-2008, 03:42 PM
 
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I can understand if there is concern over placebo mix up, but when people ask "what are the rates for unvaccinated?" or the like...or say that the comparison between the vaccinated group and the placebo group in regards to intussception means nothing because of the placebo...that seems to be saying that there is something in the placebo (not a mixed up one, but the actual placebo) causing the problem.

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#76 of 112 Old 02-07-2008, 03:45 PM
 
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I thought that part of the discussion was specific to one particular study--the vaxed and unvaxed in this study are comparable, but if some of the placebo and vax were mixed up, then a different datapoint to find the background rate of intususception (sp?) is needed. I read it as very specific to what the cause of the 2 kids with the vaccine strain in their poop was about.
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#77 of 112 Old 02-07-2008, 04:13 PM
 
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Basically, if there was a study on this vaccine where no placebo children shed the vaccine virus and yet the rates of intussusception in the placebo and vaccinated group were the same, then we could accept those numbers?

I guess that is what I am trying to get others to answer. If those numbers could not be accepted to show no link between the vaccine and the problem, would we then have to look at the placebo? (and I would be interested in other theories on the placebo such as teh one offered about FBS)

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#78 of 112 Old 02-07-2008, 04:24 PM
 
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Well, this here makes me think we will be getting a lot more data on this soon:

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In order to further observe RotaTeq™ for the potential that it could be associated with increased rates of intussusception or other serious adverse events, the manufacturer, Merck and Co., Inc., has committed to conducting another study after licensure of approximately 44,000 children, and CDC will also conduct a large study in its Vaccine Safety Datalink Program (VSD), which evaluates vaccine safety among approximately 80,000 US infants every year. In addition, for the first three years of licensure the manufacturer will report cases of intussusception to FDA within 15 days of receiving them, and all other serious side effects on a monthly basis. FDA and CDC will be closely monitoring the Vaccine Adverse Event Reporting System (VAERS) for any reports of intussusception. Although there is no evidence to date that RotaTeq™ causes intussusception, this aggressive post-licensure monitoring should enhance our ability to detect this risk.
This information is just more reason for us not to consider this vaccination for our new babe. I wouldn't want to do it until these new numbers come out. So maybe others on the fence might want to think about that as well.

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#79 of 112 Old 02-07-2008, 05:20 PM
 
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This information is just more reason for us not to consider this vaccination for our new babe. I wouldn't want to do it until these new numbers come out. So maybe others on the fence might want to think about that as well.
:

For this very reason I will not even CONSIDER new vaccines. I don't want my kids to be test-cases.

-Angela
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#80 of 112 Old 02-08-2008, 01:32 AM
 
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It seems thata is the hypothesis, but the link above says the rate is still quite similar, between 1 and 4 in every 1,000. But with the vast majority of kids probably getting this vaccine (not sure how many states require/push it) it still doesn't make me feel better, as the general population studies are going to be conducted on kids getting this vax.

but this is a relatively new vax, even the older one was still kind of new. Do we know if intussusception rates were measured before they were vaxing for rotavirus and if so what were they?

Why are you all concerned about two kids out of 72,000? That is statistically insignificant. Even if they were my two kids I would understand that statistically it is insignificant that they got rota and I would not worry about it. They could have picked it up at the local children's museum or at a playdate. They were not contained in a bubble during the trial.


As for age of vaccines, for those of you who would never consider a new vaccine, how many years would you want to pass before you would consider it? Age alone I mean? Deferring all other factors, what age would a vaccine have to be for you to consider it for your children? Would it matter if your children were immune compromised and had problems with things like bowel obstructions and thus it would be life threatening for them to get rotavirus? Or if they had a respiratory ailment, would you get a new pneumonia vaccine? How many years would you want to wait before getting it?



Just asking a few questions.
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#81 of 112 Old 02-08-2008, 01:42 AM
 
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As for age of vaccines, for those of you who would never consider a new vaccine, how many years would you want to pass before you would consider it? Age alone I mean? Deferring all other factors, what age would a vaccine have to be for you to consider it for your children? Would it matter if your children were immune compromised and had problems with things like bowel obstructions and thus it would be life threatening for them to get rotavirus? Or if they had a respiratory ailment, would you get a new pneumonia vaccine? How many years would you want to wait before getting it?
In general I would want a vax in use for 5-10 years to consider it. I would consider it if there were *extraordinary* circumstances.

-Angela
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#82 of 112 Old 02-08-2008, 01:43 AM
 
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Okay. I'm seeing where the disconnect is now...

There is a difference between wild rota and vaccine strain rota....

these children (we know of 2) had VACCINE STRAIN rotavirus in their stool, but the researchers couldn't figure out how it got there.

That's what they were discussing in the link. That they tested the strain and positively identified it as vaccine strain. So no, it's not significant that they got rota...it's that the researchers found proof-positive that they were literally pooping out the vaccine (by finding vaccine strain rota in their stool).

I'll let someone else answer the rest as I don't plan on vaxxing at all, regardless of how new/old. (And my middle child is apparently considered to be an immunocompromised child as a result of steriod asthma treatments.)
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#83 of 112 Old 02-08-2008, 01:52 AM
 
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As for age of vaccines, for those of you who would never consider a new vaccine, how many years would you want to pass before you would consider it? Age alone I mean? Deferring all other factors, what age would a vaccine have to be for you to consider it for your children? Would it matter if your children were immune compromised and had problems with things like bowel obstructions and thus it would be life threatening for them to get rotavirus? Or if they had a respiratory ailment, would you get a new pneumonia vaccine? How many years would you want to wait before getting it?

Just asking a few questions.
we won't be vaxing because the long term data would not be there. so unless someone invents a time machine, i don't have the information necessary to make a decision to vaccinate. i'm a big-picture, long-range plan kinda person. and trading acute disease in the short term for possible chronic disease in the long term (as well as possible acute disease too...at least we know that the immunity from vaccines is not permanent) just does not strike me as an intelligent, healthy thing to do.

and being intelligent and healthy are up there in my book.

as for having medical issues, that would be even more reason to not vaccinate. vaccines are tested with the healthiest of the healthy, and a child with medical issues would be even MORE of a guinea pig. no way would that happen to a child of mine. i'm not a gambling woman.
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Okay. I'm seeing where the disconnect is now...

There is a difference between wild rota and vaccine strain rota....

these children (we know of 2) had VACCINE STRAIN rotavirus in their stool, but the researchers couldn't figure out how it got there.

That's what they were discussing in the link. That they tested the strain and positively identified it as vaccine strain. So no, it's not significant that they got rota...it's that the researchers found proof-positive that they were literally pooping out the vaccine (by finding vaccine strain rota in their stool).
Oooooohh...

Is that what you were confused about, Pansy?

I was sort scratching my head over here wondering what the heck you thought statistical significance had to do with it...
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#85 of 112 Old 02-08-2008, 05:37 AM
 
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Everytime a new vaccine is licensed, you go back to square one, because now you have absolutely no studies done on giving a child this new vaccine along with all the others. Not one long term study.

How long would I wait? Until the drug companies or FDA or some other acronym agrees to fund studies on adverse reactions.

When I read that there is inadequate understanding of biologic mechanisms underlying adverse events, I will wait until there is an adequate understanding. At that point, I will reconsider my current decisions, again, using the current information available at that point in time. Because like everyone else, we can only base our decisions on the information that is available at that point in time.
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#86 of 112 Old 02-08-2008, 02:43 PM
 
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Oooooohh...

Is that what you were confused about, Pansy?

I was sort scratching my head over here wondering what the heck you thought statistical significance had to do with it...
I still do not see the problem. So what? Are you all imagining that there are serious lab issues, that safety protocols were compromised, that the scientists screwed up? Are you all thinking this is proof positive that scientist don't know squat and that these studies are useless? They still could have gotten it from each other. They could be in playgroups with each other for all we know. We do not know who these two children are. And, even if it does mean that there was a teeny breech in protocol in the lab, it is only two children. I do not think it refutes the whole study or invalidates it. It does not mean that the vaccine got into the placebo. Since we do not know for sure how it happened, conjecture is doing no one any good here.

I still think you are making a mountain out of a molehill.

But, for the sake of argument, someone please explain to me why I, as an S&Der who has vaxed my youngest with rotateq, should think that this piece of evidence is damning enough to stop. Why does it matter that 2 children out of 72000 pooped out vaccine strain rota during the trial for rotateq enough that I should no longer vax with it. What I am asking is why is that piece of evidence alone enough to discredit the vax. Nothing else, just that piece of evidence.
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#87 of 112 Old 02-08-2008, 03:02 PM
 
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I still do not see the problem. So what? Are you all imagining that there are serious lab issues, that safety protocols were compromised, that the scientists screwed up? Are you all thinking this is proof positive that scientist don't know squat and that these studies are useless? They still could have gotten it from each other. They could be in playgroups with each other for all we know. We do not know who these two children are. And, even if it does mean that there was a teeny breech in protocol in the lab, it is only two children. I do not think it refutes the whole study or invalidates it. It does not mean that the vaccine got into the placebo. Since we do not know for sure how it happened, conjecture is doing no one any good here.

I still think you are making a mountain out of a molehill.

But, for the sake of argument, someone please explain to me why I, as an S&Der who has vaxed my youngest with rotateq, should think that this piece of evidence is damning enough to stop. Why does it matter that 2 children out of 72000 pooped out vaccine strain rota during the trial for rotateq enough that I should no longer vax with it. What I am asking is why is that piece of evidence alone enough to discredit the vax. Nothing else, just that piece of evidence.
why does it have to be so black and white and based on one issue alone?

imho, if there is a possibility of a breach of study protocol (whether it's human error or something else), i would take that into consideration as to how much i would trust the results of that study. i would want to know that the study investigators were looking into the anomalous event to determine how it may have happened. even if it's statistically insignificant, the fact that something SO unusual happened does render it significant.

scientists are human. sometimes they do good. sometimes they screw up collosally. just like all of us. even smart people make mistakes. i know i do!
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#88 of 112 Old 02-08-2008, 03:49 PM
 
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Please post these statistics


My baby refused pedialyte both times she had it. Refused. Would not take it in any form, no matter what I did. We were freaked she was getting dehydrated and we were checking her for it all the time. We almost took her to the hospital for rehydration. It was scary.




I am glad you did not worry.

Most humans have, throughout time, always worried about babies with diarrhea and vomitting, whether they knew which of many illnesses was causing it or not.
Breastmilk is better than pedialyte.
Rotovirus went through my daycare (caught from a newly vaxed kiddo's sibling). My own kids had it, I had it. It was miserable, but staying hydrated was the key. All 10 of use got through just fine with no hospitalizations.

Heather married to my highschool sweetheart 6/7/02 :cop: Mother to Dani age 14 and Timmy age 10 Nadia 1/29 :
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#89 of 112 Old 02-08-2008, 05:24 PM
 
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What I am asking is why is that piece of evidence alone enough to discredit the vax. Nothing else, just that piece of evidence.
I think the biggest question it raises is whether there were some mix-ups in labelling between the placebo and the vaccine because then we don't know whether the rate of intussusception is actually comparable between vaccinated and unvaccinated children.
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#90 of 112 Old 02-08-2008, 05:33 PM
 
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I'm not too worried about this "mix up" (or possible just that a babe shed it and they got it from them or whatever it was that happened). There are other studies on the vaccine such as here:

http://iah.iec.pa.gov.br/iah/fulltex...n9p807-816.pdf

But I'm still firmly in the "waiting" camp. I think the issue for me is that there are more studies happening and we know about them and we can expect them soon...so....

With everything else we have decided to get, there is quite a bit out there and no connections to past problems like this vaccine has. WHich is, possibly, an emotional decision and not really a 100% scientific one, but I don't think I could possible even go back to considering this one until this new info comes out.

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