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Quote:

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?
 
Quote:

Originally Posted by amnesiac View Post
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/

Quote:
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.
 
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.
 
Quote:

Originally Posted by amnesiac View Post
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!!
 
Quote:

Originally Posted by amnesiac View Post
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.
 
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?).
 
Quote:

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?
 
Quote:

Originally Posted by suschi View Post
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.
 
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?
 
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.
 
Quote:

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.

Quote:

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.
 
Quote:

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.
 
Quote:
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.
 
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.
 
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.
 
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)
 
Well, this here makes me think we will be getting a lot more data on this soon:

Quote:
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.
 
Quote:

Originally Posted by carriebft View Post
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
 
Quote:

Originally Posted by Steve's Wife View Post
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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