HELP! Rotarix, Prevenar, Infanrix Hexa!

HindaRochel

Wed, Feb 01 2012, 3:09 pm

e_plus3 wrote:

HindaRochel wrote:

nylon wrote:

There are some scare pages on rotavirus vaccines, in part because the first rota vaccine, Rotashield, may have been associated with a bowel complication. This is why rota must be given before a certain date, because the overall risk of this complication changes with age and this enables doctors to be sure the vaccine didn't cause it.

Nylon, do you know what in rotashield caused the problem? And how significant was the problem in terms of children who had a reaction? (Real numbers as well as percentages. And make sure to dot all your I's and cross all your t's Smile

) Seriously, I'm trying to do some research on my own but if you know I'd be interested in hearing numbers.

When I have more time later I will go try to find the hard data. They didn't conclude that the Rotashield definitely caused the intussusception (actually a lot of researchers don't think it did, but it's not clear), but it was pulled because of the possibility that it did (and as far as I know, there was never any indication of why it might have led to that complication).

Quote:

I take this as proof that they are watching out for the best interest of the kids--no matter how many studies you did before releasing any medication or vaccine, you won't catch the extremely rare side effects because you don't have enough of a sample size.

Anyway, my point is that when they brought out Rotateq, they actually had special surveillance programs to make sure that there wasn't an increased incidence of intussusception, after they had been careful to look for any indication of this in the preliminary studies.

I tend to agree with you regarding the bolded.
From what I learned via Google, which doesn't at all equal the learning of someone who is actually in medicine, it seemed the incidences of the problem increased above the norms. And yes, it was pulled extremely quickly. CDC and FDA are very well run programs.

nylon

Wed, Feb 01 2012, 4:28 pm

There was no real conclusion. Here's a slide set from Paul Offit (the inventor of Rotateq, but he spent a long time studying rota before that...) Quite technical, but there's a theory on intussusception at the end (I always have trouble spelling that!)

http://www.sabin.org/files/Paul%20Offit.pdf

The CDC page has stats. it appears that the incidence did rise above baseline. However, the incidence naturally rises at a certain age. Hence the age rules for RotaTeq and Rotarix: if intussusception occurs naturally at the higher risk age, we can know for sure that the vaccine didn't do it, because it was given well before.