How Do We Feel About This One?? (Vaccine Related)

[DVCLiz]

I don't know anyone whose baby had the rotovirus, so I'm not very familiar with this one. Moms with younger children, is this something you read about in the literature? What are your thoughts if they recommend this for infants??
FDA Clears Glaxo Diarrhea-Virus Vaccine

WASHINGTON - Drugmaker GlaxoSmithKline has received federal approval for a vaccine to stop the leading cause of diarrhea in infants, a market dominated by rival Merck.

The Food and Drug Administration on Thursday approved the company's Rotarix vaccine to prevent the rotavirus in infants, the company said in a statement.

Rotarix is given in a two-dose oral regimen that can be completed by the fourth month after birth. Merck already markets a similar product, Rotateq, which is usually given in three doses over the course of six months. Rotateq was Merck's second-best selling vaccine last year with revenue of $525 million.

Len Friedland, Glaxo's clinical director for vaccines, suggested Thursday its vaccine would be more convenient for parents than Merck's because it can be completed in fewer visits to the doctor's office.

FDA cleared the vaccine, which is made from a weakened strain of the virus, based on testing in 75,000 infants. Those results showed no evidence of life-threatening intestinal problems seen with the first rotavirus vaccine approved in the U.S. That vaccine, RotaShield from Wyeth, was pulled from the U.S. market in 1999 after it was linked to an increase in intussusception, a twisting of the intestines.

Whitehouse Station, N.J.-based Merck added language about intussusception to Rotateq's label last year after receiving 28 reports of children developing the disorder. The FDA said the reports did not exceed the number expected to occur naturally each year.

While Glaxo's vaccine currently contains no language about intussusception, Friedland said that may change after it has been on the market.

"This is a disease that occurs naturally in children and I expect there will be reports of it with our vaccine as there have been with Merck's," Friedland said.

Glaxo is currently negotiating terms of a follow-up study with FDA to track the vacinne's safety in the U.S. The FDA based its approval of Rotarix on studies in South America, Europe, Asia and Africa.

About 55,000 U.S. children are hospitalized each year due to the rotavirus, according to the Centers for Disease Controls. The U.S. government and several medical societies recommend vaccination for all infants.

Despite FDA's approval Thursday, Glaxo does not expect the vaccine to gain widespread use until June, when the government's committee on immunization meets to recommend new vaccines.

Shares of London-based GlaxoSmithKline PLC rose 21 cents to close at $44.72 on Thursday.

 

[Pennykay]

Hi, Liz

Well, since the first rotavirus vaccine was recalled:

The First Rotavirus Vaccine is Recalled

In 1998, vaccine manufacturer Wyeth released a new vaccine against Rotavirus called RotaShield. Aside from the usual side effects seen in vaccinations, RotaShield became linked to an alarming condition called instussception, which is a "blockage or twisting of the intestines" that sometimes requires surgery and can be fatal. After 76 reported cases in less than a year, the CDC recommended postponing the vaccine, and it was recalled.

And the second one that is currently out has a warning from the FDA for similar issues:


FDA Public Health Notification
Information on RotaTeq and Intussusception
February 13, 2007

The Food and Drug Administration (FDA) is notifying health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co., Inc. Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine.

Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, is unknown.

FDA is issuing this notification both to encourage the reporting of any additional cases of intussusception that may have occurred or occur in the future after administration of RotaTeq, and to remind people that intussusception is a potential complication of RotaTeq,.


I think I would wait and see how the third does long term before making any decisions on vaccinating my children with it.

 

[DVCLiz]

Yes, I saw the information about the vaccine that was available in 1998 - ten years ago. I also see that the occurrences of the intestinal complication (can't remember how to spell it since I can't see the post right now!!) are said to be the same as the naturally occuring cases - ie. the ones that happen spontaneously in the general population.


FDA cleared the vaccine, which is made from a weakened strain of the virus, based on testing in 75,000 infants. Those results showed no evidence of life-threatening intestinal problems seen with the first rotavirus vaccine approved in the U.S. That vaccine, RotaShield from Wyeth, was pulled from the U.S. market in 1999 after it was linked to an increase in intussusception, a twisting of the intestines.

Whitehouse Station, N.J.-based Merck added language about intussusception to Rotateq's label last year after receiving 28 reports of children developing the disorder. The FDA said the reports did not exceed the number expected to occur naturally each year.

While Glaxo's vaccine currently contains no language about intussusception, Friedland said that may change after it has been on the market.

"This is a disease that occurs naturally in children and I expect there will be reports of it with our vaccine as there have been with Merck's," Friedland said.



I was really more curious about this rotavirus and its prevalence in the population, and if younger moms thought this was something important that almost everyone would embrace, or if would be seen more as a Gardasil "too new and my child probably won't get that" scenario.

 

[Mouse House Mama]

Young Mom here! We have some experience with the rotovirus here. That said I have not vaccinated my kids for it. I don't feel it is neccesary since they are still (IMO) not really sure of the effects of it so it is not worth the risk for me. I feel the same way about the Gardisil vaccine.

 

[rie'smom]

It may not have exceeded the the expected number but what a coincidence that the kids who suffered from intussusception also had the vaccine.

 

[Jen_in_NH]

I didn't vaccinate my son for it either. My thought was that he wasn't very likely to be exposed to it anyways (not going to daycare, which is one of the top ways to get it). I wasn't completely convinced about the intussuseption risk either - the FDA was sure that the first Rotavirus vaccine was fine, and then had to recall it. The newer vaccine hasn't been out long enough for me to be completely comfortable yet.

But that's just me. I'm sure may people disagree.

 

[tiggger1]

My son got vacinated but that was because my dd had it bad when she was a baby.

 

[girlegirl7101]

my 18 month old got it, but i declined it with the baby.

 

[DVCLiz]

It may not have exceeded the the expected number but what a coincidence that the kids who suffered from intussusception also had the vaccine.

Oh, I was assuming that the vaccine was the cause of the intussusception - just that the findings were such that the same number would have occurred naturally in the population if the vaccine hadn't been administered.

 

[1Prince3Princesses]

Deleted

 

[The Disney Bunch]

and how is this Disney budget minded? Isn't there a debate board here somewhere - sorry but I think this is the wrong board for such a controversial topic.

 

[newtodcl]

We elected not to get it as I do not give any "new" vaccines and as few as possible under 6 months. When we went for the 6 mo checkup, they said there was not a need for it any longer as the baby was too old for it, which I was aware of....so maybe just weigh the time of year, risk of infection with age of the child.

The first dose should not be administered to children aged greater than or equal to 7 months because of an increased rate of febrile reactions after the first dose among older infants. Second and third doses should be administered before the first birthday. Implementation of these recommendations in the United States should prevent most physician visits for rotavirus gastroenteritis and at least two-thirds of hospitalizations and deaths related to rotavirus.

http://www.cdc.gov/MMWR/preview/mmwrhtml/00056669.htm

 

[carmie3377]

My son had rotovirus when he was 2 weeks shy of turning 1. He got it from the neighbor kids. They first started exhibiting symptoms while we were there or no way would we have been over there. Anyway, he ended up in the hospital. We weren't given the choice for him, but had we had, he would have received the vaccine.

All it takes is a parent not washing his/her hands after changing a diaper (yes, gross I know), going into the supermarket, touching the buggy, leaving, you grab that buggy, and you now have the virus on her hands. Same with doorknobs, ect. So, you may not think your kids can't be exposed to it, but it happens.

 

[DVCLiz]

and how is this Disney budget minded? Isn't there a debate board here somewhere - sorry but I think this is the wrong board for such a controversial topic.

Then just skip over it - if you're not interested in the topic you're not required to open the thread.

We've had two off topic vaccine threads going today, so I wanted to get the opinions of the moms who had already been discussing the subject.

And no, there isn't a Debate Board anymore. The Community Board would be the closest thing, but again, Budget Board moms are the ones who've been discussing it today.

 

[DVCLiz]

We elected not to get it as I do not give any "new" vaccines and as few as possible under 6 months. When we went for the 6 mo checkup, they said there was not a need for it any longer as the baby was too old for it, which I was aware of....so maybe just weigh the time of year, risk of infection with age of the child.

The first dose should not be administered to children aged greater than or equal to 7 months because of an increased rate of febrile reactions after the first dose among older infants. Second and third doses should be administered before the first birthday. Implementation of these recommendations in the United States should prevent most physician visits for rotavirus gastroenteritis and at least two-thirds of hospitalizations and deaths related to rotavirus.

http://www.cdc.gov/MMWR/preview/mmwrhtml/00056669.htm

So the first dose of the vaccine really has to be given before 6 months, but the virus itself can cause illness in children older than six months, is that right? How old are kids when they stop being at risk for this?? I don't remember hearing about it for my girls.

 

[drivencrazy]

Ok, my kids are older... 13, 10, 5 and 3... NON of them got it... my brother and SIL's 2 kids got it when it first came out... they BOTH had problems and the doctors decided it was from that shot that SIL decided they should get even though it was REALLY new at the time... they are now 12 and 10 and most of the probles that came from the shot have since gone, but the 12 year old (boy) still has some issues. I did NOT give my children the shot since it was new and I didn't want to risk anything... my poor SIL still to this day says that she wishes she didn't let them give it to her kids.

 

[katerkat]

I didn't vaccinate my son for it either. My thought was that he wasn't very likely to be exposed to it anyways (not going to daycare, which is one of the top ways to get it). I wasn't completely convinced about the intussuseption risk either - the FDA was sure that the first Rotavirus vaccine was fine, and then had to recall it. The newer vaccine hasn't been out long enough for me to be completely comfortable yet.

Rotavirus went through my Mom's Club (a group for SAHMs) two months before I joined. A friend's daughter, who wasn't in daycare, caught it. Plus, Russ caught coxsackie from a playground.

That being said, I wouldn't get it for a future kid. But then, Russ doesn't have the chicken pox vaccine, so I'm already a weird mom.

 

[bumbershoot]

I don't know anyone whose baby had the rotovirus, so I'm not very familiar with this one. Moms with younger children, is this something you read about in the literature? What are your thoughts if they recommend this for infants??

Reading only the original post, replying, and moving on...

A drug that is related to drugs that have caused intussusception (a situation in which a part of the intestine has in******ted into another section of intestine, similar to the way in which the parts of a collapsible telescope slide into one another) is not ever going to make me feel safe.

DS had rota twice, first at 1 and then at 2 years old. If you're ever in the house with a kid with it, you KNOW they have it. Very very distinctive smell to the poops. Beyond distinctive. Don't even need to have anyone diagnose it, it's so distinct.

Nursed him even when he threw the milk right up. Nursed, nursed, nursed. And he got through it just fine. I never had to worry about dehydration or anything, b/c of all the nursing. Very simple in our household.

Except for the diapers. Those were horrid. But ultimately no biggie; I just washed 'em (cloth dipes) a couple times, dried them, and moved on with my quickly healthy baby.

Therefore, I would not risk intestines collapsing in themselves like a telescope, for something I can just nurse a baby through.

 

[carmie3377]

Nursed him even when he threw the milk right up. Nursed, nursed, nursed. And he got through it just fine. I never had to worry about dehydration or anything, b/c of all the nursing. Very simple in our household.

Therefore, I would not risk intestines collapsing in themselves like a telescope, for something I can just nurse a baby through.

What works for some, doesn't work for others.

I'm glad nursing worked for you. But it didn't work for us. Cameron refused, absolutely refused to nurse or take anything by mouth. He wouldn't latch on, nothing. How do you tell 11 month old to nurse? The pedi said to force liquids down him with a syringe. He spit it out. What he didn't spit out, he vomited very shortly. A child (or anyone) will dehydrate if they are not taking any liquids in. Simple as that. We went from onset of roto to hospitalization in less than 36 hours. That is how fast an infant can dehydrate.

 

[disalways]

I remember the Ped telling me it was time to give the Rotaivirus vaccine when my twins were a few months old. My dd who was 4 1/2 at the time never had it... and I had no clue what rotavirus was. I asked for literature on it, and decided to pass since it was such a new vaccine. Then of course the vaccine was pulled due to the complications. This is exactly what I bring up when folks around here want to discuss the Gardasel vaccine... There are too many unknowns.