Rotavirus Vaccine

[Stayinhom]

This will make you crazy...
In India 100,000 children die every year from the Rotavirus.
In the United States approx. 12 children die every year from Rotavirus.
In 2006, the U.S. government will add the Rotavirus Vaccine to infant vaccination schedules in the U.S.
The vaccine will Not be available to anyone in India.
In vaccine trials, one child died after receiving the vaccine and 50 more had to undergo emergency surgery. The vaccine is given orally and caused intestinal blockage.
Most children have had Rotavirus before their eighth birthday. You get it from contaminated water and it gives you bad diarrhea. In the U.S. it is not a problem, because we rehydrate our children and have clean water readily available. Not so in India...the children continue to drink from the same contaminated stream.
So why is it being given unneccesarily to children in the U.S. and not even an option in India? Because the drug makers will make money here!
This is madness...someone tell Michael Moore.

[Robyn]

They introduced this vaccine a few years back in 1998 and MANY kids had intestinal obstruction and there where also deaths. Sounds like from the study that things haven't changed.

[Gitti]

Originally Posted by Stayinhom

So why is it being given unneccesarily to children in the U.S. and not even an option in India? Because the drug makers will make money here!
This is madness...someone tell Michael Moore.

No, it's basically because any time a vaccine is introduced we have to give it to 'our children' first in order for third world countries to accept it.

We have passed much medicine, pesticides, and other poisons to them with dire affects and it has made them leery of us.

So we have to prove that we send them only what we would also give our 'own' children.

Little do they know that in order to make a buck we would kill our own kids just as readily as theirs.

[Red Sonja]

One of the online surveys I took the other day was about rotavirus and a rotavirus vaccine - I think they may be getting ready to release one in the US again. I wish the survey had a comment box, I certainly would have given them some comments.

[townmouse]

Stayinhom, can you provide a link or a source of your info?

[CallMeIshmael]

Originally Posted by Stayinhom

In 2006, the U.S. government will add the Rotavirus Vaccine to infant vaccination schedules in the U.S.
The vaccine will Not be available to anyone in India.
In vaccine trials, one child died after receiving the vaccine and 50 more had to undergo emergency surgery. The vaccine is given orally and caused intestinal blockage.

I'm confused.

Merck and GlaxoSmithKline are in Phase III trials for two new (competing?) versions of a rotavirus vaccine, RotaTeq and Rotarix. I can find no reports of death or 50 cases of emergency surgery during these trials -- seems to me that that would cause a pretty abrupt cancellation of their plans, considering what happened with Rotashield! Can you provide a link?

Also, I'd be interested in reading about the FDA's plans to add the vax to schedules next year. As far as I can tell, it's not licensed yet, but I'd be curious about how fast they are about this kind of thing.

Looks like the PATH foundation is partnering with various folks to release an Indian rotavirus vax in 2006.

[Isaac'smama]

I'm not stayinhom, but this is a link I was given about a month ago.

http://www.taipeitimes.com/News/taiw.../13/2003219189

Not sure about the emergency surgeries, though.

[suschi]

Is this supposed to be reassuring?

From the link above,

"Taiwan's Center for Disease Control said that if the unlicensed rotavirus vaccine leads to an infant's death, the bereaved families can appeal for insurance compensation from the hospital."

[Tracy]

seems to me that that would cause a pretty abrupt cancellation of their plans,

from the link provided... I guess not.

sigh.

[Tracy]

Sometimes it is informative to just go to the companies who are involved.....


From Biovirx, InC.


Their corporate mission:


The Company plans on becoming a leader in gastrointestinal disease management (including rotavirus infection) and then to use its innovative portfolio acquisition strategy to acquire other FDA approved products that the Company can commercialize domestically and internationally. BIOVIRx will first commercialize the oral rotavirusvaccine, RotaShield®.


And the market opportunity?....

Market Opportunity Based on World Health Organization (WHO) data that every child in the world is exposed to rotavirus before they reach the age of five, it has been estimated that the total worldwide market for a rotavirus vaccine exceeds $1 billion. The Company estimates that using the World Health Organization’s EPI program as a model, long term, it could deliver a rotavirus vaccine to 80 million (64%) of the infants born globally each year. The Company estimates that it may be able to achieve annual sales of $298 million by the fifth year of its business plan by providing a rotavirus vaccine to 52 million infants each year (representing 156 million doses of the rotavirus vaccine per year).

and competitive advantages:

The Company believes it can establish itself as a worldwide market leader in the management of diseases such as rotavirus infections. BIOVIRx intends to leverage its opportunity of being “first” in the market with the RotaShield® vaccine and establish a sustainable competitive advantage. The following facts support the Company’s strategy: • First in the market. • There are no approved, competing rotavirus vaccines. • There are no drug treatments or prophylactics for rotaviral infections. • An estimated five years may be required before any competing rotavirus vaccine reaches the market.

http://216.239.57.104/search?q=cache...+vaccine&hl=en

[AllyRae]

I can't BELIEVE they're trying the vax again... Ugh. Honestly, my son had it at 4 months, and we kept him very hydrated (on breastmilk, not formula) and he recovered in 10 days. It wasn't too terribly horrible at all (well, nothing that requires a vaccine...he had a tummy ache and a lot of messy diapers). Now I can see why 3rd world countries would have problems because of the water, but there, and here, the problem can be SOLVED with constant NURSING to keep the child hydrated!

Oh, and it's not only contaminated water... Bran got it from an airport changing table...I didn't realize he had put his hand on the stupid thing during a diaper change.

[CallMeIshmael]

Originally Posted by AllyRae

Oh, and it's not only contaminated water... Bran got it from an airport changing table...I didn't realize he had put his hand on the stupid thing during a diaper change.

Ohhhhhh! [lightbulb goes on in head]. That explains why Cordelia got it 48 hours after we flew to my folks' house. Made for quite a crappy Christmas (literally!)

[Stayinhom]

Rotavirus Info.

Sorry I don't have a thread.
But I got my info from the Los Angeles Times (the business section, no less).
The trial was done in July 1999, the drug was licensed by Wyeth and sold as Rotashield. They determined the risk of intussusception (bowel obstruction as 1 in 30,000. During the trial, one child died and "dozens" required emergency surgery.
I believe currently Glaxo Smith is testing its Rotavirus drug and so is Merck.
However, Biovirx has acquired the license for the bowel obstructing RotaShield and is saying it is NOT dangerous if the first dose is administered in the first three months of life.

[schatz]

The push to make vaxes like this mandatory just reinforces my skepticism about vaxes for the "terrible" diseases of the past like polio, etc. If the CDC and others think rotavirus, flu, chicken pox, etc. are so scary in America today that we must vaccinate our children for them, then I really question their knowledge and perspective on the diseases of the past. Of course, I'm sure they think they can wipe out the diseases of today with the new vaxes. Ugh. My dd had rotavirus at 15 months and got it from either another kid or toys at my aunt's house (her water is fine). Lasted barely a week and like AllyRae, we nursed dd through it. In fact, dh got it too. It only lasted about three days for him but he was worse off. Should he have the vax too? Duh.

Thank you to all of the knowledgeable mamas that post such good info and insights on this board!

[gothmommy]

UGH! My 2 older kids had bad cases of rota (AJ was hospitalized 3 days and on potassium for a critical case of hypokalemia from the dehydration, Nate was about one puke away from me giving him an IV at home). It was a real inconvenience and took alot of attention to get them through it but with close attention they were fine. NO WAY would I advocate a rota vax!!!! It is still as dangerous as the 1st vax (rotashield)!!!

[CallMeIshmael]

Here's the original article. (I think!) It's a very interesting discussion of the politics and economics of vaccines.

Just to clarify, the (one) death and ("couple of dozen") emergency surgeries were from RotaShield, after it had been licensed. This is why it got yanked from the market, although apparently a company in Minnesota is still trying to market it in the third world (no takers so far.)

The new (improved?) versions of the vaccine, RotaTeq and Rotarix, are still in phase III trials but do not seem to have caused any intusussceptions. Yet. Not sure what how that death in Taipei fits in. It's unclear from the Taipei Times article which vaccine it was, since GSK's only testing in Latin America and Merck is testing in the US. If the CDC's involved, it may be one of their "special" developing nation vaxes. I suppose they'll have to decide whether the death attributable to the vax or not, and then take it from there.