FDA VOTES TODAY ON NEW ROTAVIRUS VACCINE

By Barbara Loe Fisher

Today, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will vote on whether or not GlaxoSmithKline has proved that its new rotavirus vaccine (Rotarix) is safe and effective. An FDA staff analysis of the clinical trial data submitted by GSK, which was released on Feb. 15, revealed that Rotarix was associated with an increase in pneumonia-related deaths and convulsions. In addition, there were 27 cases of Kawasaki disease, which involves fever and blood vessel inflammation, a serious disease that has also been associated with Merck's rotavirus vaccine (RotaTeq).

Vicky Debold, PhD, RN, who is Director of Patient Safety for the National Vaccine Information Center (NVIC), has been appointed as the consumer voting member on VRBPAC and will be participating in the FDA Committee's discussion of the quality and quantity of the science presented by GSK in its efforts to secure a license for Rotarix. VRBPAC briefing documents on Rotarix may be viewed HERE.

Barbara Loe Fisher is with The National Vaccine Information Center.

Comments

[Stagmom]

I remember sitting at a David Kirby lecture last year where he mentioned somthing about the World Health Organization mandating that any vaccines we sell to developing nations also be on our own schedule - therefore, we're vaccinating American kids for diseases that aren't a problem here where we have clean water and access to health care and antibiotics.

I can see how Rotavirus DOES kill in the third world where diarrhea is a daily death sentence. But not in America, for the vast majority of children.

Then there's that whole, 100,000,000+ customers for pharma in American kids. The stat in New Jersey to add Gardasil was 250,000 girls/new customers when that vaccine was added. Follow the money honey.

[passionlessDrone]

Hello friends -

There should be some perspective here. In developing countries, where nutrition, clean water, and other medicines are not as readily available as they may be where we can access ageofautism.com during lunch hour, rotovirus regularly kills tens of thousands of children every year, maybe more. This is not a scare tactic, but a fact.

While it hasn't been tested alongside all other 'recommended' vaccines, I do think that there have been some very large scale trials of this vaccine along the lines of tens, or hundreds of thousands of participants. It may not always keep you from getting rotovirus, but it did appear to reduce the amount of people who had to be hospitalized as a result by a large, large margin. If you live in sub saharan africa many miles from a clinic, much less a hospital, this would be rather significant. Of course, who knows about what potential long term effects there may be.

We need to acknowledge that in some areas, a miniscule increase of incidence of some very bad things, on the whole, may be superior to the status quo. If, as a community, we cannot be seen to accept this, we have little hope of being seen as anything but ranting Luddites, with a corresponding impact on our chances of affecting policy. This is not by any means meant as a defense of our current vaccination schedule, nor the machinations of vaccine production, approval, and advertisement.

I would tend to agree with Sandy in that in developing countries, there is very little reason to encourage, much less mandate, this vaccine.

Take care!

- pD

[Sandy Gottstein]

Rotavirus is not considered a problem in developed nations like ours. In developing nations, especially third world ones, where diarrhea is a killer, it can be dangerous. But rather than provide a safer living environment, including safe water, the vaccine manufacturers will be pushing the vaccine. (A pusher is a pusher. Stop pushing vaccines.) In this country, however, where rotavirus is not much of a risk, but the vaccine may well be, it will be bordering on the criminal, in my opinion, if a rotavirus vaccine is even encouraged, let alone required.

Here are a couple of quotes from 2002, including one from Congressman Burton on the earlier vaccine that ended up being withdrawn: http://www.vaccinationnews.com/scandals/feb_8_02/rotavirus_vaccine.htm

The process is so corrupt it would be laughable if it weren't so terrible.

[Twyla]

I have never ever known anyone who had a problem with rotavirus. Or if they did, it must have been a passing bout of diarrhea -- no big deal. This is a typical example of ignoring the risk of vaccinating all children compared with the slight risk of the disease. It is just crazy.

[Come Offit]

Is that Dr. Paul Offit, vaccine champion, owner of patents, king of conflict of interest hanging out at the Ferrari dealership in Jersey waiting to see if this deal goes through?