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The FDA says it's safe to use rotavirus vaccines

May 14, 2010 | 11:13 am

The Food and Drug Administration on Friday said that it is safe to resume the use of the Rotarix rotavirus vaccine and to continue the use of the RotaTeq rotavirus vaccine. The agency in March had cautioned physicians to stop using Rotarix because the manufacturer had found trace amounts of a pig virus in the vaccine. Both the FDA and the manufacturer of the RotaTeq vaccine then found traces of the pig virus in it as well.

Following extensive studies by the manufacturers and the FDA, however, the agency said there is no risk from the viruses, called porcine circovirus 1 and 2. The viruses do not infect humans and are not known to cause any diseases, either in humans or pigs themselves. Moreover, "the vaccines have strong safety records, including clinical trials involving tens of thousands of patients, as well as clinical experience with millions of vaccine recipients."

A report from the Centers for Disease Control and Prevention on Wednesday estimated that the vaccines are preventing more than 50,000 hospitalizations of infants in the United States each year. Rotavirus infections, which are thought to kill as many as half a million children worldwide each year, are characterized by diarrhea and severe dehydration. The benefits of the vaccine, the FDA said, far outweigh any risks, which are only theoretical.

-- Thomas H. Maugh II

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Comments (4)

They are saying that it is perfectly fine to have pig viruses in their vaccines? Wow. Just wow.... No wonder the pharma companies and the government have zero credibility left.

Wow, another used car sales pitch courtesy of the US GOV/PHARMA /MEDICAL/BIG FOOD, INSURANCE/CHEMICAL/ INDUSTRY.
It's a lemon but what do we long as we get more of your hard earned money.

When is the last time you have heard of a child in the US dying of diarrhea, to say nothing of the relatively mild rotavirus diarrheal illness. There are now documented xenoviruses in the vaccine. Where is the regulatory concern of the FDA, where is their commonsense? Irregardless of questions of efficacy or other safety concerns there is a documented health risk in the vaccine, of course it needs to be pulled, all previous batches destroyed and the vaccine kept off the market until the problem is demonstrably rectified. However, this won't happen as the FDA is a pig with its snout in the trough of big pharmaceutical companies largess.

"The viruses do not infect humans and are not known to cause any diseases, either in humans or pigs themselves."

The FDA did NOT say in the linked release that the viruses don't cause disease in pigs, because type 2 does.

Type 2 causes wasting. There is a vaccine for it, of course.

As placed in the midst of a link and a quote, I got the impression the entire paragraph was a paraphrase of the latest government stance. You may wish to clarify that.


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