Monday, March 22, 2010

Baby Vaccine Pulled From Market

Since vaccines are required to be sterile, and this vaccine was not sterile, how was it a "difficult decision" to stop use of the vaccine? This should have been an easy decision by the FDA to protect consumer's health.

The vaccine is supposed to prevent diarrhea. A wildly exaggerated statement from the medical community, "... rotavirus is too serious a disease to ignore, said Dr. William Schaffner ...".


FDA Suspends Glaxo Rotavirus Vaccine as Precaution

U.S. health officials told pediatricians Monday to temporarily quit using one of two vaccines against a leading cause of diarrhea in babies, after discovering that doses of GlaxoSmithKline's Rotarix were contaminated with bits of an apparently benign pig virus.

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But vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean — Merck's RotaTeq — the FDA decided to err on the side of caution.

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"This was a difficult decision for us to make because there is no evidence at this time that there is a risk to patients who have received this vaccine, and we know there are real benefits for children to be vaccinated against rotavirus."

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Hamburg said the pig virus DNA fragments have been found in Glaxo's cell bank, meaning they were present from the vaccine's earliest development.

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Parents should switch to the Merck vaccine for now — it requires three doses instead of Glaxo's two — because rotavirus is too serious a disease to ignore, said Dr. William Schaffner, a vaccine specialist at Vanderbilt University who was briefed on FDA's decision.

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CDC Vaccine Advisor Pockets $29 Million Promoting Vaccines
Monday, June 01, 2009 by: David Gutierrez, staff writer

(NaturalNews) Dr. Paul Offit of the Children's Hospital of Philadelphia (CHOP) received at least $29 million from his share of royalties for Merck's Rotateq vaccine after using his position with the Centers for Disease Control and Prevention to ensure that childhood vaccination with the vaccine became compulsory.

According to a report on the Web site "Age of Autism," a review of CHOP's royalties schedules reveals that Offit likely received between $29 million and $55 million for his work developing the Rotateq vaccine for rotavirus, which causes diarrhea in infants. ...

"Clearly, based on the distribution of income rights outlined in [CHOP's policies], Paul Offit had a greater personal interest in Rotateq's commercial success than any other single individual in the world," article authors Dan Olmsted and Mark Blaxill write. "And more than other individual in the world, he found himself in a position to directly influence that success."

Between 1998 and 2003, Offit sat on the U.S. government's Advisory Committee on Immunization Practices (ACIP). His involvement with development of Rotateq began before and ended after these dates.
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"Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the ACIP," Olmsted and Blaxill write. "In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months."
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