By: Lynn Swearingen (c) copyright 2010  All Rights Reserved

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Suppose your child could become seriously ill and Rotavirus could be bypassed with the use of a vaccine. Your Pediatrician’s recommendation? Rotarix, which is developed and marketed by GlaxoSmithKline.

Well, Rotarix won’t be the recommendation any longer because the FDA has discovered that – oops – this vaccine that was given to over 30 million children worldwide since 2008 contained a contaminating virus known as PCV-1. Rotarix use has been “temporarily suspended”.

“The contaminating virus in Rotarix is called porcine circovirus type 1 or PCV-1. This is not known to cause disease.”

The recent recall and FDA statement of safety seems to be quite clear:

“PCV-1 does not multiply in humans and is not known to cause illness in humans. It is found in everyday meat products and is frequently eaten with no resulting disease or illness,” the company said in a statement on Monday

“This was a difficult decision for us because there is no evidence at this time that there is a risk to children,” said Dr. Margaret Hamburg, the Food and Drug Administration commissioner. “

Really?  According to a PubMed.gov 2004 study, which just happens to be the NIH (U.S. National Library of Medicine National Institutes of Health),

“Infection of PCV1 was observed with 293, Hela and Chang liver cells, infection with PCV2 only in Rd cells. In addition, religated viral DNA of PCV1 and PCV2 has been used to transfect adherent human cell lines.”

The World Health Organization began recommending in 2009 that all Nations include this vaccination in their immunization program. Based on  research during a clinical trial in which GlaxoSmithKline suprisingly enough participated in the funding.

So just so we understand this:

  • NIH completes a study in 2004 showing clear crossover from Porcine to Human cell lines (2004)
  • GlaxoSmithKline develops Rotarix (2005)
  • GlaxoSmithKline funded the clinical trials (2006)
  • GlaxoSmithKline sells Rotarix (2008 forward)
  • GlaxoSmithKline gets caught with a contaminated product (2010)
  • FDA/GlaxoSmithKline soothes parents with double-speak (2010)

The stated data indicates that over 500,000 children die each year from the effects of Rotavirus.   The other 31 million?   Well one could just wait and see what data is true.   The FDA, GSK or the NIH?      Or I suppose one could contact the Consumer Affairs Branch of the FDA and request clarification/investigation into the recall of Rotarix. One might also request exactly why the NIH says PCV-1 can be transferred to humans when the FDA is denying such can occur.

Consumer Affairs Branch (CBER)

ocod@fda.hhs.gov

    Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448

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