cryptogon.com news – analysis – conspiracies

March 23rd, 2010

Update: It’s One Million Children in the U.S. Alone, 30 MILLION Worldwide

Via: CNN:

Rotarix, made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant material is DNA from porcine circovirus 1, a virus from pigs that is not known to cause disease in humans or animals, Hamburg said.

About 1 million children in the United States and about 30 million worldwide have gotten Rotarix vaccine, she said.

— End Update—

One million children have been injected with a vaccine that contains a pig virus that wasn’t supposed to be in the vaccine.

According to Fierce Pharma Manufacturing, Rotarix has been “contaminated” since its early stages of development:

Researchers stumbled on DNA from porcine circovirus type 1–believed nonthreatening to humans–while using new molecular detection techniques. More work is being done to determine whether the whole virus or just DNA pieces are present. Additional testing has confirmed presence of the matter in the cell bank and seed from which the vaccine is derived, in addition to the vaccine itself. So the vaccine has been contaminated since its early stages of development.

Via: Los Angeles Times:

The Food and Drug Administration on Monday warned doctors and parents against using the Rotarix rotavirus vaccine until further testing can confirm that it is safe.

The warning follows an academic research group’s discovery — subsequently confirmed by the FDA and Rotarix manufacturer GlaxoSmithKline — that the vaccine contains a pig virus called porcine circovirus 1, or PCV1. The virus is not known to cause illness in humans, and no adverse effects have been observed in children vaccinated with Rotarix, but the agency decided to err on the side of caution with the warning until more information can be obtained.

For the time being, the agency recommends that pediatricians use a competing vaccine, RotaTeq, manufactured by Merck. Preliminary tests have found no traces of PCV1 in this vaccine.

Rotavirus causes severe diarrhea and dehydration and is thought to cause more than 500,000 deaths in infants worldwide each year, primarily in low- and middle-income countries. Before the introduction of RotaTeq in the U.S. in 2006, the disease caused an estimated 50,000 hospitalizations and several dozen deaths each year. Rotarix was introduced in 2008. Most U.S. children who have been vaccinated against rotavirus as part of their normal vaccinations have received RotaTeq, the FDA said. About 1 million have received Rotarix.

The agency is now attempting to determine whether the vaccine contains intact PCV1 or simply viral fragments, as well as how it got into the vaccine. The agency said it will convene an expert advisory panel in four to six weeks to make further recommendations.

The World Health Organization and the European Medicines Agency are not expected to change current guidelines for using the drug, arguing that the benefit from the vaccine far outweighs any potential risk, according to a statement by GlaxoSmithKline.

An estimated 69 million doses of the vaccine have been administered globally. Worldwide sales of the vaccine in 2009 were $425 million, the company said, with $115 million in the U.S.

Many pediatricians have switched to Rotarix because it requires only two oral doses, compared with three for RotaTeq.