FDA Suspends Vaccines Contaminated with Virus

24 March 2010

The FDA recommends suspending the use of Rotarix vaccine which is manufactured by  the pharmaceutical company GlaxoSmithKline. A US research team has detected viral contamination of the vaccine. This prompted the FDA warning to suspend usage of Rotarix in the USA until further notice. Rotarix is an oral vaccine given to infants to prevent rotavirus disease. Rotavirus can cause diarrhea and dehydration and is responsible for over 500,000 infant deaths annually worldwide. Countries with low incomes have the highest mortality rate. It is estimated that prior to rotavirus vaccination programs, over 50,000 hospitalizations occurred annually in the USA due to this disease. The FDA reports that dozens of deaths occurred in the USA annually prior to initiation of vaccination programs.

The FDA notes that there is no evidence of a safety concern from the contaminated Rotarix vaccine. The suspension of its use is viewed as a preventative measure. The FDA will conduct research into the viral contamination issue to determine whether the PCV1 contaminant is an intact virus or merely DNA fragments. Additional recommendations concerning the vaccine will be made in about one to two months when the FDA is convening an expert panel to look into this issue. The FDA will report this information to patients, doctors, nurses, and the World Health Organization (WHO) as information surfaces.

The Director of the Centers for Disease Control and Prevention speculates that many countries will continue to use the Rotarix vaccine until further information becomes available. Citing dangers of rotavirus, the director anticipates that the vaccine warning will be weighed against the threat of the disease. In balance, he feels that many countries will risk the potential dangers of the vaccine to prevent rotavirus outbreaks. RotaTeq vaccine, manufactured by Merk pharmaceuticals, is not affected by this FDA warning. RotaTeq is also used to prevent rotavirus and no viral contamination has been discovered in this product.
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