PCV1, PCV2 DNA detected in RotaTeq

[mzmolly]

Evidence of contamination with http://en.wikipedia.org/wiki/Porcine_circovirus">porcine circovirus type 1 and type 2 has been found in RotaTeq, Merck’s pentavalent rotavirus vaccine, according to an FDA official who spoke during a hearing on rotavirus vaccines.

After discovering “very low levels” of porcine circovirus type 1 and type 2 (PCV1 and PCV2) DNA in RotaTeq, Merck researchers revealed their findings to the FDA. Officials said, however, these results do not indicate an immediate health threat.

“There is no evidence at this time that DNA from PCV causes any disease in humans,” Merck said on its website. “We remain confident in the safety profile and quality of RotaTeq.”

The FDA suspended use of the monovalent rotavirus vaccine Rotarix from GlaxoSmithKline in March after detecting PCV1, although officials said the virus did not appear to be harmful to humans. Despite the evidence of similar contamination in RotaTeq, however, the FDA has not recommended against using the vaccine.

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