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UAE Ministry of Health suspends Rotarix vaccine

Mar 24, 2010 - 03:17 -

WAM ABU DHABI, March 24th, 2010: The UAE Ministry of Health has decided to temporarily suspend usage of GlaxoSmithKline's Rotarix vaccine which is found to be contaminated with extraneous viral DNA bits from the porcine circovirus 1 (or PVC1), Dr Amin Al-Amiri, CEO for Medical Practice and Licensing at the Ministry announced Wednesday.

A circular by the Ministry has ordered the immediate suspension of importing, distributing and selling any Rotarix suspended. It also ordered the manufacturer to completely pull the drug from the UAE markets and hospitals.

"The vaccine which is given to infants to inoculate them against the rotavirus is very rarely used and there is no evidence at this time that it poses a safety risk," said Al-Amiri.

The suspension of Rotarix, he added, followed warnings by the US Food and Drug Administration (FDA) recommending that pediatricians and health care practitioners stop using the vaccine until the agency further examines the situation.

The manufacturer earlier notified FDA of the presence of viral genetic material in Rotarix.

Rotarix is an oral vaccine given to infants less than 12 months of age to prevent rotavirus, which can cause vomiting, diarrhea and fever.

WAM/MMYS