Rotarix vaccine recalled in UAE

BY PMA RASHEED

The Gulf Today, 25 March 2010

The use of oral vaccine against rotavirus infection, Rotarix, was temporarily suspended in the UAE on Wednesday, in light of the global recall of the medicine which is tested to be contaminated with a pig virus.

The vaccine manufactured by GlaxoSmithKline is given to infants and young children throughout the world, to immunise them against the rotavirus, a leading cause of severe diarrhoea, vomiting and dehydration in infants.

The UAE ministry of Health (MoH) has ordered GlaxoSmithKline to completely recall the drug from the UAE markets and hospitals, according to a WAM report.

The US Food and Drug Administration (FDA) had issued a drug safety warning on March 22 to alert healthcare professionals and patients across the globe that Rotarix vaccine was tainted with DNA from porcine circovirus type 1 or PCV-1.

GlaxoSmithKline notified the FDA about the swine virus contamination in the drug, which was proved in an academic research.

Dr Amin Al Amiri, CEO for Medical Practice and Licensing at the MoH, said the health ministry has issued a circular ordering the immediate suspension of the Rotarix vaccine's import, distribution and sale in the country.

"The medicine's recall has been inspired by FDA warnings, which urged pediatricians and health care practitioners across the world to stop using the vaccine until further announcement pending results of detailed investigations being carrying out by the agency on the situation," he added.

"The Rotarix vaccine is highly contaminated with extraneous viral DNA bits from the apparently harmless swine virus, Porcine Circovirus 1. The manufacturer had earlier notified FDA of the presence of the viral genetic material in Rotarix," pointed out Dr Amiri.

According to him, the vaccine is very rarely used and there is no evidence at this time that it poses a safety risk.

Switzerland had also suspended use of the vaccine on Tuesday. The European Medicines Agency has asked GlaxoSmithKline to look into how the DNA of a foreign viral strain got into the vaccine.

The World Health Organisation (WHO) says the most symptomatic episodes due to infection of the rotaviruses occur in young children between the ages of 3 months and 2 years.

"The virus spreads rapidly, presumably through person-to-person contact or airborne droplets. However, there is no specific drug treatment for rotavirus infection, although oral rehydration therapy is recommended," WHO pointed out.