23 Mar 2010
The Department of Health (DH) has ordered a recall from shelves, hospitals and doctors of a registered rotavirus vaccine, Rotarix, on quality grounds and recommended that its use be suspended in Hong Kong.
The decision followed assessment of the United States Food and Drug Administration's (FDA) confirmation on March 22 of the detection of DNA of an extraneous virus, porcine circovirus 1 (PCV 1), in Rotarix by an independent US academic research team. This has not been detected in RotaTeq, another vaccine also licensed in the United States against rotavirus infection. The FDA has given assurances about the lack of evidence for Rotarix's safety risk. However, it has recommended a temporary suspension, pending further investigation by the agency.
From a global angle, the World Health Organisation (WHO) has encouraged all places using the vaccine to carefully consider the significant benefits of its continued use in any decision about further employment. It is understood that the European Medicines Agency does not consider any action necessary at this point because the finding does not pose a public health risk.
In Hong Kong, Rotarix is a registered pharmaceutical product manufactured by GlaxoSmithKline. It is given by mouth to children six weeks and older against diarrhoea and vomiting due to rotavirus infection.
The virus, PCV1, is commonly found in pork and meat products, and is not known to cause disease in other animals or man.
A spokesman for the DH, elaborating on the decision, said that as the alternative vaccine is also available here, the quality defect of Rotarix itself warrants appropriate risk management, amounting to a recall. The department will continue to monitor the development of the issue, including maintaining liaison with the WHO and its various counterparts.
The manufacturer in Hong Kong will set up a hotline for public enquiries.