Virus contamination found in GSK’s Rotarix
pharmafile | March 23, 2010 | News story | Business Services, Manufacturing and Production, Sales and Marketing | Contamination, GSK, Vaccine, manufacturing compliance
The European Medicines Agency has demanded more information “as a matter of urgency” from GlaxoSmithKline over a virus in its vaccine product Rotarix.
GSK’s own tests revealed DNA from porcine circovirus type 1 (PCV-1) – a virus commonly found in some meat and not known to cause disease in either animals or humans.
Rotarix is an orally-administered vaccine for children above six weeks old to protect against gastroenteritis due to rotavirus infection, with worldwide sales of £282 million last year.
The Committee for Medicinal Products for Human Use (CHMP) has said there is not a public health threat and no action is necessary at present.
But it added: “It is nonetheless clear that viral DNA should not be present in the vaccine and that its source is unclear.”
However, the FDA has recommended that US doctors suspend the use of Rotarix as a precaution.
The FDA is expected to meet in a month or so to review the available data and make further recommendations.
“No safety issue has been identified by external agencies or GSK,” insists Thomas Breuer, chief medical officer of GSK Biologicals.
“GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world,” he added.
The World Health Organisation (WHO) estimates that rotaviruses lead to 527,000 deaths per year, mostly in poor countries in Africa and Asia.
Approved in the European Union in February 2006, Rotarix is not usually part of childhood vaccination schedules here although around 68 million doses have been distributed worldwide to date.
A meeting of the CHMP Vaccine Working Party is due to take place imminently, with the WHO expected to take part.
Rotarix is also to be discussed at an extraordinary meeting of the CHMP to be held later this week on 25 March.
PCV-1 was detected by a US research team and then confirmed by additional tests conducted by GSK.
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