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Virus found in GSK's Rotarix vaccine

The US FDA has recommended the suspension of GSK's rotavirus vaccine, Rotarix, after traces of porcine circovirus 1 (PCV1) were detected

The US Food and Drug Administration (FDA) has recommended the suspension of GlaxoSmithKline's (GSK) rotavirus vaccine, Rotarix, in the US after traces of the virus porcine circovirus 1 (PCV1) were detected in the vaccine.

The FDA has made the decision while it finds out more about the virus. The agency attempted to allay fears concerning the discovery though, saying "PCV1 is not known to cause illness in humans or other animals" and that "there is no evidence at this time that this finding poses a safety risk."

GSK confirmed the presence of the virus in a statement, though also played down a potential safety risk saying: "It [PCV1] is found in everyday meat products and is frequently eaten with no resulting disease or illness." 

The traces of PCV1 were first discovered following research by an independent team in the US using a new technique for detecting viruses.

Further tests by both GSK and FDA confirmed the presence of viral components since the early stages of the vaccine's development, including clinical studies. Preliminary testing on Merck's RotaTeq, another rotavirus vaccine, has found no traces of PCV1.

Thomas Breuer, head of Global Clinical R&D and chief medical officer of GSK Biologicals, said: "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."

This includes the European Medicines Agency (EMA), who also stressed "the findings do not present a public health threat" but has requested more information from GSK before making further decisions.

The EMA also confirmed a meeting of the Committee for Medicinal Products for Human Use (CHMP) Vaccine Working Party has been called for March 23-24, which will include participation from the World Health Organisation, and international regulators including from Canada and the US. Further plans will be considered at an extraordinary meeting of the CHMP to be held on March 25.

Despite the discovery of the virus, it is thought that the countries most affected by rotavirus, which causes severe gastroenteritis and diarrhea, will be likely to continue using the vaccine while these decisions are made.

"In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine," said Dr Thomas Frieden, director of the Centers for Disease Control and Prevention. "We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known."

The WHO estimates that the rotavirus is responsible for around 527,000 deaths each year, with more than 85 per cent of these deaths occurring in low-income countries in Africa and Asia. 

Rotarix was tested on around 100,000 children during clinical trials and was found to have an excellent safety record, with more than 69 million doses of Rotarix vaccine distributed globally since its introduction in 2006.

GSK has said it is "now reviewing how best to replace, in a timely way, the cell bank and virus seeds used as base production material. In the meantime, and in accordance with the regulators, the company will continue to manufacture Rotarix to the existing approved production and quality standards to meet public health needs worldwide."

23rd March 2010

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