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news.GlaxoSmithKline has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine Rotarix. The material was first detected as a result of the work done by a research team in the US using a new technique for identifying viruses and then confirmed by additional tests conducted by the company.
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Retrospective testing of Rotarix, using new molecular detection techniques, has confirmed that material from PCV-1 has been present since the initial stages of the vaccine’s development in the cell bank and rotavirus seeds used as base production material.
The European Medicines Agency (EMA) and WHO, after having reviewed the information and data submitted by GlaxoSmithKline, and information available regarding PCV-1 from the world’s literature, will also be issuing statements confirming the positive balance of benefits and risks of the vaccine despite the presence of the material from PCV-1 and have not recommended any change to the way that healthcare practitioners in Europe and rest of the world use Rotarix. PCV-1 is found in everyday meat products and is frequently eaten with no resulting disease or illness.
Likewise, the US FDA has issued a statement confirming that there is no evidence that this finding poses a safety risk based on the safety profile of Rotarix and evidence that PCV-1 is a known virus that does not multiply in humans and is not known to cause illness in humans. Rotarix has been produced according to FDA standards as reviewed and approved for US licensure in 2008.
Notwithstanding its statement, the agency is recommending that US clinicians and public health professionals temporarily suspend the use of Rotarix as a precautionary measure. It has also stated that it intends to convene an advisory committee, within approximately four to six weeks, to review the available data and make recommendations on rotavirus vaccines licensed in the US. The FDA will also seek input on the use of new techniques for identifying viruses in vaccines.
GSK claimed that the safety profile of Rotarix is based on extensive clinical data from vaccine clinical trial program conducted by the company, enrolling around 90,000 participants in Europe, Latin America, Asia, Africa and the US. In addition, the post marketing surveillance data represents more than 69 million doses of Rotarix vaccine distributed globally and reflects a good safety profile.
Thomas Breuer, head of global clinical R&D and chief medical officer of GSK Biologicals, said: “No safety issue has been identified by external agencies or GSK. 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.”
GSK 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.