IDT to make rotavirus vaccine for BIOVIRx

Published: 28-Mar-2006

BIOVIRx, a privately held biopharmaceutical company located in Minneapolis, US, and IDT of Tornau, Germany, are to develop the oral rotavirus vaccine RotaShield for global commercialisation. Rotavirus gastroenteritis causes more than 2 million hospitalisations and up to 600,000 deaths annually in infants and young children worldwide.


BIOVIRx, a privately held biopharmaceutical company located in Minneapolis, US, and IDT of Tornau, Germany, are to develop the oral rotavirus vaccine RotaShield for global commercialisation. Rotavirus gastroenteritis causes more than 2 million hospitalisations and up to 600,000 deaths annually in infants and young children worldwide.

BIOVIRx has an exclusive worldwide licence for RotaShield, while IDT (Impfstoffwerk Dessau-Tornau), a contract manufacturer that develops, manufactures and markets vaccines for export, has production capacity for the vaccine. IDT also plans to construct a new facility at Tornau for expanded production of the vaccine.

Leonard Ruiz, ceo of BIOVIRx said: "This agreement will allow us to deliver to the world markets a safe, effective and affordable vaccine that can help in the prevention of a major disease problem and assist in saving the lives of 1,600 children lost every day due to this highly infectious virus".

RotaShield received FDA approval in 1998 and was administered to over 600,000 infants in the US before being voluntarily withdrawn from the market in 1999 because of an association with a higher risk of a naturally occurring blockage of the intestine called intussusception. However, BIOVIRx says recent re-analysis of the data on intussusception and RotaShield revealed that the higher intussusception risks were related to the vaccine being used in infants older than what was recommended in the RotaShield package insert.


BIOVIRx and IDT are planning to meet with the regulatory authorities to discuss the requirements for reintroduction of the vaccine.

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