Global Processing

Impurities in Glaxo Vaccine Will Lead to Significant Sales Loss

March 29, 2010
According to Bloomberg, UK-based GlaxoSmithKline is set to lose more than one month''s sales of its Rotarix vaccine against gastroenteritis in the U.S. after impurities in the product were discovered. The Food and Drug Administration advised doctors to switch to the rival Rotateq vaccine made by Merck until it convenes an expert meeting within the next six weeks to discuss the issue. Both vaccines protect children against the rotavirus infection and are widely used in Latin America and some other parts of the developing world. The World Health Organization and European regulators have not advised a switch away from the vaccine. The suspension follows work by an independent research group using a new technique that identified in Rotarix elements of a virus called PCV-1, which does not multiply in humans and is not known to cause illness in them. GSK said the virus had been present in the cell bank and seeds used to produce the vaccine, raising broader questions about the possibility of other previously undetected impurities in a wide range of biological products. The group said it was considering how to replace the cell bank and seeds, action that could pose significant challenges for regulators and may require extensive additional testing. Monitoring of its vaccine, of which 69m doses have been distributed worldwide, had shown it to have an "excellent safety profile", GSK said.