FDA Recommends Doctors Suspend Usage of Rotarix Rotavirus Vaccine
The manufacturer of Rotarix, GlaxoSmithKline, has released a statement indicating that they notified regulatory authorities about the presence of the virus, PCV-1, in its oral rotavirus vaccine. GlaxoSmithKline further stated that not only is PCV-1 not known to multiply in humans, it is found in everyday meat products and is frequently consumed without resulting in disease or illness¹.
An independent U.S. academic research team using a novel approach initially detected the contamination, which was subsequently verified during follow-up tests conducted by GlaxoSmithCline. The academic researchers as well as the FDA have tested another licensed vaccine for rotavirus, RotaTeq, for components of the PCV-1 virus with the results coming back negative. RotaTeq is manufactured by Merck.
Both Rotarix and RotaTeq are given to infants by mouth to prevent rotavirus, the leading cause of severe gastroenteritis among children below the age of five. Rotavirus kills one child per minute worldwide - more than half a million children each year ². The FDA licensed RotaTeq in 2006 and Rotarix in 2008. The majority of children in the United States are vaccinated with RotaTeq.
The FDA has stated that the risk from rotavirus is so great in many countries that the benefits of the vaccine far outweigh any potential risks and have recommended the continued use of the vaccine. GlaxoSmithKline is currently reviewing their procedures and are looking for the best way to replace the cell bank and virus seeds used as the base production material for Rotarix.
According to GlaxoSmithKline's website, worldwide Rotarix sales in 2009 were £282million with U.S. representing £76million.
The FDA has stated that it will continue to gather information about the PCV-1 components in Rotarix, including whether it is an intact virus as opposed to DNA fragments. The FDA intends to convene an expert advisory committee in four to six weeks to make additional recommendations regarding the use of rotavirus vaccines. The agency has said that it will continue to update providers and patients as well as the general public as more information becomes available.
Sources:
1- http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10029.htm
2- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm
Published by Kathrine Lloyd
Born and raised on the east coast of the United States and transplanted to Seattle in the Pacific Northwest, Kathrine caught nature fever and can be found out and about in Seattle s wild spaces photographing... View profile
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- The FDA has recommended that clinicians in the United States suspend the use of the vaccine Rotarix.
- Independent U.S. academic research team using a novel approach initially detected the contamination.
- The FDA does not believe there is a safety concern.