The FDA is recommending that healthcare practitioners temporarily suspend use of GlaxoSmithKline's Rotarix vaccine for rotavirus immunization in the U.S. while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.
GSK confirmed that it has notified regulatory authorities of the presence of material from a virus called PCV-1, which is not known to cause illness in humans, according to a company statement. The material was first detected following work done by a research team using a novel technique for looking for viruses. Follow-up tests by GSK and FDA scientists confirmed the academic team's findings and that viral components have been present since the early stages of the vaccine's development, including during clinical studies.
Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.
"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine," FDA Commissioner Margaret Hamburg says in an agency announcement. "There is no evidence at this time that there is a safety concern." The agency will gather more information about the PCV1 components in Rotarix. In four to six weeks, it will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines. It also plans to seek input on the use of new techniques for identifying viruses in vaccines.
Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries.
Thomas Breuer, head of global clinical R&D and CMO of GSK Biologicals said the company is discussing the issue with regulatory bodies worldwide.
- see the FDA release
- read GSK's statement