Advisers to the US Food and Drug Administration say that GlaxoSmithKline and Merck & Co’s rotavirus vaccines should remain on the market despite contamination with a pig virus.
In March, the FDA advised doctors to temporarily suspend use of the rotavirus vaccine after impurities were discovered in some batches of GSK’s Rotarix, namely fragments of porcine circovirus type 1 (PCV1). Last week, two strains of the virus were then found in Merck’s RotaTeq.
This led to an FDA advisory committee meeting convened to discuss recent findings of PCV in rotavirus vaccines and although the panellists did not issue any formal recommendations, GSK said that “members widely acknowledged that the benefits of vaccinating infants worldwide against rotavirus disease clearly outweigh the theoretical risks”.
The advisory committee also discussed “current and emerging techniques to detect viruses” and the implications of using such techniques to test vaccines currently licensed or in development. Thomas Breuer, head of global development at GSK Biologicals, noted that “evolving technologies can lead to new findings that were not known at the time of licensure” but “decisions on the application of these new technologies must continue to be based on sound science and consideration of the benefit/risk profile of the respective vaccine”.
