Scientific Publications by FDA Staff

J Infect Dis 2005 Apr 1;191(7):1123-8

The rat-based neurovirulence safety test for the assessment of mumps virus neurovirulence in humans: an international collaborative study.

Rubin SA, Afzal MA, Powell CL, Bentley ML, Auda GR, Taffs RE, Carbone KM

Rubin SA, US FDA, DVP, OVRR, Ctr Biol Evaluat & Res, Bldg 29A,Rm 1A-21,8800 Rockville Pike, Bethesda, MD 20892 USA US FDA, DVP, OVRR, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA US FDA, Off Blood Res & Review, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA US FDA, Off Director, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA Natl Inst Biol Stand & Controls, Div Virol, Potters Bar EN6 3QG, Herts, England

Because of the highly neurotropic and neurovirulent properties of wild-type mumps viruses, most national regulatory organizations require neurovirulence testing of virus seeds used in the production of mumps vaccines. Such testing has historically been performed in monkeys; however, some data suggest that testing in monkeys does not necessarily discriminate among the relative neurovirulent risks of mumps virus strains. To address this problem, a collaborative study was initiated by the National Institute for Biological Standards and Control in the United Kingdom and the Food and Drug Administration in the United States, to test a novel rat-based mumps virus neurovirulence safety test. Results indicate that the assay correctly assesses the neurovirulence potential of mumps viruses in humans and is robust and reproducible.