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National Vaccine Program Office
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Proposal Number: | N57 |
PI Name: | Rubin, Steven |
PI Email: | |
PI Title: | Biologist |
Project Title: | Validation of the newborn rat neurovirulence assay for mumps virus vaccines. |
Project Start: | 2003 |
Project End: | 2005 |
Abstract: For the first time in over 30 years, new mumps virus vaccines are being licensed in the European market and have been proposed for introduction in the United States. Historically, the neurovirulence safety of mumps virus vaccines has been assessed in monkeys. However, several laboratories have demonstrated that the monkey assay is poorly predictive of the ability of mumps virus strains to cause disease in the humans. The inability to reliably predict the risk of central nervous system adverse events from mumps virus vaccination is illustrated by unacceptably high rates of meningitis following vaccination and the removal of licensed mumps vaccines from international markets (e.g., Canada, England, Europe) and cessation of national mumps vaccination programs (e.g., Japan). Clearly, neurovirulence needs to be reliably evaluated in new, live virus vaccines prior to licensure. We recently developed and tested a rat-based mumps virus neurovirulence safety test that appears to be predictive for neurotoxicity in humans. To propose use of this rat assay as a regulatory requirement for license of new mumps virus vaccines, it is critical to perform validation studies carried out through collaborative efforts with other international research and regulatory laboratories. This project will be initially carried out with the participation scientists at the National Institute for Biological Standards and Control, England's Food and Drug Administration equivalent. Other interested regulatory authorities include the Centers for Disease and Prevention, Health Canada and Pan America Health Organization. This project fulfills two goals: 1) vaccine safety and 2) improvement of immunization benefits and risks communication to the general public and providers.
Institution: Food and Drug Administration
Date: July 2003
Last revised: February 13, 2009
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