IABS Scientific Workshop on Neurovirulence Tests for Live Virus Vaccines

Overview

This report reflects the discussion and conclusions of a group of experts on regulatory aspects of vaccines from national and international regulatory agencies and scientists involved in vaccine manufacture and development, who attended an informal scientific workshop on neurovirulence testing of live attenuated viral vaccines in Geneva on 31 Jan - 1 Feb 2005. The workshop was jointly organized by the International Association for Biologicals, the European Pharmacopoeia and the World Health Organization. The background to the workshop was the desire to clarify and obtain an international consensus on the need for neurovirulence testing of live viral vaccines. Such testing currently is a common recommendation or requirement of regulatory guidelines for many live vaccines. There is concern that in several cases there is an absence of scientific data justifying such testing, and often no clear definition of criteria for assessment of the results of tests or the absence of the use of appropriate reference vaccines for use in the tests. In addition, since the testing method and its variability are not well established, the interpretation of the test can result in problems and false conclusions in both directions.