Scientific Publications by FDA Staff
Influenza Other Respir Viruses 2011 Nov;5(6):438-42
Confronting the next pandemic-Workshop on lessons learned from potency testing of pandemic (H1N1) 2009 influenza vaccines and considerations for future potency tests, Ottawa, Canada, July 27-29, 2010.
Hardy S, Eichelberger M, Griffiths E, Weir JP, Wood D, Alfonso C
The 2009 H1N1 influenza pandemic created an urgent need to expedite vaccine manufacture, bringing to light the shortcomings of the methods and processes used in the release of influenza vaccines. The single-radial immunodiffusion (SRID) assay has been the standard assay to measure potency of inactivated influenza vaccines since the late 1970¿s. Potential difficulties and delays in the preparation, standardization, and distribution of SRID reference reagents triggered the need to develop alternative methods for potency testing as a step toward pandemic influenza vaccine preparedness. Health Canada, the United States Food and Drug Administration, and the World Health Organization jointly organized a workshop in order to identify lessons learned from potency testing of H1N1 2009 pandemic influenza vaccines and to discuss alternative methods and their potential future application. While knowledge and technologies are expanding, more research and confidence building are needed before alternative approaches can be incorporated into routine regulatory decision-making. As a first step, it was recommended that improvements be made to the SRID assay. In parallel, alternative methods should continue to be evaluated for potential future application.
|Category: Journal Article|
|PubMed ID: #21668676||DOI: 10.1111/j.1750-2659.2011.00250.x|
|Includes FDA Authors from Scientific Area(s): Biologics|
|Entry Created: 2011-10-03||Entry Last Modified: 2012-11-15|