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NSHPC Report Used to Develop Guidance on Smallpox Vaccines

26 July, 2002

Arlington, VA - The recent Interim Report on Smallpox Vaccines and Vaccination issued by the Institute’s National Security Health Policy Center (NSHPC) has been used by the European Agency for Evaluation of Medicinal Products (EMEA) to develop revised guidelines for the development of smallpox vaccines. The EMEA is the pan-European equivalent of the United States Food and Drug Administration (FDA) and plays a central role in the licensure of pharmaceutical products that are used in Europe. The NSHPC report provided key information that EMEA incorporated into their “Note For Guidance On The Development Of Vaccinia Virus Based Vaccines Against Smallpox” issued on June 24, 2002. In the NSHPC report, and the new EMEA guidelines, the requirement to utilize virus strains that have documented histories of use in the prior smallpox vaccination programs for the development of new vaccine products is emphasized. The NSHPC report, which clarified the status of the virus strains and their use in the smallpox vaccination programs, enabled the EMEA to provide additional details and guidance in their document. The EMEA guidance provides advice regarding the manufacture of ‘second-generation’ smallpox vaccines and forms the basis of assessments by regulatory authorities of smallpox vaccine quality, safety and immunogenicity. The NSHPC contribution to the important work of the EMEA and FDA is part of an ongoing study by the Center that is focused on ensuring that the lessons from previous vaccination programs to prevent smallpox in humans is available to the research and development teams that are now developing the new smallpox vaccines. The NSHPC interim report can be viewed at Studies and the EMEA guidance document at www.emea.eu.int. Further information on NSHPC and its projects can be obtained from Dr. Stephen Prior at sprior@potomacinstitute.org.