NVAC W. R. Dowdle

Laboratory Containment of Wild Poliovirus in the United States Phase I National Survey and Inventory Final Report January 15, 2004

The Purpose of Laboratory Containment To minimize the risk of reintroducing wild polioviruses into the community after eradication 2nd edition 2003

Purpose of Phase I To encourage labs to dispose of unneeded wild poliovirus materials Establish National Inventories of laboratories retaining such materials.

US Survey and Inventory Began in October 2001 NVPO through contract with the Task Force for Child Survival and Development Working in partnership with CDC

Steps in the survey process Develop the Action Plan Authorize the survey (WHO, HHS, OMB) Enlist support of laboratory community Perform pilot surveys (x2) Establish database of institutions/labs Develop survey instruments Implement the survey

Database: Categories of Institutions CLIA Certified Non-Complex Testing Most likely to possess (1,216) Least likely to possess (26,844) CLIA Certified Complex Testing May possess (4,369) Academic Federal Government Industry State and Local Government Hospitals Private Labs

Survey Database (Institutions) Yet to Respond Most likely to possess ## Academic 4370 Federal Government 130 Industrial 6680 State & Local Government 980 Subtotal 1,2160 May possess CLIA certified complex testing 4,3690 Least likely to possess CLIA certified non-complex testing 26,8442,638 Total32,429 † 0 Results of National Survey* * November 2003 † Represents a total of 105,356 laboratories surveyed

Finding no WPV materials among 24,206 responders confirmed small clinical labs were unlikely risks. Follow-up of “least likely” labs discontinued per NVAC workgroup.

Institutions Retain- ing Materials Laboratories Retaining Materials Most likely to possess #InfectiousPotential Infectious BothTotal Academic Federal Government Industrial State & Local Government Subtotal May possess CLIA certified complex testing Least likely to possess CLIA certified non-complex testing Total Number of institutions on National Inventory/ Types of materials retained* * As of November 2003

Post-survey literature search To confirm that all institutions/laboratories publishing on wild poliovirus materials are on the National Inventory To identify laboratories publishing on infectious agents that share common enteric origins or replicate on poliovirus-permissive systems.

Selected PubMed Literature Search 2002 & 2003 Bacterial and Viral n = 1906

Sensitivity of search of >12,000 citations ( ) CategoryInventorySearchPercent Academic Fed. Gov Industry24625 State & local Totals

Institutions publishing ( ) on any poliovirus and not listed on survey database 1 community college, environmental project now discontinued 1 biotech startup, now defunct

Institutions publishing ( ) on associated viruses and not listed on survey database 1 water service Co. R&D lab 2 non-profit foundation laboratories 1 community college 2 biotech startups, 1 now defunct

Summary ( Phase I) The US national survey of >32,000 institutions and >105,000 labs is complete. The quality and completeness of the survey is validated by a10 year literature search The National Inventory consists of 122 institutions with180 labs. Recommendations for Phase II are made and responsibilities defined in the Report

Acknowledgements Kim Koporc (TFSCD), Sandra Browning and Alison Mawle (CDC) CDC advisors and support staff Departments of the Executive Branch Thousands of administrative and lab staff NVAC Polio Laboratory Containment Workgroup

Next steps HHS submits Phase I report to PAHO US begins planning for Phase II

Wild Poliovirus*, 24 Dec 2002 to 23 Dec 2003 Data in WHO HQ as of 23 Dec 2003 *Excludes viruses detected from environmental surveillance and vaccine derived polio viruses. The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.  WHO All rights reserved Case or outbreak following importation Endemic countries Wild virus type 1 Wild virus type 3 Wild virus type 1 and 3