NVAC02-04-04

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 The Purpose of Laboratory ContainmentContainment

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 CertifiedNon-Complex

Testing

Most likely to possess (1,216)

Least likely to possess (26,844)

CLIA CertifiedComplex Testing May possess

(4,369)

Academic

Federal Government

Industry

State and Local Government

Hospitals

Private Labs

National Survey Implementation Timeline/Results

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

30 May 02 11 Oct 02 5 Dec 02 1 Feb 03 4 Mar 03 28 Apr 03 23 May 03 1 July 03 7 Aug 03 20 Nov 03

Date

% N

on

-Re

sp

on

din

g

packet sent out32,000 labs/inst.

trial & pilot surveys

1st reminder letter to 361 academic inst. and 481 bio/pharma inst.

1st reminder letters to17,765 CLIA labs

2nd reminder letter to74 academic inst.41 bio/pharma inst. telephone reminders

to 55 bio/pharma/academic instit.

telephone reminders to 419 CLIA labs most likely to have WPV

2nd reminder letters to4,456 CLIA labs

Follow -up continues w ith labs that may possess and most likely possess WPV

100% response rate achieved

Survey Database

(Institutions)

Yet to Respond

Most likely to possess

# #

Academic 437 0

Federal Government 13 0

Industrial 668 0

State & Local Government 98 0

Subtotal 1,216 0

May possess

CLIA certified complex testing 4,369 0

Least likely to possess

CLIA certified non-complex testing 26,844 2,638

Total 32,429† 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

# Infectious Potential Infectious

Both Total

Academic 63 49 29 16 94

Federal Government 10 9 17 3 29

Industrial 24 22 6 2 30

State & Local Government 17 4 4 10 18

Subtotal 114 84 56 31 171

May possess

CLIA certified complex testing 8 3 0 6 9

Least likely to possess

CLIA certified non-complex testing

0 0 0 0 0

Total 122 87 56 37 180

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 Search2002 & 2003

Bacterial and Viraln = 1906

Coxsackievirus7% Echovirus

1%Enterovirus

6%

Hepatitis A or E41%

Picornavirus11%

Poliovirus5%

Rhinovirus2%

Rotavirus5%

Campylobacter5%

Cholera13%

Shigella3%

Typhoid fever1%

Sensitivity of search of >12,000 citations (1993-2003)

Category Inventory Search Percent

Academic 71 51 72

Fed. Gov. 10 5 50

Industry 24 6 25

State & local

17 2 12

Totals 122 64 52

Institutions publishing (1993-2003) on any poliovirus and not listed on

survey database

• 1 community college, environmental project now discontinued

• 1 biotech startup, now defunct

Institutions publishing (1993-2003) 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 2003. All rights reserved

Case or outbreak following importation

Endemic countries

Wild virus type 1 Wild virus type 3

Wild virus type 1 and 3