Guidance for Laboratories

Announcement

National Inventory for Poliovirus Containment

Laboratories and other facilities that handle or store infectious and potentially infectious poliovirus materials pose a risk for polioviruses to be re-introduced into communities after eradication. Among samples collected from asymptomatic people living in an area with known poliovirus transmission, or where oral polio vaccination is taking place, as many as 19% of stool samples and 1% of respiratory samples have demonstrated growth of polioviruses.

The WHO Global Action Plan to Minimize Poliovirus Facility–Associated Risk after Type-Specific Eradication of Wild Polioviruses and Sequential Cessation of Oral Poliovirus Vaccine Use (GAPIII)Cdc-pdfExternal, endorsed by the World Health Assembly in 2015, describes the requirements for poliovirus containment.

Looking For every Last Poliovirus In Global Sample Collections

Guidance for Laboratories

To determine if you possess infectious or potentially infectious materials you can refer to the GAPIII definitions and examples. If you have materials that meet these definitions contact the U.S. National Authority for Containment at poliocontainment@cdc.gov or 404-718-5160.

If laboratories and facilities want to keep their wild poliovirus (WPV), vaccine derived poliovirus (VDPV), or oral polio vaccine (OPV) infectious materials (IM), they must apply to become a poliovirus essential facility (PEF). As a PEF, the facility must meet all of the elements outlined in GAPIIICdc-pdfExternal, including increased biosafety measures over and above the current Biosafety in Microbiological and Biomedical Laboratories (BMBL) BSL-2/ABSL-2 recommendations.

For more information on Poliovirus Containment in the U.S. and how to become a PEF, please visit the or email poliocontainment@cdc.gov.

Laboratories and facilities that maintain possession of wild poliovirus (WPV) or vaccine derived poliovirus (VDPV) potentially infectious materials (PIM) must apply to become a poliovirus essential facility (PEF). As a PEF, the facility must meet all of the elements outlined in GAPIIICdc-pdfExternal, including increased biosafety measures over the current Biosafety in Microbiological and Biomedical Laboratories (BMBL) BSL-2/ABSL-2 recommendations.

GAPIIICdc-pdfExternal requirements do NOT apply to oral polio vaccine (OPV) PIM. Laboratories and facilities that think they may be in possession of OPV PIM should review and follow the  Guidance for non-poliovirus facilities to minimize risk of sample collections potentially infectious for polioviruses (PIM Guidance)Cdc-pdfExternal.

For more information on Poliovirus Containment in the U.S. and how to become a PEF, please visit the or email poliocontainment@cdc.gov.

All facilities that continue to handle and store poliovirus type 2 will require certification as a poliovirus essential facility (PEF). A PEF is a facility that maintains the ability to work with and/or store infectious and potentially infectious materials. These facilities serve critical national and international functions, including vaccine production, vaccine testing, public health and research, and diagnostics.

At this time, only poliovirus type 2 (PV2) is subject to GAPIII containment. All facilities are encouraged to work towards GAPIII containment for poliovirus type 1 and 3 materials, and to destroy materials that will not be used for essential work. All poliovirus types will be subject to GAPIII containment after final eradication of all poliovirus types..

All questions about poliovirus containment or the destruction or transfer of poliovirus materials should be directed to the NAC.

Download PDFCdc-pdf

On May 26, 2018, the World Health Organization (WHO) and its Member States ratified a resolution as part of the continuing global efforts to eradicate poliovirus. The resolution, titled “Poliomyelitis – containment of polioviruses,” calls for the destruction and containment of existing stocks of poliovirus in accordance with the WHO Global Action Plan III. Poliovirus type 2 is the first serotype eradicated.

National health authorities can assist with these efforts by expediting a review of human plasma-derived immunoglobulin products tested with poliovirus type 1.

The CDC, as the National Authority for Containment of Poliovirus, is strongly urging all immunoglobulin manufacturers in the United States (U.S.) to discontinue the use of poliovirus type 2 for testing immunoglobulin products. This allows manufacturers to destroy poliovirus type 2 materials. After making this change, fewer facilities will possess poliovirus type 2, and more of the virus can be destroyed. These actions will reduce risks associated with continued use of poliovirus type 2, protect eradication, and help advance the goals of WHO Global Action Plan III. The U.S. Food and Drug Administration approves of using poliovirus type 1 for testing immunoglobulin products.

As all WHO member countries move forward to support poliovirus containment and eradication, the assistance of national health authorities in reviewing human plasma-derived immunoglobulin products tested with poliovirus type 1 rather than poliovirus type 2 will substantially further these efforts. This will be an important step towards a polio-free world.

The CDC, as the National Authority for Containment of Poliovirus, is strongly urging all immunoglobulin manufacturers in the United States (U.S.) to discontinue the use of poliovirus type 2 for testing immunoglobulin products. This allows manufacturers to destroy poliovirus type 2 materials. After making this change, fewer facilities will possess poliovirus type 2, and more of the virus can be destroyed. These actions will reduce risks associated with continued use of poliovirus type 2, protect eradication, and help advance the goals of WHO Global Action Plan III. The U.S. Food and Drug Administration approves of using poliovirus type 1 for testing immunoglobulin products.

As all WHO member countries move forward to support poliovirus containment and eradication, the assistance of national health authorities in reviewing human plasma-derived immunoglobulin products tested with poliovirus type 1 rather than poliovirus type 2 will substantially further these efforts. This will be an important step towards a polio-free world.

The U.S. National Authority for Containment (NAC)

The U.S. National Authority for Containment (NAC) strongly encourages facilities to destroy all poliovirus containing samples that are not deemed essential.

If you think you have any of these materials, please contact the U.S. NAC for assistance

Email poliocontainment@cdc.gov or call 404-718-5160.

The NAC can help you:

  • determine if any of your specimens are poliovirus potentially infectious materials
  • distinguish between WPV/VDPV PIM and OPV PIM
  • work with you to capture this information and complete the national poliovirus survey
Page last reviewed: November 20, 2018, 01:15 PM