Implementation of Poliovirus Containment in the US
In December 2015, the World Health Organization (WHO) requested that all countries conduct an inventory of their poliovirus-containing materials. On behalf of the US Department of health and Human Services, CDC initiated a survey of federal facilities, academic institutions, state and local health departments, industrial facilities, commercial diagnostic laboratories, and hospitals in the United States. This survey, which was limited in scope to those entities known or presumed to work with poliovirus and other at-risk enteric microbes, marked the beginning of Phase 1 in the implementation of the Global Action Plan to Minimize Poliovirus Facility–Associated Risk after Type-Specific Eradication of Wild Polioviruses and Sequential Cessation of Oral Poliovirus Vaccine Usepdf iconexternal icon (GAPIII).
In January 2018, the U.S. Department of Health and Human Services designated the CDC Poliovirus Containment Activity as the U.S. National Authority for Containment (NAC). The NAC is responsible for implementing the containment plan in the U.S., which includes completing all three phases of GAPIII.
National inventory activities expanded in December 2018 with the launch of a new online survey – National Inventory for Poliovirus Containment. This survey is ongoing and expected to remain open through 2020.
All facilities that continue to handle and store poliovirus type 2 (WPV2/VDPV2 and OPV2) and WPV3/VDPV3 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 poliovirus materials. These facilities serve critical national and international functions, including vaccine production, vaccine testing, public health and virologic research, and diagnostics. The NAC strongly encourages facilities to destroy unneeded materials containing poliovirus. Upon final declaration of poliovirus eradication, all facilities retaining poliovirus will require certification as a PEF.
GAPIII specifies requirements for containment, including facility risk management, biosecurity, engineering controls, community population immunity, and local sanitation standards. It states that PEFs follow the requirements in Annex 2 pdf iconexternal iconand Annex 3 pdf iconexternal iconof GAPIII.
GAPIII Containment Certification Scheme
The GAPIII Containment Certification Schemepdf iconexternal icon (CCS) was endorsed by the WHO Strategic Advisory Group of Experts on Immunization in October 2017. The GAPIII CCS outlines the steps that facilities must take to become a PEF. The NAC will manage the application process and audit candidate PEFs to validate containment conditions and compliance with GAPIII.
National Authority for Containment (NAC):
Performs audits and provides certification to all PEFs according to CCS; ensures national poliovirus inventory is maintained
Global Commission for the Certification of the Eradication of Poliomyelitis (GCC):
Endorses facility certification approved by the CWG; receives national survey reports from the RCC
Containment Working Group (CWG):
Reviews and approves PEF applications and audits received from NACs for national containment certification and makes recommendations to the GCC
Containment Advisory Group (CAG):
Advisory body to the Director-General of WHO; makes recommendations on technical issues related to the implementation of GAPIII
Regional Commission for the Certification of the Eradication of Poliomyelitis (RCC):
Independent global experts who review national survey reports
National Certification Committee for Polio Eradication (NCC):
Independent experts who review, verify, and submit country documentation to RCC related to Phase 1 survey activities