U.S. Poliovirus Containment

Implementation

The U.S. Department of Health and Human Services designated the U.S. National Authority for Containment (NAC) in January 2018. NAC is located at the Centers for Disease Control and Prevention.

NAC was designated to implement 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) in the U.S.

In July 2022, WHO replaced GAPIII with the WHO Global Action Plan for Poliovirus Containment 4th Edition (GAP IV). WHO expects to complete the transition to GAPIV by July 2025.

U.S. Poliovirus Containment Survey

Beginning in December 2018, the NAC launched an online survey to reach all U.S. facilities that may retain poliovirus materials including those working with biological and wastewater materials. The survey builds on national surveys conducted in 2002 and 2015. The current survey represents an ongoing evaluation of the poliovirus inventory in the U.S.

Poliovirus-Essential Facilities

All facilities that continue to handle and store wild and vaccine-derived poliovirus types 2 and 3 and oral polio vaccine type 2 infectious materials must be certified as a poliovirus-essential facility (PEF) to retain these materials. Poliovirus-essential facilities serve critical national and international functions. Those functions include vaccine production, vaccine testing, public health and virologic research, and diagnostics.

The NAC strongly encourages any U.S. facility to destroy unneeded or nonessential materials containing poliovirus. All facilities retaining poliovirus will require certification as a PEF.

GAPIV specifies all poliovirus containment requirements including:

• Facility risk management
• Biosecurity
• Engineering controls
• Community population immunity
• Local sanitation standards

GAPIV focuses on risk elimination as a primary goal, wherever possible. GAPIV has shifted to a risk- and evidence-based approach for risk control, but this does not change the tolerance for minimal risk.

Containment Certification Scheme

The Containment Certification Scheme (CCS) was endorsed by the WHO Strategic Advisory Group of Experts on Immunization in October 2017. It outlines the steps that facilities must take to become a PEF. The NAC manages the U.S. facility application process and audits candidate PEFs to validate containment conditions and compliance with GAPIV.

Accomplishments

*Data as of August 2023** Data as of July 2022