Progress of polio eradication and containment requirements after eradication

Abstract

Wild poliovirus (WPV) is nearing eradication, and only three countries have never interrupted WPV transmission (Pakistan, Afghanistan, and Nigeria). WPV2 was last detected in 1999, and it was declared eradicated in 2015. WPV3 has not been detected since 2012. Since 2016, WPV1 has been detected in only two countries (Afghanistan and Pakistan), with only 22 cases reported in 2017 and 12 cases reported in 2018 (as of July 10). Because of WPV2 eradication and the risk of emergence of type 2 vaccine–derived polioviruses from continued use of trivalent oral polio vaccine (OPV), trivalent OPV was replaced by bivalent OPV (types 1 and 3) in a globally coordinated effort in 2016. WPV2 eradication and trivalent OPV cessation also mean that breach of containment in a facility working with type 2 poliovirus is now a major risk to reseed type 2 circulation in the community. As a result, the World Health Organization has developed a “Global Action Plan to minimize poliovirus facility‐associated risk after type‐specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.” Because poliovirus has long been used as a standard for qualification of intravenous immunoglobulin, disinfectant products, and sanitation methods, poliovirus containment has implications far beyond poliovirus laboratories.

Immune globulin potency: challenges and opportunities

“…As discussed by Oberste, wild‐type poliovirus type 2 is officially eradicated and types 1 and 3 are soon to follow . The World Health Organization has initiated a Global Action Plan to prevent accidental dissemination of polioviruses, by setting forth requirements for laboratories and vaccine manufacturers who need to culture poliovirus . The Global Action Plan safeguards against accidental release of poliovirus are complex and costly, and include alterations of laboratory and manufacturing facilities such as laboratory restructuring for microbial containment including placement of showers, changes related to decontamination and waste disposal, monitoring of personnel, and placement at locations where the population has demonstrably high vaccination rates against polio.…”

“…17 The World Health Organization has initiated a Global Action Plan to prevent accidental dissemination of polioviruses, by setting forth requirements for laboratories and vaccine manufacturers who need to culture poliovirus. 18 The Global Action Plan safeguards against accidental release of poliovirus are complex and costly, and include alterations of laboratory and manufacturing facilities such as laboratory restructuring for microbial containment including placement of showers, changes related to decontamination and waste disposal, monitoring of personnel, and placement at locations where the population has demonstrably high vaccination rates against polio. In addressing this concern, workshop participants discussed: 1) What are the advantages of continuing to use poliovirus antibodies as a potency specification for IG products; 2) what are the drawbacks to continued use of the standard poliovirus assay for IG potency; and 3) can relevant and validated Biosafety Level 2 assays be developed to replace the current bioassays requiring live poliovirus?…”

Assuring immune globulin potency in a world of changing pathogen challenges

“…Potency testing for poliovirus antibodies using neutralization assays requires use of live virus to demonstrate antibody functionality. As well described by Oberste, World Health Organization Global Action Plan requirements for continued use of polioviruses will require costly retrofitting, physical locations within a radius of a population with proven high levels of immunity, and generally unwieldy requirements for existing quality control and research laboratories. Use of a hyperattenuated poliovirus strain that is incapable of causing paralytic disease can provide a pathway that would permit testing without Global Action Plan requirements.…”