Poliovirus Potentially Infectious Materials:
Risk Classification and Risk Mitigation
Biosafety Branch, Ministry of Health
7 & 15 January 2019
Contents
• Definitions & background
• WHO Guidance document for non-poliovirus facilities• Risk Classification
• Risk Mitigation Measures
Differentiating Poliovirus IM and PIM
Infectious Materials (IM)
PotentiallyInfectious
Materials (PIM)
Definitions
Poliovirus Infectious Material (IM)
Any sample that has been tested or is known to contain poliovirus e.g.
Wild-type poliovirus (WPV)
Vaccine derived poliovirus (VDPV)
Oral poliovirus vaccine/Sabin (OPV/Sabin)
For definition of the different types of poliovirus infectious materials, please refer to WHO Global Action Plan III (http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/containment-resources/)
Definitions
Poliovirus Potentially Infectious Material (PIM)
Faecal, respiratory, concentrated sewage samples or derivatives of such samples, collected at a time of poliovirus circulation in the community, or when live, attenuated poliovirus vaccine is used; regardless of the purpose of sample collection
WPV PIM Any of the above sample types or derivatives of such samples, collected at a time of wild-type poliovirus circulation in the community
VDPV PIM Any of the above sample types or derivatives of such samples, collected at a time of vaccine derived poliovirus outbreak in the community
OPV/Sabin PIM Any of the above sample types or derivatives of such samples, collected at a time when live, attenuated poliovirus vaccine is used in the community
Modified from WHO Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses (http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/containment-resources/)
WHO Poliovirus Eradication and Endgame Strategic Plan
Outside the Laboratory/Facility Laboratory/Facility
• Interruption of WPV and VDPVtransmission
• Containment of poliovirus IM & PIM;poliovirus type 2 followed by type 1 and 3
• Strengthen immunization programme and withdraw oral poliovirus vaccine
• Poliovirus essential facility (PEF):Undergo certification for containment of WPV IM & PIM, VDPV IM & PIM, OPV/Sabin IM
• Non-poliovirus essential facility: Risk elimination or risk mitigation for containment of OPV/Sabin PIM
Long term goal: minimize risk of reintroducing PV into the population
Modified based on WHO Polio Eradication & Endgame Strategic Plan 2013-2018 and WHO Global Action Plan III
WHO Poliovirus Containment Timeline
Phase 1
Preparation for containment of poliovirus type 2
Identification of poliovirus-essential facility (PEF)
Phase 2
Poliovirus type 2 containment period
Containment of WPV2, VDPV2 IM & PIM, OPV/Sabin2 IM
Switch from tOPV to bOPV
Certification of PEF
Safe-handling of OPV/Sabin PIM in non-PEF
Phase 3
Final containment of all WPV, VDPV IM & PIM
Final containment of all OPV/Sabin IM
Cessation of bOPV use
Certification of PEF
Safe-handling of OPV/Sabin PIM in non-PEF
Certification of PEF
Safe-handling of OPV/Sabin PIM in non-PEF
Modified based on the containment timeline in WHO Global Polio Action Plan III
Singapore: PV IM and PIM
WPV2 IM & PIM
OPV3 IM & PIM
Prior to 31 Dec 1972
OPV2 IM & PIM
1 Jan 1979 to 31 Jul 2016 1 Aug 2016 onwards
OPV1 IM & PIM
WPV3 IM & PIM
WPV1 IM & PIM
1 Jan 1973 to 31 Dec 1978
Cessation of bOPV
Overseas Samples: PV IM and PIM
• Determine whether samples are WPV2/VDPV2 or OPV/Sabin2 IM or PIM based on collection period and country of origin; also sample type for PIM
• Country and territory-specific poliovirus data is available in Annex 2 of WHO guidance document
Extracted from Annex 2 of WHO Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses (http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/containment-resources/)
Containment in Non-Poliovirus Essential Facility
• WPV2/VDPV2 IM and PIM, OPV/Sabin2 IM: Destroy or transfer to a poliovirus essential facility
• OPV/Sabin 2 PIM: Destroy or implement risk mitigation based on risk classification
Material identification
• Determined based on sample type and associated work activitiesRisk
Classification
• Determined based on risk classificationRisk Mitigation
Risk Classification of OPV/Sabin PIM
Type of PV PIM* Procedure used with PIM Risk Level
Faecal samples or concentrated sewage
Inoculation into PV-permissive cells Moderate
Other laboratory procedures** Low
Extracted nucleic acid from faecalsamples or concentrated sewage
Transfection into PV-permissive cells Moderate
Other laboratory procedures** Lowest
Respiratory tract samples Inoculation into PV-permissive cells Low
Other laboratory procedures** Lowest
Extracted nucleic acid from respiratory tract samples
Transfection into PV-permissive cells Low
Other laboratory procedures** Lowest
* Cerebrospinal fluid (CSF), serum/blood, and other clinical materials not listed in Table 1 are not considered PV PIM** Other laboratory procedures may include, but are not limited to, inoculation into PV non-permissive cells, bacterial culture, PCR (DNA or RNA), mass spectrometry, or ELISA.
PV PIM that have been inactivated using a validated method are no longer considered PIM
Source: WHO Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses (http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/containment-resources/)
Some examples of PV-permissive cell linesCell lines Origin
CaCo-2 Human
HeLa Human
HEp-2 Human
HEK Human
MRC-5 Human
Various neuroblastoma (e.g. IMR-32, SK-N- MC) Human
BGMK (sometimes referred to as BGM or GMK) Non-Human Primate
LLC-MK2 Non-Human Primate
MA-104 (Vero derivative) Non-Human Primate
Primary monkey kidney cells Non-Human Primate
Vero Non-Human Primate
L20B Mouse
Source: WHO Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses (http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/containment-resources/)
Risk Mitigation Strategies for Handling PV PIMRisk level
Risk mitigation strategy Moderate Low Lowest Storage only2
Declare PV PIM in National PV Survey and maintain accurate inventory
Biosecurity (including, for example, locked freezers, limited access, staff training)
Biosafety (including, for example, good laboratory/microbiological practices, and documentation and validation of methods/ standard operating procedures, as described in GAPIII, Annex 6)
n/a
Risk assessment for specific procedures being used
Required polio immunization of staff n/a3 n/a
Certification to a national or international standard that includes biosafety and biosecurity components
n/a n/a n/a
Source: WHO Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses (http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/containment-resources/)
: must comply with the risk mitigation strategy; n/a: not applicable 2 For short-term retention while the final disposition of the collection is being considered. If “stored” samples are to be handled, the risk mitigation strategies for moderate, low, and lowest risk groups must be applied as appropriate for the sample type and procedure (Table 1). 3 recommended
What do I need to do?
• Each facility to complete and submit “Facility Reporting Form 1” by 18 February 2019• Facility information
• Types of samples that are destroyed or being retained
• Risk classification of work activities and rationale for sample retention
• Each facility retaining OPV/Sabin type 2 PIM, to submit Risk Mitigation Plan in place by 18 March 2019
Reference Materials from WHO
WHO Containment Resources• WHO Guidance to Minimize Risk for Facilities Collecting, Handling or Storing
Materials Potentially Infectious for Polioviruses
• Annex 2 of WHO Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses
• WHO Global Action Plan III