Polio eradication efforts have significantly reduced polio cases worldwide since 1988, but containment of polioviruses remains an ongoing challenge. The WHO recommends poliovirus materials be contained according to phases that began with preparation for poliovirus type 2 containment by 2016. Containment involves inventorying, transferring, and destroying unnecessary materials or nominating essential facilities for certification. While minimizing risk, challenges include the large number of facilities handling potentially infectious materials and balancing containment with vaccine supply. Key resources provide guidance on containment procedures and certification of essential facilities.

1. Maria Iakovenko, PhD, Containment consultant WHO/Europe, Copenhagen, Denmark
(iakovenkom@who.int)
WHO/Europe update on
polio eradication
and laboratory containment
requirements and challenges
ECDC National Microbiology Focal Points Fifteenth Meeting
Stockholm, 13-14 October 2016

2. IPV – inactivated polio vaccine
OPV – oral polio vaccine
PV – poliovirus
WPV – wild poliovirus
 GPEI launched in 1988 (WHA 41.28 resolution)
Outcomes
• Polio cases decreased worldwide from ~350 000 in 1988 to 74 in 2015 (by over 99%)
• Only three countries are still endemic for polio (by 04 October 2016)
• WPV type 2 transmission stopped since 1999, and its eradication declared in September 2015
• Four of six WHO Regions are certificated as free from the endemic polio
(European Region certificated in 2002)
 IPV and OPV successful implementation since the mid-1950s
 Large polio outbreaks affected hundreds of thousands
of children every year in the early 20th century

3. Nigeria 06-Aug-16 3 NA 0
Guinea NA 0 14-Dec-15 3
AFR 06-Aug-16 3 14-Dec-15 3
Pakistan 27-Jul-16 30 NA 0
Afghanistan 11-Aug-16 16 NA 0
EMR 11-Aug-16 46 0
Lao People's
Democratic Republic
NA 0 11-Jan-16 8
WPR 0 11-Jan-16 8
Myanmar NA 0 05-Oct-15 1
SEAR 0 05-Oct-15 1
Global 11-Aug-16 49 11-Jan-16 12
Country
Wild poliovirus cVDPV
Onset of most
recent case
Total
WPV1
Onset of most
recent case
Total
cVDPV
Data in WHO HQ as of 04 October 2016
1Excludes viruses detected from environmental surveillance
2In Nigeria, 1 cVDPV2 from a healthy child contact of WPV1 case
3Onset of paralysis 05 October 2015 – 04 October 2016
Endemic country
Wild poliovirus type 1
cVDPV type 1
cVDPV type 22
Global Wild Poliovirus & cVDPV Cases1,2, Previous 12 Months3
cVDPV – circulating highly evolved vaccine-derived poliovirus

4. Current efforts are based on:
 Polio Eradication and Endgame Strategic Plan
2013-2018
 WHA 68.3 resolution on Poliomyelitis, May 2015
 Report of the SAGE meeting, December 2015
 WHO global action plan to minimize poliovirus
facility-associated risk (GAPIII)
 Containment Certification Scheme (CCS; draft)
 Directive 2000/54/EC on the protection of workers
from risks related to exposure to biological agents
at work
Effective
epidemiological
PV surveillance
Implement
PV
safe-handling
and
containment
measures
OPV
cessation –
eliminate the
risks of VAPP
and VDPV
Eliminate
the risk
of WPV
transmission
Polio-free
world
OPV – oral polio vaccine
PV – poliovirus
VAPP – vaccine-associated paralytic poliomyelitis
VDPV – vaccine-derived polioviruses
WPV – wild poliovirus

5. Poliovirus Containment activities and relevancy to GPEI
 Polio Eradication and Endgame Strategic Plan 2013-2018
Four major objectives run in parallel
April 2016
• to accelerate implementation of GAPIII – completing of Phase I:
- to update national inventories of facilities that hold or handle PVs
- to destroy WPV2 by end 2015 and any other type 2 containing materials including Sabin PVs by July 2016
• to develop a targeted advocacy and communication plan, including establishment of a national
authority for containment (NAC) and national regulation for containment of poliovirus in designated PEF
 SAGE meeting, October 2015 (Report - December 2015)
• Containment of WPV2 in poliovirus essential facilities (PEFs) by the end of 2015
• Containment of PV2 Sabin in PEFs within 3 months of global withdrawal of the OPV type 2
component in April 2016
• Containment of monovalent OPV2 national stockpile (if applicable) in compliance with GAPIII
 WHA 68.3 resolution on Poliomyelitis, May 2015

6.  WHO global action plan to minimize poliovirus facility-associated risk after type-specific
eradication of wild polioviruses and sequential cessation of oral polio vaccine use (GAPIII)
 Containment Certification Scheme (CCS; as a draft)
• Key
principle – to minimize the risk through minimizing the number of PEFs worldwide
(only PEFs that serve critical functions: vaccine production and storage, crucial research)
• Based on – a biorisk management system composed by ≈16 elements derived from CWA 15793;
Laboratory Biorisk Management (2011)
• Addressed – all areas associated with the design, operation and management of PEFs
• Should be implemented in 3 Phases: I. Preparation for containment of PV2
II. PV2 containment period
III. Final PV containment
• Outlines – the certification scheme for PEFs, including key roles, responsibilities and associated mechanisms
for stakeholders relating to the scheme
• Based on – other risk-based management system certification schemes
• Designed to – enable PEFs to demonstrate PV-specific control measures,
while improving performance through the consistent adoption of recognized good practice
in biorisk management
Poliovirus Containment activities and relevancy to GPEI

7. GAPIII endorsed by the WHO SAGE in October 2014

8. What do we contain?

9.  clinical materials from confirmed PV infections including those from
OPV-recipients
 environmental sewage or water samples, positive for the presence of PV
 cell culture isolates, and PV reference strains
 seed stocks and infectious materials from polio vaccine production
 PV-infected animals or samples from such animals
 laboratory PV constructs, containing capsid sequences
 full-length PV RNA or cDNA that include capsid sequences
 cells persistently infected with PV
PV (wild or vaccine) infectious materials
as defined in GAPIII

10.  faecal or respiratory secretion samples collected for any purpose
in a time and geographic area of PV circulation
 products of such materials from PV-permissive cells or animals
 uncharacterized enterovirus-like cell culture isolates from
countries known or suspected to have circulating PV at the time of
collection
 respiratory and enteric virus stocks handled under conditions
where PV contamination or replication is possible
PV (wild or vaccine) potentially infectious materials
as defined in GAPIII
Revision of this category of materials is currently under progress

11. GAPIII - 16 Elements - Biorisk management standard for PEFs
Element
1 Biorisk Management System
2 Risk Assessment
3 Poliovirus Inventory and Information
4 General Safety
5 Personnel and Competency
6 Good Microbiological Technique
7 Clothing and Personal Protective Equipment (PPE)
8 Human Factors
9 Health Care
10 Emergency Response and Contingency Planning
11 Accident/Incident Investigation
12 Facility Physical Requirements
13 Equipment and Maintenance
14 Decontamination, Disinfection and Sterilization
15 Transport Procedures
16 Security

12. When do we need to contain it?

13. Phase I:
Preparation for containment of PV2
Phase II:
PV2 containment period
Phase III:
Final PV containment
3 mo after
the global OPV2 withdrawal
(31 July 2016)
After 6x Certification
of WPV eradication
Phase I procedures
need to be completed
by each Member State
• Conduct PV2 inventory
• Destroy unneeded PV2 materials
• Nominate poliovirus essential
facility (PEF) if keep holding
PV2 materials
• Transfer needed PV2 materials
to PEFs
• Nominate National Authority
for Containment (NAC)
in case of PEF nomination
• Prepare for PEF certification
In European Union:
- 10 of 13 countries with PEFs
- 21 of 25 PEFs
- 11 of 12 PV vaccine manufacturing
sites
PV containment schedule and procedures
• IIa: all WPV2 are contained in
certified PEFs
• IIb: all OPV2/Sabin2 PVs are
contained in certified PEFs
(commences within 3 months of OPV2
withdrawal)*
• IIIa: all WPVs are contained
long-term in certified PEFs
• IIIb: all OPV/Sabin PVs are
contained long term in certified
PEFs
(commences within 3 months of
bOPV cessation which is planned
1 year after the certification of global
WPV eradication)*
* OPV/Sabin PV containment may be temporarily suspended in areas where mOPV is
used in response to emerging or re-emerging WPV/cVDPV transmission

14. 2014# 2015-
2016@
EU countries
2015-2016
Countries with
WPV/WPV2*
22 18/13 13/10
Countries
without WPV
29 35 16
Countries
without any PV
- 15 2
Sites in
inventory
289 198& 97
Sites with
WPV/WPV2
69 53/34 45/28
Sites with
Sab/Sab2
- 157/62 72/38
Countries
planning PEFs
- 13 10
(BEL, CRO, DNK,
FRA, HUN, ITA, NET,
ROM, SWE, UNK)
No of planning
PEFs
- 25 21
(BEL (5), CRO, DNK,
FRA (4), HUN, ITA,
NET (3), ROM, SWE,
UNK(3))
* WPV – starting from 2015 this definition includes WPVs, VDPVs, WPV-PI
# Data from official statements provided by 51 Member States in their APR for 2014
@ Data from official statements provided by 53 Member States as of October 2016
& This number includes all facilities holding WPV and/or Sab materials and registered in regional inventory
Phase I part a – containment procedures
toward WPV2 materials
(to destroy/transfer or to nominate PEF/NAC)
WHO/Europe inventory summary and containment progress

15. • Several rounds of high-level communication
• Collaboration with EC and ECDC on PVC established
• Several rounds of BRM trainings for Labnet, NPCCs, NACs
and PEFs conducted
• Trainings for auditors are planning
• PVC online portal is under development
Major activities – PV containment

16. Is it easy to contain it?

17. Containment Certification Scheme (CCS, draft)
PEF – poliovirus essential facility
NAC – National authority for containment
GCC – Global Certification Committee
CP – Certificate of Participation (max 1yr + 6mo extension)
ICC – Interim Certification of Containment (max 3yrs)
CC – Certification of Containment (3yrs with annual audits)
PEF
GAPIII
IMPLEMENTATION
NAC
GAPIII
CERTIFICATION
CP/ICC/CC
Application
for certification
• Achieves
and
maintains
containment
certification
GCC
GLOBAL
OVERSIGHT
• Provides
legislation
• Receives,
reviews and
accepts
applications
• Organises and
coordinates
regular audits
WHO
CONSULTING
• Reviews
application
reports from NAC
• Confirms global
containment
• Coordination
and CCS
implementation
support
• Technical
assistance
• Expert advise
GAPIII and CCS’ fundamental principle –
the responsibility for the design and implementation
of oversight measures relating to individual PEFs and
their alignment to local conditions (including national
regulations) rests with the NACs

18. Facilities that could handle PV potentially infectious materials
Types of facilitiesTypes
of PV potential infectious materials
diagnostic
research
educational
Laboratory
dealing with
Viruses
Bacteria
Fungi
Helminths
Faecal samples
Respiratory samples
reference
purposes
Industrial
facilities
Screening
the collections
of faecal or
respiratory
samples during
validation
procedures
Number of such facilities is very large
Collected in the area
and at time of PV circulation
• endemic regions,
• polio outbreaks,
• OPV implementation areas,
• cVDPV circulation areas,
• iVDPV excretors

19. How to minimize the risk of PV containment breach
 Be aware of the probability of PV presence in PV potentially infectious
materials such as faecal and respiratory samples
 Safe handling with these samples in accordance with general biosafety
procedures (controlled access [locked storage], biosafety cabinets, etc)
 Destroy any unneeded poliovirus potentially infectious materials
in accordance with appropriate biosafety procedures
 Maintain good knowledge of origin and degree of risk of PV potentially
infectious samples in your laboratory
 In case you have questions – proactively contact a National Poliovirus
Containment Coordinator or/and the nearest WHO Polio Laboratory

20. • PV containment is a dynamically evolving field. GAPIII
is a working document
• Certification of PEFs is a national responsibility. Some
countries will lack the required expertise
• IPV manufacturers as PEFs – containment and vaccine
supply balance
• Potentially infectious materials – how much to contain?
(respiratory samples as an example)
Areas of improvement (general)

21. Key resources
 Polio Eradication and Endgame Strategic Plan 2013–2018. WHO 2013.
http://polioeradication.org/wp-content/uploads/2016/07/PEESP_EN_US.pdf
 World Health Assembly 2015 resolution on poliomyelitis. WHA 2015.
http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_R3-en.pdf
 WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication
of wild polioviruses and sequential cessation of oral polio vaccine use (GAPIII). WHO 2015.
http://polioeradication.org/wp-content/uploads/2016/09/GAPIII_2014.pdf
 SAGE Meeting, Executive Boardroom, Geneva. 2015.
http://www.who.int/immunization/sage/meetings/2015/october/SAGE_YB_October2015.pdf
 Biorisk management. Laboratory biosecurity guidance. WHO 2006.
http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf
 GPEI containment pages.
http://polioeradication.org/polio-today/preparing-for-a-polio-free-world/containment/
 WHO/Europe containment pages.
http://www.euro.who.int/en/health-topics/communicable-
diseases/poliomyelitis/activities/implementation-of-the-polio-eradication-and-endgame-strategic-plan-
20132018-in-the-european-region/containment-of-polioviruses-in-the-european-region

22. Thank you for your attention