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

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

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 RepublicNA 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 surveillance2In 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

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

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

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

GAPIII endorsed by the WHO SAGE in October 2014

What do we contain?

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 materialsas defined in GAPIII

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 materialsas defined in GAPIII

Revision of this category of materials is currently under progress

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

When do we need to contain it?

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

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

• 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

Is it easy to contain it?

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)

PEFGAPIII

IMPLEMENTATION

NACGAPIII

CERTIFICATION

CP/ICC/CC

Application

for certification

• Achieves

and

maintains

containment

certification

GCCGLOBAL

OVERSIGHT

• Provides

legislation

• Receives,

reviews and

accepts

applications

• Organises and

coordinates

regular audits

WHOCONSULTING

• 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

Facilities that could handle PV potentially infectious materials

Types of facilitiesTypesof 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

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 materialsin 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

• 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)

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

Thank you for your attention