Polio Outbreak SOP Introduction

Responding to poliovirus events and outbreaksStandard
Operating
Procedures 2016

• Part 1: General SOPs
• Event & outbreak definition
• Notification and confirmation of an outbreak
• Response to events & outbreaks
• GPEI support
• Assessment and closure of outbreak
• Part 2: Protocol for responding PV2
• Key strategic principles for responding to PV2
after OPV2 cessation
• Notification
• Classification of VDPV
• Confirmed, probable & possible transmission
• Factors influencing response
• Response scenarios
• mOPV2 stockpile
• http://www.polioeradication.org/Portals/0/Document/Resources/PolioEradicators/1a.PolioOutbreakGuideline201604part1.pdf
• http://www.polioeradication.org/Portals/0/Document/Resources/PolioEradicators/1a.PolioOutbreakGuideline201604part2.pdf
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Poliovirus event and outbreak response - SOPs
Responding to poliovirus event and outbreak - SOPs

 National government’s ownership and role
 Scenario following tOPV-bOPV switch
 Several decision trees + flow charts are added
for better understanding
 Protocol for post-switch PV2 response is a new
document any type 2 PV detection post-
switch will have highest priority and be
responded to as an outbreak
 mOPV2 stockpile release procedure
Responding to poliovirus event and outbreak - SOPs3
Major emphasis in SOPs 2016

Briefing objectives
To achieve a common understanding on the
response to poliovirus events and outbreaks in
different scenarios
4 Responding to poliovirus event and outbreak - SOPs

Briefing outlines
• Technical issues
• Strategic approaches
• Management functions
There are overlaps among technical, strategy &
management functions

– Definitions & classifications
– Risk assessment & grading
• Strategic approach
Briefing outlines

Event & outbreak definition

Evidence of circulation as key factor to
distinguish PV 'events' from PV 'outbreaks
• Event: single PV isolate without evidence of
circulation (as yet)
Probable or possible ongoing transmission
Medium to low risk of further transmission
• Outbreak: evidence of circulation
Confirmed ongoing transmission
High risk of further transmission
Ref: Table 1 of SOPs part 1 & part 2
8
Event or outbreak definitions

9
Poliovirus event
• WPV or VDPV or
Sabin2
• Human or
environment
• As yet no evidence of
transmission
• Probable or possible
transmission
• Low-medium risk of
further transmission
Typology Definition
Event
(as yet, no evidence
of transmission)
Human
Detection of
1) VDPV in:
 Single AFP case or asymptomatic person (e.g.
contact) or
 One or more persons,a
with no evidence of further
community-level circulation (iVDPV or an aVDPV
isolates) OR
2) Sabin like 2 isolate from individual sample(s) OR
3) WPV2 infected individual with documented type 2 virus
exposure in a laboratory or vaccine production facility
Environmental
Detection of
1) WPV single environmental sample without follow-up
evidence of virus excretion b
OR
2) VDPV without evidence of further transmission, such as
 single environmental sample without evidence of
prolonged circulation of >1.5 years or
 an aVDPV OR
3) Sabin like 2 isolate from environmental sample(s)

Poliovirus outbreak
• WPV or VDPV
• Human or
environment
• Evidence of
transmission
• Confirmed
transmission
• High risk of further
transmission
Typology Definition
Outbreak
(evidence of
transmission)
Human
Detection of
1) Any WPV infected individual(s)a
(an addition for type 2: “without documented exposure to a
type 2 virus in a laboratory or vaccine production facility”) OR
2) Any cVDPV infected individual(s)a
Environmental
Detection of
1) Two or more separatec
environmental samples positive
for WPV with genetic sequencing information indicating
sustained local transmission OR
2) A single environmental sample positive for WPV with
follow-up evidence of virus excretion b
OR
(an addition for type 2: “no documented exposure in a
laboratory or vaccine production facility”)
3) Any cVDPV positive environmental sample(s)

Summary event & outbreak

Vaccine derived poliovirus (VDPV)
classification
VDPV - genetically altered vaccine virus
that occurs in low immune population

Vaccine-derived polioviruses (VDPVs)
• Identified based on degree of genetic divergence from
parent OPV virus strain
– >1% divergent ( > 10 nt changes) for type 1 and 3
– > 0.6% divergent (> 6 nt changes) for type 2
• Classified into 3 categories
– Immunodeficient-related VDPV (iVDPV): arising in the guts of
persons with primary immunodeficiency
– Circulating VDPV (cVDPV): when there is evidence of person-to-
person transmission in the community
– Ambiguous VDPV (aVDPV): classification of exclusion, when
investigation does not support classification as cVDPV or iVDPV

GPLN Reports VDPV
Genetic link to ≥1 known current or historic
cVDPV or previously detected aVDPV
YES NO
Classify as
'c' VDPV
Detailed case investigation and field investigation of
AFP case or of environmental isolate
Additional PV isolate
(case, ES) with link to
known VDPV
Classify as
‘c' VDPV
Isolate detected in
an immune deficient
person (PID)
Classify as
‘i' VDPV
No additional isolate linked to
VDPD Or isolate
Not related to an immune
deficient person (PID)
Classify as
‘a' VDPV
Classification of VDPV isolates

Risk Assessment &
Grading of Outbreak

• Criterion 1: Potential for transmission in country
and spread beyond national borders
• Type and classification of poliovirus isolate
• Travel links and transmission routes
• Population immunity in the affected area
• Existence of vulnerable populations
• Breach of containment
• Duration of circulation/surveillance gaps
• Criterion 2: Strength of the country’s capacity to
respond and contain the outbreak
• Country health infrastructure (immunization service
delivery)
• Capacity to mobilise human resources
• Security situation, including the presence of armed
conflict or significant areas of insecurity or inaccessibility
The EOMG performs a risk assessment using two main
criterias
Transmission
risk:
High,
medium or
low
Country
capacity:
Strong,
moderate or
weak
EOMG
Conclusions

Risk profile matrix for grading of outbreak
Grading helps to determine type of response
needed and scale of GPEI support required

Key factors determining type & scope of
PV2 outbreak response
• Countries exclusively using IPV
• Countries which used tOPV in the last 12
months prior to type 2 OPV withdrawal
• Time: # Months elapsed between OP2 cessation and PV2
detection (phases)
• Place: Affected area + other high risk areas, travel links (outbreak
zone)
• Characteristics of affected population: population immunity, HR
profile, etc. (risk zone)

Phases of risk for type 2 poliovirus
emergence and circulation
19
Phase Time after
cessation of
OPV2
Comment Relative Risk for
initial type 2
occurrence
Risk for
further
circulation
1 <1 year General population immunity
remains high if mucosal immunity is
boosted in <5 population by pre-
switch tOPV SIAs
High Low
2 2-3years General immunity still reasonably
high, but overall mucosal immunity
declining and absent in new birth
cohorts
Medium Medium
3 >4 years Mucosal immunity declines sharply Low High
We are in phase1 now

Risk zone for transmission
20
Risk
Zone
Country/area and population characteristics Risk for
further
transmission
1 • Evidence of sustained circulation of WPV or cVDPV2 since 2005; or
• Affected community with other risks factors for low immunity* or
• High mobility links to susceptible communities
High
2 • Consistently low DTP3 coverage <80% in the previous 3 years; or
• H/o imported WPV or cVDPV or aVDPV2 in the previous 3 years; or
• DTP3 coverage <90% adjacent to affected area
High-Medium
3 • DTP3 coverage consistently >80%;
• Affected community with few risk factors for sustained transmission
(low immunity)
Low
*E.g. high birth rate, high population size and density, low routine immunization coverage, failure to reach unvaccinated
children in pre-switch SIAs, and other conditions associated with high levels of fecal-oral transmissionRisk zone helps determining
the area of response

Briefing outlines
• Strategic approaches
– Key strategies
– Response to event and outbreak
– Outbreak assessment & outbreak closure
– Travellers and quarantine

• Communication strategies
– External communication and media management
– Communication for Development including
Social/community mobilization
– Preparedness and prepositioning of interventions.
• Surveillance strategies
– Enhance surveillance, AFP & env. surveillance (ES)
– Contact sampling, community sampling,
– Set target at NPAFP rate ≥3/100,000
• Immunization strategies
– Rapid, right scale, specific vaccine type, high quality,
special strategies where needed
Key strategies

External communication and media management
• At the onset of the event/ Outbreak
– WHO and UNICEF should conduct social mapping
of vaccine hesitancy and community influencers
jointly as part of the epidemiological assessment
and using global guidelines
– Conduct media monitoring and briefing to address
key concerns.
– Consult the global communication guide and FLW
training curricula in designing strategies.
23

At the onset of the event/ Outbreak
– Ensure coordination with all partners regarding
communication planning and integration of
interventions as part of the program
implementation.
– Using available data and results of field
investigation, draft the strategies and activities
that will be integrated as part of the national
response plan.
Communication for Development

• Upon confirmation and After
– Integrate the final communication plan within the overall
response plan.
– Use existing tools with adaptation if required to kick off the start
of activities ASAP.
– Ensure community engagement plan is integrated as part of the
operational and microplans.
– Ensure using the global IM monitoring forms that are inclusive
of social indicators measures.
– Review missed children patterns and adjust strategies as
required.
– Follow up on OBRA recommendations towards the conclusion of
the outbreak.
Social mobilization

• Vaccine choice
– mOPV2 ±IPV (fIPV)
• Number of SIAs
– Confirmed transmission: ≥ 4 SIAs, based on the risk zone
– Probable transmission: At least 1 SIA and then based on the situation
• Speed of SIAs
– First SIA within 14 days of confirmation of outbreak
• Interval
– Subsequent SIAs at 2-3 weeks intervals
• Target age group
– Children <5 years unless evidence in older age groups
• Target population
– SIA 1: minimum 500,000 children
– Subsequent SIAs: minimum 2 million children
SOPs for event and outbreak response
Immunization strategies for PV2 transmission
fIPV: Fractional dose IPV

Response

Immunization response to PV2 event
WPV2 in ES:
SIA1: mOPV2 for 500,000 children in Zone1*
aVDPV2 or unclassified VDPV2 (ES, human):
Plan for ≥3 SIAs
• SIA1: mOPV2 500,000 children in ≤14 days
• SIA2/3: mOPV2±IPV, implement depending on the situation
iVDPV2 (ES, human):
IPV for HH & close contacts
Sabin 2 (ES, human):
SIA not recommended
*Zone1: Clear history of sustained WPV or reported cVDPV2 since 2005; OR affected community with other risks for low immunity*
or high mobility links to susceptible communities
All type 2 poliovirus event should be
responded to and as an outbreak

Immunization response to PV2 outbreak
WPV2 in human or cVDPV2 or Sabin2 in ES or human
Response protocol deals;
• Countries used tOPV in the last 12 months
prior to type 2 OPV withdrawal
• Phase 1 period
• Confirmed, probable or possible transmission
• Risk zone

VDPV2 response scenarios

Outbreak assessment and
closure

Response assessment
• Outbreak response assessment
– Conducted at 3 months intervals by external experts
– To assess the quality of implementation of the response plan
– To identify evidence of quality of sensitive surveillance, high
population immunity and evidence of interruption of PV transmission
– To identify gaps which need additional attention and support from
National governments and GPEI
• Event response assessment
– For PV2 event, assessment to be conducted similar to the assessment
for outbreak
– For PV1,3 event, especially if there is immunization response or
surveillance strengthening activities, assessment to be conducted as
per need

33
Outbreak assessment & closure
*No poliovirus detected from stool specimens from
reported AFP cases or contacts or human or
environmental samples that had onset or collection
date during the specific time period
PV outbreak confirmed
OBRA at 3 months interval since the
outbreak confirmation
Evidence of high quality eradication
activity including high quality SIA and
sensitive surveillance
OBRA >6 months after the most recent detection
of PV type 1 & 3
Outbreak closed (PV1, OR PV3) Outbreak NOT closed
Outbreak closed as OBRA team recommends
(All PV types)
OBRA after 12+2 months after the most recent PV detection in
human or environment
*No poliovirus detected or no evidence of PV transmission
for >12 months period since the most recent detection
OBRA continues at 3 months intervals
Lack of evidence of high quality
eradication activity including high
quality SIA and sensitive surveillance
*No poliovirus detected for at least 6 months
months

Travellers and quarantine

Travellers and quarantine for PV2 outbreak
• Generally quarantine measures have limited
impact in restricting ongoing transmission
• Travel links are important to assess risk zones
• Consider local quarantine for individual with
documented exposure to PV2 (containment
breach)
• Consider local travel restrictions and/or proof
of polio vaccination into/out of outbreak area

Briefing outlines
• Strategic approach
– Notification obligations & confirmation
– mOPV2 stockpile release
– High level leadership

1. All States to notify WHO of all events that may cause
public health emergency of international concern
(PHEIC)* (IHR 2005, article 6)
2. Poliomyelitis due to wild poliovirus should be
notified to WHO as a PHEIC (IHR 2005, annex 2)
3. Circulation of VDPV should be treated as a PHEIC
and thus should be notified to WHO (IHR EC-PHEIC
25 Nov 2015)
4. Emergence of Sabin 2 beyond Sept 2016 is notifiable
to WHO under IHR 2005, and will be considered a
PHEIC
* PHEIC- If meets 2/4 criteria: event may have serious public health impact, unusual or unexpected event,
significant risk of international risk & significant risk of international travel or travel restrictions
Obligation of notification

• Lab result available at the polio lab
• Polio lab /GPLN should notify the National
government and WHO within 24 hours of he result
– Day zero
• WHO RO, in consultation with National government
and GPLN, confirms the event/outbreak
– Confirmation
• ≤ 24 hours of receiving notification from RO: WHO HQ polio
eradication focal point informs Strategy Committee &
Eradication and Outbreak Management Group
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Notification & Confirmation of event/outbreak

mOPV2 stockpile release

• Nov 2013, SAGE recommended establishment of a global
stockpile of mOPV2 as one of the five major component of the
strategy of type2 PV detection and response post switch
http://www.who.int/wer/2014/wer8901.pdf?ua=1
• May 2014, the WHA67 endorsed the SAGE recommendation
to establish a global stockpile of mOPV2 for responding to
type 2 outbreaks post OPV2 cessation
http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_38-
en.pdf
40
Background

Operational framework
for mOPV2 Global stockpile
• Stockpile objectives
i. Ensure rapid and universal supplies
ii. Maximizing the containment
• Eligibility: All countries – UNICEF, PAHO RF, self-procuring
– Note: any country that establishes a national stock of mOPV2 must comply
with GAPIII
• Stockpile content
Finish products + semi-finished products + bulk products
i. 50 mill doses in finished product & 50 mill doses in semi finished product
ii. 419 million in bulk
• Stockpile location, management, governance: Manufacturers
• Decision making for release of vaccine: DG WHO

Regulatory considerations for mOPV2
• In 2015 the WHA68 urged all member states to
establish procedures to authorize the importing and
use of mOPV2 in the event of a type 2 outbreak
http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_R3-en.pdf
• The mOPV2 products in the stockpile is WHO
prequalified and licensed in the country of origin
– Recipient countries may preemptively authorize use of mOPV2 based
on licensure issued by the stringent NRA process in the producing
country and the knowledge that the vaccine is prequalified by WHO
• Vaccine request should include the authorization of
importing and use of mOPV2 in the country

County requests for mOPV2
• Based on the conclusions of the risk
assessment & response scenarios, National
authority should send the request for mOPV 2
to WHO in two stages
– Vaccine for SIA1, within 24 hours of the risk
assessment and decision of immunization
response by the Advisory Group
– Vaccine for subsequent SIAs, within two weeks
following outbreak/event confirmation

Release of mOPV2 from the
Global stockpile Lab reports the
results of PV2
Advisory Group
WHO DG
Country req. for
mOPV2 to WHO
Global
Stockpile
• Vaccine request form & protocols
• NRA-vaccine registration/licencing
• How the request goes to manufacturer
• Mechanism for self procuring country
AG
recommendationsApprove
release
mOPV2 in
Country
mOPV2
shipment
WHO
GPLN
Day 4/5Day 8/11
Day 0
Day 3/4

Post-switch era, countries have zero balance of type2 OPV as all tOPV were disposed of at
switch. Re-introduction of type2 OPV through deployment of mOPV2 needs very careful and strict
management. Ensure that mOPV2 is deployed promptly as per outbreak /event response plan
• Before and during SIA rounds
– Stock management: Carefully monitor mOPV2 utilization and stock balances and
adjust supplies accordingly to avoid both overstocking as well as shortages at all
levels of the supply chain
• Between SIA rounds
– Used/partially used vials: Recall, contain and dispose all remaining balance of
mOPV2 (used/partially used vials) at the end of each SIA round
– Unopened vials: Retrieve and store unopened vial in between mOPV2 SIA rounds
• After final SIA rounds
– All mOPV2 vials: Recall, contain and disposed all mOPV2 (used/partially
used/unused vials) at the end the final SIA round
– Validation of disposal: Zero balance of mOPV2 validated
Country’s outbreak response plan should clearly mention all these components of mOPV 2
management
Ref: draft guidance on mOPV2 vaccine management
Responding to poliovirus event and outbreak-SOPs45
mOPV2 deployment:
Special precautions for vaccine management

High level leadership

Strategic response framework
1. Government leadership
2. Risk assessment and determining risk zone
3. Robust immunization response
4. Effective communication and Soc. Mob
5. Enhance surveillance

GPEI partnership support
1. Outbreak response and assessment
2. Coordination and advocacy
3. Technical and human resources
4. Information management
5. Communication, Soc. mob
6. Finances and logistics
Surge support
Deployment of surge team – team A & team B
No regrets policy
“No-regrets” financing policy (an advance of up to US$ 500,000)

Advocacy and coordination
Advocacy
• WHO & UNICEF representatives jointly briefs Minister of Health on ASAP
• HM briefs the office of the Head of Government or head of State and
advocate three key functions,
– Declare National public health emergency
– Establish an emergency operation centre (EOC) led by a senior
government official
– Establish a systematic oversight mechanism by the National level to
monitor provincial and district officials engagement and activities
Coordination
• Communicate to IHR
• Partner collaboration through EOC
• Establish mechanism of regular discussion through calls
• Expedite visa processes for external human resources
• WHO/UNICEF reps seeks support from RO for country response capacity
Emergency committee under IHR and the Global community will
look forward to see strong political commitment and full
engagement of the highest level of the Government authority in
order to rapidly interrupting poliovirus transmission

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Polio Outbreak SOP Introduction

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