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2017-02-07

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Pandemic Influenza Risk Management Guidance

WHO/WHE/IHM/GIP/2017.1

Update May 2017

© World Health Organization 2017

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Pandemic Influenza Risk Management Guidance

Pandemic Influenza Risk Management


WHO Guidance
Contents

ACKNOWLEDGEMENTS......................................................................................................................................... 6

ABBREVIATIONS AND ACRONYMS........................................................................................................................ 7

EXECUTIVE SUMMARY .......................................................................................................................................... 8

New in the 2013 guidance ................................................................................................................................ 8

Emergency Risk Management for Health .................................................................................................... 8

Risk-based approach.................................................................................................................................... 9

Approach to global phases and uncoupling global phases from national actions ...................................... 9

Pandemic Influenza Preparedness (PIP) Framework .................................................................................. 9

1. INTRODUCTION .............................................................................................................................................. 10

2. WHO GLOBAL LEADERSHIP ............................................................................................................................. 11

2.1 Coordination under the International Health Regulations (2005) ........................................................... 11

Convening of an Emergency Committee, declaration of a Public Health Emergency of International


Concern and issuance of IHR (2005) temporary recommendations ......................................................... 11

Provision of information and support to affected States Parties.............................................................. 12

Measures adopted by States Parties in relation to travel or trade ........................................................... 12

2.2 Pandemic phases ...................................................................................................................................... 13

2.3 Pandemic Influenza Preparedness (PIP) Framework ............................................................................... 14

Virus sharing .............................................................................................................................................. 15

Benefit sharing........................................................................................................................................... 15

Governance and review............................................................................................................................. 15

Member States’ responsibilities ................................................................................................................ 16

2.4 Pandemic vaccine production .................................................................................................................. 16

3. EMERGENCY RISK MANAGEMENT FOR HEALTH ............................................................................................ 17

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3.1 Principles of Emergency Risk Management for Health ............................................................................ 18

3.1.1 Ensuring ethical Emergency Risk Management for Health .............................................................. 18

3.1.2 Emergency Risk Management for Health throughout the whole of society .................................... 18

3.2 Emergency Risk Management for Health: essential components ........................................................... 18

3.2.1 Policies and resource management ................................................................................................. 19

3.2.2 Planning and coordination ............................................................................................................... 20

3.2.3 Information and knowledge management ....................................................................................... 21

3.2.4 Logistics and infrastructure .............................................................................................................. 23

3.2.5 Health and related services .............................................................................................................. 24

3.2.6 Community capacities ...................................................................................................................... 24

4. NATIONAL PANDEMIC INFLUENZA RISK ASSESSMENT ................................................................................... 26

4.1 Influenza viruses and pandemics.............................................................................................................. 26

4.2 National risk assessments......................................................................................................................... 27

4.3 Assessment of pandemic severity ............................................................................................................ 30

5. NATIONAL PANDEMIC INFLUENZA RISK MANAGEMENT ............................................................................... 32

5.1 Policy and resource management ............................................................................................................ 32

5.2 Planning and coordination ....................................................................................................................... 33

5.3 Information and knowledge management ............................................................................................... 34

5.4 Health infrastructure and logistics ........................................................................................................... 37

5.5 Health and related services ...................................................................................................................... 38

5.6 Community capacities .............................................................................................................................. 40

REFERENCES........................................................................................................................................................ 41

ANNEXES ............................................................................................................................................................. 45

Annex 1 Guidance revision process ................................................................................................................ 45

Declaration of interests ............................................................................................................................. 45

Annex 2 Planning assumptions ....................................................................................................................... 47

A2.1 Modes of transmission ...................................................................................................................... 47

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A2.2 Incubation period and infectivity of pandemic influenza ................................................................. 48

A2.3 Symptom development and clinical attack rate ............................................................................... 50

A2.4 Dynamics and impact of a pandemic ................................................................................................ 51

Annex 3 Ethical considerations....................................................................................................................... 54

Annex 4 Whole-of-society approach .............................................................................................................. 55

A4.1 Role of government........................................................................................................................... 56

A4.2 Role of business................................................................................................................................. 58

A4.3 Role of civil society ............................................................................................................................ 58

A4.4 Critical interdependencies among essential services ....................................................................... 59

Annex 5 Business continuity planning ............................................................................................................ 59

Annex 6 Representative parameters for core severity indicators.................................................................. 60

Annex 7 Containment measures .................................................................................................................... 62

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Pandemic Influenza Risk Management Guidance

ACKNOWLEDGEMENTS
The World Health Organization (WHO) wishes to acknowledge the contributions of experts who participated
in the peer review of this guidance:

F. Allot (France), A. Bratasena (Indonesia), B. Cowling (Hong Kong Special Administrative Region, China),
B. Gellin (United States of America), W. Haas (Germany), A. Kandeel (Egypt), V. Lee (Singapore), W. Luang-on
(Thailand), C. Mancha-Moctezuma (Mexico), A. Nicoll (Sweden), H. Oshitani (Japan), N. Phin (United
Kingdom), C. Reed (United States of America), D. Salisbury (United Kingdom), L. Simonsen (United States of
America), M. Van Kerkhove (United Kingdom).

The following WHO/UN staff was involved in the development and review of this document and their
contribution is gratefully acknowledged:

J. Abrahams, T. Besselaar, D. Brett-Major, S. Briand, C. Brown, R. Brown, P. Cox, J. Fitzner, K. Fukuda,


V. Grabovac, M. Hardiman, D. Harper, G. Hartl, A. Huvos, F. Kasolo, M. Khan, F. Konings, R. Lee, A. Legand,
A. Mafi, K. Mah, A. Mounts, E. Mumford, C. Mukoya, T. Nguyen, B. Olowokure, C. Penn, B. Plotkin,
P. Prakash, S. Ramsay, A. Rashford, C. Roth, N. Shindo, S. Tam, F. Tshioko Kweteminga, K. Vandemaele,
L. Vedrasco, C. Wannous, W. Zhang.

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ABBREVIATIONS
ARI Acute Respiratory Infections

CAR Clinical Attack Rate

CFR Case Fatality Ratio

ERMH Emergency Risk Management for Health

GAP Global Action Plan for Influenza Vaccines

GISRS Global Influenza Surveillance and Response System

IHR (2005) International Health Regulations (2005)

ILI Influenza-like Illness

MAARI Medically attended acute respiratory illness

PHEIC Public Health Emergency of International Concern

PIP Framework Pandemic Influenza Preparedness Framework for the sharing of influenza viruses
and access to vaccines and other benefits

SAGE Strategic Advisory Group of Experts on Immunization

SARI Severe Acute Respiratory Infection

UN United Nations

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Pandemic Influenza Risk Management Guidance

EXECUTIVE SUMMARY
Influenza pandemics are unpredictable but recurring events that can have consequences on human health
and economic well-being worldwide. Advance planning and preparedness are critical to help mitigate the
impact of a pandemic. This WHO guidance document, Pandemic Influenza Risk Management, updates and
replaces Pandemic influenza preparedness and response: WHO guidance document, which was published in
2009. This revision of the guidance takes account of lessons learned from the influenza A(H1N1) 2009
pandemic and of other relevant developments.

The influenza A(H1N1) 2009 pandemic was both the first of the 21st century and the first since the adoption
of the IHR 2005. The experience of Member States during the pandemic varied, yet several common factors
emerged. Member States had prepared for a pandemic of high severity and faced difficulties to adapt their
national and subnational responses adequately to a more moderate event. Communications were also
demonstrated to be of immense importance: the need to provide clear risk assessments to decision-makers
placed significant strain on ministries of health; and effective communication with the public was
challenging. These, and other areas with improvement potential, were identified by the Review Committee
on the Functioning of the IHR (2005) in relation to Pandemic (H1N1) 2009.

The influenza A(H1N1) 2009 pandemic provided a wealth of additional information to the established and
growing body of knowledge on influenza viruses at the human–animal ecosystem interface. Other notable
developments since the publication of the 2009 guidance include the adoption by the Sixty-fourth World
Health Assembly of the Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza
viruses and access to vaccines and other benefits. In addition, risk management of acute public health events
that have the potential to cross borders and threaten people worldwide continues to improve as a result of
IHR (2005) and States Parties’ obligations on capacity strengthening.

This guidance can be used to inform and harmonize national and international pandemic preparedness and
response. Countries should consider reviewing and/or updating national influenza preparedness and
response plans to reflect the approach taken in this guidance. Also articulated are the roles and
responsibilities of WHO relevant to pandemic preparedness, in terms of global leadership and support to
Member States in line with other United Nations (UN) policies of crisis and emergency management. This
document is not intended to replace national plans, which should be developed by each country.

New in the 2013 guidance

Emergency Risk Management for Health

The approach taken in the 2013 guidance applies the principles of all-hazards Emergency Risk Management
for Health (ERMH) to pandemic influenza risk management. The objectives of ERMH are to:
- strengthen capacities to manage the health risks from all hazards;
- embed comprehensive emergency risk management in the health sector; and
- enable and promote multisectoral linkage and integration across the whole of government and whole of
society.

This guidance therefore aligns more closely with the disaster risk management structures already in place in
many countries and underscores the need for appropriate and timely risk assessment for evidence-based
decision-making at national, subnational and local levels.

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Pandemic Influenza Risk Management Guidance

Risk-based approach

This guidance introduces a risk-based approach to pandemic influenza risk management and encourages
Member States to develop flexible plans based on national risk assessment, taking account of the global risk
assessment conducted by WHO. To support implementation, content on the application of assessments of
risk and severity have been strengthened.

Approach to global phases and uncoupling global phases from national actions

In response to lessons learned from the influenza A(H1N1) 2009 pandemic, a revised approach to global
phases is introduced in this guidance. The phases, which are based on virological, epidemiological and
clinical data, are to be used for describing the spread of a new influenza subtype around the world, taking
account of the disease it causes. The global phases have been clearly uncoupled from risk management
decisions and actions at the country level. Thus, Member States are encouraged as far as possible to use
national risk assessments to inform management decisions for the benefit of their country’s specific
situation and needs.

PIP Framework

The Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines
and other benefits, commonly known as the PIP Framework, brings together Member States, industry, other
stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response.
Its key goals include:
 to improve and strengthen the sharing of influenza viruses with human pandemic potential; and
 to achieve, inter alia, more predictable, efficient and equitable access for countries in need of life-
saving vaccines and medicines during future pandemics.
The Framework was developed by Member States and became effective on 24 May 2011, when it was
adopted by the Sixty-fourth World Health Assembly.

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1. INTRODUCTION
The influenza A(H1N1) 2009 pandemic was the first to occur since WHO had produced preparedness
guidance. Guidance had been published in 1999, revised in 2005 and again in 2009 following advances in the
development of antivirals and experiences with influenza A(H5N1) infections in poultry and humans. The
emergence of the influenza A(H1N1)pdm09 virus provided further understanding of influenza pandemics
and requirements for pandemic preparedness and response. The report of the Review Committee on the
Functioning of the IHR (2005) in relation to Pandemic (H1N1) 2009 concluded: “The world is ill-prepared to
respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health
emergency” (1).

The Review Committee recommended that WHO should revise its pandemic preparedness guidance to
support further efforts at the national and subnational level. Revisions recommended included:
simplification of the pandemic phases structure; emphasis on a risk-based approach to enable a more
flexible response to different scenarios; reliance on multisectoral participation; utilization of lessons learned
at the country, regional and global level; and further guidance on risk assessment. The Review Committee’s
report reflected the broad experiences of Member States during the influenza A(H1N1) 2009 pandemic –
and the key point that previous pandemic planning guidance was overly rigid. Member States had prepared
for a pandemic of high severity and appeared unable to adapt their responses adequately to a more
moderate event. Communications also proved to be of immense importance during the influenza A(H1N1)
2009 pandemic, within the health and non-health sectors and to the public. Provision of clear risk
assessments to decision-makers placed significant strain on ministries of health, and effective
communication with the public was challenging.

This 2013 guidance is based on the principles of all-hazards ERMH, thereby aligning pandemic risk
management with the strategic approach adopted by WHO, in accordance with World Health Assembly
resolution 64.10 (2). Commensurate with this approach, this guidance promotes building on existing
capacities — in particular those under the IHR (2005) (3) (IHR [2005]) core capacities, in order to manage
risks from pandemic influenza. Certain aspects of implementation of ERMH for national pandemic
preparedness may therefore be linked with the core capacity strengthening activities required by IHR (2005).
This guidance can therefore be used as a model to illustrate how the mechanisms required for response to
and recovery from pandemic influenza can be applied, as appropriate, to the management of all relevant
health emergencies.

A risk-based approach to pandemic influenza management is emphasized and Member States are
encouraged to develop flexible plans based on national risk assessments. This guidance also places pandemic
planning in the whole-of-society context. This 2013 revision therefore:
(1) reflects the approach taken at national level where pandemic influenza planning often rests with national
disaster management authorities, and
(2) introduces or promotes all-hazards ERMH at Ministry of Health level, including mechanisms for wider
national engagement.

This guidance also summarizes the roles and responsibilities of WHO relevant to pandemic preparedness, in
terms of global leadership and support to Member States in line with other UN policies for crisis and
emergency management.

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Pandemic Influenza Risk Management Guidance

2. WHO GLOBAL LEADERSHIP


WHO is responsible for providing leadership on global health matters, shaping the health research agenda,
setting norms and standards, articulating evidence-based policy options, providing technical support to
Member States, and monitoring and assessing health trends. WHO promotes health as a shared
responsibility, involving equitable access to essential care and collective defence against transnational
threats.

As the directing and coordinating authority for health within the UN system, WHO has a mandate for global
pandemic influenza risk management (4, 5), which is reflected at all levels of the Organization and which
aligns with other related UN policies for crisis management, e.g., the Inter-Agency Standing Committee
(IASC) System-wide Level 3 (L3) Activation Procedures for Infectious Disease Events (6). Key mechanisms
through which WHO fulfils this obligation are summarized below.

2.1 Coordination under the International Health Regulations (2005)

The IHR (2005) are binding upon 196 States Parties including all 194 Member States, and provide a global
legal framework to prevent, control and respond to public health risks that may spread between countries.
While important for all serious international public health risks, the IHR (2005) are particularly relevant for
pandemic influenza preparedness and operational response, should such an event occur, in three main
areas:

1. The core capacity development requirements for all countries under the IHR (2005) establish a binding
framework for developing capacities to be able to detect and contain potential or actual outbreaks locally to
the benefit of the country and the global community of nations;

2. The IHR (2005) obligations include the precise tasks that all States will have to be able to implement in any
pandemic in order to apply health measures to international public health events; and

3. The central role for WHO in any international influenza event, including any which may become a
pandemic and/or Public Health Emergency of International Concern (PHEIC).

Convening of an Emergency Committee, declaration of a Public Health Emergency of


International Concern (PHEIC) and issuance of IHR (2005) temporary recommendations

The IHR (2005) provide the legal framework for the timely and effective management of a broad range of
serious and potentially international public health risks and events. In addition, the Regulations provide a
specialized mechanism for collective global action for certain rare events of particular importance. Such
serious events that endanger global public health are specified by the Regulations as a Public Health
Emergency of International Concern (PHEIC). The term is defined in the IHR (2005) as “an extraordinary
event which is determined to constitute a public health risk to other States through the international spread
of disease and to potentially require a coordinated international response”. This definition implies a situation
that: is serious, unusual or unexpected; carries implications for public health beyond the affected State’s
national border; and may require coordinated international action.

The responsibility of determining whether an event is within this category lies with the WHO Director-
General and requires the convening of a committee of health experts – the IHR Emergency Committee. This
Committee advises the Director-General on recommended measures to be implemented on an emergency
basis, known as temporary recommendations. Temporary recommendations may include health measures to

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C
C M C
C M Y M K
Pandemic Influenza Risk ManagementM Guidance
Y Y
Y

be implemented by the State Party experiencing the PHEIC, or by other States Parties, to prevent or reduce
the international spread of disease and avoid unnecessary interference with international traffic.

The Emergency Committee also gives advice to the Director-General on the determination whether an event
is a PHEIC in circumstances where there has not been agreement within 48 hours of the assessment of the
event between the Director-General and the affected country/countries. The Emergency Committee
continues to provide advice to the Director-General throughout the duration of the PHEIC, including any
necessary changes to the temporary recommendation and on the termination of the PHEIC. WHO maintains
an IHR Experts Roster and the members of an IHR Emergency Committee are selected from this Roster
and/or WHO expert advisory panels. At least one member of the Emergency Committee should be an expert
nominated by a State Party within whose territory the event arises, and such States Parties are invited to
present their views to the Emergency Committee.

Provision of information and support to affected States Parties

The IHR (2005) also provide a mandate to WHO to perform public health surveillance, risk assessment,
support States Parties, and coordinate the international response to significant international public health
risks and events. After preliminary assessment, WHO is obliged by the IHR (2005) to obtain verification from
States Parties of unofficial reports of events that may constitute a PHEIC. If verification is sought, including in
the context of potential pandemic influenza, States Parties are required to respond to WHO within a
prescribed time period and include available relevant public health information. The legal requirement to
respond to requests for verification by WHO aims to provide early identification and assessment of, and
response to, any public health event with international implications. WHO is also obligated to provide public
health information to all States Parties as soon as possible regarding public health risks, to enable them to
respond and protect their populations. When WHO intends to make information available to other States
Parties, it has an obligation to consult with the country experiencing the event.
Under the IHR (2005), WHO must offer assistance to States Parties in assessing or controlling public health
events occurring within their territories. This support can be in the form of technical advice and guidelines,
specialized materials, deployment of international teams to affected areas, and coordination of international
support from various sources.

Measures adopted by States Parties in relation to travel or trade

The IHR (2005) seek to limit the public health measures taken in response to disease spread to those “that
are commensurate with and restricted to public health risks, and which avoid unnecessary interference with
international traffic and trade”. To achieve this objective, WHO regularly issues advice on trade and travel
measures related to public health events where such measures are likely or relevant. While the IHR (2005)
do not prevent States Parties from implementing specific trade and travel related measures, they do require
States Parties to inform WHO of these measures and the justification for their introduction when they will
result in significant interference. This is defined in the IHR (2005) as resulting in delays to movement of
international travellers, baggage, cargo, containers, conveyances, goods, and the like, of greater than 24
hours. In addition to providing other States Parties with information on these measures, WHO can request
the implementing State Party to reconsider their application.

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Pandemic Influenza Risk Management Guidance

2.2 Pandemic phases

The pandemic influenza phases reflect WHO’s risk assessment of the global situation regarding each
influenza virus with pandemic potential infecting humans. These assessments are made initially when such
viruses are identified and are updated based on evolving virological, epidemiological and clinical data. The
phases provide a high-level, global view of the evolving picture.

The global phases – interpandemic, alert, pandemic and transition – describe the spread of the new
influenza subtype around the world, taking account of the disease it causes. As pandemic viruses emerge,
countries and regions face different risks at different times. For that reason, countries are strongly advised to
develop their own national risk assessments based on local circumstances, taking into consideration the
information provided by the global assessments produced by WHO. Risk management decisions by countries
are, therefore, expected to be informed by global risk assessments but be based on local risk assessments.

The risk-based approach to pandemic influenza phases is represented in Figure 2.1 as a continuum, which
also shows the phases in the context of preparedness, response and recovery, as part of an all-hazards
approach to emergency risk management. Both WHO guidance and international standards exist that
describe formats and conduct of such risk assessments (see Section 4.2). One of the underlying principles of
this guidance is to acknowledge that emergency risk management at country level needs to be sufficiently
flexible to accommodate different consequences within individual countries, for example, different severities
and different numbers of waves of illness.

The global phases will be used by WHO to communicate the global situation. They will be incorporated into
IHR (2005) related communications to National IHR Focal Points, in Disease Outbreak News releases and
various other public and media interactions, including through social media channels.

Figure 2.1: The continuum of pandemic phases*

*This continuum is according to a “global average” of cases, over time, based on continued risk assessment and consistent with the
broader emergency risk management continuum.

Interpandemic phase: This is the period between influenza pandemics.

Alert phase: This is the phase when influenza caused by a new subtype has been identified in
humans. Increased vigilance and careful risk assessment, at local, national and global levels, are
characteristic of this phase. If the risk assessments indicate that the new virus is not developing into
a pandemic strain, a de-escalation of activities towards those in the interpandemic phase may occur.

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Pandemic phase: This is the period of global spread of human influenza caused by a new subtype
based on global surveillance. Movement between the interpandemic, alert and pandemic phases
may occur quickly or gradually as indicated by the global risk assessment, principally based on
virological, epidemiological and clinical data.

Transition phase: As the assessed global risk reduces, de-escalation of global actions may occur, and
reduction in response activities or movement towards recovery actions by countries may be
appropriate, according to their own risk assessments.

The global phases and their application in risk management are distinct from (1) the determination of a
PHEIC under the IHR (2005); and (2) the declaration of a pandemic based on assessment of the risk
associated with the emerging influenza virus. These are based upon specific assessments and can be used for
communicating the need for collective global action, or by regulatory bodies and/or for legal or contractual
agreements, should they be based on a determination of a PHEIC or a pandemic declaration.

Determination of a PHEIC: The responsibility of determining a PHEIC lies with the WHO Director-
General under Article 12 of the IHR (2005). The determination of a PHEIC leads to the
communication of temporary recommendations; see Section 2.1.

Declaration of a pandemic: During the period of spread of human influenza caused by a new
subtype, based on risk assessment and appropriate to the situation, the WHO Director-General may
make a declaration of a pandemic.

While the determination of a PHEIC and/or declaration of a pandemic may trigger certain regulatory actions
by WHO and Member States, as well as UN agencies under related policies of crisis and emergency
management, actions at national level should be based on national/local risk assessments and be
commensurate with risk.

Actions by WHO occur throughout the phases continuum; their nature and scale at any point in time will be
in line with the global risk assessment. For further examples of WHO actions, see Section 3.2.

The nature and scale of national actions at any point in time will be in line with the current national risk
assessments, taking into consideration the global risk assessment. The uncoupling of national actions from
global phases is necessary since the global risk assessment, by definition, will not represent the situation in
individual Member States. For further information on suggested national actions, see Section 5.

2.3 Pandemic Influenza Preparedness Framework

The Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines
and other benefits – widely known as the PIP Framework – brings together Member States, industry, other
key stakeholders and WHO to implement a global, Member State-developed approach to pandemic
influenza preparedness and response (7). The Framework aims to improve the sharing of influenza viruses
with pandemic potential and to achieve, inter alia, more predictable, efficient and equitable access for
countries in need of life-saving vaccines and medicines during future pandemics. The PIP Framework became
effective on 24 May 2011, when it was adopted at the Sixty-fourth World Health Assembly. The Framework
has three core components, described as follows.

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Virus sharing

Member States share PIP biological materials1 to ensure ongoing global monitoring and risk assessment and
the development of safe and effective influenza vaccines. The Standard Material Transfer Agreement 1
establishes the rights and obligations of Global Influenza Surveillance and Response System (GISRS)2
laboratories when transferring PIP biological materials within GISRS and to parties outside GISRS.

Benefit-sharing

Member States and WHO aim to ensure that benefits arising from the sharing of PIP biological materials are
made more accessible and available to countries based on public health risk and need. Various key
components are as follows:

 The Standard Material Transfer Agreement 2 is a binding contract between WHO and all recipients of PIP
biological materials outside of GISRS. These recipients include: influenza vaccine, diagnostic and
pharmaceutical manufacturers; biotechnology firms; and research and academic institutions. Non-GISRS
recipients must assess benefits they can commit, or consider committing, to the PIP benefit-sharing
system based on their nature and capacity.
 Partnership contribution: An annual contribution to WHO by influenza vaccine, diagnostic and
pharmaceutical manufacturers who use GISRS. The Framework specifies that the contribution will be
used to improve global pandemic influenza preparedness and response (8).
 Other benefits: As listed under Section 6 of the PIP Framework, other benefits include laboratory and
surveillance capacity building; regulatory capacity building; and the establishment of antiviral and
interpandemic vaccine stockpiles.

Governance and review

The Framework puts in place an oversight mechanism with three pillars.

 The World Health Assembly to oversee implementation of the PIP Framework.


 The WHO Director-General to promote implementation.
 The Advisory Group to provide guidance to the Director-General, monitor PIP Framework
implementation and report thereon annually to the Director-General.
WHO acts as the secretariat for implementing the PIP Framework and works with private and public
partners to facilitate achieving results as efficiently as possible.

Member States’ responsibilities

1 For the purposes of the PIP Framework and its annexed Standard Material Transfer Agreements and terms of reference and the
Influenza Virus Tracking Mechanism, “PIP biological materials” include human clinical specimens; virus isolates of wild-type human
H5N1 and other influenza viruses with human pandemic potential; and modified viruses prepared from H5N1 and/or other influenza
viruses with human pandemic potential developed by WHO GISRS laboratories, these being candidate vaccine viruses generated by
reverse genetics and/or high growth reassortment. Also included in “PIP biological materials” are ribonucleic acid (RNA) extracted
from wild-type H5N1 and other human influenza viruses with human pandemic potential and cDNA that encompass the entire coding
region of one or more viral genes.

2 GISRS monitors which influenza viruses are circulating in humans around the world throughout the year. GISRS comprises WHO
Collaborating Centres, National Influenza Centres, H5 Reference Laboratories, and Essential Regulatory Laboratories. The major
technical roles of GISRS are to: monitor human influenza disease burden; monitor antigenic drift and other changes (such as antiviral
drug resistance) in seasonal influenza viruses; obtain suitable virus isolates for updating of influenza vaccines; and detect and obtain
isolates of new influenza viruses infecting humans, especially those with pandemic potential. WHO also develops logistics
management capacity to ensure that public health laboratories have access to protocols, tests and diagnostic reagents necessary to
identify non-seasonal influenza virus infections. (See http://www.who.int/influenza/gisrs_laboratory/en/index.html, accessed April
2013.)

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Pandemic Influenza Risk Management Guidance

Under the Framework, Member States are responsible for (1) ensuring the timely sharing of influenza viruses
with human pandemic potential with GISRS; (2) contributing to the pandemic influenza benefit-sharing
system, including by working with relevant public and private institutions, organizations and entities so they
make appropriate contributions to this system; and (3) continuing to support GISRS.

2.4 Pandemic vaccine production

WHO issues biannual recommendations on the composition of seasonal influenza vaccines. Since 2004, WHO
has also been reviewing vaccine candidate viruses for A(H5N1) and other influenza subtypes with pandemic
potential. This process is undertaken in consultation with WHO Collaborating Centres for Influenza, National
Influenza Centres, WHO H5 Reference Laboratories and key national regulatory reference laboratories. It is
based on surveillance conducted by GISRS. The recommendations and availability of vaccine viruses are
announced in a public meeting and simultaneously on the WHO website (9). They are also communicated to
influenza vaccine manufacturers via the International Federation of Pharmaceutical Manufacturers and
Associations and the Developing Country Vaccine Manufacturers Network.

A critical action by WHO during an emerging pandemic is the selection of the pandemic vaccine strain and
deciding when to the switch from seasonal to pandemic vaccine production. As soon as there is credible
evidence to suggest that an influenza virus with pandemic potential has acquired the ability to sustain
human-to-human transmission, WHO will expedite the process of review, selection, development and
distribution of vaccine viruses for pandemic vaccine production, as well as vaccine potency testing reagents
and preparations, involving all stakeholders as necessary. The efficiency of this process depends on the
timely sharing of viruses and clinical specimens with WHO via GISRS and the WHO Collaborating Centres for
Influenza.

Consideration of whether and when to move to pandemic vaccine production will be done in collaboration
and consultation with relevant technical advisory bodies including the Strategic Advisory Group of Experts on
Immunization (SAGE) and GISRS, with due consideration to applicable requirements under the IHR (2005),
including any applicable advice from an IHR Emergency Committee, should one be convened. At any stage of
the process, WHO may - based on risk assessment - recommend the production of pandemic vaccine as well
as the virus strain that should be used in the vaccine. This may entail critical steps including switching from
production of seasonal vaccine to pandemic vaccine (10, 11).

The decision to revert to seasonal vaccine production will be based on the formal recommendation for the
composition of influenza vaccines, which is based on the virological and epidemiological information
provided by GISRS and on the advice of relevant technical advisory bodies.

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3. EMERGENCY RISK MANAGEMENT FOR HEALTH


3.1 Principles of Emergency Risk Management for Health

Health and the systems that support it are vulnerable to loss and disruption from a variety of acute hazards
including: (1) health events such as pandemic influenza, chemical spills and nuclear contamination; (2)
hazards secondary to emergencies and disasters such as cholera outbreaks following floods; as well as (3)
system destabilizers such as earthquakes or acute energy shortages. Management of the risk associated with
such hazards is central to the protection and promotion of public health.

To a varying extent, risk is managed within existing health systems and via programmes focused on specific
hazards. However, some functional components of hazard-specific preparedness and response systems are
common to all hazards and can therefore be consolidated into a comprehensive system of emergency risk
management for health (ERMH). The objectives of ERMH are to:

 strengthen country and community capacities to manage the health risks from all types of hazards (12).
 ensure that the essential components required in a comprehensive emergency risk management
programme are in place in the health sector.
 link and integrate these components into (1) health systems, (2) multisectoral disaster management
systems, and (3) other mechanisms across the whole of society, including relevant risk management
within non-health sectors.
 enable the health sector to advocate for and strengthen the health aspects of national and international
policies and frameworks related to emergency and disaster risk management, particularly in the
reduction of risk and health impact from all hazards.

The ERMH continuum describes the range of measures to manage risks through prevention and mitigation,
and preparing for, responding to and recovering from emergencies3. Risk management measures for any
health emergency, including pandemic influenza, should be made on the basis of national and local risk
assessment, taking account of the global assessment produced by WHO as appropriate.

ERMH is based on the principles listed below.

Comprehensive risk management: A focus on assessment and management of risks of emergencies rather
than events.

All-hazards approach: Use, development and strengthening of elements and systems that are common to
the management of risks of emergencies from all sources.

Multisectoral approach: Recognition that all elements of government, business and civil society have
capacities relevant to ERMH.

Multidisciplinary approach: Recognition of the roles of many disciplines in health is required to manage the
health risks of emergencies through risk assessment, mitigation, prevention, preparedness, response,
recovery and capacity strengthening.

Community resilience: Utilization of capacities at community level for risk assessment, reporting, providing
basic services, risk communication for disease prevention and long-term community care and rehabilitation.

3 For the purposes of risk management for pandemic influenza, three main groups of measures are used: preparedness, response
and recovery. Prevention and mitigation are important in the context of comprehensive ERMH. They are reflected in both
preparedness and response activities to be considered in national Pandemic Influenza Risk Management, Section 5.

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Sustainable development: Recognition that development of country and community capacities in health and
other sectors requires a long-term approach to protect health and build resilience.

Ethical basis: Consideration of ethical principles throughout ERMH activities.

3.1.1 Ensuring ethical Emergency Risk Management for Health

Management of an influenza pandemic, as with any urgent public health situation, requires certain decisions
that balance potentially conflicting individual and community interests. For example, during the influenza
A(H1N1) 2009 pandemic, countries experienced pressures on critical services that required prioritization (13)
which had an impact on the individual level. In addition, questions about social distancing measures, forced
isolation and quarantine arose, together with debates on mandatory vaccination of health care workers.

Ethics do not provide a prescribed set of policies; rather, ethical considerations will be shaped by the local
context and cultural values. Nevertheless, it is important that any emergency measures that limit individual
rights and civil liberties be necessary, reasonable, proportional, equitable, non-discriminatory and in full
compliance with national and international laws (Annex 3) (14).

3.1.2 Emergency Risk Management for Health throughout the whole of society

A pandemic will affect the whole of society. No single agency or organization can effectively prepare for a
pandemic in isolation, and uncoordinated preparedness of interdependent public and private organizations
will reduce the ability of the health sector to respond. A comprehensive, coordinated, whole-of-government,
whole-of-society approach to pandemic preparedness is required (Annex 4).

In the absence of effective planning, the effects of a pandemic at country level could possibly lead to social
and economic disruption, threats to the continuity of essential services, lower productivity, distribution
difficulties and shortages of supplies and human resources. It is therefore essential that all organizations –
private and public – plan for the potential disruptions that a pandemic may cause. Business continuity
planning should be considered for all essential service providers (Annex 5).

3.2 Emergency Risk Management for Health: essential components

The six categories of ERMH essential components are: policies and resource management; planning and
coordination; information and knowledge management; health infrastructure and logistics; health and
related services; and community emergency risk management capacities. A summary of the essential
components in each of the categories is provided in Table 3.1.

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Table 3.1: Essential components in each category.

Categories Essential components

 Policies and legislation


Policies and Resource Management  Capacity development strategies
 Monitoring, evaluation and reporting
 Financing
 Human resources
 Coordination mechanisms
Planning and Coordination  ERMH units in Ministries of Health
 Prevention and mitigation planning and coordination
 Preparedness and response planning and coordination
 Recovery planning and coordination
 Business continuity management
 Exercise management
 Risk assessments
Information and Knowledge Management  Early warning and surveillance
 Research for ERMH
 Knowledge management
 Information management
 Public communications
 Logistics and supplies
Health infrastructure and logistics
 Safer, prepared, and resilient health facilities
 Health care services
Health and related services  Public health measures
 Specialized services for specific hazards
 Local health workforce capacities and community-centred
Community ERMH capacities
planning and action

WHO has been mandated by a series of World Health Assembly resolutions to provide Member States with
guidance and technical support regarding pandemic influenza (4, 5). Some of these obligations are specific to
pandemic influenza and others overlap with the Organization’s responsibilities in all health emergencies.
Examples of the various functions, which are fulfilled at all levels of WHO, are provided for each category of
essential component.

3.2.1 Policies and resource management

Appropriate policies, plans, strategies and legislation form the basis of effective governance of ERMH.
Policies and legislation should use an all-hazards approach, i.e. one that recognizes that risk management
measures for hazard-specific emergencies have common elements and should cover the ERMH continuum
through prevention and mitigation, preparedness, response and recovery.

Legislation should clearly articulate procedures for declaring and terminating a national public health
emergency, based on national risk assessment. It should also define emergency management structures
across the government national emergency/disaster management authority and should articulate the
precise roles, rights and obligations of different organizations during a health emergency, based on an
ethical framework to govern policy development and implementation. National legislation should be
consistent with legally binding international agreements and conventions. Policies specific to the health
sector should be compatible with legislation and should include defined roles and responsibilities,
procedures and standards of implementation of ERMH. Policies and mechanisms to finance all ERMH
activities need to be considered.

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This category of essential components also includes the management of human and material resources. A
human resource plan should be developed and should contain the staffing requirements for the
management of health emergencies and define the competencies needed. These plans should also specify
the roles, responsibilities and authorities of the responders with written terms of reference for each specific
function.

Capacity development is central to ensure that the health workforce is well equipped to implement ERMH.
These efforts should be systematic and start with a thorough capacity assessment and analysis of training
available for different target groups (15). Based on these analyses, training programmes that are
appropriate, effective and efficient should be developed and instigated within educational institutions and as
continuing professional development for the workforce.

Role of WHO in supporting policies and resource management

 Provide support to assess, strengthen and maintain core capacities in order to meet IHR (2005)
obligations (16).
 Provide technical support to document the disease burden and economic impact of seasonal influenza
and develop a national vaccine policy, if indicated.
 Advise on ethical frameworks to govern policies.
 Provide support and guidance to strengthen workforce capacities, e.g. health care worker training.
 Strengthen GISRS and other laboratories to increase influenza diagnostic and surveillance capabilities
and provide technical support, capacity-building and technology transfer for influenza vaccines and
diagnostics.
 Promote the increase of global production capacity for pandemic vaccines in developing countries,
through the Global Action Plan for Influenza Vaccines (GAP) (17).

3.2.2 Planning and coordination

The health sector should be properly represented at all levels of government in any emergency/disaster risk
management coordination forum to ensure that health needs are identified and technical advice is provided
to other sectors. One of the roles of these fora will be to develop and strengthen appropriate command and
control systems across the national disaster management authority, within each government ministry and at
subnational levels. Another important role of these fora is to ensure that the most current evidence is
available to inform policy decisions.

In addition, an operational entity within the Ministry of Health or related institution should be responsible
for coordinating and supervising emergency risk management implementation throughout the health sector,
with stakeholder involvement. Similar entities should be in place at all subnational and local administrative
levels.

Prevention and mitigation actions for any risk should be determined following a detailed risk assessment and
be included in ERMH programmes at the national and subnational levels. The implementation of prevention,
mitigation and preparedness measures should be coordinated with relevant technical departments inside
the Ministry of Health and with the whole of government, business and civil society (Annex 4).

Effective coordination should be integral to all aspects of the response, starting with the initial risk
assessment and including: the development of short and long-term action plans; the assignment of
resources to priority needs; and the provision of urgent community care and support. Incident management
systems may be considered to facilitate the coordination under a common management structure. ERMH

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processes should be well documented in contingency plans and should include standard operating
procedures that are appropriately disseminated, regularly exercised and updated.

Recovery needs to be an integral part of response planning and should be done in parallel with other risk
management actions, i.e. well in advance of an emergency. Sufficient attention should be given to recovery
planning for the health sector.

Role of WHO in planning and coordination

 Consistent with the whole-of-society, whole-of-government approach required for robust risk
management for pandemic influenza, advocate collaboration and coordinate prioritized activities with
organizations of the UN system, bilateral development agencies, nongovernmental organizations, the
private sector and stakeholders in non-health sectors.
 Establish joint initiatives for closer collaboration with national and international partners in (1) early
detection, reporting and investigation of influenza outbreaks of pandemic potential; and (2) coordination
of research on the human–animal ecosystem interface.
 Collaborate with the animal health sector, e.g. the Food and Agriculture Organization of the UN and the
World Organisation for Animal Health, on preparedness, prevention, risk assessment and risk reduction
mechanisms to decrease exposure of humans to influenza viruses at the human–animal ecosystem
interface.
 Promote agreements for international technical assistance, resource mobilization and fair sharing of
influenza products such as through the UN prequalification programme, Essential Medicines List and the
PIP Framework (7, 18, 19).
 Provide guidance and/or technical support to Member States in the preparation of pandemic influenza
risk management plans and in identifying priority needs and response strategies and assessing
preparedness.
 Facilitate regional/cross-border collaborations.

3.2.3 Information and knowledge management

Information and knowledge management encompasses technical guidance for risk management,
communications and early warning and surveillance, which are highlighted below, as well as risk assessment
(see Section 4.1), research for emergency risk management and information management.

3.2.3.1 Technical guidance

Practitioners should be provided with practical technical guidance on all aspects of ERMH. This guidance
should include clinical and operational management of the event. Continuity of health care provision
strategies should be periodically updated to reflect new research findings and lessons learned from past
health emergency events.

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3.2.3.2 Communication

Effective and efficient communication is critical throughout the ERMH continuum and includes information
dissemination within the health sector, between health and other sectors and, crucially, with the public.

In risk communication, national and local government authorities provide information to the public in an
understandable, timely, transparent and coordinated manner before, during and after a health emergency.
The objectives are to develop and maintain public trust in local and national health systems and to convey
realistic expectations about capacities for ERMH. Risk communication also promotes the effective exchange
of information and opinion among science, public health and veterinary experts, which facilitates the
assessment, implementation and coordination of risk management activities.

A communications strategy involves processes to collect, develop and distribute information in a timely
manner and procedures to ensure that formats are appropriate to the target audiences. The strategy should
take into account behavioural aspects of how people react to, and act on, advice and information they
receive, not only from authorities but also from sources such as mass and social media. Public understanding
of hazards and risks is complex, context-dependent and culturally mediated. Thus, communications strategy
development may benefit from community participation (20).

ERMH plans and activities across all hazards should use the principles of risk communication to build the
capacity to understand and anticipate public concerns and develop effective and responsive dialogue
mechanisms. This can be achieved through an emergency communications committee that has developed
and tested standard operating procedures to ensure streamlined, expedited dissemination of information
for decision-making and public communication.

3.2.3.3 Early warning and surveillance

Accurate timely information is one of the most valuable commodities during a health emergency or disaster.
This information serves as the evidence base for critical decisions at all levels of administration and defines
the messaging for public communication and education. An effective system, with minimal data sets of
information required throughout the management of an emergency, should be developed and tested in
preparation for a response.

The systems required for early warning and surveillance should be robust and enable the capture of data
required for assessment of severity, the implementation of protocols for operational research, including
efficacy studies on interventions applied and assessments of national impact based on criteria such as
workplace and school absenteeism, regions affected, groups most affected and essential worker availability.

Role of WHO in information and knowledge management


 Provide guidance and/or technical support to Member States on identifying priority needs, prevention,
mitigation and response strategies to support preparedness planning.
 Facilitate development of national guidelines for relevant activities such as targeted vaccination
campaigns, laboratory biosafety and safe specimen handling/shipping.
 Promote public health research priorities relevant to all resource settings for pandemic, non-seasonal
and seasonal epidemic influenza over the medium to long-term period via the WHO Public Health
Research Agenda for Influenza (21).
 Provide support and guidance on capacity-building for health systems (22), infection prevention and
control in health care settings (23), surge capacity and national vaccine deployment (24).
 Assess and monitor the type and pathogenicity of circulating influenza viruses through information
provided through GISRS.

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 Provide technical guidance and advice to support Member States to develop effective and responsive
pandemic communications, including risk communication and behavioural interventions messaging (25).
 Provide guidance, technical support and tools for detection, investigation, rapid risk assessment and
reporting (26).
 Provide technical support and information to national authorities:
o to enhance surveillance and collection of clinical, virological and epidemiological data to facilitate
assessment of the extent of human-to human transmission and the epidemiological situation;
o on risk assessment of clusters of influenza-like illness (ILI); and
o on interventions to reduce the spread of influenza disease.
 Define standards for initial case investigations and for routine sentinel surveillance.
 Establish and refine global case definitions for reporting by countries of human cases of influenza caused
by viruses with pandemic potential.
 Coordinate and disseminate relevant public health messages through channels such as the WHO
website, published materials, press conferences and social media.
 Provide regular and timely feedback on the results of the analysis of data reported to WHO by Member
States.
 Periodically reassess and modify recommended interventions in consultation with appropriate partners,
including those outside the health care sector, on the acceptability, effectiveness and feasibility of
interventions.
 Provide principles and update guidance for appropriate: infection prevention and control; laboratory
biosafety (27); clinical management in health care facilities and home-based care (28); use of antivirals;
and use of seasonal and pandemic vaccines.

3.2.4 Logistics and infrastructure

Effective management of health emergencies requires access to and management of adequate


infrastructure and logistics. The most important of these measures involve transportation,
telecommunications, stockpiling and distribution of medicines and supplies, and the establishment of
temporary health facilities. To ensure that logistic support will be available during health emergencies, the
Ministry of Health should consider making advance arrangements with government departments
responsible for transport, communications, public works and the armed forces together with external
agencies such as nongovernmental organizations, UN agencies and private companies. The type and quantity
of supplies and medicines will be determined by the nature of the hazard. The most critical supplies for
pandemic influenza are those needed to prevent and treat the disease and its complications while
maintaining critical non-influenza health services.

The Ministry of Health or the central coordinating body could also consider identifying, supporting, training
and deploying operational and logistics response teams.

Role of WHO in supporting health infrastructure and logistics

 Manage the WHO strategic global stockpile of antivirals, and access to pandemic vaccines under the
Standard Material Transfer Agreement 2 under the PIP Framework. Relevant standard operating
procedures will be developed to ensure rapid deployment of these strategic public health supplies. As
appropriate, reference will be made to the “Guiding Principles for use of PIP Partnership Contribution
Response Funds” dated 23 October 2014
http://www.who.int/influenza/pip/guiding_principles_pc_response_funds.pdf?ua=1.

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 Develop logistics management capacity to ensure that public health laboratories have access to
protocols, tests and diagnostic reagents to be able to identify non-seasonal influenza virus infections
(29).

3.2.5 Health and related services

Regardless of the nature of a health emergency challenge faced, health and related services will need to be
provided to the affected population to save lives, manage public health, prevent secondary effects and
maintain essential non-hazard-related emergency services. While many of these health services do not differ
from services provided in non-emergency situations, their organization and delivery may change significantly
during a health emergency. This will require thoughtful planning beforehand. Health services related to
triage, emergency care and maintenance of non-influenza acute care are among the many specified services
requiring effective planning for implementation during a pandemic. Examples include activating contingency
plans for health and laboratory facilities to deal with potential staff shortages, adjust triage systems as
required, and implementing mortuary management procedures as necessary.

In addition to service provision and public health measures, this essential component also includes
identifying priorities and response strategies for public and private health care systems triage and surge
capacity. Surge capacity should be planned in advance for different scenarios with predetermined
procedures for mobilizing staff on short notice. Mechanisms for ensuring adequate human resources for
long-term events - such as an influenza pandemic - should be considered based on national plans, including
planning for staffing of alternative care facilities for cohorting influenza patients. It is also important to
consider ensuring that health care workers have the opportunity for rest and recuperation.

Role of WHO in supporting health and related services

 Provide advice and technical guidance on organization and delivery of health and related services, e.g.
laboratory services, blood services, non-pharmaceutical measures and mass casualty management
systems.
 Utilize existing clinical networks to review clinical information and effectiveness and safety of clinical
interventions.
 Provide advice on measures for controlling international disease spread through temporary
recommendations issued under IHR (2005).
 Support health system capacity assessments for emergency risk management (15).

3.2.6 Community capacities

Community capacities are a vital component of ERMH. The community-based health workforce is a crucial
front line for ERMH activities and has the language and cultural skills to implement effective local ERMH
activities, including social mobilization. This workforce may include appropriately trained and accredited
community health workers, trained volunteers, community-based organizations that promote health, health
education and social mobilization, and those from key sectors (water, sanitation, hygiene, agriculture, food
security, shelter and education) that contribute to promoting health. Developing local action plans based on
national plans for any hazard is also an important consideration for strengthening community capacities.

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Role of WHO in supporting community capacities

 Promote the role played by the community-based health workforce in emergency risk management and
advocate for the scale-up of this vital resource (30).
 Advise on strengthening community-based health workforce programmes, including recruitment,
training, supervision, evaluation, deployment and retention (31).
 Provide guidance on training community health workers (32).
 Provide advice and guidance on community community-level response activities during an influenza
pandemic. (22).

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4. NATIONAL PANDEMIC INFLUENZA RISK ASSESSMENT


4.1 Influenza viruses and pandemics

Influenza, a viral respiratory disease, can cause high morbidity and mortality in humans and is known to
affect some animal species. Clinical disease can range from mild to severe and, in some cases, result in
death. While influenza B remains a human disease, influenza A viruses are found in human, avian and some
mammalian species. An influenza pandemic occurs when an influenza A virus to which most humans have
little or no existing immunity acquires the ability to cause sustained human-to-human transmission leading
to community-wide outbreaks. Such a virus has the potential to spread rapidly worldwide, causing a
pandemic.

Past pandemic influenza viruses have been reported to arise through either (1) genetic reassortment: a
process in which genes from different influenza viruses combine to create a strain with a new complement
of genes, (2) genetic mutation: a process in which genes in an animal influenza virus change allowing the
virus to infect and transmit easily in humans, or (3) some combination of both. Gaps in the virological record
have meant that it has not been possible to determine exactly which of these processes have occurred nor
their order. As influenza viruses are unpredictable, it is uncertain what combination of changes will allow the
next pandemic influenza virus to emerge. Influenza pandemics are unpredictable but recurring events that
can have significant global consequences. Since the 16th century, influenza pandemics have been described
at intervals ranging between 10 and 50 years with varying severity and impact. Characteristics of the past
four pandemics are summarized in Table 4.1.

Table 4.1: Characteristics of the past four influenza pandemics (33)

Pandemic year Area of Influenza A Estimated Estimated Estimated Age groups


of emergence origin virus subtype (type of reproductive case attributable most
and common animal genetic number (34, fatality excess affected
name introduction/recombination 35) mortality (36)
event) worldwide

1918 Young
Unclear H1N1 (unknown) 1.2–3.0 2–3% (37) 20–50 million
“Spanish flu” adults

1957–1958 Southern All age


H2N2 (avian) 1.5 <0.2% 1–4 million
“Asian flu” China groups

1968–1969 Southern All age


H3N2 (avian) 1.3–1.6 <0.2% 1–4 million
“Hong Kong flu” China groups

2009 -2010 Children


North 100 000–400
“influenza H1N1 (swine) 1.1–1.8 (38) 0.02% (39) and young
America 000 (40)
A(H1N1) 2009” adults

In June 2009, WHO declared the first influenza pandemic of the 21st century after the emergence of the new
A(H1N1)pdm09 virus subtype. This virus was first isolated from humans in Mexico and the United States of
America in April 2009. Within a few weeks, the virus had spread rapidly, and there was sustained human-to-
human transmission worldwide. The triple-reassortant virus contained a unique combination of gene
segments from avian, swine and human influenza viruses. Risk factors for severe influenza A(H1N1)pdm09

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disease were similar to those for seasonal influenza, e.g. pregnancy and many chronic medical illnesses,
although younger age groups were more affected than usual.

Prior to 2009, much of the focus on influenza viruses with pandemic potential was on the avian influenza
subtype A(H5N1). A human outbreak of avian influenza A(H5N1) was detected in 1997 in Hong Kong SAR,
China. This was the first recognized instance in which a highly pathogenic avian influenza virus had been
transmitted to humans and resulted in serious illness. Since its widespread re-emergence in 2003–2004, this
avian virus has resulted in millions of poultry infections and over 800 human cases. On rare occasions,
limited human-to-human transmission of influenza A(H5N1) has occurred – most often to a family or other
household member acting as a caregiver. However, none of these events has so far resulted in sustained
community-level transmission.

Most animal influenza viruses do not cause disease in humans. However, viruses circulating in animals or
derived from viruses circulating in animals have caused infections in humans, including avian and swine
viruses and reassortants, notably of the H1, H3, H5, H7, H9 and H10 subtypes. Most of these human
infections have been sporadic and the viruses have not spread further among people.

Humans generally acquire these infections through direct contact or close exposure to infected animals or
contaminated environments. Control of influenza among animals is therefore essential to reduce the risk of
human infection, to reduce the potential for pandemic strains to evolve, and to prevent or reduce the
economic consequences to the animal industry. Successfully meeting this challenge requires long-term
commitment from countries and strong coordination between animal and human health authorities and
practitioners.

Experience with the emergence of such a variety of different influenza strains that transmit from animals to
humans illustrates the highly unpredictable nature of influenza viruses such that assumptions about where
the next influenza virus with pandemic potential will emerge, or what its characteristics will be, cannot easily
be made. This uncertainty underscores that planning should not focus only on avian influenza but should be
based on broad and robust surveillance and evidence-based risk assessment.

4.2 National risk assessments

Risk assessment is a systematic process for gathering, assessing and documenting information to assign a
level of risk (26). Risk assessment aims to determine the likelihood and consequences of events that impact
on public health at global, national, subnational and local levels. It provides the basis for taking action to
manage and reduce the negative consequences of risks to public health. It provides evidence-based
information for decision-making to manage and reduce the negative consequences of risks to public health
and it facilitates the communication of risks and uncertainties to the public. In an all-hazards approach, risk
assessments can be performed to identify and prioritize preparedness, including mitigation and prevention,
activities and response and recovery programmes, as illustrated in Figure 4.1.

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Figure 4.1: Pivotal role of risk assessment in preparedness, response and recovery actions

For each influenza virus with pandemic potential, WHO will conduct global risk assessments in collaboration
with the affected Member State(s), to inform decision-making for risk management (41). While WHO will
communicate these global assessments and the uncertainties that surrounds them throughout the event,
each Member State is strongly advised to assess national risk related to pandemic influenza in the context of
their local experience, resources and vulnerabilities. Member States are also encouraged to share their risk
assessments through networks or multilateral arrangements and to utilize regional resources for risk
assessment.

At any point in a pandemic, one or many Member States may be responding to a national-level epidemic,
while other Member States may not be affected for some months to come. Consequently, each Member
State is encouraged to conduct its own risk assessments, which will determine the timing, scale, emphasis,
intensity and urgency of the actions required at their national and local levels. More information on
suggested national actions is provided in Section 5.

National pandemic influenza risk assessment should involve a multidisciplinary team representative of the
whole of government, together with stakeholders and relevant decision-makers. Since pandemic risk
assessment has similar components across the whole of society, it should be conducted collaboratively with
stakeholders at national, subnational and local levels.

A risk assessment considers hazard, exposure and context coupled with risk characterization. A hazard
assessment relevant to pandemic influenza includes: identifying influenza viruses of concern; reviewing key
virological and clinical information about each influenza virus; and ranking them by pandemic potential and
possible consequences.

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An exposure assessment seeks to define the groups of individuals known to have been, or likely to be,
exposed to an influenza virus of concern and to delineate the susceptibility of these groups in terms of
immunity and disease severity. This process incorporates epidemiological and susceptibility factors such as
travel history, incubation period and estimation of potential for transmission.

These two assessments are then complemented by a context assessment. A context assessment is an
evaluation of the environment in which the event takes place. It examines factors that affect risk, including:
social, technological and scientific, economic, ethical, and policy and political factors, see Table 4.2.

Table 4.2: Factors to consider in context assessments

Factor Examples

 population size and characteristics such as distribution of high-risk groups


Social  behaviours
 impact of seasonal influenza
 impact on lifestyle, e.g. acceptability and applicability of any social distancing
recommendations
 ability to implement surveillance and mitigation activities
Technical and scientific  the likelihood that all suspect cases can be identified
 the availability of mechanisms to reach specific high risk groups
 the availability and acceptability of effective preventive measures and of treatment or
supportive therapies
 direct and indirect financial costs including:
Economic o household income
o hospitalization costs
 potential impacts on tourism and trade
 impact on business continuity of essential services
 privacy issues
Ethical  use of unlicensed products
 transparency
 unequal risk burden
 potential requirements for the protection of critical infrastructure
 likely response of key stakeholders and media
Policy and political  government capacity to participate in risk management efforts
 the country’s recent experience with influenza
 past and ongoing emergencies with implications for future hazards, vulnerabilities and
capacities.

Once the hazard, exposure and context assessments are conducted, the risk can be characterized. Risk
characterization seeks to organize the assessments into a determination of likelihood and impact of each risk.
In the context of pandemic influenza, risk characterization employs these assessments to evaluate whether a
particular influenza virus has pandemic potential and the degree to which such an event will impact on
society, and, consequently, the urgency and scale of risk management actions to be implemented.

Throughout the risk assessment process, the uncertainty for each part of the assessment should be recorded
and shared by the evaluating team. This documentation should include an overview of the basis for each
assessment to ensure ongoing consistency in risk assessment processes.

Risk assessment is a continuous process throughout the risk management continuum. Member States are
encouraged to conduct risk assessments at the national, subnational and local levels, in order to prioritize
the development of risk management programmes tailored to the hazards present.

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4.3 Assessment of pandemic severity

Gauging the severity of an influenza pandemic – a critical component of overall pandemic risk assessment –
is an important consideration for WHO and Member States in planning for and responding to a pandemic.
Early information about severity can help support decision-making at global and country levels. As a
pandemic spreads from country to country, data derived from existing influenza disease and virological
surveillance, coupled with field investigations and other data sources, can be used to adjust global and
national responses. Some of these data-collection processes are provided through existing WHO guidance
and related resources (42).

Early assessments in countries first affected by human infection with a new influenza subtype will inform the
global community. However, each country’s context and pandemic influenza-related severity will differ,
requiring careful evaluation not only of the data reported but the capacities, demographics and other
features of the country in which the observations are made. In addition, continual severity assessments will
be necessary over the course of a pandemic since the accuracy and precision of severity-related information
will change.

Severity assessments should be conducted at the community, national and global level. Each of these
assessments will enable refinement of risk assessments at the other levels. As when conducting other
components of risk assessments, a country may measure a severity parameter directly with the assistance of
an external partner or rely on applicable information from others. For example, during the influenza A(H1N1)
2009 pandemic, informal networks of experts in epidemiology, clinical medicine, virology and mathematical
modelling shared preliminary information with WHO to enable a global assessment of severity.

To be useful, the severity assessments should be done when public health decisions are needed. To that end,
a risk assessment, incorporating severity, should provide as much information as possible to answer the
following key questions about an emerging pandemic.

 How rapidly are new cases accruing?


 What types of illnesses and complications are being seen?
 What groups of people (e.g. age groups or groups at risk of severe outcomes) will become severely ill
and die?
 Is the virus sensitive to antiviral agents?
 How many people will become ill?
 What will be the impact on the health care sector, including such factors as health care utilization and
impact on the health care work force?

Operationally, these questions will help guide decisions regarding vaccine production and strategy for usage,
antiviral use, mobilization of health care resources, school closures and other social distancing strategies.

The data that answer each of these key questions will be considered in the context of three indicators. Each
of these indicators will contain information derived from a variety of different types of data, including
virological, epidemiological and clinical. The data will be grouped into the following indicators to help make
them more accessible and understandable to the public and policy-makers.

Transmissibility: Reflects the ease of movement of the virus between individuals, communities and
countries. The factors that will go into describing transmissibility include both virological factors and
epidemiological observations. As with all of the indicators, the values of each of the observations or
measurements that are used to reflect transmissibility will be interpreted in the context where they are
made as they will be influenced by social and climatic factors.

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Seriousness of disease: A pandemic virus that has a high level of clinical severity can result in a
disproportionate number of persons with serious or grave illness, some of whom will die in the absence of
effective treatment or adequate clinical management. However, the severity or virulence of a virus will also
depend on the presence of underlying medical conditions that predispose individuals to severe illness, as
well as age. An infection is likely to be much more severe for some segments of a population than others and
descriptions of the groups at risk will be part of this indicator.

Impact: If the health care sector and other critical essential services are impacted at a high level, it may not
be able to accommodate the stress on its resources. The impact on the health sector will also be influenced
by public concern and health care policies put in place in response to the event. As such, assessing impact
will aid in understanding how these issues interact with inherent characteristics of the virus and the way it
behaves.

Examples of representative parameters for each indicator are provided in Annex 6. As appropriate, some of
these data may also be communicated directly to policy-makers and planners. WHO will communicate with
its geographically and technically diverse group of staff, networks and external experts to help interpret the
available qualitative and quantitative data provided through national severity assessments. The severity
assessments must be flexible in order to accommodate unforeseen characteristics of the pandemic as it
evolves (e.g. a new indicator could be included or a known one excluded).

Any severity assessment plan has inherent limitations. Assessments are dependent upon the data available.
Data first must be sought, then found, collected, shared, analyzed and communicated. Resource availability
and competing interests may impede any of these steps and the ways in which these steps proceed will
affect the validity of the data. Even under the best operational circumstances, data must accumulate over
time before accuracy can be achieved. The case-fatality ratio, a commonly sought and communicated
severity-related parameter, is well reported to have significant variability over the course of a pandemic and
is not useful in the very early stages of an event because it is likely to be inaccurate and misleading (43, 44).
In these very early stages, the proportion of known cases requiring mechanical ventilation, for example,
might be used instead of the case-fatality ratio.

Severity varies within a population owing to a variety of risk factors (45). Population risk factors in terms of
community resilience have not been carefully studied. However, general health status, availability of
resources, including health care services and medications, and cultural dynamics that affect transmission and
care-seeking are likely to be relevant and will complicate comparisons between populations. As such, WHO
will attempt to interpret the observations described above in the context in which they are made and project
how they might affect subsequently affected Member States whose context is different. To do this, it will be
necessary to communicate a wide variety of data to describe the full profile of the event. These
considerations further increase the need for severity assessments to occur in the context of robust risk
assessments. Further information on the representative parameters for core severity indicators is provided
in Annex 6.

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5. NATIONAL PANDEMIC INFLUENZA RISK MANAGEMENT


Individual countries may be exposed to the pandemic influenza virus at different times, have different case
and case fatality rates, surveillance and response capacities, and vulnerabilities. They may experience
different numbers and severities of waves of illness arising from the pandemic virus. Therefore, flexibility
must be embedded in planning such that movement between the groups of activities below can be done
with agility to reflect the national situation and meet local needs. For example, activities in the recovery
period may need to be supplemented, as necessary, by response actions should there be a subsequent
pandemic wave. Mechanisms must be in place to enable this flexibility and for national emergency response
procedures to be implemented – as guided by national risk assessment – irrespective of the global phase.

The following national actions are grouped by the six categories of essential components of ERMH (Table 1)
and are indicative of actions to be considered following risk assessments. The degree of implementation
should be commensurate with the degree of risk, national priorities and needs. These suggested national
actions are intended to build on the progress made in developing and strengthening existing systems.
Programmes to develop and implement activities at the local level based on local risk assessments, resources
and needs should be coordinated and consistent with national plans, policies and legislation.

5.1 Policy and Resource Management

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Review or develop national pandemic risk management programmes, including preparedness activities
and response plans. Establish, as needed, the full legal authority and legislation required to sustain and
optimize pandemic preparedness, capacity development and response efforts across all sectors.
 Perform forecasts of the national economic impact of a pandemic and cost-effectiveness of
preparedness to advocate for funding and to aid risk management planning.
 Integrate pandemic risk management plans into existing national emergency risk management
programmes.
 Establish goals and priorities for the stockpiling and use of pandemic influenza vaccines and antiviral
drugs.
 Explore ways to provide drugs and medical care free of charge (or cover by insurance) to encourage
prompt reporting and treatment of human cases caused by a non-seasonal influenza virus or virus with
pandemic potential.
 Strengthen and maintain capacities to detect, assess, notify and report events, the capacity to respond
promptly and effectively and the capacities at designated points of entry relating to the identification
and management of pandemic risks in accordance with IHR (2005) Annex 1A and 1B.2.
 Advise subnational and local governments on best practices in pandemic planning and implement a
quality control system to regularly monitor and evaluate the operability and quality of local and regional
plans.
 Develop procedures for access to and timely allocation of resources for preparedness, capacity
development and intervention implementation at national and subnational levels, including activities to
be fulfilled by humanitarian, community-based or nongovernmental organizations.
 Create a national roster of experts to provide high-level technical advice in areas such as ethics, risk
assessment, infection prevention and control, respiratory diseases and emergency management.
 Assess existing capacities and identify priorities for pandemic risk management at national and
subnational levels.

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 Develop strategies, plans and training to enable all health care workers, including community-level
workers, to respond during influenza outbreaks and throughout a pandemic (31).
 Develop occupational health policies for essential services workers and develop guidance and policies to
enable workers to stay home when ill.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Prioritize and guide the allocation and targeting of additional human and material resources to achieve
the goals of pandemic risk management plans.
 Assess whether international assistance is required to meet humanitarian needs. Alternatively, consider
providing resources and technical assistance to countries experiencing outbreaks of influenza with
pandemic potential (46).

Consider activation or deactivation of specific legislation or procedures, based on pre-determined national-


level triggers.

Recovery activities to be considered

Review the lessons learnt about policies and resource management and revise national and subnational
pandemic risk management plans; encourage stakeholders across all public and private sectors to do
likewise. Implement mechanisms for restocking of resources.

5.2 Planning and coordination

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 If not already in place, consider appointing a cross-governmental, multi-agency national pandemic risk
management committee. Suggested activities of this committee could include the following:
o Develop, exercise (47) and periodically revise national and subnational pandemic risk management
plans in close collaboration with all relevant public and private partners. Review subnational
pandemic plans against the national plan and involve subnational and local representatives in testing
interoperability.
o Provide the key assumptions, guidance and relevant information to promote development of
pandemic business continuity plans and strategies for public and private sector workplaces (Annex
5).
o Lead and coordinate multisectoral resources to mitigate the societal and economic impact of a
pandemic (Annex 4).
o Consider planning for containment measures (Annex 7).
 Planning and coordination activities of the Ministry of Health entity responsible for ERMH could include
the following activities:
o Identify, brief regularly and train key personnel to be mobilized as part of a multisectoral expert
response team for influenza outbreaks of pandemic potential.
o Encourage collaboration with neighbouring countries on aspects of pandemic preparedness planning
that may have regional or cross-border implications through information-sharing. Participation in

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regional and international initiatives, exercises, and coordination of responses to address trans-
border issues including interoperability of plans.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Update leadership and other relevant sectors on global and national pandemic influenza risk
assessments.
 Provide the key assumptions, guidance and relevant information to public and private sectors to
facilitate implementation of their pandemic business continuity plans.
 Finalize preparations for an imminent pandemic by activating national and subnational command and
control systems.
 Activate pandemic contingency planning arrangements for the health sector and all sectors deemed
critical for the provision of essential services.
 Switch to pandemic working arrangements.
 Respond, if possible, to requests for international assistance by offering resources and technical
assistance to countries with ongoing pandemic activity.
 Collaborate with neighbouring countries on information-sharing.
 Provide regular updates on the evolving situation to WHO and other partners to facilitate response
coordination.
 Review and, if necessary, revise pandemic risk management plans to manage possible future pandemic
wave(s).
 Evaluate the resources and capacities needed to monitor and respond to subsequent waves.

Recovery activities to be considered

Review the lessons learnt about planning and coordination across all sectors and share experiences with the
international community. Review and, if necessary, revise pandemic risk management plans to manage a
possible future pandemic.

5.3 Information and knowledge management

5.3.1 Technical guidance

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Develop and disseminate guidance on all aspects of pandemic response including: clinical management;
prevention and control of health care-associated infections; surveillance throughout the pandemic;
public health measures; surge capacity; and management of non-influenza acute care patients.
 Establish linkages with and consider developing rosters of experts. For example, academics, health
professional groups, who could be engaged in developing technical guidance. Similarly, develop and
maintain lists of stakeholders to facilitate the dissemination of technical guidance.
 Anticipate the need for rapid revision and dissemination of guidance, e.g. new laboratory protocols as
the diagnostics for the new strain become available.

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 Develop and maintain lists of stakeholders to facilitate the dissemination of technical guidance and test
guideline dissemination mechanisms. Develop case-finding, treatment and management
protocols/algorithms.
 Provide guidance to health care workers to test and report cases of suspected pandemic influenza
infection in patients with respiratory illness, especially those who have travelled to an affected
country/countries or their close contacts.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Update, if necessary, national guidance and recommendations on the use of planned interventions
taking into account information from affected countries.
 Update, if necessary, laboratory protocols for virus detection, identification, shipping and sharing with
WHO Collaborating Centres for Influenza.
 To the extent possible, use standardized protocols to monitor safety, efficacy and supply of
pharmaceutical interventions.
 Revise case definitions and diagnostic and treatment protocols/algorithms, as required.

Recovery activities to be considered

Communicate to the public and other stakeholders the lessons learnt about the effectiveness of policy and
technical guidance during the pandemic and how the gaps discovered will be addressed. Evaluate guidance
dissemination mechanisms and work with professional associations towards improvement. In addition,
analyse data collected during the event for dissemination and consider revising the national risk assessment
algorithms.

5.3.2 Communications

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Develop effective strategies to inform, educate and communicate with individuals and families to
improve their ability to take appropriate actions before, during and after a pandemic.
 Identify appropriate spokespeople.
 Identify communications channels and assess their ability to reach all target population groups. Develop
protocols and provide training to spokespeople for each communication channel.
 Pre-test messages through each medium, including social media, and test communications procedures
through exercises.
 Build effective relations with key journalists and familiarize them with influenza and pandemic-related
issues.
 Develop communication strategies to support the implementation of non-pharmaceutical interventions
including restrictions on mass gatherings and school closures.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

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 Provide regular briefing updates to all spokespeople to ensure that the information conveyed is
consistent and up-to-date.
 Conduct frequent and pre-announced public briefings through popular media outlets such as the web,
television, social media and radio to counter panic and dispel rumours.
 Activate mechanisms to ensure the widest possible dissemination of information. Topics likely to require
regular communication include:
o What is known and not known about the virus, the state of the outbreak, use and effectiveness of
measures and likely next steps.
o What is known and not known about the pandemic disease, including transmission patterns, clinical
severity, treatment and prophylaxis options.
o The importance of compliance with recommended measures to stop further spread of the disease.
o Societal concerns such as the disruption to travel, border closures, school closures and the impact on
the economy or society in general.
o Sources of emergency medical care, resources for dealing with urgent non-pandemic health care
needs, and resources for self-care of medical conditions.
o Any changes to the status of the pandemic.
o The ongoing need for vigilance and disease-prevention efforts to prevent any upswing in disease
levels.
o Advice for travellers.
 Ensure effective communication of public health measures to reduce the spread of pandemic influenza,
e.g. hand and respiratory hygiene, reduction of unnecessary travel and overcrowding of mass transport
systems, self-isolation for sick individuals, except their nominated caregiver, and minimization of contact
with others.
 Gather feedback from the general public, vulnerable populations and at-risk groups on attitudes towards
the recommended measures and barriers affecting their willingness or ability to comply.
 Update communications strategies as feedback from the general public and stakeholder organizations is
collected and analysed.

Recovery activities to be considered

Publicly acknowledge the contributions of all communities and sectors to the pandemic effort. Review the
lessons learned about communications and revise in readiness for the next major public health event.
Communicate that the event may be over but that a second (or subsequent) wave(s) is/are possible and that
the pandemic virus will revert to a seasonal pattern and be present as one of the circulating viruses for some
time to come.

5.3.3 EARLY WARNING AND SURVEILLANCE

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Ensure that mechanisms are in place for meeting obligations under IHR (2005) to detect, assess, notify
and report events. Such mechanisms include the capacities to respond promptly and effectively and
requisite capacities at designated points of entry relating to the identification and management of
pandemic risks in accordance with IHR (2005) Annex 1A and 1B.2.

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 Develop or strengthen national surveillance to collect up-to-date virological, epidemiological and clinical
information on trends in human seasonal influenza infections to aid estimates of additional capacities
needed to detect increases in pandemic activity.
 Enhance virological and epidemiological surveillance to detect and investigate unusual cases/clusters of
influenza-like respiratory illness or deaths associated with non-seasonal influenza viruses; identify
potential animal sources of human infection; and assess the risk of human-to-human transmission.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Undertake a comprehensive assessment of the earliest national cases of pandemic influenza.


 Ensure that, as required under the IHR (2005), any notification is followed by ongoing communication to
WHO of timely, accurate and sufficiently detailed public health information on the event including,
where possible, case definitions, laboratory results, source and type of risk, number of cases and deaths,
conditions affecting the spread of the disease and the public health interventions employed.
 Collect and analyse available data to evaluate the virological, epidemiological and clinical characteristics
of the national epidemic.
 Modify national case definitions and update clinical and laboratory algorithms for diagnosis, as
necessary.
 Collect specimens for testing and virological characterization using protocols and procedures developed
in collaboration with WHO.
 Document the evolving national epidemic including population susceptibility, changes in epidemiological
and clinical features, geographical spread, trends and impact.
 Collect more detailed epidemiological and clinical data as time and resources permit.
 Maintain adequate virological surveillance to detect antigenic and genetic changes and changes in
antiviral susceptibility and pathogenicity (48, 49).
 Continue to update the health sector and other relevant ministries and decision-makers on new
information or other changes that affect disease status, signs and symptoms, case definitions, protocols
and algorithms.
 Activate the surveillance activities required to detect subsequent pandemic waves.
 Monitor and assess national impact using criteria such as workplace and school absenteeism, regions
affected, groups most affected and essential worker availability.

Recovery activities to be considered

Review and revise situation monitoring and assessment tools for subsequent waves of disease, the next
pandemic and other public health emergencies. In addition, resume seasonal influenza surveillance
programmes incorporating the pandemic virus subtype as part of routine surveillance.

5.4 Health infrastructure and logistics

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Develop pandemic risk management plans throughout the health sector, including for health facilities,
laboratories and other allied health services (50).

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 Plan for the increased need for antibiotics, antipyretics, hydration, oxygen and ventilation support within
the context of national clinical management strategies.
 Develop mechanisms and procedures to select, procure, stockpile, distribute and deliver antivirals,
essential pharmaceuticals, personal protective equipment, diagnostics tests and vaccines, when
available and based on national goals and resources. Consider whether these mechanisms are adequate
to conduct containment measures (Annex 7).
 Develop a deployment plan to deliver pandemic influenza vaccines to national and subnational
distribution points within seven days from when the vaccine is available to the national government and
develop a mass vaccination campaign strategy (23).

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Implement vaccine procurement plans.


 Implement distribution and deployment plans for antivirals, vaccines and other pharmaceuticals, other
medical supplies and personal protective equipment, according to national plans.
 Monitor essential health-related resources such as: medical supplies; antivirals, vaccines and other
pharmaceuticals; health-care worker availability; hospital occupancy/availability; use of alternative
health facilities; laboratory material stocks; and mortuary capacity.
 Deploy pandemic vaccine when available in accordance with national plans, priorities and vaccine
availability.

Recovery activities to be considered

Restock medications and supplies and service and renew essential equipment in preparation for possible
subsequent waves of pandemic virus-induced disease or other health emergencies. In addition, review the
status of, and replenish, national and local stockpiles.

5.5 Health and related services

5.5.1 Health services

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Consider policy and needs of an in-country approach to antivirals and vaccination, including mechanisms
for evaluating effectiveness and monitoring for adverse events.
 Estimate and prioritize requirements for antiviral treatment or prophylaxis and vaccination during a
pandemic.
 Consider capacity and resources for stockpiling essential medicines and equipment (51).
 Consider mechanisms for identifying, and measures to protect, vulnerable populations.

 Assess health system capacity to detect and contain outbreaks of pandemic influenza disease in hospital
settings.

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 Develop mechanisms to monitor uptake, compliance, safety and effectiveness of mitigation measures
and share findings with the international community and WHO.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Implement national plans for antivirals and/or vaccination campaigns according to priority status and
availability, in accordance with the evidence or modify/adapt antiviral and vaccine strategies based on
monitoring and surveillance information.
 Enhance infection prevention and control practices in health care and laboratory settings and issue
personal protective equipment as needed in accordance with national plans.
 Activate alternative strategies for case isolation and management as needed.
 Address the psychological impacts of the pandemic, especially on the health workforce, and provide
social and psychological support for health care workers, patients and communities.
 Reassess the capacity to implement mitigation measures to reduce the spread of pandemic influenza.
 Consider vaccination of health care workers, when available and based on national goals and policies.
 Conduct ongoing evaluations of antiviral effectiveness, safety and resistance, and vaccine coverage,
effectiveness and safety, throughout their deployment, according to national plans, mechanisms and
procedures.

Recovery activities to be considered

Based on national/local risk assessments, resources and needs:

 Conduct a thorough evaluation of all the specific responses and interventions used, including: (1)
antiviral effectiveness, safety and resistance; (2) vaccine coverage, effectiveness and safety, and share
findings with the international community.
 Begin rebuilding essential services in preparation for subsequent waves of disease and/or other health
emergencies.
 Work to increase seasonal influenza vaccination coverage of all groups at high risk, in accordance with
national policy.

5.5.2 Public health-related measures

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Identify the range of non-pharmaceutical interventions that might be recommended and develop
protocols and communications to support their implementation (52, 53).
 Develop a framework to facilitate decision-making for activation and de-escalation of specific measures,
such as school closures or cancellation or restriction of mass gatherings based on appropriate risk
assessment criteria.
 Plan for actions relating to temporary recommendations issued under IHR (2005), especially measures to
slow the spread of disease.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

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 Assess and determine whether cancellation, restriction or modification of mass gatherings is indicated.
 Implement social distancing measures, as indicated in national plans, such as school closures and other
societal-level disease control measures including adjusted working patterns.

Recovery activities to be considered

Based on national/local risk assessments, resources and needs:

Conduct a thorough evaluation of the effectiveness of the individual, household and societal measures
implemented and update guidelines, protocols and algorithms accordingly.

5.6 Community capacities

Preparedness activities to be considered

Based on national/local risk assessments, resources and needs:

 Develop guidance and plans to provide necessary support for prevention, treatment and infection
prevention and control for ill persons isolated at home and their household contacts.
 Develop plans and mechanisms to enable increased access to treatment and care for community
members, including the involvement of civil-society organizations and other partners providing
community services.
 Develop public health education campaigns, including creating messages and feedback mechanisms
targeted towards hard-to-reach, disadvantaged or minority groups.

Response activities to be considered

Based on national/local risk assessments, resources and needs:

 Initiate public health education campaigns, in coordination with other relevant authorities, on individual-
level infection control measures.
 Implement appropriate individual/household medical and non-medical disease control measures for
suspect cases and their contacts in households.
 Advise household contacts to minimize their level of interaction outside the home and to isolate
themselves at the first symptoms of influenza.
 Advise individuals to stay home when ill.
 Provide infection control guidance for household caregivers taking into account relevant WHO guidance.

Recovery activities to be considered

As needed, provide psychosocial services to facilitate individual and community-level recovery.

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ANNEXES
Annex 1 Guidance revision process

The content of this WHO guidance document, Pandemic influenza risk management, has been largely based
on Pandemic influenza preparedness and response: WHO guidance document, which was published in 2009.
The draft content was reviewed by a WHO Internal Steering Committee, comprising technical experts in
influenza, multisectoral collaboration for influenza, risk management, event management, communications,
influenza at the human–animal ecosystem interface, antivirals, vaccine research and ERMH, and assessed for
relevance and continued applicability to the risk management of pandemic influenza.

Throughout the revision process, the Internal Steering Committee met four times, with significant email
correspondence between meetings. Members of the Internal Steering Committee were invited to provide
inputs and updates to relevant sections of the document, according to their expertise.

During 11–12 April 2013, an external Peer Review Group meeting was convened to: (1) consider the revised
guidance in relation to ERMH as well as recommendations from the report of the Review Committee on the
Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009; and (2)
provide feedback, comment and input on the draft guidance.

The peer reviewers’ comments were noted, and taken into account in a revised draft of the document. The
revised draft was sent to the peer reviewers for acknowledgement of the changes requested and inclusion of
additional comments, then finalized for Member State engagement.

Commenting Process
All 194 Member States were informed in writing of the publication of the interim guidance and invited to
contribute comments to the document. The commenting period was open from 10 June 2013 – 30
September 2013. A reminder was sent in writing to the Focal Points of the Permanent Missions to the UN in
Geneva on 9 September 2013.

Over 65 comments were received from 18 Member States. They were analysed to ensure they did not
duplicate other comments, categorized according to subject matter, and reviewed by the Internal Steering.
Comments received were examined against, and analysed for, their added value and feasibility.

Declaration of interests

All external peer reviewers acknowledged herein completed and submitted a “WHO Declaration of Interest
for WHO Experts” form. These declarations of interest were assessed and presented to the Peer Review
Group meeting. The chair of the Peer Review Group formally declared no interests. Of the 16 other external
peer reviewers who participated in the review of this guidance document, three declared interests. The peer
reviewers with declared interests are listed below, together with a short description of the interests
concerned.

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Peer reviewers with declared interests

Dr Nick Phin

At the time of the Peer Review Group meeting, Dr Nick Phin was about to undertake a retrospective review
of clinical and safety data on patients given aqueous zanamivir during the influenza A(H1N1) 2009 pandemic
and the 2010–2011 influenza season as part of the compassionate use programme. The research is being led
by Public Health England with some sponsorship from GlaxoSmithKline. This sponsorship consists of £25 000
for a short-term researcher post and £25 000 to reimburse the resources used by hospitals to identify and
provide the data. As the review is retrospective and there is no specific information on the use of medicines
included in this project, no conflict of interest was determined.

Professor Lone Simonsen

In 2011, Professor Lone Simonsen provided consulting services in the area of influenza and respiratory
syncytial virus disease burden modelling and methodological issues with observational study designs to
GlaxoSmithKline and BioCryst for US$ 10 000 and in 2012 received less than US$ 5000 to participate in
expert panels for GlaxoSmithKline, Merck, AstraZeneca and Novartis. As no specific information on burden
modelling is included in this guidance, no conflict of interest was determined.

Dr Benjamin Cowling

Dr Benjamin Cowling was paid US$ 2000 for consultation work on influenza treatment and prevention
strategies for Crucell NV in 2012. He was also the principal investigator and account-holder for an
investigator-initiated trial of influenza vaccine supported by significant funding from MedImmune in 2009–
2010. This was vaccine-specific research. As there are some references to vaccines and vaccine policy
throughout this guidance, it was felt this research could constitute a conflict of interest and therefore Dr
Cowling was excluded from discussions on vaccine-related issues.

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Annex 2 Planning assumptions

Planning for a future influenza pandemic is challenging, in part, because important features of the next
pandemic are not known. In this situation, assumptions relating to the epidemiology of influenza are needed
in order to make decisions in public health planning, as well as estimating required resources.

This Annex provides some planning assumptions to be considered by national authorities in developing a
pandemic influenza risk management strategy. These assumptions are based on information known at the
time of publication about seasonal influenza, avian influenza and past influenza pandemics. These data
should not be taken as predictive of features of the next pandemic. The characteristics and impacts of past
pandemics have varied between and within countries. These differences are most likely attributable to both
the characteristics of the pandemic virus and the local vulnerabilities to the disease.

It is not the intention of this Annex to provide a comprehensive review of the epidemiology of influenza.
However, it will be updated as new scientific data become available that significantly change these
assumptions. Key references are provided for readers to review the existing literature.

A2.1 Modes of transmission

Assumptions
 Modes of virus transmission of pandemic influenza are expected to be similar to those of seasonal
influenza: via the large droplet or contact (either direct or indirect) route, with a contribution by particle
airborne route, or a combination of both.
 The relative contribution and clinical importance of potentially different modes of transmission of
influenza are unknown. However, epidemiological patterns suggest that the spread of the virus is mostly
through close contact via the droplet or contact route.

Implications
 To decrease viral transmission, good hand hygiene, isolation of ill people and the use of personal
protective equipment are important measures when caring for people with influenza.
 An airborne precaution room is not indicated for routine care. However, health-care workers should
wear eye protection, a gown, clean non-sterile gloves and particulate respirators during aerosol-
generating procedures.

Scientific basis
 Droplet and contact transmission appear to be major routes of transmission for seasonal influenza
(Brankston G et al, 2007; Bridges CB et al, 2003).
 However, data are insufficient to determine the relative importance of the different modes of
transmission. In addition, there is lack of standardization and consensus about the technical definition
(i.e. particle size) of an aerosol versus a droplet (Tellier R, 2006; Lemieux C et al, 2007, Lindsley W, 2012).
 Relative heat and humidity affect the efficiency of transmission of influenza via aerosol. (Hanley BP,
2010). Some have reported the lack of aerosol transmission at 30 oC, while transmission via the contact
route was equally efficient at 30 oC and 20 oC. (Lowen AC et al, 2007; Lowen AC et al, 2008).
 Certain procedures performed in health care settings can create aerosols. Some of these procedures
have been associated with a significant increase in the risk of disease transmission and have been
termed “aerosol-generating procedures associated with pathogen transmission” (WHO, 2007). These
procedures include intubation, cardiopulmonary resuscitation, bronchoscopy, autopsy and surgery
where high-speed devices are used (WHO, 2007).

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Selected references
 Brankston G et al. Transmission of influenza A in human beings. Lancet Infectious Diseases, 2007,
7(4):257–265.
 Bridges CB, Kuehnert MJ, Hal CB. Transmission of influenza: implications for control in health care
settings. Clinical Infectious Diseases, 2003, 37:1094–1101.
 Hanley BP, Borup, B. Aerosol influenza transmission risk contours: A study of humid tropics versus winter
temperate zone. Virology Journal, 2010, 7:98.
 Lemieux C et al. Questioning aerosol transmission of influenza. Emerging Infectious Diseases, 2007,
13(1):173–174.
 Lindsley WG et al. Quantity and size distribution of cough-generated aerosol particles produced by
influenza patients during and after illness. Journal of Occupational and Environmental Hygiene, 2012,
9:443-449.
 Lowen AC et al. Influenza virus transmission is dependent on relative humidity and temperature. PLoS
Pathogens, 2007, 3(10):1470–1476.
 Lowen AC et al. High temperature (30 degrees C) blocks aerosol but not contact transmission of
influenza virus. Journal of Virology, 2008, 82(11):5650–5652.
 Tang JW et al. Factors involved in the aerosol transmission of infection and control of ventilation in
health-care premises. Journal of Hospital Infection, 2006, 64(2):100–114.
 Tellier R. Review of aerosol transmission of influenza A virus. Emerging Infectious Diseases, 2006,
12(11):1657–1662.
 Infection prevention and control of epidemic- and pandemic-prone acute respiratory diseases in health
care – WHO interim guidelines. Geneva, World Health Organization, 2007. (Available at:
http://www.who.int/csr/resources/publications/WHO_CDS_EPR_2007_6c.pdf, accessed February 2013.)

A2.2 Incubation period and infectivity of pandemic influenza

Assumptions
 Incubation period: 1–3 days.
 Latent period: 0.5–2 days.
 Duration of infectiousness: about 5 days in adults and possibly longer in children.
 Basic reproduction number (R0): 1.1–2.0.

Implications
 The incubation period and the duration of infectiousness are useful for planning purposes with regard to:
length of isolation for cases; development of a definition for contacts of cases; and the length of
quarantine for contacts.
 A relatively short incubation period would make it difficult to stop the spread of pandemic influenza by
contact tracing and quarantine.
 Viral shedding before symptoms develop would make it difficult to stop the spread of pandemic
influenza solely by screening and isolating clinically ill persons.
 Once the pandemic begins, it will be important for countries to undertake surveillance and special
studies to assess the incubation period and the duration of infectiousness of the pandemic virus.

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Scientific basis
 An early study using Australian maritime statistics suggested that the mean incubation period of the
1918 pandemic influenza was 32.71 hours (1.4 days). (McKendrick and Morison as reviewed by Nishiura,
2007).
 A meta-analysis of 56 volunteer studies (Carrat et al, 2008) found that:
o an increase in the average total symptoms score was noted by day 1 after inoculation, total scores
peaked by day 2 and returned to baseline values by day 8;
o viral shedding increased sharply between 0.5 and 1 day after challenge and consistently peaked on
day 2 (mean generation time 2.5 days) and the average duration of viral shedding was 4.8 days;
o viral shedding curves and total symptom score curves showed similar shapes, although viral
shedding preceded illness by 1 day.
 Longer durations of viral shedding are not rare. As reviewed by Carrat et al, in one study subgroup, five
participants (20%) shed influenza B virus 8 days after inoculation, while another study also reported 9
days of shedding for influenza A(H3N2).
 Reasonable estimates of the basic reproduction number (R0): for past pandemic viruses as well as
seasonal influenza viruses converge between 1.5 and 2.0 (Ferguson NM et al, 2005; Ferguson NM et al,
2006; Colliza V et al, 2007; Vynnycky E et al, 2007) and for A(H1N1) 2009 ranged from 1.1-1-8 (Fraser et
al, 2009; Lessler et al, 2010; Opatowski, et al 2011).
 The incubation period of influenza A(H5N1) human cases (7 days or fewer; mostly 2–5 days) appears to
be longer than that of seasonal influenza. In clusters in which limited human-to-human transmission has
probably occurred, the incubation period appears to be approximately 3–5 days, although in one cluster
it was estimated to be 8–9 days (WHO Writing Committee, 2008).
 Patients with influenza A(H5N1) disease may have detectable viral RNA in the respiratory tract for up to
three weeks; data, however, are limited. (Reviewed by WHO Writing Committee, 2008; and Gambotto et
al, 2007).

Selected references
 Carrat F et al. Time lines of infection and disease in human influenza: a review of volunteer challenge
studies. American Journal of Epidemiology, 2008, 167:775–785.
 Colliza V et al. Modelling the worldwide spread of pandemic influenza: baseline case and containment
interventions. PLoS Medicine, 2007, 4(1):95-110.
 Ferguson NM et al. Strategies for containing an emerging influenza pandemic in Southeast Asia. Nature,
2005, 437(8):209–214.
 Ferguson NM et al. Strategies for mitigating an influenza pandemic. Nature, 2006, 442:448–452.
 Fraser C et al. Pandemic potential of a strain of influenza A(H1N1) : Early findings. Science 2009,
324:1557-1561.
 Gambotto A et al. Human infection with highly pathogenic H5N1 influenza virus. Lancet, 2007,
371:1464–1475.
 Lessler J et al. H1N1pdm in the Americas. Epidemics 2010 2:132-138.
 Nishiura H. Early efforts in modeling the incubation period of infectious diseases with an acute course of
illness. Emerging Themes in Epidemiology, 2007, 4:2.
 Opatowski L et al. Transmission characteristics of the 2009 H1N1 influenza pandemic: comparison of 8
Southern hemisphere countries. PloS pathogens 2011, 7(9):e1002225.
 Vynnycky E, Trindall A, Mangtani P. Estimates of the reproduction numbers of Spanish influenza using
morbidity data. International Journal of Epidemiology. 2007, 36:881–889.
 Writing committee of the second WHO consultation on clinical aspect of human infection with avian
influenza A(H5N1) virus. Update on avian influenza A (H5N1) virus infection in humans. New England
Journal of Medicine, 2008, 358:261–273.

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A2.3 Symptom development and clinical attack rate (CAR)

Assumptions
 About two-thirds of people with pandemic influenza are expected to develop clinical symptoms.
 Uncomplicated clinical symptoms of pandemic influenza are expected to be similar to those of seasonal
influenza: respiratory symptoms; fever and abrupt onset of muscle ache and headache or backache.
 Averaged overall (across all age groups), population CARs are expected to be 25% to 45%.

Implications
 Existing clinical criteria for ILI can serve as the basis for pandemic disease surveillance. However,
countries are encouraged to monitor closely the evolution of clinical characteristics of pandemic
influenza to facilitate refinement of a clinical case definition.
 Since clinical presentations of influenza are usually nonspecific, pandemic surveillance should be
supported by laboratory diagnosis. This step is critical to confirm and describe comprehensively the first
cases in each country.
 Because the number of ill persons may overwhelm existing health care capacities, countries should plan
for rapid scale up of health care capacity and prioritization of limited resources.
 Wide variations in CARs among different age groups and localities have been observed with previous
pandemics. Countries are encouraged to estimate CARs based on their own data and experiences.

Scientific basis
 A pooled analysis of 522 persons who were voluntarily infected with influenza reported the proportion
of symptomatic infection (any symptoms) as 66.9% (95% CI: 58.3, 74.5). No significant differences were
noted according to the virus type or the initial infectious dose (Carrat et al, 2008).
 A modelling study using 1957 pandemic data from the United Kingdom estimated that 60–65% of
infected individuals experienced clinical symptoms (Vynnycky E et al, 2008).
 An analysis of an influenza outbreak experience in an isolated island, Tristin da Cunha, in 1971 suggested
that almost all susceptible persons developed symptomatic illness (Mathews JD et al, 2007).
 During the 1918 pandemic in the United States of America, ILI rates averaged 28%, with a low of 15%
and a high of 50% (Frost WH, 1919). These data were derived from house-to-house surveys.
 In one report, age-specific serological attack rates for the 1957 pandemic averaged 40%, with a low of 5%
and a high of 70%. In contrast, a 20% serological attack rate was reported for the 1968 pandemic (Stuart-
Harris CH, 1970).
 A retrospective questionnaire survey from one USA city revealed the overall CAR during the 1968
pandemic was 39%; and it was similar among all age groups (Davis LE et al, 1970). Another serological
survey found that about 25% (range of 21% to 27%) of children tested positive for antibodies to the
influenza strain that circulated in 1968 (Chin J et al, 1974).
 CAR calculated from an estimated basic reproduction number (R0): between 1.5 and 2.0; range from
approximately 25% to 45% (Ferguson NM et al, 2005; Ferguson NM et al, 2006; Germann TC et al, 2006;
Colliza V et al, 2007; Halloran ME et al, 2008).
 CAR from A(H1N1)pdm 2009 were estimated to be 7% to 15% (Fraser C et al, 2009) with a secondary
attack rate from 7-13% (Cauchemez S et al, 2009, WHO writing group 2009).
 Gastrointestinal symptoms have been observed among patients with influenza A(H5N1) but have varied
by clades (WHO writing committee, 2008).

Selected references

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 Cauchemez S et al. Household transmission of 2009 Pandemic Influenza A(H1N1) Virus in the United
States New England Journal of Medicine 2009, 361:2619-2627.
 Frost WH. The epidemiology of influenza. Public Health Reports, 1919, 34(33). Republished in Public
Health Reports, 2006, 121(S1):149–158.
 Stuart-Harris CH. Pandemic influenza: an unresolved problem in prevention. Journal of Infectious
Diseases, 1970, 122:108–115.
 Davis LE, Caldwell GG, Lynch RE. Hong Kong influenza: the epidemiologic features of a high school family
study analysed and compared with a similar study during the 1957 Asian influenza epidemic. American
Journal of Epidemiology, 1970, 92:240–247.
 Chin J, Magoffin RL, Lennette EH. The epidemiology of influenza in California, 1968–1973. Western
Journal of Medicine, 1974, 121:94–99.
 Germann TC et al. Mitigation strategies for pandemic influenza in the United States. Proceedings of the
National Academy of Sciences of the United States of America, 2006, 103(15):5935–5940.
 Halloran ME et al. Modeling targeted layered containment of an influenza pandemic in the United States.
Proceedings of the National Academy of Sciences of the United States of America, 2008, 105(12):4639–
4644.
 Mathews JD et al. A biological model for influenza transmission: pandemic planning implications of
asymptomatic infection and immunity. PLoS ONE, 2007, 2(11):e1220.
 WHO Writing Group. Transmission dynamics and impact of pandemic influenza A(H1N1) 2009 virus.
Weekly Epidemiological Record 2009, 46:481-484.
 Vynnycky E, Edmunds WJ. Analyses of the 1957 (Asian) influenza pandemic in the United Kingdom and
the impact of school closures. Epidemiology and Infection, 2008, 136(2):166–179.

A2.4 Dynamics and impact of a pandemic

Assumptions
 An influenza pandemic can begin at any time of the year and in any place in the world. It is expected to
spread to the rest of the world within several weeks or months.
 The duration of a pandemic wave is expected to be from several weeks to a few months but will likely
vary from country to country. Within a single country, variations may be seen by community.
 Most communities are expected to experience multiple waves of different magnitudes of a pandemic.
 Increased hospitalizations, excess mortality and secondary complications are expected to vary widely
among countries and communities. Vulnerable populations are expected to be affected more severely.
 Workplace absenteeism is expected to be higher than the estimated CAR.

Implications
 Each county should develop and strengthen its capacity to detect the early emergence of a potential
pandemic event and to respond rapidly.
 Countries should guide their local governments and communities develop their own pandemic influenza
risk management plans.
 Actions during the post-peak periods between pandemic waves should be considered in overall
pandemic risk management plans.
 Countries are encouraged to further estimate and prepare health care needs based on their own
resources and experiences, with particular concern to vulnerable populations.
 In a series of waves as experienced with 20th century pandemics, an early wave may lead to depletion of
stocks of consumables, such as personal protective equipment and pharmaceuticals, before later waves.

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 Countries are encouraged to further estimate excess workplace absenteeism during a pandemic based
on their own contexts and to guide all sectors to develop business continuity plans for high and possibly
fluctuating levels of absenteeism throughout the pandemic.

Scientific basis
 Early reports and later analysis of epidemiological evidence suggest that milder epidemic waves (in
Europe in April and May, 1918 and in the USA in the (Northern Hemisphere) Spring of 1918 preceded the
most severe pandemic wave in (Northern Hemisphere) Autumn 1918 (Frost WH, 1919; Olson SR et al,
2005).
 A review of data from the North Denmark region for the A(H1N1) 2009 pandemic indicated three waves
with the third in December 2010-January 2011 being the most severe (Orsted et al, 2013)
 An influenza virus A(H1N1) resistant to oseltamivir was first reported from Norway in January 2008 and
then spread throughout much of the Northern Hemisphere during the next two months (WHO, 2008). It
was subsequently detected in the Southern Hemisphere during the influenza season of 2008.
 Excess mortality data from 1918–1920 show that population mortality varied more than 30-fold across
countries (Murray CL et al, 2006).
 Excess mortality estimates among countries during the 1918 pandemic ranged from a low of 0.20%
(Denmark) to a high of 4.39% (India) (Murray CL et al, 2006).
 Variation of excess mortality within countries for the 1918 pandemic ranged from
 46 2.12% to 7.82% in India and from 0.25% to 1.00% in the USA. During the 1918 pandemic in the United
States of America, there were marked and consistent differences in morbidity and mortality among
persons of different economic status: the lower the economic level, the higher the attack rate. This
relationship persisted even after adjustments were made for factors such as race, sex, age and other
conditions (Sydenstricker E, 1931).
 A multinational analysis of the 1968 pandemic showed very different epidemic patterns in the six
countries studied (Viboud C et al, 2005).
o In the USA, a large epidemic was observed in 1968–1969, followed by a milder wave in 1969–1970,
late in the winter season.
o In Canada, the two epidemic patterns were similar in amplitude and timing.
o In other countries (Australia, France, the United Kingdom and Japan), the first epidemic was mild,
followed by a much more intense epidemic in the next season.
 A simulation study in the United Kingdom estimated that, overall, about 16% of the workforce is likely to
be absent due to school closures during a pandemic. This estimate rises for sectors with a high
proportion of female employees, such as health and social care (Sadique MZ et al, 2008).

Selected references
 Cockburn WC, Delon PJ, Ferreira W. Origin and progress of the 1968–69 Hong Kong influenza epidemic.
Bulletin of the World Health Organization, 1969, 41:345–348.
 Dawood FS et al. Estimated global mortality associated with the first 12 months of 2009 pandemic
influenza A H1N1 virus circulation: a modelling study. Lancet infectious diseases, 2012, 12(9):687-95
 Murray CL et al. Estimation of potential global pandemic influenza mortality on the basis of vital registry
data from the 1918–20 pandemic: a quantitative analysis. Lancet, 2006, 368:2211–2218.
 Olson DR et al. Epidemiological evidence of an early wave of the 1918 influenza pandemic in New York
City. Proceedings of the National Academy of Sciences of the United States of America, 2005,
102(31):11059–11063.
 Orsted I et al. The first, second and third wave of pandemic influenza A (H1N1)pdm in North Denmark
Region 2009-2011: A population based study of hospitalizations. Influenza and other Respiratory Viruses,
2013, Feb 9 2013, DOI: 10.1111/irv.12093.

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 Sadique MZ, Adams EJ, Edmunds WJ. Estimating the costs of school closure for mitigating an influenza
pandemic. BioMed Central Public Health, 2008, 8:135.
 Sydenstricker E. The incidence of influenza among persons of different economic status during the
epidemic of 1918. Public Health Reports, 1931, 46(4). Republished in Public Health Reports, 2006,
121(S1):191–204.
 Van Kerkhove MD et al. H1N1pdm serology working group. Estimating age specific cumulative incidence
for the 2009 influenza pandemic: a meta-analysis of A(H1N1)pdm09 serological studies from 19
countries. Influenza and Other Respiratory Viruses, 2013, Jan 21. doi: 10.1111/irv.12074.
 Viboud C et al. Multinational impact of the 1968 Hong Kong influenza pandemic: evidence for a
smoldering pandemic. Journal of Infectious Diseases, 2005, 192:233–248.
 WHO expert committee on respiratory virus diseases. First Report. WHO Technical Report Series No 170.
Geneva, World Health Organization, 1959.
 Influenza A (H1N1) virus resistance to oseltamivir: preliminary summary and future plans. Geneva, World
Health Organization, 2008. (Available at:
http://www.who.int/influenza/patient_care/antivirals/oseltamivir_summary/en/, accessed April 2013.)

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Annex 3 Ethical considerations

Preparedness planning for an influenza pandemic involves balancing potentially conflicting individual and
community interests (12). In emergency situations, individual human rights and civil liberties may have to be
limited in the public interest. However, efforts to protect individual rights should be part of any policy.
Measures that limit individual rights and civil liberties must be necessary, reasonable, proportional,
equitable, non-discriminatory and in full compliance with national and international laws.

Ethics do not provide a prescribed set of policies; rather, ethical considerations will be shaped by the local
context and cultural values. The principles of equity, utility/efficiency, liberty, reciprocity and solidarity are
especially helpful in the context of influenza pandemic preparedness planning.

For example, the principle of utility suggests that resources should be used to provide the maximum possible
health benefits, often understood as “saving most lives”. Utility considerations include the following:

For individual benefit:


 the likelihood that an individual with pandemic influenza disease will experience a medical benefit if
provided antiviral or adjuvant treatment;
 the likelihood that an individual at risk of infection will become infected/ill if influenza-specific antiviral
prophylaxis is not provided.

For community benefit:


 the likelihood that an infected individual will infect other persons if not given access to antivirals (for
treatment or prophylaxis) and infection control measures;
 the overall reduction in disease burden expected to result from the intervention;
 the potential value of giving priority to:
o essential health-care workers,
o other workers who provide life-saving services,
o workers who provide critical services necessary for society to function as normally as possible. Such
policies should be developed with great care, given the danger that decisions favouring certain
categories of workers may be perceived as unfair and undermine public trust.

Another important principle, which may sometimes conflict with utility considerations, is equity.
Considerations of equity in use of antivirals may lead to giving priority to:
 the worst-off (in terms of severity of illness);
 vulnerable and disabled populations;
 uninfected persons who are at high risk of developing severe complications and death if they become
infected.

Regardless of the criteria selected to govern the allocation of therapeutic and preventive measures, certain
basic elements will be important in all plans; for example, those which:
 facilitate access to the highest level of treatment possible given available resources, with careful
attention to the needs of all populations.
 provide health care workers with clear and transparent screening and treatment protocols in line with
the latest guidance from WHO or relevant national health authorities.
 incorporate mechanisms that:
o ensure that the guidelines and protocols are followed;
o enable health care workers to inform health authorities when clinical experience suggests the need
for revisions of protocols;

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o enable health-care workers to (1) take part in the process of updating guidelines and protocols as
the pandemic progresses, and (2) propose prioritization criteria for maintenance of a functioning
health-care system in a crisis situation;
o ensure a fair balance of treatment for pandemic influenza patients and patients with other serious
conditions;
o enable prioritization protocols for non-influenza patients and their access to the general health care
infrastructure;
o identify the pandemic influenza patients who will receive hospital-based versus home-based care
and criteria for early discharge (potentially even if still infectious).

As part of pandemic influenza planning, policy-makers are encouraged to establish a fair process for setting
priorities and promoting equitable access to services and supplies that: (1) involves civil society and other
major stakeholders in the decision-making process so that decisions about the criteria to be used in
allocating scarce resources are made in an open, transparent and inclusive manner and (2) incorporates
clear, pre-established mechanisms for revising decisions based on new evidence when appropriate. An open,
trusted process will strengthen solidarity and enhance the whole-of-society approach to pandemic risk
management.

Annex 4 Whole-of-society approach

An influenza pandemic will test the resilience of nations, businesses, and communities, depending on their
capacity to respond. No single agency or organization can prepare for a pandemic on its own. Inadequate or
uncoordinated preparedness of interdependent public and private organizations will reduce the ability of the
health sector to respond during a pandemic. A comprehensive approach to pandemic risk management is
required.

As illustrated in Figure A.1, the whole-of-society approach encompasses three major groups in society –
governments, business and civil society – at the global, national, subnational, local and community levels.
The nine circles around the disaster management continuum of mitigation, prevention, preparedness,
response, and recovery represent nine key essential areas: health, defence, law and order, finance,
transport, telecommunications, energy, food and water.

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Figure A.1: Whole-of-society approach (53)

All sectors of society should be involved in pandemic risk management. A concerted and collaborative effort
is required by government ministries, businesses and civil society to sustain essential infrastructure and
mitigate impacts of pandemic influenza on health, the economy and the functioning of society.

All levels – global, national, subnational, local and community – should prepare for a pandemic. The global
and national levels should provide leadership and strategic planning while the local level should prepare to
take specific actions. All organizations should incorporate pandemic preparedness into existing crisis and
continuity management systems. As the impact and duration of pandemic waves are unpredictable, and may
continue for multiple seasons, local communities should develop flexible plans to support the full spectrum
of their potential needs.

A4.1 Role of government

In national pandemic influenza risk management, the government is the natural leader for overall pandemic
coordination and communication efforts. The national government should help other public and private
agencies and organizations by providing guidance, planning assumptions and making appropriate
modifications to the laws or regulations at all levels and sectors to enable appropriate pandemic response.
These efforts are supported by WHO and other UN organizations under the IHR (2005) (4). As part of their
capacity-building activities under the IHR (2005), governments globally have been assessing and revising
their national legislation and regulations to ensure they can fully comply with their obligations. These
activities include intersectoral collaboration and ERMH at all governmental levels.

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Leadership should be based on strong political will and engagement with all stakeholders and sectors with
good coordination and command and control mechanisms between the Ministry of Health, national public
health authorities and non-health sectors. Emergency management roles, responsibilities and mechanisms
also need to be clarified, communicated and tested, with particular attention to sustainability of response
capacity and decision-making roles (55).

Pandemic risk management is a whole-of-government responsibility. All ministries should work with the
Ministry of Health within the national coordination system to ensure a consistent approach to preparedness
and business continuity planning. Plans that encompass a variety of scenarios should be developed from risk-
based assumptions generated by the Ministry of Health and should be tested for compatibility. In addition,
pandemic risk management processes need to take place at the national, subnational, local and community
levels; the central government should stipulate which level is responsible for specified activities. The central
government should also provide guidance to local authorities on preparedness planning; conduct training to
ensure effective dissemination at all levels; and design and implement exercises to test plans and encourage
community mobilization. Throughout the whole of government, roles, responsibilities, designated leads and
chains of command should be clearly mapped. Standard operating procedures can help generate common
understanding and coordinated implementation (54).

All ministries are responsible for ensuring their respective sectors are well prepared to respond to and
recover from pandemic influenza. Examples of ministry-specific activities are provided below.

 Ministries of Transportation should plan to minimize infection risks and staff absences in vital
transportation, airports and seaports, and loading and unloading facilities, to enable continued supply of
medicines and food. Mechanisms for communication and education of public transport users should be
considered well in advance.
 Ministries of Finance should plan to maintain essential cash, credit, banking, payment, international
funds transfers, salary, pension and regulation services in the face of significant absenteeism; systemic
resilience to pandemic risk should be tested. National-level financial planning for pandemic risk
management is also a task for the national emergency committee and the Ministry of Finance and the
mechanisms to draw down emergency funding for interventions should be tested prior to a pandemic.
 Ministries of Justice should consider how to maintain all essential legal and administrative operations
during a pandemic. Measures should also be considered to minimize the spread of infection in prisons
and other institutions under their authority. Plans for infection control and risk reduction in facilities
should be tested in conjunction with the Ministry of Health plans to ensure that messaging is consistent
and that public health principles are upheld.
 Ministries of Defence should consider which military assets could be released and mobilized in the event
of a pandemic, based on Ministry of Health planning assumptions and risk assessment.
 Ministries of Education should have a key role in the surveillance and reduction of influenza risk to
communities. Surveillance of absenteeism in schools can be used as a proxy indicator of community
transmission. Linking of school surveillance systems with the Ministry of Health is therefore vital to
ensure that school-based interventions, including closures, are guided by public health principles.
 Ministries of Energy should ensure that key providers within the energy sector have well-developed and
well-exercised preparedness plans. Alternative plans for energy supplies, in case of major disruptions,
should be evaluated.
 Ministries of Communication should have the responsibility to ensure that communications channels
remain open at times of crises. As the formal partner to the Ministry of Health in disseminating
information, the Ministry of Communication should be closely involved in the development of a national
communications plan across the government.
 Ministries of Agriculture and Animal Health should have a key role in the surveillance and monitoring of
non-seasonal influenza viruses and on preparedness, prevention, risk assessment and risk reduction

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mechanisms to decrease exposure of humans to influenza viruses at the human–animal ecosystem


interface.
 In addition to leading the health sector response, Ministries of Health should provide planning
assumptions and technical input for the development of plans by other sectors, provide public education
and other communication messages and provide advice on reducing risk of infection in essential
workers.

A4.2 Role of business

In many countries, a mix of public and private providers provides essential services. It is therefore vital that,
along with public agencies, private essential goods and service providers undertake pandemic risk
management activities. At a national level, the business sector should be represented in the national
planning committee, to ensure a consistent planning approach and establish formal communication
channels.

The continuity of activities by businesses involved in medical supplies and services, e.g. manufacturers,
distributors and providers, is critical to pandemic risk management. Other business sectors also have
important roles. For example, human resource surveillance systems in larger businesses to monitor
absenteeism can provide valuable information for national risk assessment and the retail sector can use
strategies to reduce population density in shopping areas. Businesses have an obligation to protect their
employees during any health emergency; the provision of accurate and timely communication messages
developed on the national communication plan, personal protective equipment and training is encouraged.

A4.3 Role of civil society

In many countries, national and international civil society and community-based organizations will have a
key role in providing community-based services to meet the needs of vulnerable populations. It is therefore
critical that these organizations have planned how to maintain or expand their essential services during a
pandemic. In addition, community-based organizations can translate scientific and government messages
and recommendations, which otherwise may be met with mistrust or scepticism by parts of society.
Community leaders can build public confidence, disseminate information and identify people at risk.
Governments should therefore involve civil society and local communities in developing pandemic risk
management plans. Governments should also work with local and international humanitarian agencies and
organizations to identify how the basic needs of vulnerable populations will be met in a pandemic. The
adoption of this whole-of-society approach will clarify responsibilities, identify gaps and avoid duplication in
planning and implementation.

Throughout the UN system, agencies, funds, programmes and partners support pandemic risk management
efforts, in particular assisting countries and promoting multisectoral and whole-of-society approaches,
facilitating and enhancing regional and global synergies and establishing norms for effective work (56). The
overarching objectives through which this work has been pursued are captured in the UN System and
Partners Consolidated Action Plan for Animal and Human Influenza, which identifies specific outputs and
activities of the UN system and partners under seven strategic objectives. Namely, these are: animal health
and biosecurity; sustaining livelihoods; human health; coordination of national, regional and international
stakeholders; communication: public information and supporting behaviour change; continuity under
pandemic conditions; and humanitarian common services support (57). The UN system also works to ensure
continuity of its essential operations during pandemics and to maintain staff health and safety to ensure a
timely, consistent and coordinated response across the UN system to a possible global threat (58).

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A4.4 Critical interdependencies among essential services

Although there are variations between countries, key essential services are: health, defence, law and order,
finance, transport, telecommunications, energy, food and water (Figure 4). Public and private providers of
these essential services are interdependent and rely on the goods and services of other sectors in order to
sustain their operations. Pandemic plans should take into account potential failures generated by
interdependencies. These include failures of individual businesses or small numbers of businesses
representing the sole providers of an essential good or service. Interdependencies need to be identified by
each individual essential service provider. Issues that need to be clarified in the process of identifying
interdependencies include:

 critical goods and services necessary for the organization to provide its essential service/s;
 key interdependencies for each critical good or service;
 the impact of the loss or reduction of any of the critical goods or services to the customers/beneficiaries;
 critical employee groups;
 the impact of the loss or reduced availability of critical employee groups; and
 likely points of failure.

The health-care sector always faces especially severe challenges during a pandemic. Health-care institutions
depend on goods and services that are delivered by the following sectors:

 transport for the movement of supplies, personnel and patients;


 telecommunications to support patient care, provide tele-triage and maintain business processing;
 energy to power facility, clinical and security systems;
 water for health care facilities, pharmaceutical operations and sanitation services;
 pharmaceuticals, including consumables, for treatment of patients; and
 finance to ensure the supply chain.

Flexible business continuity plans should be developed for multiple scenarios ranging from some
delays/interruptions to significant interruptions to essential services, with corresponding action plans.

Annex 5 Business continuity planning

Business continuity plans, which document business continuity management processes, are at the heart of
preparing all levels and groups of society for an emergency. Pandemic risk management should be an
integral part of any establishment’s business continuity management. Business continuity plans should be
based on risk assessment of the potential effects of a pandemic on the ability to maintain or expand
operations. The risk assessment should include consideration of vital components outside the specific
organization, such as the resilience of supply chains for essential goods and services. The plans can be used
to manage business interruptions, including significant absences of staff or disruption of supplies.

Business continuity plans should be based on explicit assumptions that characterize the parameters of a
pandemic and its potential impacts. Public health authorities should communicate planning assumptions and
guidance to other sectors of society.

Regardless of the type of the organization, business continuity plans should include the following actions:

 Identify the critical functions that need to be sustained.


 Identify the personnel, supplies and equipment vital to maintain critical functions.
 Consider how to deal with staff absenteeism to minimize its impact on critical functions.
 Provide clear command structures, delegations of authority and orders of succession.

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 Assess the need to stockpile strategic reserves of supplies, material and equipment.
 Identify units, departments or services that could be downsized or closed.
 Assign and train alternative staff for critical posts.
 Establish guidelines for priority of access to essential services.
 Train staff in workplace infection prevention and control and communicate essential safety messages.
 Consider and test ways of reducing social mixing (e.g. telecommuting or working from home and
reducing the number of physical meetings and travel).
 Consider the need for family and childcare support for essential workers.
 Consider the need for psychosocial support services to help workers to remain effective.
 Consider and plan for the recovery phase.

Annex 6 Representative parameters for core severity indicators

Indicator Representative parameters

Transmissibility From initial investigations

 Number of symptomatic cases of influenza/ILI per week


 Basic reproduction number (R0): the average number of secondary cases generated from one case at
the start of the epidemic
 Generation time: the mean delay between the time of infection of an index case and the times of
infection of secondary cases infected by the index case
 Serial interval: the average length of time between symptom onset of individual cases and the persons
they infect
 Secondary attack rate: the proportion of individuals exposed to a known case who become infected,
e.g. in a household where a case is discovered
 Clinical attack rate (CAR): the proportion of the population that is symptomatically infected in a given
time period. CAR is relatively simple to measure since it does not rely on detection of asymptomatic
individuals. CARs can be calculated for different age groups, different settings (e.g. school, workplace)
and different risk groups (e.g. pregnant women)
 Spatial distribution of cases: mapping of countries/regions in which the virus has been detected in a
given time period

From later investigations

 Attack rate: the proportion of the population that become infected in a given time period (e.g. as
obtained from population serologic studies)
 Incidence proportion: the proportion of people who develop new disease during a specified time period
 Prevalence: the proportion of people who have disease at a specific time
 Mode of transmission, particularly if new modes or previously uncommon modes of transmission (e.g.
faecal–oral) are important

From influenza (sentinel) surveillance systems

 Weekly ILI (influenza-like illness) or MAARI (medically attended acute respiratory illness) cases as a
proportion of total visits, or incidence rates.
 Weekly percentage of respiratory pathogen samples testing positive for influenza.
 Combination of weekly ILI or MAARI weekly percentage positivity rates for influenza.

Seriousness of From initial investigations: molecular


Disease
 Sensitivity to available antiviral medicines
 Presence of genetic markers that have been associated with increased risk of severe disease
 Pre-existing immunity in the population, as measured by the level of cross-reactive antibodies

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From investigations: clinical

 Case-fatality ratio (CFR): the proportion of symptomatic cases that die. Estimations of CFR are
particularly difficult at the early stages of a pandemic. Since reliable case-fatality ratios will only be
available in later stages of a pandemic, other parameters that may be of use are:
o the proportion of hospital admissions attributed to respiratory causes that require mechanical
ventilation or die
o the proportion of influenza admissions, intensive-care admissions and deaths with pre-existing
medical conditions

From later investigations

 The proportional distribution of cases by clinical illness (i.e. the proportions of cases that are
asymptomatic/have mild illness/severe illness/die – the “clinical severity pyramid”)

From influenza (sentinel) surveillance systems

 Cumulative death: hospitalization ratio (ideally for confirmed influenza)


 Cumulative ICU: hospitalization ratio (ideally for confirmed influenza)
 Severe Acute Respiratory Infections (SARI) /Acute Respiratory Infections (ARI) or ILI ratio

Impact From initial investigations

 Daily hospitalization rate: the number of persons in a given population who are hospitalized each day,
expressed in terms of confirmed or suspected cases
 The proportion of emergency department visits attributed to pandemic influenza
 The proportion of emergency department visits that require hospitalization
 The proportion of hospitalized cases that require admission to an intensive-care unit or require
mechanical ventilation
 The proportion of all hospital beds occupied by patients with pandemic influenza
 The percentage of overall laboratory capacity directed to influenza testing

From later investigations

 Number of deaths attributed to influenza


 Crude disease-associated mortality rate: the number of persons in a given population who die of the
illness, expressed in terms of confirmed or suspected cases

From influenza (sentinel) surveillance systems

 weekly or monthly number or proportion of SARI cases with percentage flu-positive among SARI cases
 weekly excess Pneumonia &Influenza (P&I) or all-cause mortality stratified by age
 weekly number of confirmed influenza cases admitted to ICU; weekly number of confirmed influenza
cases admitted to hospital

Potential societal impact parameters from other sectors

 Interruption of critical infrastructure and services


 Work and school absenteeism
 School closures
 Tourist visitor numbers and expenditure
 Gross Domestic Product
 Border, travel and trade actions by countries
 Nature of public perception

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Annex 7 Containment measures

Before the presence of human infection with a new influenza subtype is identified, the clinical syndrome
associated with a new influenza subtype is likely to be similar to that caused by currently circulating seasonal
viruses. It will therefore be very difficult to recognize an emerging pandemic sufficiently early to achieve
containment at source, given current capacities for detection and intervention (59). Evidence supporting
containment at source is extremely limited, with theoretical evidence only. Modelling studies suggest that
containment may be possible in certain near-ideal scenarios characterized by low to moderate
transmissibility (basic reproduction number, R0 ≤1.7); very early detection of initial cluster/outbreak (within
15–21 days); a non-urban pandemic epicentre with limited size (60), density and mobility; access to well-
trained response workers within a highly organized response infrastructure; a short period of
communicability and low rate of asymptomatic illness; and antiviral drug susceptibility.

However, even in these near-ideal situations, it is unlikely that this approach would be feasible given the
large amount of resources (antiviral drugs, geographical cordon, health care personnel) that would need to
be mobilized (61). The data from theoretical modelling studies are based on mass use of neuraminidase
inhibitors within a defined “containment zone” coupled with movement restrictions (geographical cordon)
and targeted at a population of 500 000 people. Moreover, the experience in 2009 was that obtaining initial
data on the R0, communicability and rate of asymptomatic illness associated with influenza A(H1N1)pdm09
was challenging. Thus, data in a future pandemic would be unlikely to be available within the timescale that
would make this approach feasible.

Nevertheless, measures that have been associated with containment such as social distancing,
hand/respiratory hygiene and judicious use of antiviral drugs may be effective in mitigating the impact of
outbreaks of a new influenza subtype in individual countries. These measures are most likely to be successful
and are better supported by data demonstrating effectiveness when implemented in specific local (smaller
scale) circumstances, e.g. households and closed or semi-closed institutions. Although there is no evidence
of any wider population-level containment effect, these measures may reduce the spread and overall impact
of the pandemic and could be considered as part of a country’s national preparedness plan, depending on
available resources.

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