訳文解説
１）“慢性的に不安定な医学的コンディションにある高齢の患者たちは、このインフルエン

ザによって病状が悪化することを怖れ、こわくて外出できないでいる。”という文について：
一見、パンデミックのとき外出しなければ、インフルエンザに暴露する機会も減り、それで良いように思えるが、そうではなく、ここでは高齢者等が自宅に引きこもってしまう
ことにより、原疾患の治療が中断したりさらには食糧が手に入らなかったりする、孤立による諸問題が生じる可能性があることを問題としている。
２）mitigation の訳について：
これから何度も出てくることばで、直訳では“軽減”となり、たぶん“被害の軽減”を意味するものと思われるが、使われる場所によっては、さらにそのための“基盤整備infrastructure”的ニュアンスが含まれるようである。ただしここでは前者を用いた。
３）stakeholders の訳について：
これも何度も出てくることばで、このプランニングではだいたいいつも partners andstakeholders といったように partners と対をなして使われている。直訳的には“利害関係者”ということになるそうである。ただし、医師会や諸学会等も含めるならば“利害”を強調するより“関係諸団体”と訳した方がよいと思われ、まとめて“利害関係者・関係諸団体”と訳したところもある。ただし partners と対比的に用いられている部分では“利害関係者”だけでも良いであろう。
４）ウイルスの遺伝子交雑とパンデミックの関係について：
１９１８年のインフルエンザ-パンデミックのウイルスも遺伝子交雑を起こしているように捉えられかねない表現であるが、実際は１９１８年のウイルスではそれを示す証拠はない。１９５７年、１９６８年のものは遺伝子交雑が示唆されるデータが示されている。
５）database / exchange/ clearinghouse の訳について：“情報データベース/情報交換サイト/情報センター”と訳したが、それらはどのように違うのかと尋ねたところ、それらをひとつにまとめたものを意識した概念で、読んだ人が具体的イメージをふくらませられるよういろんなことばを使って表わしたものとの回答であ宮城パンデミック-インフルエンザ研究会

った。
６）“generic”guide lines および“generic”public health measures における“generic”の訳について。
これも何度も出てくることばである。このことばは、最近ジェネリック・ドラッグ等の使い方でよく耳にするようになっているが、ここでは”general”と同義にとって良いとのことであった。特に前者の場合には、“一般的な”ガイドラインの意味する裏側には、そこの状
況に応じて、その具体的な詳細は、変更されるべきであるといった意味が含まれているとのことであった。
７）non-traditional medical care setting について：
これは、当初、伝統・民間療法以外の医療施設と訳したが、これでは意味が通じず尋ねたところ、通常の病院以外の、臨時に設置されるであろう収容所とか簡易病院を意識したものであるということであった。
８）表１Vaccination of medically high-risk groups with pneumococcal vaccine について：
ここにある with の使い方がよくわからず、それを尋ねたところ、ここの with はインフ
ルエンザワクチンと肺炎球菌ワクチンを一緒にという意味でのもので、肺炎球菌ワクチン
単独という意味ではないとのことであった。この肺炎球菌ワクチンは、インフルエンザで起こりうる肺炎球菌による重篤な細菌性二次感染の予防の意味で、これによる免疫は数年続くとされており、パンデミックが始まる前にやっておくワクチンとしては価値あるものと考え、表に入れたとのことであった。
９）直訳すれば“一般相談オフィス”となるが、これでは何のことかわからない。たずねたところ、the legal office すなわち法律に関する質問を扱う部局ということであった。
１０）日本の１１９番に相当する
１１）air support について：具体的には管制官や運行管理者等をいう。
１２）図１．緊急事態における明確な全体の方針決定のための指揮・命令系統 (“Commandand control” system)の確立を意味する。
１３）図１．Pre-event planning と Mitigation は、ともにパンデミック被害の軽減をめざ

宮城パンデミック-インフルエンザ研究会

すものであり、その区別がよくわからないといった質問を送ったところ、確かにわ
かりにくいとの返事であった。ただし、前者は明確にパンデミックに対しての準備の内容であるが、後者の方は、通常のインフルエンザシーズンにおける被害軽減になっているという違いはあるとのことであった。Dr．Fukuda からは、基盤整備的
準備とパンデミック前の計画立案の双方をあわせて pre-pandemic event とひとまとめにしても良いのかもしれないといったコメントを頂いている。
１４）１９１８年のパンデミックでは、病院施設が不足し、公園に診療テントが張られた
り、学校の体育館、講堂、市民ホール等に臨時病棟が設置された。
１５）パソコン上で再生可能な音声データのこと
１６）パンデミックの全期間中における人口１，０００人当りの数として表わされている。
１７）論文としてすでに発表されている：
The economic impact of pandemic influenza in the United States: priorities forintervention. Emerging Infectious Diseases, 5, 659-671, 1999.

宮城パンデミック-インフルエンザ研究会

National Vaccine Program OfficePandemic Influenza: A Planning Guide for State andLocal Officials (Draft 2.1)
The next influenza pandemic unfolds ...
An outbreak of unusually severe respiratory illness is identified in a small village inSouth China.

At least 25 cases have occurred, affecting all age groups; 20 patientsrequired hospitalization at the local provincial hospital, 5 of whom died from fulminantpneumonia and acute respiratory failure.

Surveillance in surrounding areas

increases, and new cases begin to be identified throughout the Province.

Viral

cultures collected from several of the initial patients are positive for type A influenza
virus, but cannot be further subtyped by the Provincial or national laboratory withavailable reagents.

The isolates are sent to the World Health Organization (WHO)Reference Center for Influenza at the Centers for Disease Control and Prevention(CDC), Atlanta, for further characterization. CDC determines, using special reagents,that the isolates are type A H7N1, a subtype never before isolated from humans.
Gene sequencing studies further indicate that hemagglutinin and neuraminidase genes
are avian in origin, with the remaining genes derived from a human H3N2 virus.
This information is immediately transmitted back to the Chinese Ministry of Health,and throughout the WHO network.

CDC dispatches a team of epidemiologists andlaboratory personnel to further study the epidemiologic and clinical features of thedisease, and notifies quarantine stations and large hospitals at major U.S. ports ofentry to be on the alert for arriving passengers with severe respiratory illness.
Isolates of the new H7N1 strain are sent to the FDA to begin work on producing areference strain for vaccine production, and influenza vaccine manufacturers areplaced on alert.

The novel influenza virus begins to make headlines in every major

newspaper, and becomes the lead story on major news networks. Key U.S. government
officials are briefed on a daily basis as surveillance is intensified throughout Southeast
Asia and the Pacific Rim.

National Vaccine Program Office, CDC

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Over the next two months, outbreaks begin to appear in Hong Kong, Singapore, South
Korea and Japan.

Although cases are reported in all age groups, young adults

appear to be the most severely affected, and case-fatality rates approach 5%.
Widespread panic begins because vaccine is not yet available and supplies of antiviraldrugs are severely limited.

Several weeks later, the CDC reports that H7N1 virus

has been isolated from ill airline passengers arriving from Hong Kong and Tokyo in Los
Angeles, Honolulu, Chicago and New York. States and local areas are asked to intensify
influenza surveillance activities and vaccine manufacturers are requested to go intofull production.

A few more weeks pass and focal outbreaks begin to be reported throughout the UnitedStates.

Rates of absenteeism in schools and businesses begin to rise.

physician offices and health departments begin to ring constantly.
accounts of illness are reported by the media.

Phones at
Exaggerated

Citizens begin to clamor for vaccine,but only 10% of the estimated needs are available.

Police departments, local utility

companies and mass transit authorities begin to have severe personnel shortages,
resulting in severe disruption of routine services.

Hospitals and outpatient clinics

become severely short-staffed when the majority of physicians, nurses and other
health-care workers become ill.

Elderly patients with chronic, unstable medical

conditions are afraid to venture out for fear of becoming seriously ill with influenza.1)
Intensive care units at local hospitals become overwhelmed, and soon there arewidespread shortages of mechanical ventilators for treatment of patients withpneumonia.

Family members are distraught and outraged when loved ones die

within a matter of a few days. Looting becomes a serious problem in major
metropolitan areas due to shortages of police officers.

Several major airports close

because of high absenteeism among air traffic controllers.

Further deterioration in

health and other essential community services occurs over the next 6-8 weeks as illness
sweeps across the country ....

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Are you and others within your jurisdiction prepared ?

ABOUT THIS GUIDE ...
Influenza viruses are unique in their ability to cause sudden, pervasive illness in all
age groups on a global scale. Three such "pandemics" have occurred this century, one ofwhich -- the infamous "Spanish flu" of 1918 -- was responsible for more than 20 million
deaths worldwide, primarily in young adults.

Although the response to andmitigation2) of the health and social consequences of an influenza pandemic will takeplace primarily at the State and local levels, most jurisdictions do not have a plan inplace to address the unique challenges that will rapidly unfold.

To assist State andlocal public health and emergency response officials in preparing such a plan, thenational Working Group on Influenza Pandemic Preparedness and Emergency
Response have developed this document in collaboration with the Council of State andTerritorial Epidemiologists (CSTE), the National Association of County and City
Health Officials (NACCHO), the Association of State and Territorial Public Health
Laboratory Directors (ASTPHLD), and other groups.

The guide is intended toprovide interim guidance for State and local officials to:● Recognize the need to develop State and local pandemic plans as rapidly as

possible:○ As a stand-alone plan and/or○ As an annex to the State's "All Hazards" Plan and/or○ As an adjunct to planning for acts of chemical or biological terrorism● Ensure that all relevant organizations in the public and private sectors actively

participate in the planning process● Build collaborative networks between the public health and emergency response

communities●

Understand relationships, responsibilities, and communication frameworks
among various organizations at the national, State and local levels● Assure that appropriate legal authorities are in place for dealing with various

aspects of the pandemic response● "Market"

the State and/or local plan to appropriate partners, stakeholders3),

lawmakers, and decision-makers to obtain the necessary support and resources inadvance of a pandemic declaration

National Vaccine Program Office, CDC

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●

Focus on actions that are most crucial to effective planning, response andmitigation at the State and local levels, including:
1.Devising the concept of operations, i.e., the command structure and lines ofauthority and communication for managing day-to-day activities during the
pandemic
2.Enhancing virologic and disease-based surveillance systems for influenza
3.Developing policies and procedures for distributing (and monitoring coverageof) influenza vaccine to the entire population in priority order (depending on
vaccine supply)
4.Developing

policies

andproceduresforprovidingantiviral

agents(amantadine and rimantadine) to high-priority target groups, especially when
vaccine is in short supply
5.Developing a comprehensive communications plan for effective interactions
with the media, the medical community, the general public, and neighboring
jurisdictions, and to transmit surveillance data and other relevant
information to the national level
6.Developing contingency plans for emergency preparedness, including theprovision of adequate medical care and maintenance of essential community
services ("human infrastructure")
7.Developing a mitigation2) strategy, including:■increased emphasis on improving coverage with annual influenza
vaccination for all currently recommended high-risk groups during thecurrent pre-pandemic period (to provide a more solid infrastructure
upon which to base a pandemic vaccination program for such groups)■

increased emphasis on improving coverage with pneumococcal vaccine
during the current pre-pandemic period (to reduce deaths caused bysecondary bacterial pneumonia)■

contingency plans for augmenting essential-services personnel in theevent of widespread absenteeism■

contingency plans for closing schools and large businesses andcanceling large community events to reduce spread if such measures
are ultimately considered as cost-effective

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Major planning and response elements included in this Guide -- along with
supplementary "checklists" provided in the annexes -- are intended to convey important
items to consider in the planning process, with each jurisdiction assuming
responsibility for deciding how each item is actually implemented. It is also recognizedthat a number of actions taken by State and local agencies will be contingent upon thedevelopment of national policies and procedures, many of which are presently underdevelopment.

ACKNOWLEDGMENTS
This Guide was originally prepared in January 1997 ("Version 1.1"), following a
consultation in Atlanta in September 1996 which involved approximately 50 State andlocal health and emergency response officials. The Guide was subsequently distributedby the Council of State and Territorial Epidemiologists (CSTE) to all 50 States andnumerous local health jurisdictions for review and comment. The Guide was also field
tested during the 1997-1998 influenza season in 5 States -- Connecticut, New York,
Maine, New Mexico, and Missouri -- and one local health district -- East Windsor
Township (NJ) Health Department -- to evaluate its usefulness in assisting State andlocal officials in the planning process. The present version of the Guide ("Version 2.1")
reflects numerous suggestions made by State and local personnel who participated inthis process, and also includes updates in activities and policies at the national level.
The guide has not been formally approved or endorsed by any governmental or
non-governmental organization, and should be considered only as an interim (draft)
guidance document as national planning efforts are completed. Consequently, questions,comments and suggested improvements related to this Guide are encouraged, andshould be addressed to the National Vaccine Program Office, Mailstop A-11, 1600
Clifton Road NE, Atlanta, GA 30333.
The principal authors of this Guide include:Peter A. Patriarca, M.D.
Center for Biologics Evaluation and Research, FDA
Raymond A. Strikas, M.D.
National Immunization Program, CDC

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Kathleen F. Gensheimer, M.D., M.P.H.
Division of Disease Control, Maine
Nancy J. Cox, Ph.D. and Keiji Fukuda, M.D.
Influenza Branch, National Center for Infectious Diseases, CDC
Martin I. Meltzer, Ph.D.
National Center for Infectious Diseases, CDC
Partial funding for this project was made available from the National Immunization
Program, CDC, through a cooperative agreement with the Council of State andTerritorial Epidemiologists.

TABLE OF CONTENTS● Introduction● Pandemic Planning: A High Priority● Assumptions in the Planning Process● Steps in the Planning Process○ Assemble an Executive Planning Committee○ Identify & Meet with Partners and Stakeholders○ Address Major Priorities■ Establish Command, Control & Management Procedures■ Establish Operational Procedures for Essential Functions■ SURVEILLANCE■ VACCINE DELIVERY■ DELIVERY OF ANTIVIRAL AGENTS■ EMERGENCY RESPONSE: health & medical, and maintenance of criticalservices■ COMMUNICATIONS: hardware, software, procedures and content○ Develop a State and/or Local Plan
● TABLE 1: Pandemic Planning & Bioterrorism: Similarities & Differences●

TABLE 2: Estimates of the medical impact of the next pandemic for planningpurposes● FIGURE 1: Principal Components of Pandemic Planning

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INTRODUCTION
Influenza viruses are unique in their ability to cause sudden, pervasive infection in all
age groups on a global scale. The importance of influenza viruses as biological threatsis due to a number of factors, including a high degree of transmissibility, the presenceof a vast reservoir of novel variants (primarily in aquatic birds), and unusual
properties of the viral genome. Rapid rates of evolution in the genes which encode themajor antigens of the virus -- the hemagglutinin (HA) and neuraminidase (NA) surface
proteins -- lead to the emergence of annual influenza epidemics which kill, on average,
approximately 20,000 Americans. More importantly, segmentation of the virus genome
has periodically led to reassortment (exchange) of gene segments between animal andhuman viruses during chance co-infections, resulting in the sudden and unpredictable
emergence of pandemics.

Three such pandemics have occurred in this century, oneof which -- the infamous "Spanish flu" of 1918 -- was responsible for more than 20
million deaths worldwide, primarily in young adults4).

Although mortality rates

associated with the more recent pandemics of 1957 (A/Asia [H2N2]) and 1968 (A/HongKong [H3N2]) were reduced in part by antibiotic therapy for secondary bacterial
infections and more aggressive supportive care, both were associated with high rates ofmorbidity and social disruption.

Moreover, based on rates of illness andcomplications observed in these pandemics, the Centers for Disease Control andPrevention (CDC) has preliminarily estimated that economic losses associated with thenext pandemic may range from ~$71 billion to ~$166 billion, depending on the attackrate.
To prepare for the next pandemic, an event considered by many experts to be inevitable,
public health officials from around the world have begun to devise strategies by which
influenza-related morbidity, mortality, and social disruption might be reduced. This
process was revisited in the U.S. in 1993, when the Federal government convened apanel of experts from the public and private sectors to review and revise the initialplan developed in 1978 and to assess the nation's current capacity to respond to thenext pandemic.

The panel not only considered tasks specifically related to thepandemic itself, but also those aimed at reducing the cumulative toll of annual
epidemics during the current pre-pandemic period.

The panel has emphasized fromthe outset that State and local health jurisdictions will play critical roles in
implementing the national plan, and should actively participate in the planning
process.

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PANDEMIC PLANNING: A HIGH PRIORITY
Contingency planning for an event on the horizon is frequently difficult to justify,
particularly in the face of limited resources and more urgent problems and priorities.
However, an influenza pandemic is unlike any other public health emergency orcommunity disaster:● Many experts consider influenza pandemics to be inevitable ... yet no one knows

when the next one will occur.
● There may be very little warning. Most experts believe that we will have between

one and six months between the time that a novel influenza strain is identified
and the time that outbreaks begin to occur in the U.S.
● Outbreaks

are expected to occur simultaneously throughout much of the U.S.,

preventing shifts in human and material resources that normally occur with othernatural disasters.
● The effect of influenza on individual communities will be relatively prolonged --weeks to months -- when compared to minutes-to-hours observed in most othernatural disasters.
● The impact of the next pandemic could have a devastating effect on the health andwell being of the American public. CDC estimates that in the United States alone:○ Up to 200 million persons will be infected○ Between 40 and 100 million persons will become clinically ill○ Between 18 and 45 million persons will require outpatient care
○ Between 300,000 and 800,000 persons will be hospitalized○ Between 88,000 and 300,000 persons will die● Effective preventive and therapeutic measures -- including vaccines and antiviral

agents -- will likely be in short supply, as may some antibiotics to treat secondary
infections.
● Health-care workers and other first responders will likely be at even higher risk of

exposure and illness than the general population, further impeding the care ofvictims.
● Widespread illness in the community will also increase the likelihood of sudden

and potentially significant shortages of personnel in other sectors who provide
critical community services: military personnel, police, firemen, utility workers,
and transportation workers, just to name a few.

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Planning for the next influenza pandemic now will not only facilitate an effective
response when the time comes, but also provide tangible benefits in the interim:●

Pre-pandemic planning will forge new and better communications between the
public health and emergency response sectors, which, in many States, operate
independently.

●

Involvement of partners and other stakeholders in pre-pandemic planning will
greatly facilitate "buy-in" for major elements of the plan when the time comes ...
rather than "forcing" or "springing" these elements upon stakeholders for the firsttime when the pandemic is imminent. Planning during the pre-pandemic period canalso clarify the role of each partner, identify gaps in the ability to respond, andensure that existing legal authorities are adequate to implement the plan when thetime comes.

●

Increasing awareness among the public health, medical and emergency response
which kill an average of 20,000 Americans every winter.

●

Improvements in infrastructure now to address the major elements of pandemic
preparedness can have immediate and lasting benefits, and can also mitigate theeffect of the next pandemic. For example, increasing routine, annual influenza
vaccination coverage levels in high-risk patients will not only reduce their risk ofdying or being hospitalized during the pre-pandemic period, but also facilitate
access to such patients -- through greater confidence in the benefits of influenza
vaccination and expanded programs to access those patients -- when the next
pandemic occurs. Similarly, increasing the coverage of pneumococcal vaccine in suchpatients could have a significant impact on the incidence and severity of secondary
bacterial pneumonia.

●

Major elements of pre-pandemic planning can also be applied to the current
counter-bioterrorism initiative, along with other rapidly emerging, infectious
disease threats (see Table 1).

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ASSUMPTIONS
For purposes of developing preliminary plans, State and local officials should assume
the following set of conditions:
1. The Federal government has assumed primary responsibility for a number of key
elements of the national plan, including:○

Vaccine research and development○

Coordinating national and international surveillance○

Assessing and potentially enhancing coordinating vaccine and antiviral capacity
and coordinating public-sector procurement (see Points #3 and 5 below)○

Assessing the need for and scope of a suitable liability program for vaccine
manufacturers and persons administering the vaccine (see Point #4 below)○

Developing a national "clearinghouse" for vaccine availability information,
vaccine distribution and redistribution○

Developing an adverse events surveillance system at the national level○

Developing a central (national) information database/ exchange/ clearinghouse5)on the Internet○

Developing "generic6)" guidelines and/or "information templates" that can be
modified and/or adapted as needed at the State and local levels, including:■ "Fact sheets" / Q & As on influenza, influenza vaccine, and antiviral agents■ Strategies and guidelines for interacting with the media and communicating

effectively with the public health and medical communities and the generalpublic■ Guidelines for triage and treatment of influenza patients in outpatient,

inpatient and non-traditional medical care settings7)■ Guidelines for setting up and operating mass vaccination programs■ Guidelines for distribution and use of antiviral agents■ Guidelines for the potential utility of "traditional" ("generic6)") public healthmeasures to curtail transmission such as the use of masks, isolation
precautions, and temporary closure of schools and large businesses.

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2.

For purposes of consistency, comparability and coordination of the national, Stateand local response, identification and declaration of the following "stages" will bedone at the national level:

Pandemic Phase

Definition

Novel Virus Alert*novel virus detected in one or more humans*little or no immunity in the general populations*potential, but inevitable precursor to a pandemic

Pandemic Alert*Novel virus demonstrates sustained person-to-person transmission
and cause multiple cases in the same geographic area

Pandemic
Imminent*Novel virus causing unusually high rates of morbidity and/or
mortality in multiple, widespread geographic areas

Pandemic*Further spread with involvement of multiple continents:
formal declaration madeSecond Wave

*Recrudescence of epidemic activity within several months
following the initial wave of infection

Pandemic over

*Cessation of successive pandemic waves, accompanied by the
return (in the U.S.) of the more typical wintertime epidemic cycle.

3.

Because of the substantial lead times required for vaccine production once a novel
strain has been identified, it is likely that vaccine shortages will exist, especiallyduring the early phases of the pandemic. National planners are presently
considering which target groups should receive vaccine in priority order (seefurther discussion below). Moreover, it is expected that individuals will need an
initial priming dose followed by a second dose approximately 30 days later toachieve optimal antibody responses and clinical protection. National planners are
currently pursuing mechanisms by which influenza vaccine can be made available
more rapidly and in larger quantities prior to and during the next pandemic.

4.

Liability protection for vaccine manufacturers and persons who administer vaccine
is a national issue and may need to be addressed by development of newlegislation.

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5.

Although antiviral agents are available that can theoretically be used for both
treatment and prophylaxis during the next pandemic, these agents will likely beavailable only for limited distribution. In the meantime, national planners areactively pursuing:○

the cost and feasibility of stockpiling additional quantities of these drugs
and/or their precursors;○

the designation of suggested target groups and guidelines for administration;○

the cost and feasibility of potential drug distribution schemes; and○the examination of legal and liability issues associated with large-scale
distribution.

6.

At the present time, very limited resources have been made available from theFederal government for purposes of State and local plan development. Based on
past history, resources can be expected to made available from the national levelfor plan implementation, although the level and nature of such resources have notbeen determined. Aside from new legislation specifically earmarked for planning,
response and mitigation, possibilities include:○

Federal contracts for the purchase of influenza vaccine○

Federal grants and/or reimbursement for vaccine distribution
and administration○

Federal purchase of at least some antiviral agents○Federal grants for enhanced surveillance○

Release of Federal funds under the Federal Response Plan (Stafford Act;
Public Law 93-288, as amended), as is done for other natural disasters(NOTE: criteria to be used for the release of funds have not yet been
determined)

Regardless of the options chosen, State and local jurisdictions should, for planningpurposes, expect to provide supplementary resources at the time of the pandemic,
including temporary redirection of personnel and financial resources from otherprograms.

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STEPS IN THE PLANNING PROCESS
1. Assemble an Executive Planning Committee
The first step in the planning process should be the establishment of an "Executive
Committee" at the State level, comprised of key representatives from the health sector-- which in most jurisdictions should take the lead -- and its emergency response sector.
This Committee will (1) devise the overall structure and responsibilities of "commandand control" operations; (2) oversee planning, response, recovery and mitigation efforts(see Figure 1, next page); and (3) ensure that the jurisdiction's pandemic plan isdeveloped, reviewed, and periodically revised.
Representation on the Executive Committee will, of course, vary from jurisdiction tojurisdiction -- depending on local circumstances, organizations, and responsibilities -but will generally include, at the State level:● Governor's Office (supplemented by representatives of the Mayor's office forlarge metropolitan areas)● State Health Officer (supplemented by County Health Officers, as needed)● State Epidemiologist●

State Office of Emergency Preparedness (and/or local emergency planningcommittees)● Public health laboratory personnel● Public health information officer● Immunization Project Director● Office of General Counsel 9)

2. Identify and Meet with Partners and Stakeholders to a) promote awareness; b)
assign specific responsibilities; and c) develop specific components of the plan
Once the Executive Committee decides on lead responsibilities for planning andimplementation, a series of meetings with potential partners and stakeholders should
occur. The pandemic preparedness plan at the State and/or local level must be
prepared in close collaboration with, and with "buy in" from a wide variety oforganizations in the public and private sectors, much like the current practice of healthagencies of forming and joining coalitions to advance a common goal.

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Such organizations may include, but not be restricted to:●

Communicable diseases personnel●

Immunization program personnel●

Contract (private) laboratories which may process clinical specimens for
influenza (as may be applicable)●

Personnel responsible for communication systems equipment, networks,
computer hardware and software●

Education administrators●

Local media officials●

Radio / CB groups●

Social services agencies●

Volunteer organizations involved in response and recovery to various disasters●

Law enforcement, fire / rescue, and emergency medical services ( including(e.g., RACES, REACT)

dispatchers / 91110) at the local level )●Area hospitals, Emergency Medical Services agencies, medical societies,
medical examiner, coroner, and other appropriate members of the medical
community●

Funeral directors●

Local military installations●

Large industries or employers in the area●

State aviation authority and/or others involved in the provision of air support11) and transport●

Representatives of major public utilities ( to ensure continued service during
the pandemic )●The jurisdiction's Chief Financial Officer, auditor, and heads of any centralized
procurement and/or resource support agencies

3. Address Major Priorities
The principal elements of the State or local pandemic plan include (1) a description of
the command, control and management structure and functions; and (2) contingency
plans to address surveillance, vaccine and antivirals delivery, communications, andemergency preparedness (maintenance of health services and essential community
functions). Each of these priorities is discussed in more detail below and in theattached annexes.

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14

Priority #1: Establish Command, Control and Management Procedures
Most States, major metropolitan areas and other large jurisdictions have emergency
preparedness plans -- sometimes known as "All Hazards Emergency Operations" Plans-- to cope with major disasters such as tornadoes, hurricanes, earthquakes, planecrashes, and the like. These plans will be very useful as a starting point for certain
aspects of pandemic planning, including command and control functions, descriptions
and operation of emergency communication systems, hospital and medical careresources, and other key response elements. However, pandemic planning will require
special emphasis on certain functions that are not normally included in All Hazards
Emergency Operations Plans, such as special surveillance operations, delivery of
vaccines and antiviral agents, and mitigation efforts (see Figure 1). One of the maindifferences between pandemic influenza and other natural disasters is the widespreadnature of health effects -- along with disruption of critical human infrastructure
because of those health effects -- which will require expansion of the typical disastermanagement team. This management team -- which should be comprised of the"Executive Committee" and key representatives from partner and stakeholder
organizations -- should:
DURING THE PRE-PANDEMIC PERIOD:●

Address each operational priority (see Figure 1 and the following sections of
this Guide)●

Ensure that a State (and/or local) pandemic plan is developed, either as anannex or supplement to the State's existing All Hazards Emergency Operations
Plan, or as a stand-alone plan●

Identify crucial gaps in State (and/or local) infrastructure and resources, laws
and/or statutes which --if not corrected in advance -- may interfere with aneffective response●

Develop a "marketing strategy" to inform key government officials, legislators,
and various stakeholders of the need to address and resolve these gaps inadvance of the pandemic●

Coordinate planning activities with bordering jurisdictions, including counties,
States, unique populations (e.g., Native American nations, certain religious
enclaves, etc.), and other countries (e.g., Canada and Mexico) in collaboration
with Federal authorities

National Vaccine Program Office, CDC

15

●

Review and modify the plan as needed on a periodic basis

DURING THE NOVEL VIRUS ALERT:●

Meet with appropriate partners and stakeholders and review major elements ofthe plan●

Modify the plan as needed on an urgent basis

DURING THE PANDEMIC ALERT:● Activate enhanced surveillance and communications plan (see below)●

Begin vaccine and antiviral distribution●

Notify key government officials and legislators of the need for additionalmonetary resources (if not already available)

DURING THE PANDEMIC IMMINENT STAGE:●

Fully activate the plan●

Coordinate activities with neighboring jurisdictions●

Interface with appropriate counterparts at the national level

NOTE: A more detailed "checklist" of major activities to consider is presently underdevelopment, and will be added to the Guide at a later date.

Priority #2: Establish Operational Procedures for Essential
Functions
SURVEILLANCE
Because the antigenic properties of influenza viruses are constantly changing, both
virologic surveillance -- in which influenza viruses are isolated for antigenic andgenetic analysis -- and disease surveillance -- in which the epidemiologic features andclinical impact of new variants are assessed -- should be viewed as equally critical for
pandemic preparedness. Although detection of antigenically novel viruses is of greatest
importance, as they may herald the onset of the next pandemic, minor antigenic
variations are also important to monitor.

National Vaccine Program Office, CDC

16

Because such changes occur continuously as circulating human strains evolve,
monitoring such changes and their impact on disease frequency and severity are
crucial in selecting the most appropriate strains for annual influenza vaccination
programs.
In the United States, international influenza surveillance activities are coordinated by
the WHO Collaborating Center for Influenza Reference and Research at the CDC.
Through its participation in the WHO's global influenza network -- which now consistsof approximately 110 national laboratories in over 80 countries and four International
Reference Centers -- the CDC maintains frequent communications with WHO
Headquarters in Geneva, with the other three WHO International Reference Centers,
and with national laboratories worldwide concerning the numbers and types/subtypesof influenza viruses isolated and the extent of influenza like disease which taking placeat the time of virus isolation. In addition, CDC annually produces and distributes
influenza reagent kits for identification of influenza viruses that are expected tocirculate worldwide.
National surveillance in the U.S. is also coordinated by CDC, with State and county
health departments assuming primary responsibility for carrying out virologic,
mortality, and morbidity components. These activities currently consist of (1) ~70
laboratories which report the number and type of influenza viruses isolated each week,
and which send representative and unusual viruses to CDC for comparative antigenic
and genetic analysis; (2) State and territorial epidemiologists who assess influenza
illness in their State each week, and who report the level of influenza activity as"widespread", "regional", "sporadic" or "no activity"; (3) a voluntary, national network ofsentinel physicians who report the number of patients with influenza-like illness (ILI)
per total number of patient visits by age group each week; (4) Vital Statistics Offices of
122 U.S. cities which report, each week, the percentage of total deaths caused byinfluenza and pneumonia (ICD-9 codes 480-487); and (5) a variety of other sources
which spontaneously report influenza outbreaks or other influenza-associated events.
CDC has devoted considerable resources to improve these basic components in recent
years, including the development of a semi-automated Internet-based reporting andfeedback system, and channeling additional funds through the Epidemiology andCapacity Program and Emerging Infections Program to strengthen the sentinel
physicians network and to build additional laboratory capacity.

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17

In addition to maintaining the five basic components necessary to carry out routine,
annual surveillance programs, pandemic preparedness will require enhancements toimprove "early warning" and "readiness" capability:●

Improved ability to detect importation and initial spread of novel variants
emerging from other countries.

Although the basic influenza surveillance

infrastructure in the U.S. has generally been adequate to monitor, on a "macro"level, the spread and impact of "drifted" strains, the sensitivity of detecting an
isolated importation event is generally poor. Resources available at the Stateand local levels vary widely, with some States having very limited ability toisolate and monitor the spread of new variants in a timely way.

●

Ability to rapidly expand surveillance activities.

The basic influenza

surveillance infrastructure in the U.S. has, in general, taken a "back seat"approach due to gradual erosion of resources in an environment of expanding
demands and priorities. Most States lack contingency plans for rapid expansionof their basic systems to provide the level of detail necessary to track the spreadand impact of a pandemic variant in State and local communities and to modify
control measures as needed.

●

Improved ability to detect the emergence of novel variants in the U.S.
Although most novel strains of influenza (pandemic variants) have emerged
from China and the Pacific Rim, such variants could arise in the U.S. In addition
to the primary focus of rebuilding State laboratory capacity, efforts are now
underway at the national level and in selected States to examine the potential
for highly pathogenic avian strains that are detected on poultry farms
nationwide and among live bird markets in the northeastern U.S. to betransmitted to humans. CDC is also collaborating with USDA to determine if
influenza viruses are being transmitted to humans from infected swine andhorses during outbreaks of influenza-like disease in domestic farm animals.

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In an effort to improve routine surveillance for "drifted" variants of influenza, and to
improve "early warning" and "readiness" capability for the next pandemic, State andlocal officials should focus on the following activities:
DURING THE PRE-PANDEMIC PERIOD:●

Improve virologic surveillance capability by ensuring that at least one
laboratory in each State and/or major metropolitan area has the capability of
isolating and subtyping influenza viruses. CDC is pursuing mechanisms toprovide periodic training for laboratory personnel from domestic WHO
collaborating laboratories. Areas of training will include hemagglutination
inhibition testing, new methods for typing/subtyping isolates and screening
methods for antiviral resistance.

●

Improve disease-based surveillance capability by expanding the existing
sentinel physicians network, with the aim of establishing a population-based
system of ~one sentinel physician per 250,000 population. This activity is also
being coordinated at the national level by CDC.

●

Developenhanced

electronicandtelecommunications

capability

withneighboring jurisdictions and with CDC.
●

Develop contingency plans for enhancing State and local virologic anddisease-based surveillance systems in the event of a novel virus alert or
pandemic alert. Such enhancements might includes surveillance of severe
respiratory illness and unexplained deaths at local hospitals; surveillance atclinics catering to international travelers; and surveillance of persons
travelling from geographic areas in which the novel strains have been isolated.

DURING THE NOVEL VIRUS ALERT:●

Monitor bulletins from CDC regarding virologic, epidemiologic and clinicalfindings associated with new variants isolated within or outside the U.S.

●

Obtain appropriate reagents from CDC to detect and identify the novel strain.

●

Meet with appropriate partners and stakeholders and review major elements ofenhanced surveillance activities; modify and update plan as needed●

Activate enhanced local surveillance to detect importation and local spread incoordination with CDC.

National Vaccine Program Office, CDC

19

DURING THE PANDEMIC ALERT:● Fully activate enhanced surveillance activities; assess functionality, timelinessand completeness of reporting (including "zero case" reporting), data entry anddissemination, and links and feedback at higher and local levels of the system.

DURING THE PANDEMIC IMMINENT STAGE:●

Implement and pilot-test final modifications, if any, in enhanced surveillancesystem.

●In collaboration with CDC and other groups at the national level, consider
special studies in concert with local public health officials, clinicians andacademicians to:○

document outbreaks of influenza in different population groups○

determine age-specific attack rates, morbidity and mortality○

describe unusual clinical syndromes (as well as risk factors for those
syndromes and appropriate treatment)○

describe unusual pathologic features associated with fatal cases○

conduct efficacy studies of vaccination or chemoprophylaxis.

○

monitor ability of hospitals and outpatient clinics to cope with increased
patient loads○

assess the effectiveness of traditional control measures such as school andbusiness closings○

assess the medical, social and economic impact of the pandemic

Draft protocols for these and other studies will have already been developed at thenational level, and shared with State and local officials who have previously shown aninterest in collaborating.
NOTE: A more detailed "checklist" of major activities to consider is presently underdevelopment, and will be added to the Guide at a later date.

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20

VACCINE DELIVERY
Following its development more than 50 years ago, inactivated influenza vaccine haslong been considered the cornerstone of influenza prevention and control. Althoughantiviral agents such as amantadine and rimantadine have since become available forthe therapy and prophylaxis of type A influenza infections -- and therefore offer apossible supplemental strategy during the next pandemic -- a number of factors,
including limited supply, will preclude their use except under very limited
circumstances (see ANTIVIRALS SECTION below). Thus, it must be assumed thatvaccination will also serve as the central preventive strategy during the next pandemic.
During the past 20 years, annual delivery of influenza vaccine to the American public
has increasingly become an "institutionalized" event. The World Health Organization(WHO) collaborating influenza centers detect and monitor new variants of influenza
virus throughout the year for potential inclusion in the next year's vaccine; vaccine
strains are ultimately chosen by Spring; the four licensed U.S. manufacturers make~70-80 million doses over the winter through summer months; and the vaccine isadministered, primarily to "high risk" patients (as currently defined by the Advisory
Committee on Immunization Practices [ACIP]), from ~September through January.
Approximately 90% of all doses are currently administered through the private sector,
with most States and counties offering relatively small amounts of vaccine throughpublicly funded programs. This system has served the American public well -- withrecord levels of vaccination coverage during the 1990's-- and continues to improve overtime.
In contrast to the "institutionalized" annual system, the next pandemic will pose anumber of challenges for vaccine delivery, particularly to State and local healthdepartments, which clearly must serve as the "linchpin" of vaccination efforts:●

The target population for vaccination will be expanded far beyond the typical"high-risk" groups to encompass, ideally, the entire U.S. population.

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21

●The "warning period" preceding spread of the pandemic strain in the U.S. islikely to be relatively short, so that vaccine will have to be distributed andadministered as rapidly as possible.

●

Because a pandemic strain can arise and be detected at any time, and because
current manufacturing procedures dictate that a minimum of 6-8 months
would elapse before tens of millions of doses would become available for
distribution, it is likely that a severe and/or moderate vaccine shortage is likely
to exist, especially early on during the course of the pandemic. Moreover, it ispossible that no vaccine will be available.

●

Immunologic responses following vaccination of unprimed (seronegative)
individuals is generally poor, so the emergence of a pandemic strain with newhemagglutinin (HA) and/or neuraminidase (NA) antigens will likely require asecond dose of vaccine ~30 days later.

Thus, mechanisms must be in place far in advance of the pandemic so that limited
vaccine supplies can be efficiently allocated and distributed to those considered to be ingreatest need (see below), to reallocate and redistribute unused vaccine promptly andefficiently, and to obtain high rates of compliance for the second dose if it is confirmedthat two doses will be necessary for optimal protection.
In view of the likely vaccine shortage, the U.S. Public Health Service, in conjunction
with various advisory committees, is in the process of formulating recommendations fora rank-order list of high priority target groups for vaccination. The order of thesegroups will be based on a number of factors, including the need to maintain thoseelements of community infrastructure that are essential to carrying out the pandemic
response plan; to limit mortality among high-risk groups; to reduce morbidity in thegeneral population; and to minimize social disruption and economic losses. Oncedeveloped, the rank-order list will also be subject to change -- and potentially on short
notice -- depending on the epidemiologic and clinical features exhibited by the actual
pandemic strain. Thus, advance preparations must have a high degree of flexibility
built into the distribution system. Until the "default" priority listing is finalized, Stateand local officials should begin to formulate plans for vaccinating the following target
groups:●Health-care workers and public health personnel involved in the distributionof vaccine and antiviral agents

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22

●Persons responsible for community safety and security, e.g., police, firefighters,
military personnel, National Guard, "first responders" not included in firstpriority group (e.g., ambulance drivers)●

Other highly skilled persons who provide essential community services whose
absence would either pose a significant hazard to public safety (e.g., nuclear
power plant workers) or severely disrupt the pandemic response effort (e.g.,
persons who operate regional telecommunications or electric utility grids).
[NOTE: Members of this target group are likely to vary widely fromjurisdiction to jurisdiction, depending on local circumstances.]●

Persons traditionally considered to be at increased risk of severe influenza
illness and mortality, as currently defined by the ACIP:○ Person of any age with high-risk medical conditions○ Pregnant women○ Persons in nursing homes and other long-term care facilities○ Persons >65 years of age without high-risk medical conditions○ Infants age 6-12 mo (if supported by epidemiologic and clinical data)●

Household contacts of persons with high-risk medical conditions●

Persons not included in Group #3 above who, in the judgement of State andlocal health officials, provide critical community services (e.g., utility workers,
funeral services personnel, personnel involved in the transport of essential
goods such as food, etc.)●

Healthy persons age 18-64 years●

Pre-school-age (especially day-care-center attendees) and school-age children[the population least likely to have severe illness]

In addition to the important differences between annual and pandemic vaccination
programs mentioned earlier, there will also likely be state and local differences withregard to: (1) the mix of public sector (Federal and/or State) and private sector vaccine
purchase; and (2) State and/or county administration through the public sector in
addition to administration through the private sector. Although the exact proportion of
vaccine to be purchased and administered through the public versus private sector has
not yet been established, it is likely that the public sector will take responsibility, at aminimum, for vaccinating health care workers, other "first responders", certain
essential community servants, the poor and the uninsured. The actual organizationand conduct of State and local vaccination programs will likely have to "customized" foreach jurisdiction and target group, depending on the extent and flexibility of the

National Vaccine Program Office, CDC

23

available infrastructure and resources within the public and private sectors. These andother aspects of vaccine delivery must be carefully thought through well in advance ofthe pandemic.

The final point which should be emphasized is that the success of the pandemic
vaccination program will be determined in large part by the strength of State and local
vaccination programs during the inter-pandemic period. Public confidence in thebenefits of influenza vaccine must continue to improve, along with increased emphasison the use of pneumococcal polysaccharide vaccine. The recent emergence ofantibiotic-resistant strains of S. pneumoniae and obstacles which may preclude
large-scale pneumococcal vaccination programs in the midst of an influenza pandemic
further underscore the need to raise pneumococcal vaccine coverage levels far above
the 30% estimate reported for high-risk patients in 1994.
Based on these general principles, a summary of priority activities follows:

DURING THE PRE-PANDEMIC PERIOD:● Enhance influenza vaccination coverage levels in traditional "high-risk" groups,

particularly subgroups in whom coverage levels are particularly low: minorities
and persons <65 years of age with chronic underlying medical conditions.
Increasing routine (annual) vaccination coverage levels in these groups now willfurther reduce the annual toll of influenza and will facilitate access to these
populations when the pandemic occurs.
● Enhance pneumococcal

vaccination coverage levels in traditional "high-risk"

groups (to reduce the incidence and severity of secondary bacterial pneumonia)●

Developaprogrammatic

schemeforprovidinginfluenzavaccinetohigh-priority target groups and the general population:
1.

In the presence of severe vaccine shortages

2. In the presence of moderate shortages
3. In the presence of no shortages● Consider

State-specific modifications or refinements in priority groups,

depending on local circumstances. For example, there may be specific groups of
persons in selected States whose absence (due to influenza illness) could posedisastrous consequences in terms of public safety or disruption of essential

National Vaccine Program Office, CDC

24

community services. Examples of such unique, special-skill groups might include
nuclear power plant operators, air traffic controllers at major airports, andworkers who operate major telecommunications or electrical grids.
Ensure that appropriate legal authorities are in place that will allow for●

implementation of major elements of the proposed distribution plan. For
example, will State law allow non-licensed volunteers to administer influenza
vaccine? Does State law allow for "mandatory" vaccination of certain groups, if
vaccination of such groups is viewed by State public health officials as being"essential" for public safety?
● Ensure that contingency plans have been considered for emergency distributionof unlicensed vaccines using emergency IND (investigational new drug)
provisions. Such provisions call for strict inventory control and record-keeping,along with completion of a signed consent form.
Coordinate proposed vaccine distribution plan with bordering jurisdictions,●

including counties, States, unique populations (e.g., Native American nations,certain religious enclaves, etc.), and other countries (e.g., Canada and Mexico) incollaboration with Federal authorities● Review and modify vaccine distribution plans as needed on a periodic basis.

DURING THE NOVEL VIRUS ALERT:● Meet with appropriate partners and stakeholders and review major elements ofthe vaccine distribution plan.
● Modify plan as needed to account for updates, if any, on recommended target

groups and projected vaccine supply.

DURING THE PANDEMIC ALERT:● Ensure that human resources and logistics are in place to begin vaccination.
● Coordinate activities with bordering jurisdictions.

DURING THE PANDEMIC IMMINENT STAGE:● Fully activate the vaccination program.
● Coordinate activities with bordering jurisdictions.

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25

NOTE: A more detailed "checklist" of major activities to consider is presently underdevelopment, and will be added to the Guide at a later date.

DELIVERY OF ANTIVIRAL AGENTS
The antiviral agents amantadine and rimantadine are chemically related drugs thatinterfere with the replication of type A influenza viruses. Many studies have shown
both drugs to be approximately 70%-90% effective in preventing illnesses caused by awide variety of naturally occurring strains in both children and adults; most experts
believe that similar levels of efficacy can be achieved with novel (pandemic) strains.
Amantadine and rimantadine can also reduce the severity and duration of signs andsymptoms of influenza A illness when administered within 48 hours of illness onset.
Because of their "generic" usefulness against all known influenza A viruses,
amantadine and rimantadine might be expected to play an important role inprevention and treatment of pandemic influenza, especially during times whensufficient supplies of vaccine may not be available. However, there are a series of
formidable problems and limitations associated with widespread use of these antiviral
agents:1. Under present circumstances, the supply of these drugs would be well below theanticipated demand during an influenza pandemic. Current annual production ofamantadine and rimantadine is estimated to be ~100 million doses, withapproximately 30-40 million doses of amantadine being used for indications otherthan treatment and prophylaxis of type A influenza (e.g. Parkinsonism). Rimantadine
has no indication other than use against influenza type A. The estimated excess
capacity of all current manufacturers of these drugs combined is ~4 times thatamount, or roughly 33 million doses per month. The recommended dosage for most
persons would require ~60 doses per month to prevent influenza infection, and ~10
doses for therapy. Thus, a maximum of only ~500,000 and 3 million persons could
receive chemoprophylaxis or therapy, respectively, each month during the pandemic.
The Federal government is presently considering the feasibility and cost of
stockpiling the two drugs and/or the raw materials (drug precursors) to make them.
Until these assessments have been completed, it should be assumed that the two
drugs will play only a minimal role in reducing the impact of the pandemic, andshould be reserved only for very high priority groups (e.g., health-care workers). The

National Vaccine Program Office, CDC

26

Federal government will also be considering ways in which limited supplies may
distributed and used equitably, and to reduce the threat of black markets.

2. Relative priorities regarding target groups and the use of limited supplies forchemoprophylaxis versus therapy have not yet been established. In general, priority
groups for receipt of antiviral agents should be consistent with priorities for vaccine
administration. However, priorities and guidelines will require "fine tuning" toaccount for differences between the two drugs in adverse event profiles, renal
excretion, and other variables. Even more problematic will be weighing theadvantages and disadvantages of using these drugs for prophylaxis versus therapy.
Although using available supplies for treatment would help to lower costs andconserve drug supplies, these would be counterbalanced by greater losses in
productivity, absenteeism and use of health care resources. It is also unknown
whether treatment will actually reduce the risk of influenza-associated complications
among persons with high-risk conditions, or whether treatment of large numbers of
persons simultaneously will give rise to greater numbers of drug-resistant virus
strains. These and other considerations are presently being discussed among experts
at the national level.
3. Widespread use of rimantadine and amantadine could lead to the widespread
emergence of drug-resistant viral strains. While the potential for emergence ofdrug-resistant viruses associated with the use of amantadine and rimantadine is very
high, the potential for sustained transmission of these viruses has not been defined. A
system for implementing virologic surveillance to detect and monitor the incidence
and prevalence of drug-resistant influenza virus strains should be developed andpilot-tested during the pre-pandemic period.
4. Adverse reactions and liability issues will be of great concern. The potential foradverse drug reactions associated with amantadine, and to a lesser extent
rimantadine, and potential adverse interactions with other drugs have raised
concerns about safety and legal liability in a scenario of large-scale distribution anduse of these antiviral agents. Increased use of amantadine and rimantadine during apandemic combined with heightened public awareness of potential side effects would
likely result in an increase in litigation for incidents such as intentional orunintentional injuries and other adverse events that could be attributed to untoward

National Vaccine Program Office, CDC

27

neurologic and behavioral manifestations considered to be possible side effects ofthese drugs (e.g., dizziness, disorientation, amnesia). The nature of side effects
associated with these drugs, especially amantadine, would make assessment ofliability extremely difficult. Special legislation may be needed to define and address
the extent of liability of pharmaceutical companies and Federal, State and local
governments.
Until these and other issues can be resolved at the national level, priority planning
activities at the State and local levels for allocation and distribution of antiviral agentsshould be relatively limited:

DURING THE PRE-PANDEMIC PERIOD:● Develop a contingency distribution system for health-care workers and otheressential community servants. It appears that the current drug distribution
network, with some modifications, could be used to distribute antiviral agentsduring a pandemic. Major wholesale distributors presently ship drugs
throughout the United States to local hospitals, pharmacies and other outlets.
This system could be used to distribute antivirals to health departments, clinics,
hospitals and other distribution sites (e.g., police stations) during a pandemic.
For prophylaxis, weekly or monthly supplies of drug may need to be dispensed toindividuals for self-administration. New systems and regulations may need to becreated to allow dispensing antiviral agents without a prescription, althoughcompliance with guidelines would be very difficult to monitor and control. Basedon current projections of excess manufacturing capacity, each State should planon the availability of no more than 600,000 doses of the two drugs combined permonth. The allocation and distribution system would need to take into accountthe need to conserve amantadine for patients who are taking this drug for otherindications such as Parkinson's disease.

DURING THE NOVEL VIRUS ALERT:●

Meet with appropriate partners and stakeholders and review major elements of
the antivirals distribution plan.

●

Modify plan as needed to account for updates, if any, on recommended target
groups and projected drug supply.

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DURING THE PANDEMIC ALERT:●

Ensure that human resources and logistics are in place to begin drug
distribution and administration.

●

Coordinate activities with bordering jurisdictions.

DURING THE PANDEMIC IMMINENT STAGE:●

Fully activate the antiviral drug distribution program.

●

Coordinate activities with bordering jurisdictions.

EMERGENCY RESPONSE: HEALTH AND MEDICAL & MAINTENANCE
OF CRITICAL SERVICES- HEALTH EFFECTS All States and local areas have emergency response plans that are geared towards
natural disasters. However, as noted elsewhere in this guide, the next influenza
pandemic is likely to pose a series of unique challenges that may not be accounted forin available "All Hazard" plans:● Unlike the typical focal disaster, the influenza pandemic will be widespread, withmany geographic areas affected simultaneously. Thus, every community will
have to be prepared, rather than (e.g.) pooling resources from several contiguouscounties, or relying on State personnel for help.
● If influenza-associated illness is especially severe (as in 1918, for example), local

health services could easily become overwhelmed very quickly, with:○potential shortfalls of ICU beds, ventilators and other critical-care needs○

potential shortages of antiviral agents (see above) and antibiotics fortreatment of secondary (bacterial) pneumonia;○

potential needs for ancillary or "non-traditional" treatment centers 12);○potential high demand for mortuary/funeral services; and○potential high demand for social and counseling services

National Vaccine Program Office, CDC

29１２）１９１８年のパンデミックでは、病院施設が不足し、公園に診療テントが張られり、学校の体育館、講堂、市民ホール等に臨時病棟が設置された。

Moreover, unlike natural disasters, demands on medical care in each community will
last 6-8 weeks until the "first wave" of infection is complete.

●

Unlike the typical disaster, essential community servants themselves (e.g.,
medical-care personnel, police, firefighters, ambulance drivers, and other first
responders) will be just as likely -- or even more likely (because of increased
exposure) -- to be affected by influenza than the general public.

● Because of the threat of exposure to influenza, the elderly and other high-risk

populations may be fearful of leaving their homes and seeking proper medical
attention for chronic medical conditions, and may require home visits forhealth care.
To assist State and local jurisdictions in developing contingency plans for handlingpotentially high demands for medical-care services, the following guidelines arepresently being developed at the national level, and will be made available to State andlocal officials as soon as possible:●

Generic "fact sheets"/ Q & A's on influenza, influenza vaccine, and antiviral
agents●Strategies

andguidelinesforinteracting

with

the

media

and

for

communicating effectively with stakeholders and the general public●

Guidelines for triage and treatment of influenza patients in outpatient,
inpatient and non-traditional medical care settings●

Guidelines for setting up and operating mass vaccination programs●

Guidelines for distribution and use of antiviral agents●

Guidelines for the use and potential effectiveness (or non-effectiveness) of"traditional" ("generic") disease control measures such as the use of masks andother hygienic barriers, as well as strategies to curtail community
transmission such as cancellation of large community events and temporary
closure of schools and large, "non-essential" businesses. It should be noted thatthe value of these and other measures is largely uncertain at the present time.

National Vaccine Program Office, CDC

30

In addition, the Centers for Disease Control and Prevention has provided preliminary
impact estimates for the next pandemic, based on experiences from earlier pandemics
and from contemporary estimates of the number of "high-risk" patients -- i.e., thosewith pre-existing, chronic medical conditions -- in the general population (see Table 2).
These estimates can be used by State and local officials to examine capacity issues intheir own jurisdictions.
- EFFECTS ON OTHER ESSENTIAL SERVICES (HUMAN INFRASTRUCTURE) In contrast to typical natural disasters -- in which critical components of the physicalinfrastructure may be threatened or destroyed -- an influenza pandemic may also posesignificant threats to the human infrastructure responsible for critical community
services due to widespread absenteeism in the workforce. Examples of such services(and personnel) in the non-health sector might include highly specialized workers in
the public safety, utility, transportation and food service industries, and will likely varyfrom jurisdiction to jurisdiction. State and local officials should carefully consider
which services (and key personnel within relevant firms or organizations) are"essential" -- i.e., which services, if interrupted, and which workers, if absent, would
pose a serious threat to public safety or would significantly interfere with the ongoing
response to the pandemic.
Based on the dual concerns of maintaining essential services in both the health andnon-health sectors, a summary of priority activities follows. NOTE THAT MANY OF
THESE EMERGENCY OPERATIONS OVERLAP WITH PREPARATIONS TO
COUNTERACT CHEM/BIOTERRORISM.
DURING THE PRE-PANDEMIC PERIOD:●

Estimate potential number of outpatient visits, hospitalizations/hospital days
and deaths in each jurisdiction over the 6-8 week period of the "first wave" of thepandemic; assume that the peak in incidence will occur at ~3-4 weeks (see Table
2 as a template for generating estimates). Examine adequacy of existing
health-care infrastructure in light of those estimates:○

Hospital beds○

ICU beds○

Ventilators

National Vaccine Program Office, CDC

31

○

Ready (or contingency) supplies of antibiotics used to treat secondary
bacterial pneumonia (e.g., beta-lactams [cefotaxime or ceftriaxone] +macrolides[erythromycin,

fluoroquinolone

alone

clarithromycin,[levofloxacin,azithromycin]

sparfloxacin,oragrepafloxacin,

trovafloxacin]).
○

Ready (or contingency) supplies of antiviral agents for treatment of illpatients and for chemoprophylaxis of health-care workers (note: see"antivirals section" above)○

Medical staff (physicians, nurses, respiratory therapists, radiology
technicians, etc.)○

Adequacy of contingency medical-care facilities designated in "All Hazards
Emergency Response Plan" (for potential use in other natural disasters)○

Adequacy of mortuary/burial services○

Adequacy of social and psychological services for families of victims● Develop contingency plans to address any of the items above which are thought tobe inadequate.
● Develop and conduct appropriate training/"table top" exercises for medical-carepersonnel.
(NOTE: prototypes expected to be developed at the national level).
● Develop contingency plans to provide food, medical and other essential life-support

needs for persons confined to their homes by choice or by direction from State andlocal health officials. Enlist appropriate military personnel (including National
Guard) and voluntary organizations as needed.
●

Develop listing of essential community services (and corresponding personnel)
whose absence would pose a serious threat to public safety or would significantlyinterfere with the ongoing response to the pandemic. Develop contingency plansfor emergency back-up of such services and/or provision of replacement personnel.
Replacement personnel could come from lists of retired personnel and/or
government or private-sector employees with relevant expertise. Note that criticalpersonnel in the non-health sector should also be considered as high-priority
candidates for vaccination and/or chemoprophylaxis (see previous sections of thisGuide).

DURING THE NOVEL VIRUS ALERT:● Meet with appropriate partners and stakeholders and review major elements of

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32

the health sector and essential non-health sector response plans.
● Modify plan as needed to account for updates, if any, on projected impact of thepandemic.
● Implement

contingency plans, if any, for obtaining critical equipment (e.g.,

ventilators) and drugs (e.g., antibiotics for treatment of secondary pneumonia).

DURING THE PANDEMIC ALERT:● Ensure that human resources and logistics are in place to provide medical care andto maintain essential community services.
● Coordinate activities with bordering jurisdictions.

DURING THE PANDEMIC IMMINENT STAGE:● Fully activate emergency response plans.
● Coordinate activities with bordering jurisdictions.

NOTE: A more detailed "checklist" of major activities to consider is presently underdevelopment, and will be added to the Guide at a later date.

COMMUNICATIONS: HARDWARE, SOFTWARE, PROCEDURES AND
CONTENT
Dissemination and sharing of timely and accurate information among public healthofficials, medical care providers, the media and the general public will clearly be one ofmost important facets of the pandemic response. Because large communications
networks must already be "up and running" for multiple purposes (see below), and withvery little advance warning, it is essential that the function and content of suchnetworks be firmly established during the pre-pandemic period. These activities will
require:● Inventories of existing communications systems (hardware and software)● Identification of gaps in existing systems that will require additional human andfinancial resources

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33

●Efforts to acquire these additional resources and for enhancements of existing
systems.

Because State and local health officials will likely face considerable difficulties injustifying the development of a sophisticated communications system for a problem
which may or may not occur in the near term -- i.e., pandemic influenza --justificationand "marketing" of such a system to policy makers and legislators should be based on amore generic approach such as responding to chem/bioterrorism events, emerging
infectious disease threats and/or other unexpected public health emergencies.
Pandemic influenza can be used as a readily understood model to emphasize theimportance for the development and ongoing enhancements of such communication
systems.

In order to develop a comprehensive, national communications strategy to better
ensure dissemination of -- and access to -- consistent, accurate and timely information,a series of activities is presently underway at the national level, including:● Continuous

improvements in pre-pandemic period communications systems( primarily based at CDC ), including enhancements of existing Internet sites,
toll-free information lines, surveillance bulletins, routine Q & A's on influenza,
influenza vaccine, antiviral agents, etc.

●

Design and development of a national, multi-component pandemic communications
system -- consisting of electronic ( including a dedicated Web site, e-maildistribution,bulletinboard,

information

clearinghouse,etc.),

telephonic,

administrative and paper components. Major focus will be creation of a Web site,with multi-level password protected access, links to other Web sites, etc., forselected/ varied audiences●

Development of prototype communication materials for use during the next
pandemic:

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34

○ Pandemic-focused Q & A's/ fact sheets/ on-line/ video and audio clips 13), etc., on

influenza, influenza vaccine, antiviral agents, etc., in various languages○ Prototype press kits, bulletins, newsletters, etc.
○ General preventive measures/do's and don'ts for the general public○ Information/ guidelines for health-care providers○ Telephonic "hot line" systems ( including hierarchical, restricted components )○ Videoconferencing capability○ Training modules ( Web-based, printed, video, etc.)○ "Canned" presentations, slide sets, videos, documentaries○ Symposia on surveillance, treatment, prophylaxis, etc.
○ Posters

１３）パソコン上で再生可能な音声データのこと

One of the main intents of these activities is to facilitate and streamline activities
within State and local jurisdictions, and to reduce duplication of effort. "Generic"materials have been -- and will continue to be -- developed in close collaboration with
State and local officials.
Based on the critical need to provide (and exchange) consistent, accurate and timely
information both horizontally and vertically, a summary of priority activities follows:
DURING THE PRE-PANDEMIC PERIOD:● Develop policies and procedures for the establishment of a "vertical" pandemic

communications system -- preferably through a "Central Information Office" -which mirrors the components of the national system ( and allow for information
flow to and from the national system ). Estimate hardware, software andpersonnel needs for the establishment of such a system.
● Develop policies and procedures for the establishment of a "horizontal" system --i.e., an information system that will include all the necessary, and, in many
instances, unique components to facilitate information exchange at the State andlocal level. Examples of such components may include intra-jurisdictional
communications about surveillance, vaccination programs and emergency response

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35

procedures; educational materials/"fact sheets" for culturally unique populations;establishment of local media links; etc.
● Develop a "marketing plan" to obtain additional resources to address important

gaps in the existing communications system. One approach may be to develop amulti-purpose communication system that can address other public health or
emerging infectious disease problems such as chem-bioterrorism.

●

Pilot test communications system ( to the extent possible ) during the
pre-pandemic period. Modify and enhance system as needed.

DURING THE NOVEL VIRUS ALERT:● Meet with appropriate partners and stakeholders and review major elements of

the "vertical" and ( especially ) "horizontal" communications system.
● Modify communications plan ( and written materials ) as needed ( in collaboration

with national officials ) to account for updates, if any, on projected effects of thenovel virus.
● Implement contingency plans, if any, for obtaining critical hardware, software, or

personnel to operate the pandemic communications system.
● Pilot test communications system.

DURING THE PANDEMIC ALERT:● Ensure that adequate hardware, software, and human resources and logistics arein place to implement the communications plan.
● Coordinate communication activities with bordering jurisdictions.

DURING THE PANDEMIC IMMINENT STAGE:● Fully activate communications systems.
● Coordinate activities with bordering jurisdictions.

NOTE: A more detailed "checklist" of major activities to consider is presently underdevelopment, and will be added to the Guide at a later date.

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36

4. Develop a State and/or Local Plan
Once the principal elements of the State or local pandemic plan have been determined-- including (1) the command, control and management structure and functions; and (2)contingency

plans

to

address

surveillance,

vaccineandantivirals

delivery,communications, and emergency preparedness -- a written State (and, in someinstances, a local) pandemic preparedness plan should be developed. This can either bedone as a stand-alone plan -- as will be done at the national level -- or as an annex to
the State's "All Hazards" Emergency Response Plan. It should be recognized that
pandemic planning is a dynamic process, with continual adjustments with changing
circumstances, resources, and technology, so that periodic revisions will be necessary.
As noted elsewhere in this Guide, it is also essential for State and local public healthofficials to consider pandemic planning as a model for responding to any rapidly
emerging or unexpected biological hazard, and to "market" the plan as such to policy
makers, legislators, and others.

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TABLE 1: PANDEMIC INFLUENZA and BIOTERRORISM

ISSUE

A Summary of Similarities and Differences
BIOTERRORISM
PANDEMIC INFLUENZA

Likelihood

High

High

Warning

None to days

Days to months

Occurrence

Focal or multifocal

Nationwide

Transmission / Duration of exposure

Point source / limited

Person-to-person / 6-8 weeks

Casualties

Hundreds to thousands

Hundreds of thousands to millions

First responders susceptible?

Yes

Yes

Disaster Med Team support/response Yes

No ( too widespread )Main site for preparedness, response, State and Local Areas
recovery and mitigation

State and Local areas

Essential Preparedness components:
Surveillance
Law enforcement intelligence
Investigation
Research
Liability programs
Communication systems
Medical triage and treatment plans

Yes
Yes
Yes
Yes
No
Yes
Yes

Yes
No
Yes
Yes
Yes
Yes
Yes

Vaccine supply issues

Yes ( for most likely threats )YesDrug supply issues

Yes

Yes

Training / tabletop exercises
Yes
Maintenance of essential community Yes
services

Yes
Yes

Essential response components
Rapid deployment teams
Effective communications / media
relations strategy

Yes
Yes

No
Yes

Vaccine delivery
Drug delivery
Hospital / Public health coordination

Yes ( for most )Yes ( for some )
Yes

Yes
Yes
Yes

Global assistance
Medical care
Mental health support
Mortuary services
Supplies and equipment

Possibly
Yes
Yes
Yes
Yes

Yes
Yes
Yes
Yes
Yes

Essential mitigation components
Enhanced surveillance
Enhanced law enforcement
intelligence
Vaccine stockpile
Drug stockpile
Pre-event vaccination

Yes
Yes

Yes
No

Yes ( selected agents )Prototype vaccines only
Yes
Yes
Vaccination of selected groups Vaccination of medically high-risk
only*groups with8) pneumococcal
vaccine**

NOTE: *current vaccines for selected bioterrorism threats are in short supply and havemarginal safety profiles.
NOTE: **It may eventually be possible to vaccinate high priority target groups and/or thegeneral population with a yet-to-be-developed "common epitope" vaccine which may provide
for a broader spectrum of protection against a variety of influenza A subtypes. It has also
beensuggested[antigenicallythat

related]pre-eventvaccination

hemagglutinins

with

and/orvaccines

containing

neuraminidases"prototype"correspondingtoantigenically novel subtypes might provide partial protection against the actual pandemicstrain and reduce the severity of illness.

TABLE 2: ESTIMATES OF THE HEALTH IMPACT OF PANDEMIC INFLUENZALOWER LIMIT16)UPPER LIMIT16)OUTPATIENT VISITS
High-risk patients
0-19 years
20-64 years
65+ years

289
70
79

403
149
130

165
40
45

230
85
74

Other ( "standard-risk" ) patients
0-19 years
20-64 years
65+ years

HOSPITALIZATIONS ( note: average length-of-stay=4,6, and 7 daysin the 0-19, 20-64, and 65+ year age groups, respectively )High-risk patients
0-19 years
20-64 years
65+ years

2.1
0.9
4

9
5.1
13

0.13
0.1
2.8

2.9
2.8
3

0.13
0.1
2.8

7.7
5.7
5.6

0.014
0.025
0.028

0.13
0.09
0.54

Other ( "standard-risk" ) patients
0-19 years
20-64 years
65+ years

DEATHS
High-risk patients
0-19 years
20-64 years
65+ years

Other ( "standard-risk" ) patients
0-19 years
20-64 years
65+ years

NOTES: (1) Estimates provided by M. Meltzer, N. Cox, and K, Fukuda, CDC[unpublished17] data]. (2) Estimates of the percentage of high-risk persons in each age groupare as follows: 0-19 years [6-11%]; 20-64 years [14-25%]; 65+ years [40-55%].
(3) Length-of-stay for hospitalizations noted above are based on data for inter-pandemic
years; these may be shorter (due to high demand) or longer (due to increased increased
illness severity) during a pandemic.