Department of Health and Human Services

Pandemic Planning 

Update

A Report from Secretary Michael O. Leavitt

March 13, 2006

“President Bush asked Congress for $7.1 billion to fund preparations, 

and in December 2005 Congress appropriated $3.8 billion to help the 

Nation prepare. Of that, $3.3 billion was allocated to HHS. This report 

outlines how that funding is being used to help achieve HHS’s five 

primary objectives.”
We are in a race. We are in a race against a fast moving virulent virus with 

the potential to cause an influenza pandemic. In November when President 

Bush announced the National Strategy for Pandemic Influenza, the highly 

pathogenic H5N1 avian flu virus was confirmed in birds in 16 countries. It was 

known to have infected 122 people and 62 – half of those infected – died. 

Today, four months later, H5N1 

has spread to 37 nations on 

three continents; 175 people 

have been infected and 96 

of them have died. To date, 

most of those people were 

exposed to infected poultry. 

Fortunately, there has been no 

sustained human-to-human 

transmission of the disease, 

but the rapid spread of H5N1 

is reason for concern. 

We are in a race, a race 

against a quick changing 

virus, for H5N1 has not only spread, it has evolved. There are now two main 

variants, or clades, of H5N1 and it is this second, newer clade that is spreading 

across western Asia into Europe, the Middle East and Africa. This second clade 

has killed over 60 percent of those it is known to have infected.

Let me be very clear. It is only a 

matter of time before we discover 

H5N1 in birds in America. The 

migration patterns of the wild 

fowl that carry the virus make its 

appearance here almost inevitable. 

The arrival of the first H5N1 bird 

in America should not be cause 

for alarm or panic. It does not 

mean that a pandemic is at our 

doorstep. It should, however, 

motivate us to pick up the pace, to 

renew pandemic preparations on 

every front at every level.

 

Message from the Secretary

1

Countries with Avian Influenza and

Cumulative Human Deaths

Countries with avian influenza in animals

Human Deaths (cumulative)

2003 2004 2005 2006

 Through March 8

Flu Terms Defined

Seasonal (or Common) flu is a respiratory illness that

can be transmitted person to person. Most people have

some immunity, and a vaccine is available.

Avian (or bird) flu is caused by influenza viruses that

occur naturally among wild birds. The H5N1 variant is

deadly to domestic fowl and can be transmitted from

birds to humans. There is no human immunity and no

vaccine available.

Pandemic flu is virulent flu that causes a global

outbreak, or pandemic, of serious illness. Because there

is little immunity, the disease can be spread easily

from person to person. Currently, there is no pandemic

flu.

“Let me be clear. It is only 

a matter of time before we 

discover H5N1 in America. 

The migration patterns of the 

wild fowl that carry the virus 

make its appearance here 

almost inevitable.”

 –Secretary Michael Leavitt, 

HHS 
 Our Five Priorities

President Bush asked Congress for $7.1 billion to fund preparations, and in 

December 2005 Congress appropriated $3.8 billion to help the Nation prepare. 

Of that, $3.3 billion was allocated to HHS. This report outlines how that funding is 

being used to help achieve HHS’s five primary objectives.

• Monitoring disease spread to support rapid response

• Developing vaccines and vaccine production capacity

• Stockpiling antivirals and other countermeasures

• Coordinating federal, state and local preparation 

• Enhancing outreach and communications planning

We are in a race, a race against time and complacency. There is a role for 

everyone and we must count on everyone to fulfill their role. 

By definition a pandemic is defined 

as a global event. In reality, a 

pandemic is a local crisis worldwide. 

It can happen in every state and 

every city and every town at almost 

the same time. 

A pandemic is not like a hurricane or 

an earthquake, where resources and 

help can be shifted from one area 

to another. Should it occur, every 

community will need to rely on its 

own planning and its own resources 

as it fights the outbreak.

Preparation is a continuum. Each day 

we prepare brings us closer to being 

ready. We are better prepared today 

than we were yesterday. And we must be better prepared tomorrow than we are 

today.

2

Message from the Secretary (continued)

Pandemic Influenza Plan Funding

2006 Appropriations: HHS Allocation ($3.3B)

(Dollars in Millions)

Vaccine

Antivirals

State & Local Preparedness

Medical Supplies

Other Domestic*

International Activities**

Risk Communications

$1,781

$731

$350

$162

$133

$125 $38

 *Other Domestic Includes:

 Surveillance, Quarantine, Lab Capacity, Rapid Tests

**International Activities Includes:

 International Preparedness, Surveillance, and

 Response

“We are better prepared 

today than we were 

yesterday. And we must be 

better prepared tomorrow 

than we are today.”
Our first line of defense is early detection. It is critical that we know 

immediately if the H5N1 influenza virus becomes capable of sustained 

human-to-human transmission. Early detection will give us the opportunity 

to respond, to attempt containment and to quickly gain the virus samples 

necessary for the development of a true pandemic vaccine.

Early detection is a race against time. Containing or slowing an influenza 

pandemic demands that a nascent outbreak anywhere in the world be 

recognized and confirmed within 1 to 2 weeks. 

 International Collaboration and Monitoring

This is a big job. For HHS, it means putting experts on the ground in numerous 

nations spread across a vast landscape. It means working shoulder to shoulder 

with our federal colleagues. 

Early detection requires international collaboration. It means working closely 

with the World Health Organization (WHO), the United Nations Food and 

Agriculture Organization, the World Organisation for Animal Health, the Institute 

Pasteur, and numerous national governments. Together, we are tracking the 

spread of the disease, conducting 

epidemiological studies of human 

infection, training local specialists and 

providing them with the tools for early 

and accurate detection. 

CDC and USAID will soon enter into an 

agreement with the Wildlife Conservation 

Society to provide additional monitoring. 

 Detection at Home

In February, the FDA approved a new 

laboratory test capable of diagnosing 

H5N1 influenza strains within four hours 

of receiving a sample. The new test cuts 

days from the time needed to confirm 

human infection. FDA is also providing scientific and regulatory assistance to 

diagnostic manufacturers to speed the development and deployment of new 

detection products. 

3

Monitoring and Surveillance

$258M

“For a couple of weeks, 

it was raining dead 

swans all over Europe.” 

 –Jan Slingenberg, 

UNFAO
As the avian infection moves closer to America, the Departments of Agriculture, 

Interior and Health and Human Services are stepping up the monitoring and 

testing of migratory birds. This surveillance is essential to provide early warning 

so the disease does not spread to people, poultry and pets and to insure the 

safety of the nation’s food supply.

To monitor possible human infection, CDC is strengthening local laboratory 

capacity and capability, improving reporting systems and accelerating 

implementation of the national BioSense program, which collects real-time data 

from hospitals and other clinical-data sources. 

 

Vaccines

The best defense against influenza is vaccination. It is also the most difficult defense to achieve. A fully effective vaccine cannot be developed until the 

virus strain it must protect against has evolved and been identified. And once 

developed, there must be the production capacity to manufacture enough 

vaccine to protect the population.

HHS, through its National Institute of Allergy and Infectious 

Diseases (NIAID), is addressing the problem in a number 

of ways. These include the development of pre-pandemic 

vaccines based on current lethal strains of H5N1 and 

collaboration with industry to increase the Nation’s vaccine 

production capacity, as well as seeking ways to expand or 

extend the existing supply. We are also doing research in the 

development of new types of influenza vaccines.

4

2004 – H5N1 reference strain created

by reverse genetics from H5N1 virus isolated from Vietnam

April 2005 – RFP for cell-based vaccine contract issued

Summer 2005 – Preliminary results from H5N1

vaccine clinical trials in healthy adults aged 18-64 indicate an

immune response predictive of protection against the H5N1

September 2005 – International Partnership on Avian

and Pandemic Influenza launched

November 2005 – Issuance of HHS 

Pandemic Influenza Plan

November 2005 – WHO Global Meeting

October 2005 – Southeast Asia fact-finding mission

led by HHS Secretary and State Department

2004 April - November 2005

Monitoring and Surveillance (continued)

At the International Pledging 

Conference on Avian and 

Human Influenza in Beijing 

in January 2006, the US 

committed $334 million 

in US grants and technical 

assistance to aid global effort. 

$1,781M
In early 2004, NIAID researchers applied a technology called reverse genetics to 

the H5N1 virus isolated from a patient in Vietnam to create an H5N1 reference 

vaccine strain. Working with industry, NIAID was able to create an inactivated 

H5N1 virus vaccine for clinical testing. In this testing, conducted in the summer 

of 2005, the vaccine induced an immune response predictive of protection 

against the H5N1 virus. We then contracted with two companies to manufacture 

nearly 8 million doses of this vaccine for strategic stockpiling.

 Vaccine for a Changing Virus

However, all influenza viruses evolve, or “drift” genetically over time. By 

2005/2006 winter the H5N1 strain had drifted enough to result in a second 

distinct strain of H5N1. This strain, also lethal, is now circulating in Europe, 

Africa and parts of Asia. Its appearance dictates that we begin developing a 

second pre-pandemic vaccine. 

The CDC has already taken the first step by producing the reference virus that 

will serve as a seed from which a second vaccine might be developed. It is 

probable that H5N1 will continue to evolve, making it necessary 

to develop a series of vaccines. There is simply no way to 

predict which strain, if any, might produce a virus capable of 

mass human-to-human transmission – or which vaccine will 

be most effective against it. For this reason it is prudent to 

maintain stockpiles against each of the main circulating H5N1 

strains.

In March, FDA released draft guidance for clinical data that 

are needed to show safety and effectiveness for new seasonal 

and pandemic influenza vaccines. The FDA also outlined an 

approach for an accelerated approval of these vaccines. 

5

Vaccines (continued)

December 2005 – Passage of the Public Readiness

and Emergency Preparedness Act (PREP Act)

December 2005 – Enrollment for clinical trials with H5N1 vaccine

in healthy adults (>65 years of age) was completed

December 2005 – Convening of States Summit,

in Washington, DC

December 2005 – Release of State and Local

Pandemic Influenza Checklist

December 2005 – Release of

Business Pandemic Influenza

Checklist

December 2005 – First State Summit, Minnesota

December 2005 –Tabletop public affairs exercises with

US Departments and representatives from Canada and the UK

December 2005 –WHO Global Pandemic Communications Meeting

in Switzerland, HHS led US delegation

December 2005

There is simply no way 

to predict which strain, if 

any, might produce a virus 

capable of mass human-tohuman transmission – or 

which vaccine will be most 

effective against it. 

Ion Channel

Haemagglutinin

Lipid Envelope Neuraminidase

(Sialidase)

Capsid

RNP
The CDC has already taken 

the first step by producing 

the reference virus that will 

serve as a seed from which 

a second vaccine might be 

developed.

Vaccines (continued) 

6

 Increasing Vaccine Capacity 

The current U.S. capacity for manufacturing egg-based vaccines is not sufficient 

to supply our entire population. HHS is working with industry to determine ways 

to increase that capacity, including developing new facilities and expanding 

production in existing facilities. A request for formal proposals will be issued in 

April 2006. 

The threat of liability has been a major obstacle to developing a strong domestic 

vaccine industry. HHS worked with the Department of Justice and Congress 

to address the problem. As a result, Congress adopted legislation (PREP Act) 

providing industry with limited liability when meeting a declared public health 

emergency.

Current egg-based vaccine manufacturing methods are complex, difficult to 

expand rapidly to meet increased demand, and subject to failure if the vaccine 

strain does not grow efficiently in eggs. HHS is supporting research into cellbased vaccine manufacture, which holds the promise of a reliable, flexible, and 

easily scalable method of producing vaccine domestically. In April 

2005, HHS announced a $97 million contract for the development of 

cell-based flu vaccine, and we expect to award additional contracts 

for developing cell-based vaccines this spring.

There is also research into ways to increase the effectiveness 

of vaccines by exploring antigen-sparing technologies such as 

adjuvants, substances that increase either the efficacy or potency 

of a vaccine. If successful, they extend a given supply of vaccine to 

protect more people.

If a pandemic occurs prior to licensure of a vaccine, the FDA can use its 

Emergency Use Authorization authority to permit the use of unapproved 

products (or to permit unapproved uses for previously approved products) if 

there’s a reasonable belief the products may be effective and if the benefits 

would outweigh risks.

January 2006 – Roughly 5 million courses in SNS stockpile

January 2006 – 6 State Summits AZ, VT, WV, RI, GA, KY

January 2006 – RFI issued on advanced

deve

Jan

lopment of promising antivirals

uary 2006 – RFI issued on increasing

egg-based vaccine capacity

January 2006 – Release of Individuals and 

Families Pandemic Influenza Checklist

January 2006 – Bilateral teams sent to Turkey, Armenia,Azerbaijan,

Georgia, Romania, Ukraine and Nigeria to assess avian flu outbreaks

January 2006 – International Pledging Conference in Beijing;

$334M in US grants and technical assistance to aid global effort

January 2006 –Tokyo WHO conference to draft WHO pandemic plan

January 2006

January 2006 – First State 

Summit with signing of a 

Planning Agreement, Vermont
Antivirals are drugs that lessen the impacts of flu. There are currently two 

FDA-approved antivirals that have shown effectiveness against the H5N1 

virus, Tamiflu, and Relenza. Both must be taken within 48 hours of the onset of 

flu symptoms. (Note that there are two other approved flu antivirals, but CDC 

studies show H5N1 to be resistant to them.)

We are building a national stockpile of these two antivirals. The immediate 

goal is to stockpile enough antivirals to treat 20 million people. The longerterm goal is to be able to treat 75 million people, or 25 percent of the U.S. 

population. Achieving this goal depends on future pandemic flu appropriations, 

manufacturing capacity and participation by the states.

 Antiviral Stockpiling

Because Tamiflu is also approved for prevention, treatment for an additional 

6 million people is also being stockpiled. This will be used in an effort to help 

contain a first outbreak of potential-pandemic influenza. The concept is to 

blanket the area of the initial outbreak, giving Tamiflu to as many people as 

possible to prevent the flu’s spread before it gets out of control.

In March, HHS purchased more than 14 million courses of Tamiflu and 

Relenza, which will increase the national inventory to nearly 20 million 

courses. The total targeted stockpile is 81 million courses by the end of 

2008. HHS will purchase 50 million out right and subsidize (by 25 percent) 

the states’ purchase of 31 million courses. (A course is the number of 

doses needed to treat one person – ten capsules in the case of Tamiflu.) 

Antivirals will be distributed among the states and territories on a per-capita 

basis.

FDA is monitoring Tamiflu shipments to identify potential counterfeits, and 

is actively investigating companies selling fraudulent, unapproved influenza 

products.

7

Antivirals

$731M

Antiviral Purchases

12/08 81 million courses

12/06 26 million courses

03/06 20 million courses*

* a course is the number of doses needed to treat one person.

February 2006 – 11 State Summits CT, IA, MA, FL, OH, NV, DE, AL,

MO, NE, MD

February 2006 – Enrollment in a pediatric H5N1 vaccine

clinical trial (children aged two to nine years) was completed

March 2006 – RFP to be issued on

advanced development for antigen 

sparing technologies

January 2006 – Release of Faith-based & Community

Organizations Pandemic Influenza Checklist

February 2006 – Risk Communications Preparedness

Workshop hosted by CDC in Thailand

February 2006 – Meeting with UN Coordinator for avian and 

pandemic influenza on how to best assist UN efforts

February 2006 March 2006

The immediate goal is to 

stockpile enough antivirals 

to treat 20 million people. 

The longer-term goal is to 

be able to treat 75 million 

people, or 25 percent of 

the U.S. population. 
 New Antivirals Needed

Influenza viruses can develop resistance to antivirals over time. New antivirals 

will be needed in the event H5N1 develops resistance to Tamiflu or Relenza. We 

are committing $200 million to the development of additional antivirals. HHS 

expects to request formal proposals later this spring and to award contracts for 

the advanced development of promising antivirals by September 2006.

It is not enough to stockpile antivirals; there needs to be a plan to distribute 

them. HHS is discussing with the states whether the antivirals should be centrally 

located or warehoused locally. To receive funding, states are being required 

to develop distribution plans now, so that if a pandemic erupts, it will be clear 

where the drugs are to go and how they will get there. In addition to stockpiling 

antivirals, $162 million will be used to procure essential medical supplies for 

a pandemic. Planned purchases this year include 6000 ventilators, 50 million 

surgical masks, 50 million N95 respirators, and face shields, gloves and gowns.

State and Local Preparedness

State and local preparedness is the foundation of pandemic readiness. 

The challenges that we will face in a pandemic will be vastly different from 

other response situations. An influenza pandemic is likely to occur almost 

simultaneously across countries and communities. It will demand that every 

aspect of our communities be self-sufficient, able to deal with the outbreak of 

illness should it hit. Political leaders, employers, school leaders, healthcare 

leaders, faith-based and community organizations, families and the media must 

all be informed, engaged, and actively involved. 

8

Antivirals (continued)

We are committing 

$200 million to 

the development of 

additional antivirals.

$350M

March 2006 – 20 State Summits SC, SD, ND, WY, WI, PA, IL, Wash DC,

NC, VI, VA, IN, PR, CO, UT, ID, TX, NM, OR, CA

March 2006 – Purchase of 12.4 million courses of Tamiflu and

1.75 million courses of Relenza

March 2006 – Guidance released on State purchase of Antivirals

with a 25% Federal Subsidy

March-April 2006 – Expected contract award 

for cell-based vaccine

March 2006 – Release of Home Healthcare Checklist

March 2006 – Pandemic Flu Supplemental Guidance sent to states

March 2006 – States receive initial grant funding

for pandemic preparedness

March 2006 Mar-Apr 2006
To that end, President Bush directed and we convened a state and local 

preparedness process. We are working to help states, tribes, cities, schools, 

businesses, churches, and families throughout our nation plan for these unique 

challenges. We are collaborating with governors’ offices in every state to hold 

pandemic planning summits and exercises. To date, we have completed 23 

summits and planned an additional 20: we expect to visit the remaining states 

and territories this spring (see map). I am hearing from governors and local 

officials that the summits are helpful, and the process is working. 

Congress allocated $350 million this year to assist local and state preparedness. 

We are awarding $100 million to states right now. The remaining $250 million will 

be distributed later according to benchmarks we establish to measure progress. 

I am asking governors to make sure that their pandemic influenza plans are an 

integral element of and coordinate effectively with the National Response Plan 

and the National Incident Management System. 

I am asking them to establish a Pandemic Preparedness 

Coordinating Committee that represents all relevant 

stakeholders in their jurisdiction. These collaborative 

committees will help states to articulate strategic priorities 

and oversee the development and execution of operational 

pandemic plans. 

One of the most important elements of the preparedness 

response is practicing. We are assisting states in the 

development and administration of tabletop exercises to 

improve our Nation’s readiness to respond and recover from 

a pandemic. We are asking states to exercise their plans 

by the end of 2006, and will invite them to participate in a 

nationwide pandemic planning exercise within the next twelve 

months. These planning and response exercises will help public health and law 

enforcement officials establish procedures and locations for quarantine, surge 

capacity, diagnostics, communication and many other pandemic-related needs. 

9

West Virginia is holding 

seven Regional Pandemic 

Flu Summits across 

their state to plan for the 

possibility of pandemic 

flu and specific WV 

preparedness needs – this is 

a direct outcome of HHS/

WV summit held there in 

January.

State and Local Preparedness (continued)

HHS Pandemic Planning - State Summit Overview

23 Completed Summits 20 Scheduled Summits 7 Unscheduled Summits 

Including Puerto Rico and the Virgin Islands

April-May 2006 – 4 State Summits TN, AK, WA, MT

April-May 2006 – RFP to be issued on advanced development 

of promising antivirals

August -September 2006 – Contract

awards expected on advanced 

development of promising antivirals

April-May 2006 – RFP to be issued on increased 

egg-based vaccine capacity

Apr-May 2006 Aug-Sep 2006
10

Communications and outreach are essential to preparedness. I am committed to telling people what we know when we know it; to inform the 

public without raising unnecessary alarm, and to collaborate with our public and 

private partners in a way that is fully transparent. It is my hope that every state 

and local partner will practice that principle as well — every person must be a 

communicator. 

We must all be ready to provide the best instructions and advice on what is 

happening, status of school, business and transportation impacts, home health 

care practices and basic infection control. 

Congress foresaw the role and value of communications and funded our efforts 

to further develop comprehensive science-based risk communication strategies 

for pandemic influenza — communications that will touch every part of our 

nation with medical, social and economic implications and information on avian 

and pandemic influenza. 

Checklists to aid in pandemic influenza preparations have been developed by 

CDC. These planning checklists provide specific 

guidance for state and local planning, businesses, 

health care providers, community organizations and 

individuals and families. Other checklists are being 

developed, along with toolkits that provide more 

specific guidance.

The global nature of pandemic preparedness and the 

enormity of potential impacts are fostering a spirit 

of collaboration across the world. Common efforts 

include surveillance of the disease, planning across 

national boundaries and economic sectors, and 

sharing research and technology. The U.S. and world 

organizations are conducting tabletop exercises and 

participating in international risk communications 

workshops and conferences at many levels.

 Outreach Resources

During the 1918 influenza pandemic it was the newspapers and word of mouth 

that carried the news and information. Today the media and web will be our 

primary pre-pandemic and pandemic communication sources. Both must be 

used responsibly to inform and educate — to help achieve a nation prepared, 

but not in panic.

Today the media 

and web will be our 

primary pre-pandemic 

and pandemic 

communication 

sources. 

Communications 

Available Checklists:

State and Local

Individuals and Families

Business

Schools (K-12)

Faith-based and Community Organizations

Medical Offices and Clinics

Home Health Services

Upcoming Checklists:

Emergency Medical Services

Preschool

Colleges and Universities

Long Term Care

Travel Industry

Transportation

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$38M
11

President Bush directed all federal agencies to establish a single, 

comprehensive web site to be the official federal source of pandemic and avian 

flu information. This web site, www.PandemicFlu.gov, hosts a vast array of 

information designed to meet diverse audience needs. It links to specialized 

information from federal agencies, states, international organizations and other 

important resources. 

New broadcast capabilities will allow us to reach media outlets more quickly and 

ultimately provide information directly to the public via satellite. Convergence 

technologies will be used to 

integrate audio and video 

production on the web. Video, 

audio, multi-media and print 

materials are being developed for 

broad dissemination. Selected 

materials will be translated as 

appropriate. 

We are working to communicate 

to all the peoples of the world the 

essential information they need to 

plan, prepare and ultimately cope 

with pandemic flu and its impacts. 

Communications (continued)