www.ahrq.gov 

The Agency for Healthcare Research

and Quality (AHRQ) is the lead agency

charged with supporting research

designed to improve the quality of

health care, reduce its cost, address

patient safety and medical errors, and

broaden access to essential services.

AHRQ sponsors and conducts research

that provides evidence-based 

information on health care outcomes;

quality; and cost, use, and access. 

The information helps health care

decisionmakers—patients and 

clinicians, health system leaders, and

policymakers—make more informed

decisions and improve the quality of

health care services.

Introduction

A bioterrorist attack using smallpox would

pose a significant threat to public health in

the United States. The reintroduction of

the smallpox virus—which has not

infected anyone in the world for nearly

three decades—into an unprotected

population could cause substantial

morbidity and mortality and overwhelm

public health resources. While the threat

of such an attack is of national concern, it

is at the local level that public health

officials and health system planners must

be ready to respond. 

On March 3, 2003, an audioconference

sponsored by the Agency for Healthcare

Research and Quality (AHRQ) examined

the implementation of the Centers for

Disease Control and Prevention’s (CDC’s)

smallpox vaccination program and

strategies to assist public health officials in

responding to a potential smallpox

outbreak. Panelists included:

s William Raub, Ph.D., Deputy Assistant

Secretary, Office of Public Health

Emergency Preparedness, U.S.

Department of Health and Human

Services;

s Nancy Ridley, Assistant

Commissioner, Massachusetts

Department of Public Health; 

s Edward Gabriel, Deputy

Commissioner for Preparedness, New

York City Office of Emergency

Management;

s Nathaniel Hupert, M.D., Weill Medical

College of Cornell University; and

s Thomas Terndrup, M.D., Director,

Center for Disaster Preparedness,

University of Alabama at Birmingham. 

Following presentations by the panelists,

listeners were invited to submit questions

during a question and answer period.

This issue brief reviews vaccination efforts

and identifies tools to help hospital

administrators and emergency responders

prepare for an outbreak of smallpox and

other deadly diseases that can be caused

by biological or chemical attacks. 

The Smallpox Threat

The last case of smallpox in the United

States occurred in 1949. The last natural

case documented in the world occurred in

Somalia in 1977. In this country,

vaccination against smallpox stopped in U.S. Department of Health 

and Human Services

Public Health Service

Bioterrorism

and Health System Preparedness

Issue Brief

Addressing the Smallpox Threat:

Issues, Strategies, and Tools

No. 1
1972 and, in 1980, the World Health

Organization declared that the disease

had been globally eradicated. Although

there is no reason to believe that

smallpox presents an imminent threat

today, the terrorist attacks of

September 11, 2001, and the anthrax

attacks that followed them have

heightened concern that terrorists may

have obtained the virus and will

attempt to use it against the American

public. 

Smallpox is one of six biological

agents that the CDC views as a highpriority threat because of the effects of

the disease and its potential for largescale dispersal.1 William Raub listed

five reasons why smallpox is

considered a threat:

s It is highly lethal; without

vaccination, 30 percent of those

infected can expect to die, and of

those who survive there can be

lifelong, serious morbidities of

various types;

s The disease is readily

communicable from person to

person; respiratory droplets are

sufficient to carry the virus, and

therefore ordinary day-to-day

contact can be sufficient exposure

to spread the disease;

s Few people have effective

immunity; with vaccination having

ended in the United States in the

1970s, individuals born since that

time have no immunity and those

of us who were vaccinated earlier

have little or none, depending on

the length of time involved;

s We have no established treatment;

the vaccine itself is protective

within a few days of exposure, but

once the symptoms present we

have no drugs or other means to

treat, much less cure, this disease;

and

s Enemies of the United States may

obtain the variola virus, which

causes smallpox. 

After eradication of the disease in

1980, only two official stockpiles of

variola virus remain—one in the

United States and the other in the

Soviet Union. Much of the former

Soviet Union’s supply is still not

accounted for today. “When scientists

and engineers left that country

following the breakup of the former

Soviet Union, we fear that they left

with more than their know-how,” said

Dr. Raub. “They may indeed have left

with samples of the virus.” 

Smallpox

Preparedness Efforts

President Bush announced the

Smallpox Vaccination Program in

December 2002. In the first phase, the

U.S. Department of Health and Human

Services was to work with state and

local governments to form volunteer

Smallpox Response Teams, composed

of health care workers and emergency

response personnel, who would receive

a “pre-event” inoculation. The

response teams would thus be

protected against smallpox and would

be ready to mobilize immediately in a

smallpox emergency to vaccinate

others. The first phase also included

vaccination of military personnel who

were or might be deployed in a highthreat area, and voluntary vaccination

of State Department personnel

assigned to such areas. 

William Raub stressed that the

program is voluntary. He went on to

explain that the plan included two

other phases. Phase 2 would include

the voluntary vaccination of additional

members of the health care and public

safety communities who, in the event

of an outbreak of smallpox, would be

among the very first to be exposed to

cases and who would want to be

protected to be able to carry out their

basic responsibilities. In the third

phase, voluntary vaccination would be

available to members of the general

public who, in the President’s words,

“insist on being vaccinated now.”

“First, I would stress that

the program is entirely

voluntary. Smallpox does

not exist in the world

right now; we believe it

would be inappropriate 

to have any mandatory

vaccination campaign for

a disease that does not

exist. But because of the

bioterrorist threats, some

preparation seems

important.” 

William Raub, Deputy Assistant

Secretary for Public Health 

Emergency Preparednes

After the President’s announcement,

CDC promulgated guidance for the

Smallpox Vaccination Program, made

educational materials about smallpox

and vaccination available to hospitals,

clinicians, and the public, and provided

smallpox vaccine to the States. The

program was implemented in late

2

1 The other agents are anthrax, botulism, plague, 

tularemia, and viral hemorrhagic fevers.
January 2003. 

Vaccination Program

Challenges

In the 5 weeks between the

implementation of the program and the

audioconference, not surprisingly,

some issues arose. Dr. Raub identified

two. The first was the logistics and

cost anticipated for Phase 2 of the

vaccination program. He explained

that most States were able to handle

the logistics and were finding funds

for Phase 1 (for which CDC had

targeted a total of 500,000 vaccinees).

With up to 10 million additional health

care workers and emergency response

personnel projected to be vaccinated in

Phase 2, however, some State and local

health officials were apprehensive

about the financial resources that

would be needed to implement such a

large-scale effort. On that scale, the

distribution of vaccine, the types of

clinics or other arrangements for

vaccination, and access to those sites

would also pose a major logistical

challenge.

The second issue was the absence of

guaranteed compensation for vaccinerelated injuries. In many States, but

not all, workman’s compensation

covers the compensation needed for

illness resulting from the possibe side

effects of vaccination. Similarly, many

health insurance programs, but not all,

provide coverage for the health care

costs associated with adverse events,

but none of them covers the costs

associated with lost work. As a result,

State officials and hospitals and others

were proceeding cautiously with the

vaccination program in the hope that a

solution to the compensation problem

would be found.

The Massachusetts

Experience

Massachusetts offers an example of

one State’s efforts to implement the

Smallpox Vaccination Program. As

Nancy Ridley explained, the

Massachusetts plan is built around its

acute care system and its emergency

response planning regions.

Massachusetts does not operate on a

county health system, but has 76 acute

care hospitals with emergency rooms

that make up the core of the acute care

system. The State has recently been

divided into seven emergency response

planning regions so that each region

has an approximately equal population

and number of hospitals.

The Massachusetts approach to Phase

1 started with planning by a statewide

smallpox workgroup that included 40

or 50 active members representing

many different constituent groups.

Their Phase 1 plan had two

components. First, State health

department personnel would be

vaccinated and would, in turn,

vaccinate approximately 7,600 hospital

staff, averaging about 100 per acutecare hospital. Second was the

vaccination of community response

team personnel. Each of the 7

emergency response regions would

have multiple 16-member response

teams, which would require

vaccinating approximately 150

community response team members

per region. Completion of the two

components of Phase 1 was expected

to take up to 6 months.

The Massachusetts plan included

several precautions. Volunteers had to

have been vaccinated previously. There

would also be very careful screening

of the volunteers and their household

contacts for contraindications. In

addition, extensive followup would be

required for adverse reactions. In light

of those precautions, the State was not

proposing or recommending furloughs.

With regard to Phase 2 of the

Vaccination Program, Ms. Ridley

added another dimension to the issues

identified by William Raub. She

described proceeding to Phase 2 as

“one of the most controversial

questions we have had to face,” and

stressed that moving to Phase 2 was

dependent on the lessons learned

during Phase 1. Specifically, she said

that what was necessary to proceed to

Phase 2 was continuation of evidence

to date that the program had been very

successful, with very small numbers of

even minor adverse reactions. 

The experience in Massachusetts with

the compensation issue was that,

3

“In terms of getting consumers and the public involved in

the program, you need to have the continuous involvement

of health care providers right from the beginning.”

Nancy Ridley, Assistant Commissioner, Massachusetts 

Department of Public Health
4

because worker’s compensation in the

State does not take effect until the

fifth day, many larger employers had

stated that they would covering those

first days. Similarly, health insurers

had said they would cover side effects

for both vaccinees and any contacts. 

Smallpox Threat

Requires Coordination,

Communication

Edward Gabriel, Deputy

Commissioner for Preparedness in the

New York City Office of Emergency

Management, stressed that planning

for a smallpox threat—or any public

health emergency—must begin with

communication and coordination

among local emergency authorities.

He described incident management

planning as “a way to bring everybody

to the table and get them to speak the

same language.” “Everybody”

includes not only hospitals and

emergency medical services, but also

local public health departments and

fire, police, and ambulance personnel.

In addition to “speaking the same

language,” incident management

planners should get to know one

another on a first-name basis, face to

face, and should consider each other

as part of the same emergency

response team.

Local planners should also work with

State and Federal representatives. In

response to a call-in question, Mr.

Gabriel said that one of the lessons of

9/11 was the importance of

coordination of emergency

management at the local, State, and

Federal levels. It is important to know

who the contact points are and “where

to go for what resources, how to get

them, and how your chain works from

the lower level to the State level to the

Federal level.” 

An especially important element of

that local-State-Federal coordination in

the event of any public emergency is

communication with the public. “Our

experiences from September 11 taught

us the importance of projecting one

voice and a consistent message to the

public,” said Gabriel. Nancy Ridley

added that one of the highest priorities

in making a smallpox plan successful

is being prepared to counter “an

epidemic of fear” among the public.

“Do your preparedness

planning not just for

bioterrorism incidents but for

all incidents.” 

Edward J. Gabriel, New York Office 

of Emergency Management

New Tools Help

Prepare for Deadly

Diseases

If a smallpox outbreak were to occur,

a large-scale vaccination program

would be necessary. Researchers at

Weill Medical College of Cornell

University have designed a new

computer model to help hospitals and

health systems plan antibiotic

dispensing and vaccination campaigns

to respond to bioterrorism or largescale natural disease outbreaks. The

model was funded by AHRQ and

developed by researchers after testing

a variety of patient triage and drugdispensing plans. 

Now, for the first time, hospital

planners can estimate the number and

type of staff needed to vaccinate an

entire community in an efficient and

timely fashion. For example, the

model can quantify the staff required

to vaccinate one million people over

14 days. The model can be

downloaded to run on common

spreadsheet software customized for

use by health officials at all levels of

government, hospital administration,

and emergency medical planning. 

“Models like this allow planners to

think with numbers when designing

mass prophylactic response strategies,”

said lead model designer Nathaniel

Hupert of Weill Medical College.

Modeling also forces a critical

examination of assumptions about

how a large-scale vaccination plan

would be executed, particularly the

issue of resource availability. Dr.

Hupert cautioned that while “models

are useful to guide planning, they

don’t replace the real thing, which is

exercises and drills that test the

response of a health care system.” 

Educating Providers

About Bioterrorist

Agents

Dr.Thomas Terndrup, Director of the

Center for Disaster Preparedness at the

University of Alabama at

Birmingham, demonstrated the Web

site (www.bioterrorism.uab.edu) that

he and his colleagues have developed

to provide resource information and

continuing education about rare

infections and potential bioterrorist

agents, including anthrax and

smallpox, to health care providers. The

biggest challenge, he said, was that

“there is limited or no clinical

experience with many of these agents,
5

and so the health care community needs

to struggle with recognition and

awareness.” 

Funded by AHRQ, the interactive

screensaver on the Web site includes

assistance with complicated differential

diagnosis, continuing education

modules, related Web links, and

publications options for the user. The

Web site was initially posted in October

2001 and has been updated regularly,

especially for smallpox and anthrax. A

pediatrics model was added in

December 2002, and other modules

were being planned, including internal

medicine and family practice to

incorporate primary care physicians

into the fold. Also in the planning stage

was a dermatology referral module that

would help medical providers to know

when to refer a patient to the

dermatology community. 

Update

Four weeks after the audioconference,

on March 26, 2003, CDC issued an

advisory that people with known

cardiac disease should not be

vaccinated. CDC’s March 28, 2003,

Morbidity and Mortality Weekly Report

contained the news that seven cases of

cardiac adverse events had been

reported among the 25,645 civilians

who had been vaccinated as of March

21, 2003, and that 10 cases of

myopericarditis had been reported

among approximately 225,000 primary

vaccinees in the military smallpox

vaccination program. In the military

program, no cases of myocarditis or

pericarditis had been reported among

approximately 100,000 persons who

had been revaccinated. CDC cautioned

that a causal relation between smallpox

vaccination and serious cardiac events

could not be excluded, and

recommended that persons with known

cardiac disease be excluded from

vaccination. 

Other notable events since the March 3,

2003 audioconference include the

following:

March 31—CDC added a supplement

on “Smallpox Vaccine and Heart

Problems” to its Smallpox PreVaccination Information Packet.

April 30—President Bush signed into

law the Smallpox Emergency Personnel

Protection Act of 2003 (SEPPA) (P.L.

108-20). The law established a no-fault

program to provide benefits or

compensation to health care workers

and emergency responders who are

injured as the result of the

administration of smallpox

countermeasures, including the

smallpox vaccine. 

May 5—HHS Secretary Thompson

announced the release of $100 million

to the States to help them prepare for a

possible smallpox attack and to

strengthen the public health

infrastructure. The $100 million was in

addition to the $1.4 billion available to

the States in Fiscal Year 2003.

May 23—The Institute of Medicine’s

(IOM) Committee on Smallpox

Vaccination Program Implementation

issued its Letter Report #3 to CDC,

reaffirming the recommendation from

its first Letter Report (January 16,

2003) that there should be a pause in

the program between Phase 1 and

Phase 2. The IOM May report cited

three reasons for the pause: to ensure

that expanded vaccination is as safe as

possible for vaccinees and their

contacts; to modify plans, data systems,

and educational materials to prepare for

a new population of potential

vaccinees; and to re-evaluate the

vaccination program’s integration into

overall smallpox preparedness

nationally and locally. 

June 18—The Advisory Committee on

Immunization Practices (ACIP) issued

a Statement on Smallpox Preparedness

and Vaccination in which it reiterates

that it is critical that smallpox

preparedness planning continue at all

levels of government. The statement

provides a list of preparedness efforts

and activities, including smallpox

vaccination. It also advises CDC not to

expand beyond ACIP’s current, preevent smallpox vaccination

recommendations, specifically because

the extent and severity of myopericarditis are not yet known. 

November 6—In its weekly update of

Smallpox Vaccination Program Status

by State, CDC reported that as of

October 31, 2003, a total of 38,759

civilians nationwide had received the

smallpox vaccination. 

For More Information

The complete audioconference on

“Addressing the Smallpox Threat:

Issues, Strategies and Tools” is

available as a streaming presentation

and as a text transcript on the AHRQ

Web site (www.ahrq.gov/bioterbr.htm). 

Information on the tools discussed in

this issue brief, and other tools and

publications related to health system

preparedness for bioterrorism, will be

posted on the AHRQ Web site as it

becomes available. Please check the

Web site frequently. 
AHRQ Pub. No. 04-P006 

January 2004