14 December 2002

U.S. Preparing to Meet Potential Smallpox Threat

Will consider vaccination requests from allies and friends

To meet the smallpox threat, said Tom Ridge, nominated to head the new Department of Homeland Security, "The strategy for the country is to provide smallpox vaccine to our front line troops, our emergency responders inside the country and our armed forces and embassy personnel that serve in high threat areas internationally."

Ridge spoke on December 13 at a White House press briefing on the smallpox vaccination program along with senior government officials and medical experts.

The U.S. recognizes that it is not the only nation under threat from a possible smallpox attack, according to Deputy Assistant Secretary of State Greg Suchan. For security reasons, Suchan said, he could not provide operational details concerning U.S. smallpox assistance to other nations.

"However, we can say that the United States will consider requests for vaccination from allies and coalition partners," Suchan stated. "And we will work with these countries to address their preparedness needs. In addition, we can assure the world community that the United States government stands ready to lend any and all feasible assistance in the event of an actual attack."

According to Ridge, there is now enough vaccine for every American. The government is now working with state and local authorities to build the infrastructure necessary to deliver the vaccine in the event of an emergency.

"The President's decision strikes the right balance," said Tommy Thompson, Secretary of Health and Human Services. "This decision best prepares us to protect the American people in emergency, while minimizing any harm to the public from a vaccine that has side effects."

Julie Gerberding, Director of the Centers for Disease Control and Prevention, said that vaccinations are one element in preventing a smallpox epidemic, coupled with isolation and other measures to prevent transmission. She also noted that the smallpox program would also serve to strengthen the nation's overall public health system, especially its ability to respond swiftly to any type of bioterrorist attack.

Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases said that the designated smallpox vaccine, Dryvax, is identical to the vaccine used in the past when smallpox was epidemic, and it is very effective. Nevertheless, he said, past studies indicate that "one can expect that with this vaccine there will be approximately 14 to 52 life-threatening adverse events per million vaccines."

Because of the potential danger to a small percentage of the population, all the experts stressed that the government is not recommending vaccination of the general public.

Following is the transcript of the December 13 White House press briefing on the U.S. smallpox vaccination program:

(begin transcript)

Office of the Press Secretary The White House December 13, 2002

PRESS BRIEFING ON SMALLPOX VACCINATION Presidential Hall Dwight D. Eisenhower Executive Office Building

GOVERNOR RIDGE [White House Homeland Security Advisor and nominee for Secretary of the Department of Homeland Security]:

Good afternoon. The President has just outlined the plan to strengthen the security of America by improving significantly our capability to protect Americans in the event of a smallpox attack.

As he described the plan, the strategy for the country is to provide small pox vaccine to our front line troops, our emergency responders inside the country and our armed forces and embassy personnel that serve in high threat areas internationally.

Joining me this afternoon are the experts in the different aspects of this plan. We'd like to take a few moments of your time to provide you more details on what the President has announced, and then we'll be happy to respond to any questions.

The decision the President announced today is really the culmination of an exhaustive process that lasted nearly 15 months, actually beginning shortly after the events of September 11th. Our nation's first need was to enhance dramatically our capabilities to respond to a situation where smallpox had already been released somewhere in the country.

Clearly, from day one, we've been concerned about weapons of mass destruction and biological and chemical and radiological and nuclear. And 15 months ago, the administration began moving simultaneously on multiple fronts to deal with different aspects of the threat across the whole array of potential WMD means of death and destruction. Clearly, one of the highest priorities involves smallpox because of the destructive consequences of its contagion. This is one of the agents that this country or any country should fear most if it's being deployed as a weapon of terror.

At that time, under Secretary Thompson's leadership, HHS accelerated efforts to increase the national stockpile and supplies of smallpox vaccine. They found medically sound solutions -- like diluting the existing vaccine five-fold, buying additional existing vaccine and producing a new vaccine. Thanks to these efforts, if there is a smallpox attack we now have enough of vaccine for every American.

In addition, at the same time we began working with state and local governments to draft plans and very importantly to build the capabilities, to build the infrastructure we need to provide the vaccine to Americans in the event of an emergency. Many states are already exercising their plans to distribute the vaccine.

Our second need was to begin a process to consider as carefully as possible the need for a broader national policy to provide for pre-attack vaccination. I want to underscore again the President has said there is no intelligence that talks about an imminent threat of a biological weapon involving smallpox. Again, because of the nature of that agent and what it could do as we look at priorities and managing risk, we knew we needed to come up with a national strategy, a national plan to deal with that possibility.

The process involved all the major federal agencies with responsibilities for public health, national defense, the economy, the threat assessment. It also involved critical input from state and local government, the professional medical and public health communities and the American public.

We had to assess the risk from terrorists or hostile governments, along with the potentially devastating consequences on our people and our way of life. Then we had to balance these risks and the consequences with several serious policy questions. What are the requirements? What are the preparations we need to take to respond and to protect Americans and America from the threat of smallpox. How do we weigh these requirements with the fact that the vaccine, itself, a highly protective preventive measure has potentially serious adverse effects to those who receive it? And then, finally, how do we respect the rights of individual citizens, of individuals, our friends and neighbors, to make an informed decision for themselves whether or not they ought to access the vaccine?

The President, himself, got personally engaged in these discussions, probably as far back as eight months ago. The President had a series of briefings from Cabinet members, from public health and medical authorities in the Oval Office. The President's homeland security council met a couple of times on the matter. And then there was a series of informational briefings and decisional briefings that began almost eight months ago, involving the President, personally, in this very difficult and very, very important decision.

The program that the President announced today is the end result of our national security community and the public health community coming together to address a national need. This process I think provides a very instructive and useful model for the new world that we are engaged in, in the 21st century. And our very able Secretary of Health and Human Services, Tommy Thompson, has been a leader in this collaborative process, will provide more details for you on how the federal government will work with the states and the cities and the public health community around this country to implement the plan the President described for you.

Thank you.

SECRETARY THOMPSON: Thank you very much, Governor Ridge. And let me thank you for your continued friendship, your support and your leadership on this issue and so many other issues.

I also want to take this opportunity to thank President Bush for a tremendous amount of time and the thoughtfulness that he put into this decision. This was not an easy decision. It was not easy because it deals with human life, how best to protect it and what risks are we as a nation willing to take to protect it. No matter what decision was made, there was and is the risk of someone getting hurt. This fact cannot and should not be lost on anyone.

The President's decision strikes the right balance. This decision best prepares us to protect the American people in emergency, while minimizing any harm to the public from a vaccine that has side effects. The President's plan strengthens our preparedness by working with state and local governments in order to create smallpox response teams. These teams will consist of public health and health care workers. And states are deciding who should be on these teams with guidance from HHS and CDC.

The plan also includes first responders: our police, firefighters, emergency medical technicians and other health care workers. We are recommending that people in these groups get the vaccine. But participation is truly voluntary, thus we fully recognize that not everyone will choose participation.

This program centers on smallpox response teams and first responders for a very strategic reason. Since a smallpox release is possible, we must prepare by offering vaccine to those most likely needed to respond. By preparing our emergency responders, we are then better able to protect the American people in an emergency, and this has to be our highest priority.

We're already working with states on setting up the logistics for identifying and vaccinating our smallpox response teams, as well as our first responders. Dr. Gerberding will get into more specific detail in just a moment. We expect the states to begin vaccinating in late January and work through the smallpox response teams as soon as they possibly can. We understand that some states will take longer than others.

While emergency responders are a priority, there is another component to this decision that recognizes that some people not on emergency response teams will insist on being vaccinated. Let me be very clear: we do not -- we do not recommend that the general public get vaccinated at this time. But we will develop a very orderly process to make vaccine available to those adult members of the general public without contra-indications who insist on being vaccinated either in 2003, with an unlicensed vaccine, or in 2004, with a licensed vaccine.

We expect to develop this process by sometime next spring or summer. Again, I emphasize the federal government is not recommending vaccination for the general public at this time. The fundamental purpose of this vaccination program is to prepare those emergency responders who will respond to an outbreak. This prepares us to protect all Americans in emergency.

Therefore, the immediate task and priority for the federal, the state and local government will be implementation of the program to vaccinate emergency responders. Also keep this in mind: the program we are announcing today is pre-event. If there was a release of smallpox we would immediately make vaccine available to the public. We have enough vaccine to cover every American in an emergency.

And we have state plans now to implement a mass vaccination program. This vaccine, however, would be unlicensed. Now, I know we're asking our states, our cities and hospitals to step up and perform a great deal in order to make this plan a success. But we do so in the name of protecting our country. By working together, we're going to better protect our citizens from harm if a terrorist were to release smallpox into our population.

Protecting our citizens from this deadly disease is definitely worth the effort and the energy that we're asking today from our states and cities, the public health community and the emergency response community. Let me thank in advance the public health workers and the hospital employees, the emergency responders and the employers who will help make this program successful.

As we implement this program, there's no doubt that we're going to experience bumps along the way. We prepared well -- very well, as a matter of fact -- but it's been quite a while since this nation saw the need for vaccinating so many people in such a limited amount of time. And it's been a while since we've had to give out the smallpox vaccine.

So obviously, we're going to encounter some obstacles and some challenges. When we encounter bumps in the road, we must work together to smooth them out and find solutions. One thing we're going to do is a great deal of education. We've already been educating those in the public health, medicine, science and the emergency response throughout the summer and fall. We will continue to do that.

We're also going to educate all of those faced with the decision of getting the vaccine. In fact, all of our citizens are able to learn more by going to the CDC website, www.cdc.gov, or the HHS site, www.smallpox.gov. Both sites feature sets of easy to find and easy to understand documents about the disease: the vaccine, the risks, as well as other important facts about the issue.

The sites also include all the technical and all the scientific information that clinicians and public health experts need in order to do their jobs. The bottom line is that the vaccination program calls for a public health partnership like no other we've seen for some time in this country.

We're going to need to work together as partners -- federal, state, and local governments -- as well as the private health care system. If we succeed in this partnership, we will strengthen a public health infrastructure that will serve Americans well -- not just for bioterrorism, but in all of our other daily health care needs.

Now, it's my privilege to introduce an individual who has worked extremely hard on this, Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention.

DR. GERBERDING: Thank you, Secretary Thompson. I really appreciate the opportunity to explain how the Centers for Disease Control and Prevention will work with state and local health departments to actually implement the President's smallpox vaccination policy.

But first let me reiterate something that the Secretary said a few moments ago: protecting the public really is our highest priority. And the President's policy will ensure we can quickly and effectively respond to an attack. By offering smallpox vaccine to the first people who have to step up to the plate and respond, we know that we can strengthen the ability of our states and our communities to protect the public in that kind of a situation.

As we move forward to implement the President's decision, it's important to note several things. First of all, we know how to fight smallpox. We have wiped out this disease before, and we have the experience and the knowledge necessary to do it again.

Second, the smallpox vaccine is the best protection we have against smallpox, but it is not the only protection. Infection control measures, and especially isolation of infected people, also help prevent transmission. And these measures can help protect when people cannot or choose not to be vaccinated.

Finally, but most importantly, as this program unfolds vaccine safety is a top priority. We intend to do everything that we can to minimize the risk and reduce the number of serious adverse reactions to the vaccine, which Dr. Fauci will describe in a moment. We've issued screening guidelines that help people understand their risks and identify those that should not receive the vaccine because they would be threatened with a serious complication.

Vaccine volunteers will be informed of the conditions that put them at risk before they even get to a vaccine clinic. And CDC is working with clinicians to make sure they can assist people in deciding whether or not there's a risk that would contra-indicate immunization. Some of those conditions include eczema, atopic dermatitis, pregnancy, AIDS, immune conditions that suppress the immune system and the body's ability to fight against an infection, and several other conditions that similarly cause immunosuppression.

CDC and the Department of Defense will be working together with outside experts to monitor the safety of this program as we go forward. However, we do stress that despite the screening and these protocols that we will put in place before people come to the clinic, and again when they present to clinics, we cannot completely eliminate the hazard of a serious adverse event. And so the monitoring systems are critically important.

People who get vaccinated will also be given very specific and careful instructions about how to care for their vaccine site. Because the wound itself needs special care so that the virus that's inoculated there is not spread to close household contacts in intimate communication with a vaccinated individual.

The credible objective system that we intend to put in place to monitor and treat adverse events will be a very central part of this program as we go forward. The states will maintain records of people who are vaccinated and will work with hospitals and clinicians and public health agencies to diagnose, manage and treat the adverse reactions should they occur.

CDC will also provide an expert referral system to assist with diagnosing and treating these reactions. This referral system will also ensure that people have access to vaccinia immune globulin, or VIG, which is a product that can help treat the serious complications of the vaccine.

Beginning in January, states will open clinics to vaccinate the smallpox response teams. We expect this occur late January in most states, although some may not be able to safely open their programs until later. And since safety is the overall priority of the program, we will be flexible in encouraging states to get started as soon as they safely can.

Public health officials will help organize these clinics, and already we have trained several thousands clinicians and public health officials in several hours of training in how to organize and conduct the clinics, how to monitor the side effects, how to safely store the vaccine and securely store the vaccine, and all of the other logistic elements necessary to make this program go safely.

As we expand the program to include the emergency responders that Secretary Thompson talked about, we're going to first prioritize the smallpox response teams. These are the people who have been pre-assigned the responsibility for investigating the initial cases of a smallpox outbreak, should one occur, and the people in health care delivery systems who will actually take care of the initial cases.

So there are two kinds of smallpox response teams. The first, we're calling public health response teams. They will consist of public health officials, doctors with special knowledge about skin conditions and smallpox, the disease detectives who will help understand the cause and the source of an exposure. It may include other emergency medical personnel who help transport the initial cases to the facilities and so forth.

The health care delivery system response teams, in turn, will include not only the clinicians, but the other hospital workers necessary to take care of an affected patient over a period of time. So that will include emergency room doctors, critical care physicians, infectious disease, dermatology specialists. It will include housekeepers, perhaps some laundry workers, people who deliver services to the intensive care unit. Anyone who would come into direct contact with a patient with smallpox during their course of treatment.

These teams are being designated now by the states in cooperation with the health care delivery system, and these are the individuals who will be first to receive the vaccine when the clinics open late in January.

As Secretary Thompson emphasized, we are not recommending this vaccine for the general public at this point in time. We are cognizant of the fact that some people feel strongly that they want to have access to the vaccine and so we're going to be working with our partners in the public health community to ensure that there is access and an orderly process sometime over the next year.

There are options available for that. One option is that people can enroll in the clinical trials of smallpox vaccine that are ongoing or are planned for the near future. In addition, it's possible we may be able to create a special protocol to include these people in an immunization program. Or they may wait to receive the smallpox vaccine when it's licensed in 2004, with the new product is in the pipeline right now.

I'd like to conclude with a couple of really critical points. First of all, this effort to enhance our preparedness for smallpox is actually enhancing our entire preparedness system that we're using to respond to all kinds of terrorism threats as well as other public health emergencies. So our capacity to detect and mount large-scale responses to emerging health threats has certainly been enhanced through this whole effort. As a result, we can respond not only to the agents of bioterrorism, but to other deadly diseases.

And I'll just remind you of the West Nile infections that were the focus of our attention over the summer and early fall, where these same systems of working with the public health community and the health care delivery system were successful in crafting an appropriate public health response.

Second, as Secretary Thompson reminded us, this is a challenging endeavor and there are going to be some bumps in the road. We expect to learn some lessons as we go forward, and we intend to be flexible, adaptive and responsive. We will also have ongoing communication with our partners and the public, and we seek suggestions that strengthen our efforts and enhance our success.

Finally, it's important to note that smallpox and emergency preparedness are all about partnerships. And our partner list is extensive. Secretary Thompson already mentioned the many partners in the public health system and the health care delivery system in government who are critical to the success of this effort. But most importantly our partners include the people we are calling upon to protect all of us in the event of a smallpox attack, those who will be serving on the smallpox response teams. At CDC, we look forward to working with all of these people and groups to successfully implement the President's policy.

Thank you and thank you for your support. At this point, I would like to introduce my colleague, Dr. Tony Fauci, who is the Director of the National Institute of Allergy and Infectious Diseases at the NIH.

Tony.

DR. FAUCI: Thank you very much, Julie.

I'd like to spend just a few moments talking about the vaccine, itself, and some of its complications or adverse events. The vaccine that will be administered to smallpox response teams, health workers and first responders in this voluntary program that the President just announced is called Dryvax. It is the identical vaccine that was successfully used for decades in this country at the time that smallpox was endemic throughout the world. Indeed, it has played an important role in the ultimate eradication of smallpox from this country and worldwide.

Thus, it is a highly effective vaccine. It is a live virus vaccine in which the virus is called vaccinia, a close relative of the true smallpox virus. Vaccinia is capable of inducing in the recipient of the vaccine a response that protects that individual from infection with the true smallpox virus.

Routine smallpox vaccination was discontinued in this country in 1972 because of the rapidly declining incidence of smallpox in the world and the vastly reduced risk of it being imported into the United States, where the last recognized case of smallpox actually occurred in 1949. Prior to 1972, each year in the United States approximately 15 million people received this vaccine. The Dryvax vaccine that will be used was produced in the 1970s, and since that time, 15 million doses of the vaccine have been stored. In recently conducted studies, sponsored by the National Institutes of Health, we demonstrated that even after more than two decades of storage, Dryvax maintains its potency.

Specifically, we examined what we call the take rate, or the induction of the characteristic skin response to the vaccine in normal volunteers. The take rate has been shown to closely correlate with the induction of a protective response. We tested these reactions in several hundred healthy volunteers who had never received a smallpox vaccination previously and compared the undiluted Dryvax to the vaccine diluted one to five or one to 10. We found out two important facts. The undiluted product had a greater than 97 percent take rate, and the one to five and the one to 10 dilutions had similar take rates. Thus, the vaccine had retained its original potency. In addition, the minor reactions and discomfort associated with vaccinations were no different than those that we had experienced over decades and decades of use of the vaccine.

We detected no serious adverse events related to these vaccinations. However, since the serious reactions are rare -- and I'll discuss that in a moment -- we would statistically not have expected to see any such toxicities when vaccinating only several hundred people. We will be using the undiluted Dryvax vaccine which we recently -- was relicensed in this current vaccination program that we're talking about today.

Now, as effective as this vaccine is in protecting against smallpox infection, it is not without rare but potentially toxicities. Historically, if one uses as a reference the national survey and the 10-state survey of vaccinated individuals in the United States in 1968, one can expect that with this vaccine there will be approximately 14 to 52 life-threatening adverse events per million vaccines. These reactions include vaccinia encephalitis, which is an inflammation of the brain, a very serious complication; eczema vaccinatum or -- spread throughout the body in individuals who have eczema or a history of eczema; what we call progressive vaccinia or vaccinia necrosum, which is the inability to contain the replication of the virus from the vaccine site and spreads in a very serious way throughout the body and some cases of generalized vaccinia.

In addition, there will be approximately 49 to 935 other serious but nonlife-threatening events per million vaccines. There will be one to two deaths per million people vaccinated according to the historical experience.

Serious toxicities are seen much less frequently in individuals who have been previously vaccinated with smallpox vaccine -- namely, people who are being re-vaccinated. In our recent vaccine trials with Dryvax we noted that as many as 50 percent of individuals experienced some degree of muscle aches and fatigue, and approximately 10 percent experienced fever. Indeed, about one-third of the vaccines had symptoms that were significant enough to have them change or alter their normal daily activities for a day or longer. These inconveniences are expected and are entirely compatible with the decades of experience with this vaccine.

Now, one way to help avoid serious adverse events is to exclude people from this voluntary program who have a condition that puts them at a higher risk than the general population for vaccine-associated adverse events. Such conditions include skin diseases such as eczema or atopic dermatitis, treatment for cancer, HIV infection, administration of medications that suppress the immune system including in transplant recipients and pregnancy.

It is important to point out that such individuals would be excluded from this voluntary pre-attach vaccine program. However, if there were a bioterrorist attack using smallpox, such people, were they exposed, would be able to receive the vaccine under special precautionary conditions which include the ready availability of Vaccinia Immune Globulin, or what we refer to as VIG, V-I-G.

Indeed, enough VIG will be available to accommodate the expected rate of adverse events in the program that is being announced today. VIG is produced by deriving gamaglobulin, a serum protein, from the plasma of people who have been recently vaccinated with smallpox vaccine. This gamaglobulin possesses protective activity against vaccinia and has been successfully used to dampen certain of the adverse events associated with smallpox vaccination.

Of note, the vaccine that would be used to vaccinate the general public, were there a smallpox release today, would be the Eventus Pasteur product that would be distributed under an investigational new drug protocol, since it is not licensed. This vaccine is quite similar to Dryvax, the vaccine that we'll be giving to the individuals in this program, and compared quite favorably with Dryvax in recently conducted and ongoing NIH-sponsored clinical trials.

The Eventus Pasteur vaccine is also one of the vaccines, along with vaccines that are currently in clinical trials, that could be used under an NID in a pre-release, voluntary program of vaccination for the general public prior to 2004 when a licensed product that is currently being produced will be available.

Finally, it is essential for anyone who volunteers to receive the smallpox vaccine to be fully informed and thoroughly aware of the risks associated with the administration of this vaccine. It is important to the effort of preparedness to have a cohort or vaccinated smallpox response personnel. However, it is also important that these volunteers understand fully the rare but real risks of this vaccination.

DR. WINKENWERDER: Thanks, Tony. Good afternoon. The Department of Defense plans to begin immunizing some of our military forces against the smallpox virus. Several principles informed this decision by the President and Secretary Rumsfeld.

First, the health and safety of our men and women in uniform are our top concerns. We have a responsibility to protect them from any threats they may face. Second, as has already been stated, I think by many, while we can't quantify the risk that smallpox would be used in a deliberate way, consequences of its use would be far-reaching. Our forces must always be able to carry on their missions. It would be difficult to vaccinate military forces after exposure in a deployed situation. The right step, therefore, for preparedness, is to vaccinate now. It may also serve as a deterrent.

Third, the smallpox vaccine, as Dr. Fauci and Dr. Gerberding have gone into great detail, is very effective. We know a lot about it. Our program will be implemented in a very careful and very effective way. We will introduce the vaccination program in stages.

First, we will vaccinate rapid response teams and other health care teams, just as is being done in the civilian sector. These personnel will have a critical role in vaccinating deployed and garrisoned troops, and they would respond to a smallpox attack and would be available, in fact, to assist, if called upon in a civilian situation.

Second, we will vaccinate certain U.S. forces that constitute mission-critical capabilities. These include forces deployed or assigned overseas, forces that would be expected to be deployed in a contingency, and forces that enable deployments to occur. In the third stage, other U.S. forces may be vaccinated, depending upon circumstances and further consideration and decision by the Secretary.

Today, we are beginning phase one and phase two, and that is today. We're starting actually today. Our program is mandatory, except for medical exemptions -- and we've talked about those and we will deal with those medical exemptions in exactly the same way as is being done by the CDC and in the civilian sector. So our program is mandatory, except for those medical exemptions for those for whom it is being provided.

We've worked closely on our efforts with the Centers for Disease Control and Prevention. We've developed very detailed clinical guidelines for health care providers and medical screening procedures for those to be vaccinated. With careful screening, monitoring and early intervention, adverse reactions can be greatly minimized. I'm confident that we will safely and effectively manage this program.

Our track record, in fact, from the 1970s and '80s, when we last gave the smallpox vaccinations -- and we did vaccinate right up until 1990, we vaccinated much of the force, full force vaccination until 1984 and then continued with the vaccination of recruits from '84 to 1990. Our track record during that 20-year period of 1970 to 1990 was quite good, in that we did not have a single documented death. And so I think that makes the point that with a lot of careful screening and monitoring and aggressive follow-up, that the adverse effects can be very well managed.

The Department of Defense and the Department of State have also established a process for considering a request for limited supplies of smallpox vaccine from our allies and other partner countries to protect their military forces and their civilian populations.

In summary, our responsibility is to do all we an to protect the health and safety of our service members. Smallpox vaccination offers a very important means of protection for them. Thank you very much. And let me introduce at this time, Mr. Greg Suchan and Dr. Cedric Dumont, from the State Department, who will speak to those issues.

SECRETARY SUCHAN: Good afternoon, my name is Greg Suchan. I am Deputy Assistant Secretary of State and, despite that, I will be brief. (Laughter.)

Obviously, the United States is not the only country in the world that is under threat of the possible use of smallpox or anthrax and we believe that the use of either smallpox or anthrax as a biological weapon would have significant and far-reaching consequences, not only for the country in which it is used, but for the entire world community. And an attack on any nation is a potential threat to all nations.

Now, in order to protect the operational details of the policy you have heard announced today, as well as to provide a high level of deterrence against potential biological weapon attacks. We are unable to elaborate on any -- on the U.S. ability to offer pre-exposure assistance to other countries. However, we can say that the United States will consider requests for vaccination from allies and coalition partners, and we will work with these countries to address their preparedness needs. In addition, we can assure the world community that the United States government stands ready to lend any and all feasible assistance in the event of an actual attack.

Now, Dr. Cedric Dumont, the Medical Director of the Department of State.

DR. DUMONT: Thank you, Greg.

Since the 1990s, the Department of State has worked to extend protection to our diplomatic personnel against nonconventional threats to the missions and countries in which they serve. Nonconventional threats, I mean chemical and biological agents.

In that context, the department plans to offer vaccination against smallpox and anthrax on a voluntary basis to personnel at posts in the Middle East. The department has worked closely with the Center for Disease Control and other relevant agencies to develop a vaccination program that addresses the unique circumstances in which these employees serve with their families far from the United States.

The department has no information, as has been mentioned several times, no information to indicate that there is an immediate or specific threat to use biological agents against our personnel. While it is not possible to quantify the threat that these biological weapons pose, however, we do know that the consequences of their use would be great. Vaccination is a prudent course to afford our personnel the utmost protection abroad. Thank you.

GOVERNOR RIDGE: I want to thank my colleagues for the extensive presentation and briefing. I suspect you have -- in spite of that you may have some questions. I'd like to just summarize very briefly.

The President's national plan, obviously, tried to deal with the notion that we inoculate in order to prevent. And we want to protect those -- the President wants to protect those who will ultimately be called upon to protect America. To that end, you protect your soldiers and members of the Department of Defense and Department of State who are in areas where there is a possible threat.

As Commander-in-Chief, the President felt that since it was going to be mandated within the Department of Defense, he's the Commander-in-Chief, leaders, respond to the circumstances and he appropriately concluded that he, too, should be vaccinated.

The second population that we ask Americans -- it's a voluntary inoculation, a voluntary vaccination program -- that program is among the health care workers and those and responders who would be called upon in the event of attack to identify the smallpox, to administer assistance, to treat those who were contagious. This is a voluntary program. And, again, it's a preventive measure to protect those who, in the event of attack, this country would ask to protect the balance of 280-plus million citizens.

The third group of individuals, general public, including the First Family and everybody else in this country. As a matter of policy, this country is not recommending that the vaccine be administered to the general public. And, again, as you detected, one of the consequences of the work of the past 15 months is not only the acquisition of the necessary vaccine, but the creation of a public health infrastructure in partnership with the state and local governments that will give this country the capacity to respond to a variety of public health problems, not the least of which will be in the event of an attack, post-attack vaccination.

If you have questions for any members of the panel, please feel free.

Q: This if for Governor Ridge. When will the President be getting his shot? And how many military personnel, how many health care workers do you anticipate will be vaccinated in this early stages?

GOVERNOR RIDGE: The President will make that decision with his treating physician here in the White House. It's just -- I can't give you a definite answer. I think most importantly he's said publicly as Commander-in-Chief he's going to get the vaccine and he and his doctor will work out those details. I don't know if there are any estimates within the public health community, since it is a voluntary program. The first thing we want to do is make sure everybody understands, through a broad education campaign, what the side effects are. And then they'll have to make those personal, individual decisions.

But I'll defer to perhaps Dr. Fauci for any estimates. Any thought, in terms of the number of people that you believe will participate in the program, the voluntary program?

DR. FAUCI: Actually, the voluntary program, if you look at the first group, which would be individuals who would be the smallpox response teams, the estimate would be approximately 500,000. The CDC and Dr. Gerberding and her colleagues have asked the states to come back as to what their estimates would be. And the estimate is quite close to that, somewhere around 450,000.

If you estimate the number of people who would be the broader, more expanded health workers, including -- in addition to the first responders, who are the policemen, the firemen, the ambulance people and others, that would come to up to 10 million people. But we don't necessarily expect that 10 million people would get vaccinated and there are estimates that perhaps half of those would opt to get vaccinated. But if the universe of them all decided to, that would be up to 10 million.

Q: And the military personnel? Is that 500,000?

DR. WINKENWERDER: We've identified the groups. It may depend, but our closest fixed number would be in the range of 500,000.

Q: Governor Ridge, I wanted to follow up on Randy's question. You're suggesting that the Vice President of the United States, the Congress, the Cabinet, the President's staff are going to be treated like the general public, they can opt in.

GOVERNOR RIDGE: Correct.

Q: Why, for continuity of government issues, was this decision made? Can you explain why were that particular concern of the President -- he decided that they opt out?

GOVERNOR RIDGE: Well, they can opt in, obviously. But --

Q: -- not opting them.

GOVERNOR RIDGE: Well, they certainly have the ability to be inoculated. But again, the purpose behind the strategy, in the absence of a specific threat of a biological event where smallpox would be used, would be to use the vaccine available to inoculate those Americans who would be called upon to respond to an attack. While the Cabinet would be called upon to respond to an attack, and members of Congress and the general public would, those at the front lines, those who would be called upon to identify the attack administer the vaccine and treat those who were affected would be the health care workers and the first responders and the decision was made to include that group and give others the option to opt in.

Q: And how are you going to treat yourself? You want to just wait for --

GOVERNOR RIDGE: I'm going to treat myself as a member of the general public. If there was a smallpox event, I would not be called upon the scene to do the analysis to treat the victim or the victims, or to be in charge in that very, very difficult environment to limit the contagion, so following the President's directive and consistent with the national strategy, I will not be vaccinated.

Q: Governor Ridge, can you tell us -- can you tell us what we know about the likelihood that the smallpox virus has fallen into the hands of Iraq, al Qaeda or other U.S. enemies, and how that knowledge has informed the decision not to recommend that average Americans get vaccinated?

GOVERNOR RIDGE: Obviously, the national strategy is predicated upon an assessment of the threat and the opportunity of and the inclination of enemies, be they sovereign states or terrorist groups to use smallpox as a weapon. It's clear that some of the enemies of this country may have within laboratories or may have access to the smallpox vaccine or the smallpox virus. But again, the strategy is predicated not on a specific threat but a concern generally that it is out there in the international community, that it is clearly one of the most destructive -- some would argue the most destructive virus that could be deployed as a weapon of terror. And, for that reason, in order to protect this country against that possible attack, we decided to embrace the strategy that the President announced.

Q: Do we know that any of our enemies do have the smallpox virus?

GOVERNOR RIDGE: We have knowledge as to who may have it or who have access to it. But again, the assessment of the threat involves an assessment as to who has it. They have the ability to deliver it. And, based on the overall threat assessment of the strategy as the President has enunciated, was developed. That is also part of the -- clearly part of the assessment involving not making a recommendation for the general public to be vaccinated.

Q: Governor, let's talk the process by which the general public can opt in. In practical terms, how easy or difficult will it be for somebody to opt in and get the vaccine now? And will that change once there is licensed vaccine?

GOVERNOR RIDGE: I'm going to defer to either Secretary Thompson or Dr. Gerberding or someone from CDC or NIH to answer that question.

DR. GERBERDING: Keep in mind that our highest priority right now is making sure that the smallpox response teams are vaccinated. So that is where the energy of the public health community needs to go first. And as we said, we'll be starting those clinics in late January in most states, and we'll be working with states to try to complete immunization of those teams as quickly as we can.

We will also be working with partners in the state and local governments to evaluate the options for programs that would provide access to the general public. And as I mentioned, there are at least three ways that can happen. One is there are clinical trials already ongoing to evaluate the vaccine products that Dr. Fauci mentioned. Those projects are going on around the country and there's a website, called www.clinicaltrials.gov, where people can go to see whether or not that would be a good way for them to access the vaccine.

But we also recognize that probably won't be a solution for everyone, and so we'll need to develop some other kind of mechanism to receive the vaccine if they want it before the licensed product is generally available. And one idea for that would be to develop another protocol for the unlicensed vaccine and to make that protocol available in all the states. So we'll be working on that with the state and local partners.

Q: What happens once the vaccine is licensed? Does it then become widely available, or will it still be a cumbersome process to --

DR. GERBERDING: Keep in mind again, even when we have licensed vaccine available, we are not recommending vaccination of the general public. So we will be easier to administrator the vaccine once it's licensed, because we won't have to go through the special paperwork and so forth that the unlicensed vaccine requires. But we would not make it a recommendation that people receive it, at least based on the threat assessment that exists at this point in time.

Q: Dr. Gerberding, I have a question about the screening process, if that's all right. When it comes to these initial people who will be screened, are you going to specifically ask that they be screened, for example, for HIV, for pregnancy test? How specific of a screening process will be employed?

DR. GERBERDING: We feel very strongly that in this situation when there's no smallpox vaccine circulating that we need to put enormous effort on the screening process. And so we are recommending that states make those tests available for pregnancy or for HIV infection, available to the volunteers in that particularly jurisdiction before they come to the vaccine clinic and appear for immunization.

So the process will vary depending on how individual states decide to implement that recommendation. But we know the expectation is to have the information provided to the individual volunteers, the information also provided to the clinicians who will be assisting people in making those assessments and decisions. And then again, once people get to the clinic, there's actually a check sheet and a list that's gone through verbally. And some counseling will be administered to each individual volunteer to make sure they don't have any of those risk conditions. And if there's any doubt, of course, they would be advised to defer until it can be straightened out.

Q: Secretary Thompson, in terms of the liability --

SECRETARY THOMPSON: Yes.

Q: -- for people who volunteer, health care workers who volunteer to be vaccinated, over and above what's already in the Homeland Security Act, there's liability protection for people who administer the vaccine. But compensation for people who receive the vaccine if they inadvertently spread it to their families, et cetera, obviously that's an issue. Where do we stand right now on that issue? And do you have any plans in the new Congress to go back to Congress if they revisit Homeland Security Act or some provisions in it to try to get them to tweak the law to put some of those compensation issues in?

SECRETARY THOMPSON: We are doing everything we possibly can to make sure that Section 304 of the law is going to cover as many people as possible. That's number one.

Number two, we're going through a whole litany of protections to make sure that it doesn't spread. As soon as you get vaccinated, there's going to be a gauze put upon you. And then subsequent to that, it will be a dry bandage. We're going to give a lot of instructions, a lot of education, how to be able to handle yourself and make sure you do not spread it.

The 304 Section allows for exoneration of liability for those individuals that are agents of the federal government. And the people that would be receiving the shot, the vaccination, they would have a right under Section 304 to sue the federal government under the Federal Torts Claims Act.

Q: They have to prove negligence.

SECRETARY THOMPSON: They have to prove negligence, which is going to be somewhat difficult. They certainly will be able to apply for worker's compensation. And we're looking at other provisions that we might be able to go into the Congress and take a look at to modify and ameliorate the law to make it a little bit easier. It is a big concern of ours, and we are looking at that -- we're looking for ways to be able to alleviate that.

Regards to the question over here, there are 439,000 individuals that we've designated right now in order to receive the vaccination in the first tranche. But I want to make sure that you understand that it's a voluntary program and not every one of those individuals will receive it. So we do not exactly know, but there are 439,000 designated right now.

Q: Many have argued that because the vaccine is not being recommended for the general public right now that you should have waited and not even offered it until it was licensed. What was the decision -- or what was the thinking to offer it more quickly?

SECRETARY THOMPSON: There was a tremendous amount of discussion going on. And as Governor Ridge has indicated, and as President Bush has indicated, we have been working on this issue. I know you've been over and you've been asking these questions for a year. We've been working on that longer than that. I want you to know that, in getting prepared for it. (Laughter.) And we were making sure that we tried to do the maximum good for the American public. We want to make sure that the first individuals are the individuals that are going to have to deal with the individual -- if there is an exposure -- coming into the hospital, taking care of that individual, to make sure that those individuals are protected.

And we're going to learn a lot from this, as I've indicated in my opening remarks, there are going to be bumps along the way and we want to make sure that we understand how we're going to be able to do this and do it better.

The second area, of course, is the first responders and the rest of the public health workers. And that is a group up to 10 million individuals, which we think more than likely about 40 to 50 percent of those individuals would get vaccinated. We just feel it's better right now to get prepared so in case there is any kind of an exposure, we had these individuals protected so that they can take of the rest of the citizens. And we've also developed programs so that we could have mass vaccination if there is an exposure.

But we want to learn ,we want to develop the programs, and we want to protect as many people up front as possible. And therefore, we're recommending that these individuals in the first group and the second group get vaccinated. But the general public, we do not believe there's enough of a risk at this time that we would recommend that they be vaccinated.

Q: Why make unlicensed vaccine available to the general public? Why not wait until it's licensed for the general public?

SECRETARY THOMPSON: Just because there are some individuals that feel so strongly that they want to be vaccinated right now, then we're going to make it available. But it's going to take a process in order to get that far down the line in order to do that. Those individuals, knowing the full circumstances, going through all of the questions in the questioner, signing the consent that they want to do it, sometime late spring or early summer, if that individual or individuals still would like to do it, and they're not available to go into a clinical trial, we'll make it available to them, and set up a procedure to do that. We'll be working with the state health departments, the local health departments, the local hospitals to make that possible.

Q: Who are these individuals, and do you have any way of quantifying how many people you think are going to insist on --

SECRETARY THOMPSON: We have no way of quantifying it right now. That's why the President, that's why Governor Ridge and that's why myself, Julie Gerberding and Tony Fauci all recommended, through you, the general public, that we do not recommend that you get the vaccination. We're hopeful that people will understand that there are risks involved and that they will not ask for it, because we do not think at this point in time they should be vaccinated.

Q: Are you already hearing from people who say --

SECRETARY THOMPSON: No, we're hearing from the press that's saying that maybe they should -- (laughter) -- but we haven't -- nobody has called me up and said, Secretary Thompson, I demand my rights under the Constitution to get my one vaccine that you promised me is there. We have not received any calls like that as of today.

Q: Are you not making the recently relicensed Dryvax vaccine -- you are not making available to those people?

SECRETARY THOMPSON: No, we're making the Dryvax. We're licensing the Dryvax. We have approximately right now 14.5 million doses of Dryvax. Some of those individuals will not be able to licensed. We're going through the process. We're going to have this set aside for the first and second group. Then we're going to -- if other individuals, it would be the on-license Eventus Pasteur, which we have 85 million doses for. Q Mr. Secretary, could you talk a little bit more about the President's involvement in this? Why did he get so personally involved instead of leaving it to the experts? Is there anything you can say --

SECRETARY THOMPSON: The President -- I want to tell you. I've been involved in a lot of those discussions. This President was absolutely engaged early on on this subject. He recognized the importance of it, he recognized how contagious and how lethal a smallpox virus exposure would mean to the country, and he wanted to do his utmost best to protect the American public, fully realizing that this vaccine has some consequences.

And therefore, he spent a lot of time, months, thinking about it, calling myself and Julie and Tony back into the office to discuss it, and making sure he had all of the information, because he wanted to make sure he had all of the information, because he wanted to make sure he made the right decision. That's why it took so long.

He also was trying to make up his own mind whether or not he should have the vaccination. And he decided, because he was the Commander-in-Chief, that he should not order the troops to get it unless he was willing to do it. But at the same time, as he indicated in his speech, he does not recommend to the general public, because nothing is out there right now that shows an imminent threat to the medical needs or the medical threats of American citizens that they would require or should get the vaccine.

Q: And for the DOD rep, when you say your program starts together, are people actually getting poked today?

DR. WINKENWERDER: Yes, today. They're small numbers of people that are being vaccinated today.

Q: How many?

DR. WINKENWERDER: Low dozens.

Q: Where?

DR. WINKENWERDER: They are being vaccinated at the Walter Reed Medical Center.

Q: Can you say what types of people are the very first?

DR. WINKENWERDER: It's the same -- just exactly parallel to the people that Dr. Gerberding described.

Q: Any reason for these particular dozens? Are they high ranking --

DR. WINKENWERDER: No, no. (Laughter.)

Q: You're not going overseas. I mean, they're geared to be first responders?

DR. WINKENWERDER: They're the first response teams.

Q: Question for Governor Ridge.

GOVERNOR RIDGE: Yes.

Q: Governor, in the event that there is a smallpox case, one or more, is the administration's plan to do a mass vaccination of the American population? Or will you do sort of a ring vaccine, as was used in the eradication program? And if you are doing mass vaccination, how long do you think it would take to vaccinate everybody?

GOVERNOR RIDGE: Well, I think the question will be answered depending on the information and the circumstances of the moment. What happens as a result of us building up this infrastructure, getting state and local plans and territorial plans, is we're in a position to deal with an isolated incident or multiple incidents. And I think the response of the country would depend on the circumstances of surrounding the detection of smallpox, whether it's a singular case, an isolated case, or multiple cases.

Q: And who will make that decision, ultimately?

GOVERNOR RIDGE: Those are medical decision. And I think one of the -- again, one of the positive consequences of this process has been Dr. Gerberding and Dr. Fauci and everybody anticipating these questions and coming up with better answers than I just gave you. (Laughter.) So I'm going to ask Dr. Gerberding to come up here.

DR. GERBERDING: That was actually a very good answer. But there's one very important thing to add to that, and that is that whenever there's a smallpox case, the first priority is to find the case and to identify the contacts of the person while they were infectious with the rash, vaccinate those people and then find all the contacts of those contacts and isolate them and vaccinate them. And that is the single most important step toward containing the spread, regardless of how small or how large the overall attack is.

Then, when the assessment is made about the scope and the threat as Governor Ridge has described, it's very likely that a broader vaccine program in that area would be indicated and, certainly, we would anticipate that the public would expect access to the vaccine under those threat conditions. And that's why our public health system under Secretary Thompson's direction has developed plans so that they can initiate a vaccine program for the entire population if the situation arrives in that manner.

Q: I don't know if it would be you or Dr. Fauci. Can you tell me about the vaccinia Immune -- VIG. How much is there? Are you making more, specifically?

DR. FAUCI: There are approximately 2,000 doses now. In mid-January there will be about 3,500. End of January, there will be about 4,500. By the time the summertime comes, there will be an awful lot, about 30,000 doses.

The formula that you use is that for every 100 doses that you have, treatment doses, that would be able to accommodate what you would expect of adverse events for one million vaccinees. So right now with the 27 or what have you, we already have enough right now for about 27 million. So we have enough right now, as I mentioned in my remarks, to cover the expected adverse events associated with the program that's been announced.

Q: How quickly do you have to get that when somebody starts showing symptoms?

DR. FAUCI: Well, it depends on -- as always, the sooner the better. But there are certain components, there are certain adverse events that respond much more readily. For example, the generalized vaccinia that I mentioned responds favorably, much more readily, to vaccinia immune globulin than someone who presents with an acute vaccinia encephalitis, which may not.

Q: Dr. Fauci, can you describe what the FDA has to do in order to license the Acambus (sp) vaccine that's being produced? What kind of inspections do they have to do, what kind of documentation do they need?

DR. FAUCI: Since I'm not FDA, I can't give you the precise answer to that. But it is the standard way that one goes through the various phases of vaccine testing. For example, the Acambus (sp) now is at the end and completed phase one. They will go to phase two in the beginning of the year and they will very likely, barring any unforeseen problems with the evolution of the trial, will go to phase three likely in the summer.

At each stage, the FDA works very, very closely with the company in examining safety data, take data, and all the variety of other scientific data together with the safety data that are accumulated.

Also, as with any product in its development, when lots are made, individual lots at each different point in the process are inspected, the plants are inspected. It's a very comprehensive process that is no different for any other vaccine or any other therapeutic. So it's the standard FDA approach towards that.

With that, it is projected -- again, there are never guarantees when you have a biologic that you're making, but it's projected that this product will be up for licensure in 2004.

Q: ; Dr. Gerberding -- this is for Dr. Gerberding. Can you tell us how long you expect the states to have to do the vaccinations of both? And I'm not sure if you're blurring the two groups of the response teams and then the 10 million other health care workers. Are they all going to be done together? How long will it take to do -- vaccinate all of these people?

DR. GERBERDING: Let me emphasize again that getting the smallpox response teams immunized is our highest priority, and that's the group that so far the states have designated about 450,000 people to be immunized. And in our planning guidance, we recommended that they try to accomplish this in 30 days, from the point at which they actually open the clinics and begin the immunization. But they need some time to get the plans approved and then the training done and all of the other steps that have to go on before clinics can actually open. That's why we don't expect that to happen until late January.

Once they start, it will take them a while to get fully operational and up to speed. Thirty days may be a reasonable estimate in some states, but there are places that are likely to take longer. And we would much rather that they do it safely than they do it fast. And so we're going to anticipate that they'll be finishing that sometime this spring. It will probably never actually be completely done because there's changeover in staff and new people coming into the system.

Q: It's other people, the health care workers --

DR. GERBERDING: As we initiate this process we'll be developing guidance for the expanded groups, because right now the states have not received any recommendations about how to go about immunizing the firemen and the police and all of the other health care workers who are not on the response team. So we will be developing that guidance at CDC, putting that out; plans will come in and we'll just repeat that process. And we'll be working with our state and local partners to make sure that they can do this safely and in a time frame that works for them.

So I'm not going to speculate on exactly when that expansion will be in full swing, but we want to do it as quickly as we can because we recognize it's an important part of our preparedness.

MR. JOHNDROE: Thank you very much.

(end transcript)