SMALLPOX VACCINE
December 13, 2002

President Bush announced that the U.S. plans to vaccinate selected military, embassy and health care workers against smallpox. Terence Smith discusses Bush's decision with Dr. Julie Gerberding, the director for the Centers for Disease Control and Prevention; and Dr. Anthony Fauci, director of the National Institute of Allergic and Infectious Diseases. The NewsHour Health Unit is funded by a grant from The Henry J. Kaiser Family Foundation. (Background Report) (Discussion)

 

Online Special: The Bioterrorism Threat Nov. 11, 2002: A simulated plague outbreak May 9, 2002: Homeland Security Director Ridge on the anthrax investigation. May 9, 2002: Homeland Security Director Ridge on the anthrax investigation. Jan. 4, 2002: Examining efforts to develop a more reliable way to detect anthrax. Jan. 3, 2002: Workers exposed to anthrax decide whether to use a controversial vaccine. Dec. 19, 2001: Dr. Anthony Fauci Dec. 4, 2001: Controversy surrounding the anthrax vaccine Dec. 3, 2001: Keeping mail safe Nov. 29, 2001: Preventing a smallpox outbreak The NewsHour's Health Spotlight Browse the NewsHour's coverage of health   News for Students: News for Students: A new form of terrorism     Centers for Disease Control and Prevention U.S. Department of Health and Human Services Food and Drug Administration's bioterrorism Web site	TERENCE SMITH: The plan the President outlined today had been in the works for months. PRESIDENT GEORGE W. BUSH: To protect our citizens in the aftermath of September 11, we are evaluating old threats in a new light. Our government has no information that a smallpox attacks is imminent, yet it is prudent to prepare for the possibility that terrorists who kill indiscriminately would use diseases as a weapon. TERENCE SMITH: Under the President's plan, vaccinations against smallpox would be given first to about half a million members of the armed forces who could see action in the event of war with Iraq, which may have a weaponized version of the virus. PRESIDENT GEORGE W. BUSH: As commander in chief, I do not believe I can ask others to accept this risk unless I am willing do to the same. Therefore, I will receive the vaccine along with our military. I'm ordering that the military and other personnel who serve America in high-risk parts of the world receive the smallpox vaccine. TERENCE SMITH: The President's plan also calls for offering the vaccine on a voluntary basis to a pool of roughly half a million health and emergency workers across the U.S. They would help treat any bioterrorist victims and carry out vaccinations as needed. Government officials will eventually expand the program voluntarily to as many as ten million other emergency responders and health care workers. Before it was officially eradicated in 1980 through a worldwide vaccine program, smallpox killed hundreds of millions of people worldwide over the past several thousand years: In total, about a third of those infected. But despite the vaccine's effectiveness, it is a live virus that carries significant risks for some groups of people, including pregnant women and those with compromised immune systems. Historically, for every one million people vaccinated against smallpox, about 900 had side effects; 15 of those were life threatening; one or two resulted in death. Today, the President of a health care workers union raised concerns about protection for workers. ANDREW STERN, President, Service Employees International Union: There's no guarantees that you get free screening; there's no guarantees that if you get sick or are hospitalized that it gets paid for; there's no guarantees if you're temporarily or permanently disabled, or, God forbid, you die, that you have any kind of compensation. We think that's really wrong. We need a no-fault system. Workers that volunteer want to do their jobs, but they have to be protected. TERENCE SMITH: The President said he saw no need to recommend a vaccination for the general public, including members of his own family and staff, but he said the vaccine would eventually be made available to those who demanded it. PRESIDENT GEORGE W. BUSH: Our public health agencies will work to accommodate them, but that is not our recommendation at this time. TERENCE SMITH: Vaccinations for members of the military began in Washington today.
	How best to prepare for a possible attack
	TERENCE SMITH: Joining me now are two top health officials involved in forming the administration's new smallpox policy. Dr. Julie Gerberding is director of the Centers for Disease Control and Prevention. Dr. Anthony Fauci heads the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. Welcome to you both. Dr. Gerberding, if as the President says there is no imminent threat of a smallpox attack on this country, then why now? DR. JULIE GERBERDING: The President has reminded us that we are fighting a war on terrorism. And while the threat is not imminent, there still is a possibility of a smallpox attack. Getting our emergency teams prepared is really the best way to ensure that we can protect the American people. TERENCE SMITH: How is it going to be done? You're talking about some very large numbers here, particularly with the military. DR. JULIE GERBERDING: There are going to be some challenges. We haven't had to use this vaccine for many, many years. What we're doing now is reviewing plans that the states have submitted to us on how they would go about immunizing the first smallpox response teams. When those plans are approved, and we expect that any day, we'll be able to work with the states to plan the training, the information campaigns that need to go on for the volunteers and then help them prepare to open the clinics. We'd expect that to happen sometime in late January. TERENCE SMITH: Dr. Fauci, tell us a little about this vaccine. For example, the President says he is going to take it. What are the risks of side effects to someone like the President? DR. ANTHONY FAUCI: Well, the vaccine is called Dryvax. It's a live virus vaccine that contains vaccinia, as Dr. Gerberding said. It has been used historically for decades and had been very influential in eradicating smallpox in this country and worldwide. However, as effective as it is, it does have rare but nonetheless potentially very serious toxicity. As you just showed on the show, one to two per million will die from it and fifteen to fifty would have life threatening complications and up to 900 would have serious but non-life threatening complications. The important thing about the program is that (a) It is voluntary (b) We know the kind of people that are at an increased risk for those toxicities, so they will be preemptively excluded from the vaccine program, but if we had an attack obviously, they would get vaccinated with some extra special precautions. The critical issue is that when people make up their mind to volunteer, they need to understand the nature of the toxicities, and that's something that we're all working very hard on, on that information flow so that when people get to the decision point, they will really know just what the risk is of the vaccine. It's very important to appreciate that.
	Determining who should be vaccinated
	TERENCE SMITH: Now, the President, for example, is over 34. He is in that group of Americans most of whom received the vaccination when they were young. DR. ANTHONY FAUCI: Yes. TERENCE SMITH: Yet it is necessary to do it again? DR. ANTHONY FAUCI: Absolutely. Even though there is some lingering or residual immunity after decades, it is certainly not felt that that amount of immunity could efficiently or effectively protect you against exposure to smallpox and getting infection and getting disease. So individuals who had not been vaccinated for that period of time, if they want to be protected, they need to get vaccinated. TERENCE SMITH: OK, Dr. Gerberding, I guess the question is why not the population at large if the threat is there and the concern is there? Why not? DR. JULIE GERBERDING: You know, this is the really difficult balancing act here. We've got a vaccine with, as Dr. Fauci said, some very serious side effects. We know the more people we immunize, the more deaths and life threatening complications we are going to see. We have a threat of smallpox but we can't really quantify it. But one thing we know for sure, if we have a smallpox attack, it could be a devastating outbreak in our country. And so by balancing this, we can prepare the people needed to protect people without endangering rest of the population. TERENCE SMITH: Now we have stockpiled -- this country has stockpiled enough to do the population as a whole, as I understand it. DR. JULIE GERBERDING: Absolutely. TERENCE SMITH: How long would that take in the case of an emergency such as you just described? DR. JULIE GERBERDING: We have asked the public health system to be able to immunize the people in this country within a ten-day window of time if we needed to. It's a big challenge but I think we are going to be able to be right on the mark. TERENCE SMITH: Dr. Fauci, I noticed the President said while he would do it, he was not going to have his family or his staff do it. DR. ANTHONY FAUCI: Right. TERENCE SMITH: So there's some decision making going on right there. DR. ANTHONY FAUCI: Right. But the rationale that the President gave for himself being vaccinated, that he said very clearly, as commander in chief of our armed forces, I will not ask my troops to be vaccinated in the sense of actually ordering them to be vaccinated-- this is the military, this wasn't not a voluntary program. He said given that, I feel that I, myself, would be vaccinated. The reason his family is not, because his family is considered as part of the general public. And he also made very clear in his remarks that although we would make available the vaccine to the general public for those who felt they still wanted to get vaccine, clearly it is not recommended for the general public. So since his family and his staff are part of the general public, they fall under the category of, if you want it you can have it, but it is not recommended for you. He made that very clear as did Secretary Thompson. TERENCE SMITH: All right. But what about the people, Dr. Gerberding, in the public, who do want to have it? DR. JULIE GERBERDING: Well, the first thing we have to do is get the emergency responders and the smallpox teams immunized. TERENCE SMITH: They number some ten million. DR. JULIE GERBERDING: Correct. We'll be working on that first. But we have some plans for how we can make vaccines available to hose to want it despite the recommendation. One way is for them to join one of the many clinical trials that is going on around the country to evaluate the new vaccine products. Another mechanism might be that we would create a special protocol so that we would be able to offer it to them when we get that put together. TERENCE SMITH: Through their individual doctors? DR. JULIE GERBERDING: It could be done through the clinicians or public health system. We'll have to work that out. But there would also be licensed vaccines in 2004 available that would be easier to be made available to the public because it would be fully licensed.
	Threats from other biological agents
	TERENCE SMITH: Dr. Fauci, if an enemy could weaponize, to use the phrase, weaponize smallpox, why not other viruses? I mean how do you approach the whole problem here? DR. ANTHONY FAUCI: Well, that's just the issue. Smallpox is not the only potential problem we have. We have to prepare as best as we can the nation for bioterrorist attack against a wide variety of agents. The CDC has done the following, which is very important, have created a categorization of prioritization so that when we in the research field gage our research endeavors, we go after what is called the Category A, which would include besides smallpox, anthrax which is still a threat, Tularemia, botulism toxin, plague, the hemorrhagic fever such as Ebola. There is activity going on in the Department of Health and Human Services of developing vaccines where appropriate and therapies not only for the Category A agents but also for agents that are less of a probability, less of an impact that we call Category B and C. So we have a very daunting task to try and protect the nation because we can't be vaccinating everyone against everything. What you have got to do is create a priority and direct your public health endeavors in that direction. TERENCE SMITH: Dr. Gerberding, do you suppose that you'll be going into those Categories B and C after smallpox? Do you envision something like that down the road? DR. JULIE GERBERDING: We are already in those categories, not just in the biologics, we're working on the chemical and the radiologic terrorism activities as well. In the middle of the smallpox planning, we have been running botulism exercises and chemical terrorism exercises. TERENCE SMITH: Do you think it will reach a point where people will actually have to be inoculated against those dangers? DR. JULIE GERBERDING: Well you know vaccination is not the only solution. Each agent has a different approach. But I think the protocol we are trying to follow is of one of constantly improving our preparedness and exercising our capacities and building the products and the people and the plans that we need. TERENCE SMITH: What is the risk, in your view, to the health care workers who are in the list of people to receive it very early on since they deal in the environment in which they work? DR. ANTHONY FAUCI: When you say the risk, the risk of the vaccine itself? TERENCE SMITH: And the side effects. DR. ANTHONY FAUCI: Well, the side effects are the same side effects that I mentioned because if you look at the broad range of people who have been vaccinated historically over time, many of them have been healthy, young adults, which is about where the health workers -- there will be some people who will be a bit older, but you are talking about individuals who are healthy enough to go to work to perform their functions, so that is what I'm getting back to what I said before is important, even for those people for whom it is recommended, it is still voluntary. So it is important for them to appreciate the side effects and the toxicity. TERENCE SMITH: Okay. Doctors both, thank you very much. DR. ANTHONY FAUCI: You're welcome. DR. JULIE GERBERDING: Thank you.