Mr. Bacon: Most of you, I hope, have gotten the release by now. We have an official from the Joint Staff who's been working on this project for the last 15 months to walk you through the basic briefing, and then we also have an official from Health Affairs to handle medical questions.

Q: Can we ask why it's on background?

Mr. Bacon: Yes, we've just decided that we would have it on background because we are still six months off from actually starting the program. We're basically at a stage where we're announcing consultations with Congress and continuing work in medical consultations and other areas. We just felt that since we made the decision on Friday and still have, as I say, a number of wickets to go through, that it made sense to announce what we're doing but in a low key way, and that's why we've chosen to do it this way.

Briefer: Thank you very much.

Good afternoon, ladies and gentlemen.

What I'd like to do here for the next few minutes is provide an overview, if I could, on the immunization plan for the anthrax vaccination, and then upon the conclusion of that take any questions you may have.

I want to focus a bit on the threat. I'd like to talk you through an illustrative scenario of how that threat might occur. The countermeasures for the threat, the anthrax threat, some information about the vaccine, and then a summary of what the program looks like.

The Chairman of the Joint Chiefs prioritizes biological warfare agent threats. Anthrax is at the top of that list. That is no change. It has been there for some time. The threat is proliferating. As you can see here, based upon different regions of the world we've got confirmed threats that anthrax stocks are in hand, and in some areas they have been weaponized. Whether they're weaponized through the use of surface-to-surface missiles such as a SCUD or weaponized with air assault delivery via aircraft. Either way, the fact is it is proliferating and it is being weaponized.

On a relative basis, with regard to other biological warfare agents, anthrax is easy to weaponize.

If I could, let me talk through here a bit, an illustrative scenario to show you how this might happen.

What we have here is a notional area that might be commanded by a commander of a Joint Task Force. This is probably a corps area. It's got several divisions in it, as you can see here. It's got a joint look to it.

Now if the threat released an anthrax cloud through a long line release, aerosol release from an aircraft, upwind of our forces, and it drifted down over them, the fact that anthrax is 99 percent lethal in an aerosol inhalation delivery means, the warfighting strength of that corps would be at about 34 percent. Onset of symptoms in 24-72 hours. It's lethal in five days. Pretty significant capability. Again, this is an aerosol release, exposed personnel who are unwarned -- we have no detectors. They are unprotected. Because we have no warning they're not in their MOPP suits with their mask on, and they are unvaccinated. Significant degradation to warfighting strength. Tremendous casualties.

So what do we do? What are the countermeasures?

Well, obviously, we need to detect the fact that there's a biological agent out there. It's a technical challenge. These are hard to find. It's not like a chemical agent which is relatively easy. A lot of these agents occur naturally, indigenously, in areas we operate. The fact that they're weaponized and they're used against us makes it extremely difficult because we're looking at incubation time for symptoms. So we need to have detectors to find those immediately. It takes time to detect. Then once we detect, we have to identify what that agent is. We may find some type of a cloud out there. To identify specifically what is in that cloud, what type of agent, takes another step in the technology.

We've got some capability now. As you know, based upon the 25 November demonstration where we brought in a lot of our chemical and biological detection gear and put it out here for demonstration purposes, we have some capability. By and large, it is point detection. You find out you have the agent when you are there with your detector. That is in place now, and there's more coming. Enhancements also are being developed where we get a standoff capability, so that we not only can see a cloud or an agent in the distance, we have the standoff to be able to detect and identify what it is before it gets to where the troops are, the service members, so they can take protective action, put on their masks that will protect them against those type of agents.

That leads me into the protection. Our current protective mask provides protection. It will filter out the spores. New technologies, again, are being developed. New capabilities to enhance our protection. The JSLIST [Joint Service Lightweight Integrated Technology] suit primarily protects against chemicals, but it can also protect against a cutaneous infection -- a cut that a service member may have that the anthrax could get into.

Lastly, medical. Three ways we can protect here -- antibiotics, antiserum, and the vaccine.

With regard to those medical countermeasures, antibiotics. They're effective in sustaining service members until antibodies are built. Provides immediate protection, but it has to be sustained over a period of time, until the antibodies are developed. There are limited minor side effects with the dosage required of the antibiotics. Antiserum is a very fast reacting, immediately protection capability, but again, it's limited, and it has to be readministered to sustain protection. It's expensive and the same minor side effects are associated with it.

Vaccines are the way to go. It takes time to develop the immunity, but the immunity lasts for a long time. Limited. Minor side effects. I think the rate of those folks that we've vaccinated over the last five years associated with their jobs -- either lab workers, workers in industry in the private sector, special operations forces, there's been about a 96-97 percent rate of no reaction at all, and those that did have had limited topical reactions, minor swelling or redness, things like that.

It's extremely difficult to circumvent a vaccine. This would ward against genetic engineering of other strains. Once that vaccine's in, it takes a major effort for an unfriendly nation to try to develop another type of anthrax strain that we would have to dissect, if you will, figure out what it was and then rework our vaccine. But it is very effective. It provides the protection we need over the long haul.

Like I said, it takes awhile to develop -- 18 months, six doses. The first shot, followed by a shot at two weeks, then two weeks after that, so three shots in four weeks; then three more shorts over six months; followed by an annual booster. The antibodies then, with the annual booster, will provide adequate protection. Again, difficult to circumvent.

It was developed jointly, actually, by England and the United States in the '50s initially for the private sector -- wool sorters, wool workers, the tannery industry, meat packing industry, veterinarians, anyone dealing with cattle, sheep, things like that. It's been licensed since 1970, proven safety record. It's been documented. Four to five hundred doses a year are given in the private sector. Now practically all of those are the boosters, other than for veterinarians that are beginning. Since 1970 we've provided it to our lab workers that deal with this type of biological agent. And as you can see, in DESERT SHIELD and DESERT STORM we vaccinated 150,000 service members. Granted, only one or two shots each, did not complete the entire protocol, but we did do that while deployed.

I might add that since DESERT SHIELD and DESERT STORM, special operations forces whose missions take them in areas where anthrax is indigenous; the Marine Chemical/Biological Incident Reaction Force, the CBIRF if you will, and the Army's Tech Escort Unit have all been vaccinated with the anthrax vaccine.

So we're back to the scenario. What does that do for us? Now we've vaccinated. We don't have any better detection, we don't have any better protection, but what we now have is this force, on the ground, vaccinated. You can see, personnel without immunity is a little enclave. What that is is, they are in the proximity of the delivery of the agent and that proximity has caused them to be hit with a dose that overwhelms their immune system even with the vaccine. So if they're very nearby, that is a potential. But the warfighting strength now with this protection is at 95 percent -- a vast difference. With enhanced detection leading to protection, we can get that up to 99 percent plus. This is the first big step. Those casualties, again, are because of over-exposure to the attack.

We believe it's the right thing to do. It's the right step at the right time.

Those are the Secretary's words on the 25th of November. "There's a clear and present danger today, and it's going to grow with time." It is growing.

This is a force protection issue. This is essentially the first step in a medical force protection program under a health force protection program that the President has talked about, I believe, on 8 November. This will be the prototype program where we will roll that out. We will track both individual service member current status and history, and we will ensure then that this program provides the wherewithal to do that.

Vaccination is safe, it's effective, it is a legitimate vaccination. It fits with our strategic concepts.

If you look at the national military strategy right now, we have four strategic concepts -- strategic agility. We're going to be moving forces around the world. We have power projection -- that's how we do that. We put our service members in harm's way all over the world right now. Forward presence. We are actively engaged shaping the environment. And overwhelming and decisive force.

Given those concepts, the vaccination is the only way to accommodate a force that is very mobile.

Provides long term protection. Obviously with six shots required in the protocol, there's a substantial challenge with regard to the logistics involved, but again, we can do that. We can track that with automated systems, and it is the right thing to do.

If I could, the decision, if you will. We're going to vaccinate the force beginning with the high threat. Those soldiers assigned to or rotating to high threat areas -- Southwest Asia, Northeast Asia. Subject to four conditions. The first is the supplemental testing, consistent with FDA standards, safety, sterility, potency, and purity. Essentially we're going to do that... Last spring the Food and Drug Administration notified the producer of the vaccine -- the Michigan Biological Laboratory -- that they had some production problems with regard to quality assurance and production practices and they needed to fix these. Those were identified, a management plan was put in place, we worked closely with the lab to do that. The problems found were not in the anthrax production line, they were in other areas of other products being produced in the lab. We felt it would be prudent if we quickly got involved in that, made sure that our product, the anthrax vaccine was well in hand. Those efforts are ongoing. To ensure that we've done everything we should and need to to validate the sterility, safety, potency and purity, we've begun supplemental testing. We'll subject the stockpile to that to ensure that those factors are met.

We must also implement a full tracking system, and that's tracking of every service member from shot one to shot six, to the boosters, and to being able to have commanders in the field one, know the status of their service members; and secondly, know not only the status of where they are in the program, but when the next shots are due. The critical point is, we can do about anything we have to if we know what it is that's upcoming and plan for it.

Approval of operational communication plans. There's two pieces to this. The operational plan is the actual movement of the vaccine to stockpile and is ensuring that the forces are at the right place, service members with vaccine at the right time. A lot of moving parts, because we're talking about a total force implementation -- 2.4 million service members initially. Then more after that as we access every year new service members.

We're also talking about a communications plan which consists of notification to key leaders in Congress, the executive branch, and other governmental and non-governmental agencies to ensure they understand what our intent is and why this is a force protection program that we must do this.

The other component of the communications strategy is to inform all the service members of why it's important that they get this vaccination, and they must fully understand, down to every one, why it's going to protect them. And also to inform then the healthcare providers. At every medical treatment facility that we have in the military who will be administering this. So they understand the criticality of this mission and to ensure that it is done on time and to standards.

Lastly, review of the health and medical plans by an independent expert. We have been putting this together for quite some time. It's a big program. There's a lot of moving parts to this. It's always good to have another look and that is why the Secretary will have an independent expert take one other look at this from a health and medical perspective. There may be something that we didn't see. We don't think so, but this will be done to ensure there's some component of this that we might be able to do better as opposed to something that hasn't been done.

I think we've covered the waterfront on that pretty well.

One last piece if I could, would be to address, and I don't know if it's been a question yet or an issue, but to address the issue of pregnancy with regard to will females pregnant be given the vaccine? The answer at this point is no. That the vaccine will not be administered to pregnant females. Once the pregnancy is over and that person comes back on duty, if you will, after the postpartum leave, then they will be enrolled in the program, but at this point the answer is no.

Q: What about those who are about to become pregnant, or didn't know they were pregnant? Is their pregnancy at risk because they are in the middle of this series of shots?

A: I will have to defer that, if I could, to my medical compatriot.

A: Thank you.

We have reviewed all the literature in regard to this type of vaccine, and there's no evidence at all, there's never been a reported case with these comparable types of killed vaccines of any difficulties with pregnancies. So our determination that in fact we will not administer it and we will actually advise people, is one of I think great caution in the face of scientific evidence. This includes a review last week of essentially all the published literature on not only these bacterial vaccines, but viral vaccines as well. But I think it's just a question of being conservative and cautious.

Q: Is this the only effective vaccine against a biological agent? Very effective vaccine against a biological agent? And how much will this cost, 2.4 million, do you have any idea?

A: Let me answer the second first. The total program cost right now is about $130 million, and that's to acquire, distribute, and implement a program. That's over several years, obviously.

The first question I'm not sure I understood. Is this the only effective...

Q: Is this the only effective vaccine against a known biological agent?

A: There are other known biological agents of which there are effective vaccines. This is a licensed vaccine.

A: We actually also vaccinate our troops against plague, which is also an approved vaccine.

A: Botulinum.

A: Well, botulinum is investigational, but plague is an approved vaccine, somewhat like this, a bacteria.

Q: So all troops already get...

A: It's a question of risk. When you go into areas where there's a high possibility of plague either being indigenous, or you could be exposed to it through water or other sources, those particular troops are immunized against plague.

Q: Plague is not as effective as this is it?

A: No. It's, as the other briefer pointed out, most bacteriologic weapons are much more difficult to both prepare, weaponize, and deliver. This is relatively simple for all three.

Q: So this is the first time that you're actually vaccinating troops against a germ agent you think might be used as a weapon?

A: Other than what was done in DESERT STORM/DESERT SHIELD for anthrax and botulinum.

Q: If this is such a good thing to do, why has it taken so long to do it?

A: A couple of reasons. One, we had to work through all the administration and the logistics of doing it. 2.3, 2.4 million times six shots times a booster gives us 18 million opportunities not to get this right. So we want to make sure that we've got the moving parts identified and synchronized.

Secondly, our national military strategy now practically mandates it. The fact that we have both active component, reserve component service members going a lot of different places, we're engaged across the world, we're engaged to shape... That is our strategy. We know now that today and in the future it will stay the same. It will be at least as much engagement as we have now, probably more so, because we have to depend upon the total force, so now is the time to do this.

Q: So if a reservist is called up for active duty, they would then get it as well?

A: Actually our intention is, after this meeting we're meeting with the Reserve Chiefs. We intend to have the sel res [selected reserves] immunized before they're called up, so... That's a part of the process that we're going to go through.

One additional thing that was an important precondition that the other briefer had on his slide, that was one of the expectations the Department had is that we would be able to electronically and centrally register the information on each and every one of these shots, and very frankly, a year ago we did not have that capability. We will have that capability this spring.

Q: To clarify, who exactly is getting these shots? You said 2.4 million. Obviously that includes all the uniformed services. You're talking about, does this also apply to reserve? And who are the civilians who are getting it? Is it all civilian employees of the Department of Defense?

A: We will initially start with all active and reserve component, 2.4 million, and all mission essential DoD personnel in the theaters that are considered high threat -- Southwest Asia and Northeast Asia. Mission essential as determined by the CINC in that theater.

Q: The families, will children...

A: Initially, no. Those are considered other than U.S. forces and this first traunch, if you will, the high threat, we are not going to do other than U.S. forces.

Q: If they ask for it can they obtain it or pay for it or have it?

A: Currently the vaccine is not approved, has never been tested or approved for children. So for under 18 it would be essentially off label, unless there was some very specific medical reason for an individual. The current plan is to focus on the troops and mission essential personnel.

One of the issues, among a large number of issues of additional people to consider would be, in fact, families, coalition forces, and others. That's going to be looked at.

Q: Does this reflect a heightened concern about the willingness of unfriendlies to use biological weapons? Do you suddenly have new intelligence that would indicate that they're more ready to do this than in the past?

A: I think it acknowledges the fact that chemical weapons are proliferating. That the best way to protect against an anthrax threat is vaccination. We have a policy, a DoD, Department of Defense policy to vaccinate when we have threats and we have an acceptable vaccine, and that's what we have, so it's time to do it.

Q: So the 2.4 million, is anyone left out of that, or is that... Does that essentially cover everyone?

A: Well, that covers the reserve component selective reserve, but it does not cover inactive reserve. It covers all AC and RC selective reserve.

Q: Civilian, military... And civilian employees of the Department of Defense?

A: No.

Q: For instance, people who work at the Pentagon...

A: As I said, it covers mission essential Department of Defense employees deployed to those two regions as determined by the CINC in those regions.

Q: One other point of clarification. Anthrax is a bacteria, right? How would you describe it? It's not a virus.

A: No.

A: It's basically a bacteria which has been known as a disease-forming bacteria, particularly in sheep and cattle and other animals for 200-300 years. The thing that makes it more dangerous is the fact that unlike most bacteria, its resting state is called a spore, which is very resistant to sunlight and heat and other things, so that at least in the inactive phase, it's relatively stable and protected. So that if you can spread that particular spore which then is taken up in your lungs, which is the preferred way of BW administration, then the spore becomes the bacteria and moves very quickly. That makes it very unique to most bacteria.

Q: The reason I ask, in your chart listing antibiotics, you were talking about the advantages and disadvantages. You had a line that said not effective against antibiotics, not effective against viruses. I'm just wondering why that was there if this was not a virus.

A: I think the slide was a generic slide looking at BW threats sort of across the spectrum of all the threats. Sort of a more generic state.

A: The antibiotic is effective in terms of sustaining the patient once they have the four symptoms, the onset of symptoms, then there are real problems.

A: It is, first of all, in very large doses and only intravenously. And if you're talking about thousands or tens of thousands of people, essentially that's going to be a logistic impossibility.

Q: How long, practically, do you think it will take to inoculate everyone? You said years. Are you talking about three years, five years?

A: Six to seven.

Q: How does this kill? Does it cause people to die of massive pneumonia? Do they...

A: Actually, this particular organism can cause a number of different illnesses ranging from skin infections or cutaneous infections; but the form which is most lethal is essentially overwhelming bacterial pneumonia with sepsis, which is deadly in some number of hours, certainly short of 18. It's a very powerful organism once it begins to be cultured in the lungs.

Q: What is sepsis?

A: Sepsis is where the infection moves into the blood stream and into all the other organs of the body.

Q: How does this vaccine interact with the other medications and prophylactic drugs that troops are administered?

A: Vaccines are specific to the protein of the particular bacteria. So like diphtheria pertussis and tetanus, mumps, all the other kinds of vaccines we get, they're designed that they react specifically or develop immunity specifically against those proteins.

For example, the reason you have to often have a flu vaccine every year is the flu virus changes. If you don't have this year's protein as an immunity, often it will then be able to break through. This is very specific to anthrax and essentially will focus only... It will not help you against anything else, nor interact with the other immunizations.

Q: What is the vaccine? Is it dead anthrax...

A: Essentially what you do is you take the protein spore and you deactivate it or kill it with a formalin mixture. Then you make it into a sterile preparation similar to a DPT vaccination, which we use routinely with children.

Q: Was the decision to track individuals the result of concern over the Gulf War illnesses and that experience?

A: I think it was more of a reflection, and the other briefer can comment on this, in the context of Joint Vision 2010, the whole idea of force protection, what do we mean by it and what needs to be done to make it work was relooked at. The determination by the Joint Staff is in order to make that work, you have to move toward an electronic capability to know the information on every individual. Ultimately I think we're going to move to a personnel information carrier. This then becomes the prototype of moving into that much bigger electronic way of tracking all the readiness considerations for all of our troops.

A: Absolutely. The key is, because we're deploying a lot to different locations, we need to have a consolidated database to where at any time we can determine not only an individual's medical status and history, to include vaccinations and immunizations, but other things in case that individual comes down with some type of illness wherever they may be deployed to. So a consolidated database is essential in being able to do that.

Secondly, commanders need to know the status of their units, whether they're trained, ready to deploy, logistically ready to deploy, and medically ready to deploy, so we need to have access into those databases for the CINC or the Joint Task Force Commander to see the level of protection that his forces have in that theater.

Q: Once you're through with this first grouping of the 2.4 million, is it your intention then that as soon as someone comes into the military they will be inoculated...

A: Yes, ma'am.

Q: No matter what their area of expertise or where they're headed for or anything like that.

A: Right. What we would do is at about year three to four, depending upon numbers we have to work with and the vaccine stockpile, is we would begin then to immunize what we call accessions which is just that -- new service members coming in. So as they come in at their basic training station they would receive initially there, and then finish up once they move into their units.

Q: Is this just to tell potential enemies out there to pour their energies into developing other agents?

A: There are a number of agents you can potentially use. This agent is the easiest to manufacture, the easiest to weaponize, and the easiest to deliver. So said more simply, there are large numbers of potential enemies who this is probably the only one they will be able to weaponize and deliver.

The fact is very sophisticated countries that can do many, many things aren't really the necessary central focus now for our concerns. It's this kind of stuff that bothers us more.

A: Exactly. The only thing I would amplify there is, indeed, it offers the possibility to find new agents, but on the other hand those agents are somewhat limited because of the ability to weaponize, and our ability then to counter that because of the limiting factor, I think makes it...

This is a very common virulent biological agent.

Q: My question was just, is this another step up from a biological arms race where you've got moves, countermoves on each side?

A: I don't know. It could be, but I'm not prepared to answer that.

Q: Does it not concern you that by going this public with how easy it is to weaponize anthrax that this would encourage some enterprising terrorists to use this against a civilian population?

A: Enterprising terrorists now pick it up on the web. It's on the worldwide web. Enterprising terrorists have been talking about it for years. It's been in Newsweek. It's been in lots of different publications. So if you're really enterprising or a terrorist, this press briefing is not going to be the way you find out about it.

Q: What would you say to the American public tomorrow who's going to read that the Pentagon is inoculating its troops, but here's this higher BW threat in American cities, should people go out and get...

A: I don't think the brief talked about higher threats in American cities. What we talked about is weaponizable anthrax in a couple of geographic areas of the world where, in fact, most probably the highest potential exposure to our citizens and troops will be. That's the first step in a process of identifying the high risk people. We very clearly are going to be in a couple of places in the world where countries have this. It's probably, if not definitely, weaponized. And we're obligated to protect the troops in those areas.

Q: So you think people shouldn't rush out then and get inoculated?

A: Absolutely not.

A: Again, the focus on our program is high threat areas. It's because we are deploying service members to those areas where we believe the threat is higher. Why are we extending it to the total force ultimately? Because the total force is subject to, again, our national military strategy of forward presence and strategic agility. So at some point in time in the future, all service members may likely rotate through those high threat areas. So again, long term protection and take a long time to get it in place. That's why we need to start now.

A: The other briefer talked about the very thoughtful, one of the questions was why haven't we done it quicker? Because it needs to be a thoughtful process. If there was a sense of emergency or urgency, we wouldn't be laying out a plan to do this over the next six or seven years. This is a prototype for how you look into the 21st Century to have a fully protected force. This is not an emergency.

Q: Who's going to pass muster on those, whether you actually get the tracking program in place and all those sorts of things, before you get started in the summer?

A: You mean the individual in the Department? The commissions? The Deputy Secretary has to be... We have to demonstrate, the different ones of us who are doing this, to the Deputy Secretary that those conditions the Secretary established are fully met, like supplemental testing.

Q: ...final checkoff before they start this summer.

A: For each of those four, to make sure that the Secretary's decision has been carried out.

Q: On the safety of the vaccine, the manufacturer's been administering 400 or 500 doses since what, 1970? That's 14,000 roughly doses. How does that testing experience compare with other types of vaccines? Is that a lot more? Is that about average?

A: First of all, we've administered 150,000 doses...

Q: ...only two or three, not...

A: Actually the safety for a vaccine, for a protein vaccine, is in the first couple of doses, like DPTs. There's also been thousands of troops administered the vaccine that are special operations, that the other briefer mentioned...

A: 3,600.

A: Plus 500 to 1,000.

So the answer to the question is, in comparison to something like DPT, obviously this is a very small number. You can't get children into school today unless they have DPT vaccine. I presume all of us are vaccinated. In the context of other vaccines, there are some number of vaccines where relatively small numbers, particularly lab workers, are done. But we're fairly confident of the safety record of this vaccine.

Q: The availability of the vaccine at this point, if you wanted to do a large program tomorrow, is there a stockpile of this vaccine available?

A: There's a stockpile right now of seven million shots, which is about 1.2 TED -- troop equivalent doses -- of six shots, if you will. So there's a large stockpile.

A: But that's the stockpile... We're redoing the testing on it just to be absolutely certain before we go out. There's been a great attention to safety in this.

Q: You found no impurities in the stockpile...

A: No.

Q: Is there an instance where somebody has used anthrax in an attack or tested it even, anywhere that you know of?

A: No one has ever used it. There have been certainly discussions and papers written, and probably games done, but there's never, to my knowledge, been a case where it's been actually delivered.

A: The agent of a specific attack? I'm not aware of any, no.

Q: How long have special operations troops been vaccinated against anthrax?

A: They've been vaccinated for quite some time in terms of their duties and missions taking them to areas where it's indigenous. Since the Gulf War, a lot of special operations forces who operate in Asia and Africa, in a lot of different kind of missions routinely have had the vaccination.

Press: Thank you.

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