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Update of Defense Department's on-going Anthrax Vaccine Immunization Program

Presenters: ASD Dr. Sue Bailey and Rear Adm. Michael L. Cowan
August 14, 1998 2:00 PM EDT

Mr. Bacon: Thank you for coming this afternoon. I see we have a young journalist in training. We are always glad to have youngsters in our briefing room.

Medical Force Protection is a key component of readiness. That is why Secretary Cohen decided in May that the entire force, active and reserve, should be vaccinated against the biological warfare agent anthrax. The vaccine is safe and it is effective. Secretary Cohen and General Shelton have just received their fourth shot out of the six-shot series, and they are as healthy as ever.

Last spring, we started vaccinating troops against anthrax in the Gulf. Next week, we're going to start with the total force vaccination program. Today, Dr. Sue Bailey, the Assistant Secretary of Defense for Health Affairs will bring you up to date on this important force protection measure. Some of you may know her. She was here as Deputy Assistant Secretary of Defense for Health Affairs in 1994 and 1995. We are glad to have you back in a loftier post. She is joined by Rear Admiral Cowan from the Joint Staff who is in charge of medical readiness issues there.

Dr. Bailey.

Dr. Bailey: Good afternoon. Thank you, Secretary Bacon. Today I would like to address the Department's total force anthrax immunization program. I am pleased to be briefing with you today with Rear Admiral Mike Cowan, who is Deputy Director for Medical Readiness for the Joint Staff. The health and safety of our soldiers, sailors, airmen and Marines are our paramount concern. The Department has embarked on an aggressive campaign to develop and implement a force health protection strategy for sustaining and preserving the health of the force.

We need to provide the commanders-in-chief a healthy, fit and medically ready force and to strengthen our ability to protect them while they are deployed around the world defending our nation.

The anthrax vaccine immunization program is a critical part of that force health protection program. As you know, last December Secretary Cohen approved the plan to vaccinate the total force against the biological warfare agent, anthrax. His approval was contingent upon the successful completion of four conditions: first, supplemental testing of the vaccine; second, assured tracking of immunizations; third, approved operational and communication plans; and, fourth, review of the health and medical aspects of the program by an independent expert.

These conditions were put into place to insure that we have a workable program, a comprehensive data collection system to monitor the shots given, and that we are absolutely confident that the vaccine is safe. All of the Secretary's conditions have been met.

First, the Joint Program Office for Biological Defense contracted with Mitretek Systems, Incorporated, to perform independent supplemental evaluation of testing being conducted by the manufacturing on all lots of anthrax vaccine, previously approved by the FDA for a lot release. Testing began in January of 1998 and is scheduled for completion this November. Initial lots have passed testing and will provide sufficient dosages to support the execution of the first part of the plan.

Second, each Service has implemented a tracking system that will fully document anthrax vaccinations and transmit the required data to the DEERS system, that is the Defense Enrollment Eligibility Reporting System. It is a centralized database. A joint immunization tracking system, Preventative Health Care System, will eventually replace the Services' individual immunization tracking system. The new system is scheduled to begin deployment in the late fall of this year. Both the interim and long-term immunization tracking systems will be used as management tools to provide commanders and administrators with information on the status of individual immunizations.

Third, each Service developed implementation plans that specify how they will administer the vaccination program for the total force. Communication of the program to the Service members, their families, the American public, and various government entities was addressed in a joint communications strategy. This strategy includes command information and education programs.

Fourth, Dr. Gerard N. Burrow, Special Advisor for Health Affairs for the President of Yale University, conducted an independent review of the health and medical aspects of the department's anthrax vaccine immunization program. Dr. Burrow completed reporting on his review on the safety and efficacy in February of '98. A copy of Dr. Burrow's report can be obtained from the DoD web site.

On May 18, 1998, the Secretary approved implementation of the total force anthrax vaccine immunization program. In approving implementation of this program, the Secretary has put into place a force protection program that will ensure our troops have available to them a safe medical countermeasure against the significant battlefield threat of anthrax.

The implementation plan is time-phased.

Phase 1 of the program is targeted to begin on Monday for forces already deployed to or rotating through high threat areas in Southwest Asia and Korea.

Phase 2 of the program will target those early deploying forces that are planned to go into the high threat areas of Southwest Asia and Korea. This phase is scheduled to commence in early fiscal year 2000.

Phase 3 of the program will commence in fiscal year 2003 and will include the remainder of the total force, new accessions, and program sustainment.

Finally, as you all know, we began the accelerated anthrax vaccine immunization program for Southwest Asia in March and, to date, more than 48,000 service members have started the anthrax vaccine series. We have had a remarkably low adverse reaction rate and, overall, the program has been extremely successful.

I'd now like to share with you some slides.

As I've indicated, anthrax is a significant battlefield threat. We have particular concern because it is easily weaponized into an aerosol form that leads to the disease inhalation anthrax.

Inhalation anthrax, as opposed to the two other forms of anthrax which are the form cutaneous anthrax and intestinal anthrax, the aerosol induced inhalation anthrax is 99 percent lethal, so that following symptomatology after exposure it is 99 percent lethal.

The anthrax medical countermeasures we've discussed include vaccines and later we will discuss some of the other ways in which we look to protect our forces.

The vaccine has been shown to be safe and effective. It has a 28-year history and is FDA licensed since 1970.

The protocol, as you know, is six doses over 18 months, at zero, two and four weeks, again at six months, then again at a year, and then at 18 months, with an annual booster.

This slide shows the chronology that has developed since 1993 when there was a directive for immunization programs for biological warfare defense. And this progression shows you the thoughtful pattern that has taken place up to now to allow us to determine to vaccinate the entire force.

Anthrax vaccine has been shown to be extremely safe. Again, a 28-year history, mostly with those working with animals, because this is what's considered a zoonotic disease. That would be people working around wool, sheep, other animals. And it has therefore been given to veterinarians and we have also been giving it to special forces so that we now have a long history of safe use. We have given over 133,000 doses and, as I mentioned, we've only had seven adverse effects.

We have reported through the FDA CDC VAER system, which is vaccine adverse event reporting, seven reports of these adverse effects. Actually, four were self-reported. You can call the VAER system yourself if you were to have an immunization and have a reaction, so four self-reported and three were reported because they met the standards that provide for their recording. Specifically, that would be loss of duty time and/or hospitalization.

We frequently see minor local reactions, much as you would have experienced with immunizations you may have received, which include soreness, redness and swelling.

Our plan is phased during a period of time, as you see here, from FY '98 up to FY '06. Following that, boosters, of course, would be provided on an annual basis.

Phase 1 indicates forces assigned now or rotating to high threat areas in Southwest Asia and Korea.

Phase 2 are the early deploying forces into high threat areas in those same areas.

Phase 3 is the remainder of the force and accession or people coming into the service who would be vaccinated.

And, finally, program sustainment, which are the boosters.

We have a special emphasis on informing service members and their families and the general public about our program. We want to be certain that people understand the reason for the total force vaccination program, the lethality of the threat of anthrax and the safety of the vaccine that we have that can protect our troops. And so we look to the health care providers, commanders, local newspaper, radio, TV, some of the Services and their magazines and now we have an Internet web site as well. We are intent upon assuring people about the safety of the program and the necessity of the program.

Finally, this is our web site where extensive information can be gleaned about anthrax and the immunization program.

I'd now like to bring Admiral Cowan up, Mike Cowan, and we'd be glad to take any questions.

Q: Well, I guess one question I have is given how public the Pentagon has been about this immunization program, in addition to that, are you more concerned now that other biological agents will pose more of a threat, now that potential enemies will know at some point in the future that all U.S. service members will be inoculated against it? What kind of other agents are you looking at as well?

A: (Dr. Bailey): Well, I think we both would like to speak to that. Clearly, we have knowledge that as many as ten nations either have or are suspected to have the capability of chemical and biologic warfare. We continue to do research so that we may provide vaccines where that's appropriate.

Admiral Cowan?

A: (Adm. Cowan): You asked about ten questions. I'd like to answer the top three or four.

The first is that there our over-arching policy is that if we have a recognized threat and we have a vaccine that can counter that threat that is safe, then we want to use it. And so just by the fact that we know the threat is out there and we know that we have this vaccine in adequate amounts, we want to use it.

The second important question imbedded in there is why anthrax. Well, it's the poor man's atomic bomb. It's ubiquitous, it's everywhere, it's easy to get a hold of, it's easy to grow. And we don't have to go out and tell anybody about that. People already know that. So we have a very dangerous bacterium, very common and easy to get a hold of, and we have a very safe vaccine against it.

Did that kind of cover what you were -- okay.

Q: Yes, one follow-up on the poor man's atomic bomb. Has it ever been dropped? I mean, has -- I'm not sure of the history. Is there a documented case of it being used in warfare?

A: (Cowan): No. We know that biological weapons development programs have gone on in a number of nations and we know that there are people who have weaponized anthrax and other things like that. But this now leaves us -- having the vaccine sort of takes this atomic bomb away. There's no point in dropping it if it's not going to harm anybody, so this really comes to the philosophy of deterrence. And that is having a posture that is unassailable. But no, nobody that I know of has ever used this on a national scale.

A: (Bailey): We should add that, however, in the wild that there have been cases of inhalation anthrax. So we clearly have experience with the lethality of it.

Q: What about smallpox? Is that another possible threat, and do you plan to do anything about that kind of threat?

A: (Bailey): Well, as you may know, in America we have not been immunizing or vaccinating against smallpox for over a decade. We last immunized in the military in 1989 against smallpox. So that is -- that was considered at the time not to be a threat.

However, in this new era where there's concern about chem-bio warfare, it clearly would be one of the things we would be looking at and concerned about and continuing to research.

Want to answer that?

A: (Cowan): There's a number of things that are potential threats and we're always looking for those. None of them are as good a weapon in terms of -- you know, for the effectiveness of the weapon as anthrax. And for many of those we don't yet have a vaccine. So there's research and development going on to counter the threats and we're constantly probing the world through intelligence sources to find out what the threats are.

And it goes back to that first principle I answered, when we identify a threat and can do something about it, then we make those decisions.

Q: How difficult a task is it to genetically engineer anthrax or anything else to circumvent this major effort you're making?

A: (Bailey): First of all, you hear a lot about genetic engineering. But fortunately for vaccines, it is difficult to surpass or circumvent the effectiveness of the vaccine. We all know that you can develop resistance to antibiotics, for instance, but it's much more difficult to circumvent the vaccine.

Let's get one in the back.

Q: Just to follow that?

A: (Bailey): Go ahead.

Q: Just to follow. So this vaccine is effective against all the strains of anthrax that we know about right now?

A: (Bailey): This vaccine is thought at this point to be effective against all he strains we know about.

Q: And in order to be effective, must one have had all the doses? Or if someone were to be exposed, let's say after the second or third does, what would be their protection?

A: (Bailey): This vaccine is highly effective. And even though you see a long string of six injections, in fact, probably within two or three you've probably got a good antigen response and good protection.

Now, I think we would want to talk about other aspects of protection, as well. It does not mean that you cannot be overwhelmed by a massive dose of inhalation of anthrax spores. But it is very effective -- and probably effective after the second or third immunization. I would like Admiral Cowan to maybe speak to the other areas of force health protection around that, though.

A: (Cowan): We focus on the vaccine and, of course, are discussing that as sort of the nexus of what we're doing. But this is one piece of a complex force protection package. We're working very hard on other aspects of this. The ideal protection against a biological attack is -- one, we know it's coming, and so we're working hard at developing newer technologies and better technologies. And, frankly, we're fielding those technologies right now. We have computer -- polymerase chain reaction, PCR technology in the field now in Southwest Asia that can take very minute bits of organic material and rapidly replicate the DNA in that material until it reaches a point where we can identify it.

So we're working on identification and surveillance. We've made pretty substantial improvements in the protective devices. If you know this man-made cloud is coming and you think it might be anthrax and you put on the new lightweight masks and over-garments for chemical and biological protection, again you're very well protected.

And in the event of attack, where we think the possibility might be that some people's immune systems will be overwhelmed by a massive initial dose, then we have antibiotics, too, as a back-up system. So anthrax is important to us. But when we put our men and women in harm's way, we're doing everything we can to make sure that nothing harms them.

Q: Actually, I have two questions. First is when is the expected date that the entire active force will be vaccinated? Second is, are there concerns of any resistant stains if the vaccine is stopped over time?

A: (Cowan): I would refer you to the time line. At the beginning of the last phase, we will begin to inoculate everybody on active duty and all those coming in. And so that would be sort of a mopping up action. And I couldn't give you a terminus date that the last injection would go in the last arm to get everybody up to date.

A: (Cowan): About the year 2000?

Q: Well, it will start at about '03. This is when the total force starts, at about '03. And I would imagine within a year or so -- but that's a swag, that's just a guess. A: (Cowan): Could you state your other question again? I'm not sure I got it.

Q: Well, I was at AFEB meeting earlier. They were discussing about if you stop taking the vaccination over time that there's -- that it could produce resistant strains of anthrax?

A: (Cowan): If you expose a bacterium to antibiotics and don't kill it, just hurt it, it makes it stronger. And antibiotic exposure to bacteria has resulted in a number of different bacteria developing resistance to the antibiotics. The same is not true for this. Because the anthrax bug, the bacterium, goes in the body and is attacked by the antibodies, not the antibiotics. So it's the body's own immune defenses and the germs can't get a resistance. So that information applies to antibiotics but not to antibodies, not to vaccination.

A: (Bailey): Yes.

Q: Just a quick follow-up from before, talking about other biological agents in the plan to basically -- if there is some sort of vaccine and we know it's a threat, that's what we act on first. Can you talk about any other agents that are out there that may be threats and if there currently is a vaccine or some sort of -- or is this the only one?

A: (Cowan): Yeah, from the strategic and tactical point of view, let me just make a couple of comments. There are others that we know potential adversaries are playing with. And I would rather get into the details of that because I don't know, you know, at what point it becomes classified.

The important part of the answer, I think, is that we're working on a series of counter measures. One particularly promising one is a multi-valent vaccine where we're using new DNA technology to take the shell of a virus, empty out its own DNA, and then insert the target genetic material from any number of other bacteria and viruses that we would like to immunize someone against and put it back in this virus, which is now not an infection but a viral capsule that carries the structures that we would like to immunize with. And then that becomes our immunization.

These things are emerging technologies. They're on the horizon. We don't have them at this point. But that's the sort of answer that we would like to come up with for all of these emerging threats.

A: (Bailey): OurService members would be happy if we could come up with a one-shot dose, as well. Yes.

Q: Just if you could help us a little bit with the practicalities of this, the phase of the program that begins Monday for the for the sailor or the airman out there, I guess those are the people who are most often deploying to the Gulf region, are they going to get -- those who are scheduled to go, are they going to get some notice you "You should report to the infirmary or the clinic, whatever, to get this?"

How it actually going to be administered so those people know what to do?

A: (Bailey): From line command.

A: (Cowan): Yeah, it's personnel management. It's getting in line and making sure you have all of the things that you need in the deployment line to go do your job. You have to have your canteen, your helmet, your anthrax shot, and it's just a matter of managing a large number of people moving back and forth.

The ideal is that units will be notified ahead of time they're rotating to Korea or to Southwest Asia and, in the 30-day window or 90-day window, whatever they have, they get up to date on their shots.

That will not always happen. Some people will go to the theater, and so injections will be given at least initially in the theater. So it's just a large number of people management issue.

A: (Bailey): I would like to add, as well, that part of the success of this program has been that, for the first time, we have a system that allows us to track exactly what is happening with these immunizations.

Specifically, that means that we know of these 133,000 immunizations, we know who received the immunization, who is on their second or third shot, who might be a week late. We know that down to the unit and we know it down to the individual.

So we've got a tracking system in place here that I think puts us in good stead for force health protection in the future.

Q: If I can ask a housekeeping question, I've seen a figure of $130 million for the vaccination program. Does that sound about right?

A: (Bailey): That's about right. That's the estimate, over six years.

Q: There were some of the sailors in the Gulf that refused to take the vaccine. Some have been discharged. Others, after the second or third shot, were disciplined. It seems like it was sort of done by the seat of the pants in the Gulf with the sailors.

Have you worked out a more formal policy about how to deal with those who refused to take the shot? Will you discharge them after the first shot or the third shot or the fourth?

A: (Cowan): These are Service specific actions. Each Service has, under the UCMJ, the authority to deal with this, and each Service is dealing with it under the rubric of disobeying a lawful order.

All of the people who have been disciplined so far have been disciplined in the non-judicial punishment. There have been no court martials.

A: (Bailey): I also want to remind you that, of all these immunizations, the 48,000 people, we have only had 15 refusals.

Q: But that was in the Gulf, where there was sort of obviously a greater threat than other areas. Are you worried that once you start immunizing people at bases in the United States, that more people will say "I would rather not take this"?

A: (Cowan): I think we may. If there's not an immediate threat and people are not so immediately concerned, that may happen.

But our position is this is very safe. I've also taken it. I have absolutely -- none of us have any concerns. And we think it's of the order of magnitude of saying to someone, "You have to wear your helmet." It's for your safety. You have to wear your helmet.

A: (Bailey): I think the message here is that we have a very mobile force. They're moving at all times into threat areas and out of threat areas. So I think the message we want to get out today is this is a lethal weapon, we need to protect you, we have a safe vaccine that can do so.

As Admiral Cowan says, we both had our immunizations, and we believe in it. We know it's safe and we know it protects.

Q: How many shots does it take to be 100 percent effective, or how many months does it usually take?

A: (Bailey): Either of us could probably answer that. As I indicated, to be fully immunized, it's going to take a year. But all of our scientific research shows us that, in fact, you have a good response and good protection probably in the first two, three doses.

That does not mean we would count on that for protection, though it is something we continue to look at, so that we can reduce the number of immunizations that people need to receive.

A: (Cowan): When you challenge the body with a vaccine, the body has what is called an anamnestic response. What that means is the body says, "Oh, yeah, I remember."

The first time you give this vaccine, some antibodies form. But the next time you do it, more antibodies form more quickly, but then they will sort of die down. And then, the third time, more and more. So you get these little waves of more and more, each one building on the last.

By the time you've had three, it's a very good reaction, but it's still, the body still sort of forgets. And then when you give it a six-month, it says, "Oh, yeah, I remember again," and then it becomes more permanent. So that by the time the whole series is done, it's a very permanent part of your immune system.

We think that it is very possible, it just hasn't been tested, that we don't need as many shot as we give. That research is going on now. But, until we know for certain that it's safer to give fewer shots, then we'll go with this standardized, approved series.

Q: Is there an accelerated program ready in case of a massive deployment, in case of a conflict, in the near future?

A: (Bailey): Accelerated in terms of compression of the shot series?

Q: No, more in --

A: (Bailey): Number of people receiving them?

Q: -- people who haven't gotten the shots yet but are about to be deployed maybe on a massive scale, is there a version of this program where you give them at least their initial shot before they go?

A: (Cowan): We have the mechanism in place to do that. That would just be a logistics exercise to get that done. It would be what is the threat, is the threat valid, are these people exposed? Then we would proceed.

Mr. Bacon: Thank you very much. I have one thing to bring you up to date on from yesterday. I got asked a question about burial at Arlington Cemetery for some of the diplomats who died in Nairobi. President Clinton has approved waivers for two of the diplomats to be buried at Arlington. One is Julian Bartley, Sr. and the second is Prabhi Kaveler. He made this decision yesterday afternoon.

As you know, Mr. Bartley, who was the consul general in Nairobi, also died with his son, and his son will be able to be buried with him in the same plot.

So those were two requests that we received and two requests that President Clinton has granted. Thank you.

Q: (Inaudible) two requests. It was originally stated like it was three people.

A: (Bacon): The request came over from the State Department for three people, but the way it operates, you can bury a husband and wife or family members in the same plot, and so that will happen with Mr. Bartley and with his son, Jay. They will be in the same plot. Thanks.

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