Also Participating: Dr. Sue Bailey, Assistant Secretary of Defense (Health Affairs) and Major General Randy West, Special Assistant to the Secretary of Defense for Anthrax and Biological Defense
Now, I know that there are several of you that are interested -- have questions on our anthrax vaccination program. And with us this afternoon is Dr. Sue Bailey and Major General Randy West, who will have very brief opening statements and then will take your questions in that regard. I will follow them with other topics, but this will be focused on our anthrax vaccination program.
DR. BAILEY: The Department of Defense is very confident in the anthrax program that we have undertaken. We have a very safe and effective vaccine against a very deadly biologic agent that we know to be in the hands of many of our adversaries and could be used against our forces. That would imply, were they not vaccinated and exposed to this agent, they would die a horrible death. It is our mission to protect those forces as they engage on the battlefield that now includes our concerns about weapons of mass destruction.
GEN. WEST: Well, as a commander of troops in Desert Storm, we learned, after we crossed the border into Kuwait, that the Iraqi forces had weaponized anthrax munitions, that they were deployed on the battlefield and pointed at our troops. The majority of my troops at that time would not have been vaccinated. One of the lessons that we learned from the intelligence that we gained after we crossed into Kuwait and Iraq, was that that capability existed and could have been used, and if it had been used, we would have lost the lives of a lot of American service men and women.
It's very important that we use the existing and available safe and effective vaccine to give our troops that go in harm's way the protection that they deserve. We have about 40,000 service men and women in harm's way every day under the threat of deliverable, weaponized, aerosolized anthrax. We have a vaccine that FDA, the organization that our country depends upon to make decisions and recommendations on vaccines, has certified to be safe and effective. And I believe that it would be irresponsible not to use that vaccine.
I was disappointed in the report that was released this morning. There are some things in it that I would champion. I'm glad that they called our vaccination program a well-intended effort. I'm glad that they recognize that there is a threat that needs to be countered.
I would champion their proposal that we aggressive seek a better vaccine. In fact, we are. There's a funded and aggressive program underway under the supervision of the Center for Disease Control in Atlanta to do just that. We also believe that anything that we can do to improve the shot protocol would be a good thing to do. If you can give this vaccination in less than six shots, you're probably going to have fewer reactions, and the fewer reactions we have, the better it is.
But after that, I find a lot of things in the report to be disappointed with. There are a lot of allegations in there that I believe were appropriately and adequately answered during the seven hearings that we had on this issue last year. And I believe if you take many of the negative comments that are made in the report and go back and bounce them against the testimony that was given, you'll find many of those concerns were adequately addressed.
QDr. Bailey, might I ask -- I guess to make a long story short, from your opening statement and the general's statement, you all, in effect, are rejecting this call to make this program voluntary rather than mandatory, until another vaccine or improved vaccine is found?
DR. BAILEY: Absolutely. As you know, there are many immunizations that are given to our troops that are also not voluntary. It is not only to protect the troops, but to protect the effectiveness of the mission.
For instance, tetanus was given in World War II, and though there were millions of wounds and causalities, we only had 12 cases of tetanus. It's that kind of protection that medicine can afford to our troops, and we are intent upon providing that to them.
QWhat is the latest data on reactions, reactions that are serious enough to have a person either hospitalized or off duty for a day?
DR. BAILEY: Well as you know, we've given now over 1.5 million immunizations to over 400,000 troops. During that time, we are reporting to the VAERS system, the Vaccine Adverse Event Reporting System, as well as monitoring our own, any adverse side effects. At this time, we see the same historical pattern we see with other vaccines in terms of generally mild reactions.
I can give you the exact numbers, though, at this point, that we have 620 reports to the Vaccine Adverse Event Reporting System. And of that, 106 included those who may have been out of work for more than 24 hours -- that's loss of duty -- for that period of time, but not hospitalized. And 70 of those appear to be related to the vaccine. We had 26 who were hospitalized, and of those, they were allergic reactions, inflammatory reactions, that we often see with vaccines. And six of those, of the 26 who were hospitalized, did appear to be related to the vaccine.
Again, this is the type of pattern we've seen historically with other vaccines that we provide.
QOnly six that were related to the vaccine. What were the others, then, if they weren't related to the vaccine?
DR. BAILEY: People often are ill for other reasons, and we often, therefore, seek to determine what was actually related to any medical intervention preceding the illness. And in this case, to the best estimate that we could obtain, six of those who were hospitalized appear to be directly related to the vaccine. The others were ill or had reactions from other things.
QAnd then of the 106 who were out of work for at least a day, 70 of those were related to the vaccine?
DR. BAILEY: Appeared to be related to the vaccine. Those are generally flu-like symptoms -- malaise, loss of appetite -- the same types of things you'd see with an influenza. By the way, they're mild and they tend to go away in several days.
QCritics of the program believe that the Pentagon really doesn't have an effective reporting mechanism, that the reactions to the vaccine, those that are reported are those reactions that are almost immediate, and that there's no follow-on reporting. Is that the case? Or what is the mechanism for reporting these possible adverse reactions?
DR. BAILEY: Well, first of all, this is a system that is -- the VAERS system is part of the HHS system. That's been around just during this decade.
We also have the AVEC [Anthrax Vaccine External Committee], which is a group of experts who are reviewing any reports that go to VAERS, and they are civilian outside experts that review the cases that are reported.
Aside from reporting to VAERS though, in fact we report, as we ordinarily would, through the health record in general, the shot record and immunization tracking systems in the different services. So there are several ways in which we track, not just with the VAERS system, though I think most physicians today would feel that that is the system that is state of the art for reporting adverse effects.
QBut I guess my question is: If someone doesn't have an immediate reaction, the reaction they believe is related to the vaccine comes two, three, four days, even weeks later, what is the mechanism for that reporting? And is there any aggressive follow-on by the Pentagon to track these individuals who have been given the vaccine?
DR. BAILEY: We have studies ongoing. One that I will mention is at Tripler in Hawaii. And there are 600 troops there that are being followed long term, following their receiving the vaccination, so that whether anything occurs or not, we are still tracking the status of their health, post-vaccination.
Also in the military, we have the ability through the health system in general -- anyone that is ill reports to the system, and so connections can be made there, as well. That's why I mentioned that the general health record is another way in which we can track this vaccine.
GEN. WEST: If I could add to that?
Any person that receives a shot, any person that gives a shot, any doctor that sees a person that believes that they have had a reaction, can submit a VAERS report anytime. There is no time limit. If it's a week or two weeks or whenever, after they have received a shot, that's still reported and investigated. I believe our system is very thorough for following up and for reporting the reactions.
QGeneral, could I ask you a question on the program to develop a better vaccine? Other than developing something that you wouldn't have to give six shots, what are perceived deficiencies in the existing vaccine that you were hoping to improve upon?
GEN. WEST: Well, we were given last year 20 million additional dollars in the last stages of the budget process, to do a combined effort with the Centers for Disease Control. And we are looking are four things with that program: One is the shot regimen. One is the gender differences. One is the method for delivering the shot. And one is an "immuno-icity" study that would determine the amounts of immunity that are built up and whether we really need an annual booster and things like that.
But we have a program and a shot profile that's approved by FDA. We should always want better medicine. We should always want to find a better vaccine. We should always want to find ways to administer it that are less invasive, if we can, and we're aggressively pursuing that. But those things take time. Those are months or years away, and we've got troops that are in danger of aerosolized, weaponized anthrax today. We can't wait until we've got a new and improved vaccine to give them the protection that they need.
QComment on what Congressman Shays called it -- he compared it to the Maginot Line in that you're just protecting against one very specific threat when there are a whole lot of other threats going on out there.
GEN. WEST: I would disagree with that, from two aspects. First of all, there are a lot of countries right now that have weaponized anthrax or are trying to get it. There are a lot of potential adversaries and former adversaries that have biological weapons programs. There are terrorist groups that are pursuing this capability. We need to be able to protect against it. We're working on a lot of things. We have protective clothing to wear, we've got some detectors that have been developed to let us know when we've experienced an attack, but you can't wear protective clothing around the clock and fight and win.
Those detectors that have been developed so far don't have the sensitivities that are needed to give us the fast response times to let us know what's happened. If you take one deep breath of aerosolized anthrax and don't know that you've breathed it in before symptoms begin to develop, which frequently is within 24 hours, if you haven't been vaccinated, you're going to die. The best intensive care facility and the best antibiotics in the world can't cure you, once you've breathed this in, unless you've been vaccinated.
And the other part of the threat is, is we get criticized sometimes by vaccinating against anthrax when it might lead potential adversaries to then choose another biological weapon. It doesn't make any sense at all to me to say that if the enemy would then try to develop another biological weapon, that we should stop now and it's acceptable to lose service men and women to the anthrax that's already out there. I see it more of a deterrent than I do as an escalation of biological warfare.
DR. BAILEY: Let me just add to that as well, that anthrax is a bacterium and it's a spore-forming bacterium.
And those spores are very hardy. This is different than many of the other biologic agents. That means they are so hardy that it is easy to weaponize them. So it's not only that you have a deadly agent, there are many deadly agents, but they're not easily weaponized. So this is our number one threat.
QWhat progress is being made on FDA approval of a new plant?
GEN. WEST: As you know, all the vaccine that has been used so far was made by a university laboratory that held the license in the state of Michigan. When DOD came out with their program, the demand and the kind of supply of this vaccine that we were going to need could not be handled by that small state facility. So the license was bought out by a company called Bioport. They literally built a new facility to manufacture that vaccine.
Getting that facility certified is a very detailed, a very comprehensive, a very demanding process. It takes some time to do that and to do that right. But that's the way we would want it. We want FDA to be that particular because when we start producing that vaccine and taking that vaccine and using it in our AVIP program, we want to know that it's good, that it has the required safety and potency.
A lot of progress has been made. I visited the facility. It's very modern. It's clean. They seem to have people on site that know what they're doing and are working aggressively to answer the rest of FDA's concerns. At the last inspection there were only approximately 30 things that still had to be resolved. Many of those have been resolved already. Many more of them are in the process of being taken care of. And we hope that by September of this year they'll be able to go into assured production of new vaccine.
QI want to go back to the development of a different vaccine. Congressman Shays pointed out that this current vaccine was produced in the '50s, a very limited production for a different kind of treatment, for veterinarians and animal husbandry people, it was not designed for vaporized anthrax spores, there's no -- it says there's been no testing that the thing is effective is against vaporized anthrax.
DR. BAILEY: Well, in fact, there is much testing, obviously outside of the human realm. This is an agent that is as deadly as ebola. This is virtually 100 percent deadly after you develop symptoms. So what we have is something that is difficult to test, virtually impossible to test in its aerosolized form with humans. However, in the monkey model, we have challenged repeatedly in tests the non-human primate and found it to be very effective against the aerosolized version of anthrax.
Furthermore, there was an episode that occurred naturally in which humans were inadvertently exposed to aerosolized anthrax in -- workers who were working around wool. And though it was a very small number, it certainly indicated being the people that were working in that area who developed inhalation anthrax were the ones who were not vaccinated, who are not part of the study of those we had vaccinated in that group in terms of looking at that point for cutaneous anthrax, which is the usual exposure for wool-workers. But they developed the inhalation form. And therefore those who were vaccinated did not get the aerosolized anthrax; those who did, died from aerosolized anthrax. This is too small a study to really generalize from. But because we are unable to do human testing we clearly would want to look at those numbers even though they are not statistically significant. We are, however, testing in the animal model and find it to be very effective.
In fact, part of why we would look at a shorter number of shots is because the vaccine that we're using today, that vaccine, with the animal model, two doses of it has protected animals against a 500 LD -- that's 500 times the lethal dose -- of inhalation anthrax.
So we believe it to be very, very effective for aerosolized anthrax.
QI'm sorry, that's an experimental new vaccine, or that's the existing vaccine?
DR. BAILEY: That is the existing vaccine.
QI have a question for General West.
GEN. WEST: If I could add just one point to your question. I believe you referred to it as 1950s technology. The vaccine was actually licensed in 1970. In the 1980s, the responsibility for biological medicines was transferred formally from NIH to the FDA. At that time, they restudied it and recertified it. And there have been other tests since then that have validated the effectiveness of the vaccine. The experimental new vaccine that we're going after might end up not even being a shot. It may be something that you can take out of an inhaler and take into your lungs and obtain the protection that you need. It might be a cocktail that will not only protect you against anthrax but other things as well. But it's not out there now, and it's not going to be out there soon. It's a long ways away, and in the meantime, we need protection for the troops that are on the battlefield today.
QA follow-up to that and then a question. Is that a DNA vaccine you're looking at for the future?
GEN. WEST: Well, they're looking at several things, but the point I wanted to make there is that there is a funded, aggressive program to do that, but that's not an answer to today's AVIP program.
QYou expressed some disappointment with the congressional report, and I wanted to ask you whether or not you feel, as a military person at this point, that things like this report, because of the problems you cite with it, are actually being divisive to the military, and that perhaps do you have some concern that it's going to lead more military people to refuse the shot? What are your thoughts on that? Is Congress simply stirring the pot here without a lot of facts behind it?
GEN. WEST: I'll stop short of saying that. I'm sure that their motives are well-intended, as ours are. But what I do believe is that there are a lot of people out there that are opposing our anthrax vaccine program for a lot of different reasons. I think some of them are against vaccines in general.
I think some of them don't think we need as big a military as we've got or as much military spending or as much research as we're doing.
And I think that they came together and they became very active, and there are a lot of people out there opposing this now for a lot of different reasons, and I think that they've flooded the Internet and the web system with information that doesn't have to stand the test of legality and validity and science and medical responsibility that what we say and do and write does. And I think that that's caused a lot of people to be misled about this program.
I do worry about divisiveness. I worry about any service man or woman that would leave the military or face any kind of disciplinary action for no reason other than the fact that he refused to take a shot that was designed only -- only -- to be good for him. It's not investigative, it's not experimental. It's safe, it's proven. The people that are responsible for saying that have said so and documented it, and I wish that people would not encourage service men and women to disobey those orders or choose not to take the shot.
QHow many people have refused it so far? Do you have a count?
GEN. WEST: Three hundred and fifty-one, I believe, as of yesterday.
QAnd can you just, for us, clarify --
QAnd that's opposed to almost a million and a half that have taken it.
QCould you just also clarify the sort of military justice system these people face when they do make that decision and clarify for us the difference and why some people face Article 15s and why some people face court martials?
GEN. WEST: Well, that's a local unit commander's decision and prerogative, and we don't try to tell them what to do. But if a person refuses to take the shot, we make sure that they get all the counseling that they'll listen to. The sergeant major talks to them, the doctor talks to them, the XO talks to them, the CO does. We try to change their minds. And if they won't change their mind and won't take the shot, then it leads to some kind of disciplinary action.
If a person is refusing to take the shot because he doesn't want to go on a deployment or if he's already got a bad record and is trying to use that as a way to get out of the military, then it might go to a more severe action. But we are -- as I said, we don't want to lose a single soldier, sailor, airman or Marine just because they refused to take a shot. So we take all the effort that we can to change their mind and get them to make a better decision.
QCan anyone who refuses to take the shot be allowed to remain in the service? Absolutely refuses to take it under any circumstances?
GEN. WEST: I don't know of any cases where a soldier, sailor, airman or Marine that is medically capable of taking the shot without adverse reaction refusing to take the shot and being allowed to remain on active duty.
But there are reasons why you wouldn't want to give a person a shot. If a servicewoman was pregnant or if they were ill on the day that their vaccine was due, or if they'd experienced a reaction to a former shot. Until we determine what the cause of that was and determine that it was safe to give them a shot, they would be exempt. So they would be allowed to remain in the service under an exemption policy.
QAnd if I could ask Dr. Bailey about the science involved here? You know, Congressman Shays said this morning that this vaccine is making people sick. There are many claims out there that people who have taken the shot have ended up with thyroid conditions, blisters, lesions. Is there any medical evidence to indicate that this vaccine has contributed to adverse effects other than allergic reactions of those kinds -- serious adverse medical effects?
DR. BAILEY: First of all, the numbers are very low and either consistent with other vaccines or lower than other vaccines we give, including the vaccines we give to children in America.
There is no evidence to support that the kinds of responses that you are indicating are related to the vaccine, systemic reactions beyond those that we have described; allergic reactions, localized reactions. Those are the responses we see with this vaccine and others. We do not see other systemic or cutaneous responses, as you have described. So the answer would be that that is not the case, nor do we expect it.
And I would further add that, though we are very interested in doing our longitudinal studies, they have classically not been done on this vaccine or any vaccine. We have been giving vaccines in America for about a hundred years, and there has never been any connection to cancer or reproductive effects from any of the vaccines we have given. And it's why the FDA has not required longitudinal studies. We have a very safe history with vaccines, and we have a safe history with anthrax vaccine.
QCan you say how many people have left the service, rather than take a shot?
GEN. WEST: I don't know that number. I know that 351 people have refused to take it. Some of them would have been discharged already; some of them would still be going through appellate reviews. Some of them may have been punished and sent back to work and subsequently decided to take it.
QIs that active-duty, the 351?
GEN. WEST: That's both.
GEN. WEST: Both active-duty and Reserve.
QJust -- if could you be a little bit more specific about the human exposure? You said in the wool plant: What year was that? Where was it?
DR. BAILEY: It was many years ago, and I can find out for you and give you the exact; I may have it here. But those studies were done early on. Again, we have been licensed since 1970. And it is licensed, by the way, for all forms of anthrax.
That particular study was some years ago. And again, it was very small. We are talking about numbers like five to 10 individuals. So it is not one that I would look to, to support the efficacy against aerosolized anthrax. I would look to the animal model, which is frequently used in medicine and clearly used here, where it would not apply that we could do human research that would be unethical to do so.
QColonel, could I ask you for a moment to put on your North Korean or Iraqi general's hat, both countries that have weaponized anthrax. And from their point of view, if they are facing American troops who have these shoots and have some immunity, how is that going to affect their thinking? Are they more likely to use it or less likely to use it?
GEN. WEST: Well, I would think that they would be much less likely to use it. If the North Koreans decided to use it and picked late one afternoon or evening with the wind blowing south at about 30 knots and were willing to use 10 barrels or so of it, they could potentially cover the whole peninsula by the time the sun came up the next morning. Not that every person that lived there would get a fatal dose, but there'd be the potential for it to cover that wide of an area.
I think knowing that the people that they would meet on the battlefield would be protected and would still be healthy would make them much less likely to use that as a weapon. They would make us very, very mad, for one thing, and the fighting force would still be effective.
Eventually, when there's enough of a supply of vaccine, we'll offer it to our dependents who are there as well on a voluntary basis. And I'm sure that many countries will want to buy it for their civilian population. There are many people that have approached the manufacturer already to buy the vaccine, some for first-responders, some for their military, and some for their civilian population. But I think that knowing that there's a valid, effective deterrent to the weapon that they would use would make it much less likely that they would choose it.
DR. BAILEY: Thank you.
ADM. QUIGLEY: One point of clarification before we move on to other subjects is the numbers one more time. In excess of 400,000 uniformed personnel have received at least one of the shots, and there have been about 1.5 million doses, 1.5 million shots actually administered. I just wanted to make it clear.
QAre these all active -- (off mike)
ADM. QUIGLEY: No, this is both. This is both active and Reserve.
QWhat's the split? Do you have a split on that?
ADM. QUIGLEY: I don't have it immediately available. We may have that -- we should have that, Andrea, I would think. I don't have it with me here, though.
ADM. QUIGLEY: Okay.