(Special briefing on the anthrax vaccine program. Also participating were William F. Raub, Ph.D., deputy director, Office of Public Health Preparedness, Department of Health and Human Services, and Navy Vice Adm. Gordon S. Holder, director for logistics, J-4, the Joint Staff.)
Winkenwerder: Good afternoon, ladies and gentlemen. I'm Dr. Bill Winkenwerder, assistant secretary of Defense for Health Affairs. I'm pleased to be joined here with Adm. Gordon Holder, from the Office of the Joint Chiefs of Staff, and Dr. William Raub, Bill Raub, from the Department of Health and Human Services.
I'm here to announce the department's resumption of our anthrax vaccine program, and the coordinated efforts of the Department of Defense, the Department of Health and Human Services and other federal agencies for the stockpiling of both antibiotics and FDA-approved anthrax vaccine for civilians.
I'd like to briefly review the principal elements that informed our decision. First, the health and safety of our men and women in uniform is our top concern. We have a responsibility for them from illness and injury. Second, we continue to believe that the threat of anthrax being used against our armed forces is very real. Anthrax is highly lethal and it's easily stored. We know that potential adversaries do possess it.
Third, we have a vaccine that protects against anthrax exposure. The vaccine is safe and effective. The Food and Drug Administration approved the vaccine for use and the FDA certified the manufacturing facility that produces the vaccine. After a comprehensive independent study, the National Academies of Science's Institute of Medicine fully endorsed the safety and effectiveness of the vaccine just a few months ago in March.
Finally, we recognize that there is a domestic need for access to the vaccine. In collaboration with the Department of Health and Human Services and in coordination with the Office of Homeland Security, we are reserving a portion of the anthrax vaccine for stockpiling for the Department of Health and Human Services to use in the event of a domestic emergency.
In balancing the military requirements and domestic needs, our policy will be to vaccinate servicemembers, essential civilians and contractor personnel, who are assigned or deployed for more than 15 days in higher-threat areas of the world, whose performance is essential for certain mission-critical capabilities.
Again, our responsibility to our servicemembers is to do all we can to protect their health and safety. The anthrax vaccine offers an important layer of protection for them, in addition to antibiotics, and we begin -- we plan to begin our vaccination right away.
I would be happy, as well as my colleagues, to take any of your questions.
Q: How many people will be vaccinated, receive vaccinations under the program? And what are the -- what's considered a high-threat area?
Winkenwerder: With respect to the first question, we're not providing specific numbers. It will be a significant increase from the current number. As you may know, we have continued to vaccinate a relative few number of people -- special mission forces, et cetera -- and so that number will be increased. But we're not identifying just who those forces are and how many. You might surmise certain areas of the world might pose a greater threat, and it will be in those areas.
Q: You're not going to identify the areas, though?
Winkenwerder: No, we're not.
Q: Can you say what portion of the supply will be set aside for civilian use?
Winkenwerder: Right now we anticipate roughly half. Now that could change, depending upon changing threat conditions. But a significant portion is being reserved and set aside for stockpiling use, for the Department of Health and Human Services and for other federal departments.
Q: What sort of -- what is the rate of delivery of doses of vaccine now that the plant in Michigan has been served by -- I presume it's up and running.
Winkenwerder: That's correct.
Q: Is it operating at maximum capacity? And if so, how many doses does it give you a month or whatever --
Winkenwerder: The BioPort manufacturing facility was licensed by the FDA and received a -- I think the vernacular would be "good manufacturing approval" -- back in -- around the 1st of February. And they soon thereafter began a production cycle, and they're producing hundreds of thousands of doses on roughly a monthly basis. So it's into the millions of doses that will be produced over the coming years.
Q: Now the Pentagon's vaccination program had to be cut back because of a shortage of vaccine. Now that you have this influx of new vaccine, are you going to be able to go back to the original plans that the Pentagon had for vaccinating -- eventually vaccinating everybody in the military? Or, because some of this has to be set aside, are you going to have to cut back some of those --
Winkenwerder: Well, this is a shift from our earlier policy, which was to vaccinate everyone, a total force vaccination policy. So, this is a policy that's focused on those in higher-threat areas. It does not intend to vaccinate everybody. We're committed to the goal of protecting everybody through antibiotics, protective clothing and equipment, intelligence, detectors and other medical countermeasures. But until conditions change, we'll continue on this track of focusing the use on higher-threat areas.
Q: One more question about the new -- is the new vaccine essentially the same as the old vaccine? Or is this new and improved?
Winkenwerder: It is the same vaccine. It's under what you might call a new-and-improved manufacturing process.
Q: Do you have even more confidence in this vaccine?
Winkenwerder: Well, I think it's fair to say that the FDA has given -- along with our assistance, worked with the BioPort company, and has given a very thorough review to them, under what I understand is a new and more rigorous manufacturing review process, and so, we're very confident in the quality of the manufactured product of BioPort.
Q: (inaudible) Will the vaccine you're going to be using just be the new BioPort production, or will you have to go back to the old lots and certify them?
Winkenwerder: We'll be using just the newly produced vaccine.
Q: Back on the -- ramp down the program. There were any number of servicemembers that only took a portion of the six-shot series. Do they have to start all over from the beginning? Can they pick it up from where they ended? If they're not in this group that you're talking about, will they even have to have the shots at all?
Winkenwerder: They'll be able to pick right back up where they left off. And this is something that -- this approach is something that's been reviewed and approved by the FDA. And so, they'll start back up as supplies become available for them to resume their vaccination series.
Q: Okay. If they're not in that group that's going to these high-threat areas, are they going to continue with the shot series?
Winkenwerder: They will. There may be a matter of timing of weeks or months before they restart, but they will eventually in order to comply with the FDA requirement that the vaccine be used to give six full doses. They would be picked back up with their schedule.
Q: When you -- I'm sorry, sir, when you first started this, the idea that there was a certain amount of time between each shot seemed to be important. I take it it's not anymore, then?
Winkenwerder: There is an approved schedule, which calls -- it's a six-shot series taken at day zero, if you will, the first day, two weeks, four weeks, six months, 12 months, and 18 months. It's a rather complex series, and so it's important to stay on that schedule if one can, obviously. But if one cannot, we've been given assurance that there is a level of immunity that's there that can be picked back up with the resumption of the series.
Q: Is it your intention that people will get the full series of shots before they go into these high-risk areas? Or would you be sending them after one, two --
Winkenwerder: We would -- we have a possible intent to begin vaccinating 45 days in advance, so that they would get at least three doses.
Q: And also, did I understand you to say that not everybody going into these high-risk areas will get the shots, only those who are judged to be in critical jobs? So, I mean, you're saying to people that we're going to send you into a high-risk area, but we don't think you're as important as your fellow servicemember, so we're not getting you --
Winkenwerder: The likelihood is that most everybody, if not everybody, in that area would be vaccinated.
Q: Why the shift from the pre-policy of total force? I'm not clear on that. And then, if you could answer, sir, who in the civilian world should be -- would be given access to these doses if there was a --
Winkenwerder: I think the shift was driven by a couple of factors. The first is that we are dealing in a constrained supply situation, one. And two, we now have the potential need for use of a vaccine in a domestic or civilian situation. And so, our approach seeks to balance both military and civilian needs.
Raub: On the question you asked, the current policy in the civilian side is to vaccinate the workers in laboratories, research laboratories and clinical laboratories who are working with bacillus anthracis, either as private research or as part of some testing activity. And we will continue that. The purpose of having a civilian stockpile that is consistent with the DoD force protection requirements is for a post-exposure situation. But were we to have a situation of an anthrax exposure, we would offer the combination of vaccination and antibiotics.
Q: I'm not -- why not administer the vaccine as they are in the military ahead of time to people who would be at high risk in the event of an anthrax incident? There already have been some anthrax incidents in which first responders have been in a situation where they could have potentially been exposed. Why isn't that population being looked at and being inoculated prophylactically?
Raub: The immediate policy is constrained by what has been the supply limitation. As the supply improves, especially if the joint efforts of the Department of Defense and HHS to develop a new anthrax vaccine that can produce some tissue culture, and therefore potentially in indefinitely large quantities, as that prospect becomes closer to reality, I think we will be obliged to revisit the question of whether some prophylactic administration of it to identify first responders would be appropriate policy. And we would do that in conjunction probably with the public health community, with the first responder community.
Q: Let me just -- you have a newer more improved version of anthrax vaccine in the works? Or being developed?
Raub: Yes. I, I -- underway now through a joint effort of the two departments initiated by work of Fort Detrick and built upon by the work of the National Institutes of Health, is an effort to develop a cell-culture-base vaccine based on recombinant technology. That would have the virtue of being able to produce almost indefinitely large quantities of vaccine in carefully controlled production methods and a very rapid flexible production system. It's in both of our interest to have that kind of capability as soon as we can achieve it.
Q: (Off mike) with fewer shots too, right?
Raub: Potentially fewer shots. Again --
Q: How far out would that -- (inaudible) --
Raub: Right now the research and development is in the advance stage. The funding is in the budget for this year for that advanced development. Moreover the president's budget request for next fiscal year includes $250 million for the acquisition of the first lots of such vaccine on the presumption that the R&D this year will be successful. The hope in it, as always in new vaccine development, is to have something that can achieve protection with either fewer doses or fewer quantity, that will be consistently safe, and while we're optimistic about it, no-one -- (inaudible) -- until it's finished, and so right now it's in intense research and development effort with the hope of having a safe effective vaccine in larger quantity with more ready productions.
Q: (Inaudible) -- how you come up with the 50/50 -- (inaudible) -- if you have certain numbers of -- (inaudible) -- what the needs would be or --
Winkenwerder: We have attempted to do a lot of coordination -- we did a lot of coordination and discussion and attempted to model out what we thought the production would be over the next few years, under the -- with the current manufacture, and then looked at proposed requirements or needs from other departments, and then tried to balance that against what we thought our requirements and needs were. So it really was an integrated effort, and it came out --
Q: (Off mike) -- have a number of people that they --
Winkenwerder: A number of doses.
Q: What -- I mean, do we know that?
Winkenwerder: Into the millions.
Winkenwerder: On the domestic side.
Q: Because, as they said, there are like two million -- estimated two million first responders. Is that --
Winkenwerder: Well, you got to remember, again, it's six doses for one person. So even two or three or four million doesn't vaccinate that many people.
Raub: Yeah. I should add that the Centers for Disease Control and Prevention, one of our agencies, has funding in its budget to conduct some clinical trials of alternative shot schedules with the current anthrax vaccine, to develop the information base that might allow for either an accelerated administration or fewer doses. Again, that's in the early clinical trial stages, and for the moment, the six-dose regimen that Dr. Winkenwerder indicated still applies.
Q: Would the new vaccine go through the same trials and take -- you know, take the same length of time as a regular drug? And also, is there -- are there any procedures being put in place to track the health of the people who, you know, were given the vaccine?
Winkenwerder: (Off mike) -- the first question. I'll take --
Raub: Yes. Mm-hmm. Okay.
On the first question, the general answer is yes, that any new vaccine must meet the basic statutory and regulatory requirements for safety and efficacy that apply to any vaccine. In this particular instance, the Food and Drug Administration is prepared to give it the highest priority, because of the important military and civilian need for it.
Also, by the nature of this disease, we cannot knowingly expose individuals to anthrax to test the vaccine. So we are heavily dependent on looking at those measures within ethical constraints that will allow us to judge the safety and the efficacy of this vaccine, compared to the current vaccine. We will rely heavily upon animal models, and we have a new regulation issued by the Food and Drug Administration that creates a better defined path for the kind of evidence a sponsor would need with animal models in those instances where it's unethical to expose humans to the actual disease. So we're doing everything we can to anticipate this need and to accelerate the development, but nevertheless the vaccine will not be approved unless it is determined by all available knowledge to be safe and efficacious.
Winkenwerder: With respect to the second part of your question, I think, in terms of how we are following people, roughly 2.2 million doses, I believe, in total, have been distributed and provided, administered to service members. I believe over 550,000 individuals or so have received the vaccine, either in full or part of the series. And so we've built a fairly significant database that tells us something about any side-effect profile and so forth.
And I think it's fair to say that we really have enhanced our systems, medical recordkeeping, et cetera, to monitor any side effects and we have an office that's dedicated to doing that for every single individual. And I think the sum of what we've learned from that is the vaccine is safe and effective. It has a not-insignificant set of local reactions associated with it, but not different from things like typhoid vaccine of influenza or hepatitis-A; it's in that same range of side effects.
Q: Last fall when there were the anthrax exposures, obviously antibiotics were given to lots of people. And I think a vaccine was offered, I think, to people, and is there any data back from that on the post-exposure use of that vaccine and whether that was significantly better than just having the antibiotics alone?
Raub: Analogous to what Dr. Winkenwerder was saying, those individuals are being followed, those that chose to accept the vaccine at the time. It's too early whether there are significant differences, but we have -- the early information indicates that is was efficacious in the sense of complementing the antibiotics. And as we continue to gather that information and analyze it, it will help inform the policy as to how we would use this stockpile.
Q: Can I follow on that? Before the anthrax exposure, I think you had something like 450 servicemembers decline to take the inoculations. First, do you think there's -- you're going to have a little easier sell this time?
Q: And second, Admiral, is there any benefit to inoculating everybody? Do you think that we should go back, sometime in the future when the quantities are back up, to inoculating everybody in the armed services?
Holder: The first answer to ensure the safety and health of our people, so administering the vaccine, as Dr. Winkenwerder has said, is our first goal, and then, ultimately, protecting our people with the best techniques available. So, in the future, if that means full vaccination, it may be that, or it may be that there's a better technique through technology that -- because this is not going to happen in thirty days.
Q: Going back to the potential side effects, as we've noted, a small number of military personnel refused to take the anthrax shots. An even smaller number than that believes that they have serious health problems as a result of the vaccine. What does the science tell us about whether or not there are truly serious -- potential for serious side effects from this vaccine, and will the program in any manner be voluntary?
Winkenwerder: I'll take the first -- actually, both parts of that. The program is mandatory for those for whom the policy applies.
With respect to the side effect profile, in serious side effects, the percentage really is quite small. In following all of those vaccines that have been administered and the people, we have no documented death that has occurred as a result of vaccination. Obviously, when you have that many vaccines given to that many people, the chance that someone might die within, you know, some period of time following a vaccination is just -- by chance is going to happen. Of course, if someone is having a reaction, you know, in that window, then the question is whether there was an association or not.
I think many of those questions are well addressed in this report from the Institute of Medicine. That really goes into great detail and has looked at the data. And their conclusion was that the serious side effects were really quite small. There are probably -- as with any vaccine, there probably are a very, very small number of people who may have what, you know, one would call as a serious reaction. And -- but -- and we intend to follow those people very closely, if they come in, and they'll be evaluated medically.
Q: Do you think there's an irrational fear among some people about this vaccine?
Winkenwerder: I think that we did not do the job that we needed to to fully educate people and inform them in the way that they need to be, and I think that had to be balanced against the risk or perceived risk at that point in time. And I think that equation has changed.
Q: Would you get the vaccine, and have you --
Winkenwerder: Absolutely. I'd have no -- I wouldn't -- I don't -- have not had it, because I'm not covered under the policy. But I'd have no hesitation about taking it.
Q: You're not important enough to -- (soft laughter) --
Winkenwerder: (Chuckles.) Not deployable currently.
Q: Just to clarify a couple things, Mr. Raub, I think you said one of the advantages of the new vaccine is that it can be produced indefinitely. That implies that there's some limit on what you can produce of the -- what's being done at BioPort. Can you tell us, is there a capacity there, or at some point are they going to be no longer able to produce vaccine, because they don't have the raw materials or -- can you clarify that?
Raub: No, the issue is the nature of the production methods. Cell culture systems are comparatively easy to establish. They're comparatively easier to replicate. And so it's more of an efficiency and volume of production than any inherent other limitation.
Q: But then the other thing -- I was just trying to clarify that. I think I'm right, but just to be absolutely certain. If John Q Civilian out there hears about this and the vaccine has now been approved and he or she wants to go to their doctor and say, "You know, I'd like to get this anthrax vaccine," they're not going to be able to do that, right? The doctor's not going to be able to help them. Unless they're a first responder or --
Raub: It is not still available --
Q: It's not going to be available publicly?
Raub: That's correct.
Q: What are the side effects?
Winkenwerder: I'm sorry?
Q: What are the specific side effects?
Winkenwerder: Locally, swelling, and again this is not for everybody; it's a percentage. A little bit of erythema, redness, swelling, pain at the injection site. Sometimes people feel a little bit of what we call malaise or, you know, flu-like feeling. Those are the main side effects.
Q: You said earlier that some servicemembers would be able to be sent over to a high-risk area without finishing the cycle. At what point does the vaccine become effective if you are going to be sending people there and they only have two or three doses?
Winkenwerder: Well, there's evidence that a fairly significant level of immunity builds even after as few as three doses. That's the purpose of this study, is to validate that with certainty. So, we believe that a significant level of protection is achieved after three doses, but obviously the current FDA-approved regimen requires the full six doses. So, we want to get those first three doses before or as they're going into an area, and then continue their series after that.
Q: After they get back? Or while they're still on deployment, can they continue to --
Winkenwerder: Both. Both.
Q: Can you tell us a little bit about how you'll define the high-risk areas? For example, would someone on a ship offshore of a combat zone or high-risk area also be considered in the high-risk area? Or a pilot flying over -- missions over an area, would he or she be considered in the high-risk area? Or would it be just people on the ground?
Winkenwerder: People on the ground and people who were deployable ashore from ships, not people in airplanes.
Q: Could you just sketch a little bit more of the debate you folks had in reaching this decision? Was the decision not to inoculate everyone in the military based solely on quantity available, or was it partly a result of concerns about opposition within the military? Or are there other factors here that I'm not aware of?
Winkenwerder: It was a very good discussion, one that was well-informed by facts, and involved the military leadership, civilian leadership, science experts, et cetera. And I don't think that there was any one predominant factor. I think it was really all those factors, when one considers the supply constraint, is the principal factor operative here, and also the fact that if we want to make certain amounts available for potential domestic use, that's another important factor, and the way it's administered -- six series, having to take it over 18 months -- it was all of those factors played into the final decision.
Q: Was there a sense of it, perhaps, as supply came up -- and this is sort of a follow-up question to one asked already -- that as the supply came up, perhaps you did want to revisit at some point the idea of inoculating everyone?
Winkenwerder: I would leave you with the impression that this is certainly open to change as the situation, the threat situation, might change.
Q: With regard to the production issue, one of the real reasons why you're in this mess is because the Pentagon, before you came, depended on BioPort, an unproven company just getting into the area. What plans have there been, or are there, to establish an alternate source of supply, either a government-operated plant or going out to Pfizer or some of the big drug companies to take this on? As I recall, last year you put out a bid and nobody came to the show.
Winkenwerder: I'll take part of that and then I'll let Dr. Raub take part of that. I think the evidence that he's just indicated, in terms of this next generation, you let a request out and have gotten a -- I'll let you speak to it -- significant response from the private industry.
Winkenwerder: And so we believe, from our discussions with private manufacturing -- vaccine manufacturing concerns, who represent, really, the bulk of the worldwide vaccine market across the board, that they're quite interested, actually, in coming forward to work on these vaccines, some of which, obviously, would not have the volume associated with them that, say for example, the flu vaccine or measles vaccine or something like that. But there is a great deal of interest and I think it's incumbent upon us to work together between Department of Defense and the Department of Health and Human Services to together define our requirement or what we think we might need, and to speak in a coordinated way, and that's what we're doing here and that's what we intend to do going forward on smallpox and other issues as well.
Q: What about a go-co [government-owned, contractor-operated], though, a specialized government plant -- there was thinking about that. Where's that thinking at today?
Winkenwerder: We believe that the private sector companies that, again, we've talked with, and that have approached us, as well as Health and Human Services, provide a ready set of great scientific assets that are ready to respond and that they can move relatively quickly, probably more quickly than the time it would take to build a large facility and hire the people and so forth. That quickest and best response is through working with the private sector. That's what happened with the smallpox vaccine and --
Raub: Yeah. In fact, I can add to that. The representatives of the vaccine industry consistently have said to us that if the government is clear that what it wants is scientifically and technically feasible, if it's clear in its requirements with respect to the volume, and if it provides some certainty that the monies are in fact in hand for that multi-year acquisition to be achieved, for them in turn to invest in it, then the industry will respond.
We've had the occasion to test that within the last year with respect to a new smallpox vaccine. So far, so good. This -- it was an excellent response, and we're moving along.
The money's in the budget this year that I mentioned, for the advanced development, and next year for -- if the Congress agrees, for the acquisition -- will be another test of that prospect. And again, so far, so good.
So we're optimistic that the needs with respect to new smallpox vaccine and a new anthrax vaccine can indeed be met by this approach with the private sector.
Q: For the foreseeable future, BioPort is the production facility --
Raub: For anthrax vaccine. That's correct.
Raub: They're the only --
Winkenwerder: The only licensed.
Raub: -- the only licensed manufacturer.
Q: I guess my point -- my question is, is there progress in trying to get alternate companies to pony -- to make this stuff? And you're saying that there's some interest right now, but they need to see more by way of dollars and --
Winkenwerder: BioPort holds the only license for the Anthrax Vaccine Adsorbed, the name of vaccine that we have right now. Are there other companies that are interested? Yes, they're interested in working with Health and Human Services, who will -- is and will take the lead on this new generation vaccine.
Raub: But they're interested in a different production method, one that uses the recombinant materials, rather than the whole organism.
Q: Have you come up with any -- did you provide any estimates on how many members of the military you expect to be vaccinated?
Winkenwerder: We didn't, and we don't intend to.
Q: Have you classified that --
Winkenwerder: We're just not sharing that right now. We think it's best to leave others guessing as who and how many.
Q: You think there's some sort of deterrent value in that?
Winkenwerder: Could be.
Staff: -- two more here, right here.
Winkenwerder: Yes, sir?
Q: Yeah. We've learned today about a couple of -- we've got this one vaccine program. We've got the next generation vaccine program.
You refer at one point to other layers of things that you're doing. I know that there's been work at the department on point detectors for biological agents. Are there any other things -- other things that you want to tell us about? And are there, for example, use of -- development of point detectors to be used in the civilian world as well as the military?
Winkenwerder: We're not prepared to talk about that at this time. But I would just say that, yes, there's a lot of talk and effort to evaluate those issues. And detection, and early detection, is a key element of an overall protection scheme. And so, there are others in the department specifically in the acquisition area -- the nuclear, chemical, biological program -- who are involved in the procurement and the purchase of that kind of equipment, but we work together closely. And they're working on those issues.
Q: Will the anthrax shot be recorded in the servicemember's shot records?
Winkenwerder: Yes, I believe it --
Q: (So they'll be aware that they're getting ?) --
Winkenwerder: Oh, yes. Yes.
Q: Just to follow up on a question here a moment ago. I think there's a common perception among people working in this building that the detectors have been placed on the perimeter here since September 11th to detect anthrax. Is that not accurate?
Winkenwerder: I'm not going to comment on that.
Q: All right. Thank you very much.
Winkenwerder: Thank you.
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