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DoD News Briefing with Assistant Secretary Winkenwerder

Presenter: Assistant Secretary of Defense for Health Affairs William Winkenwerder
October 16, 2006
           Also participating; Col. Randall Anderson, director, Military Vaccine Agency           
          
           MR. JONES: Hello, everybody. Have we got some folks out there?
 
            Q     Yep.
 
            Q     Yep.
 
            Q     Hello.
 
            Q     Hello.
 
            MR. JONES: Oh, glad you're there. This is Terry Jones. I'm here -- (interrupted by computerized message) -- I'm here today with Dr. William Winkenwerder, who is going to be talking to you in a few minutes here. But I just want to alert you to a few things.
 
            First of all, this conversation is on the record, and that we -- (interrupted by computerized message) -- that we are recording for transcript, and we're also recording for C-SPAN. Today --
 
            (Interrupted by computerized message.)
 
            MR. JONES: I guess we're going to have that for the next few minutes or so. But Dr. Winkenwerder is going to be talking to you today about the Department of Defense and our resumption of the mandatory anthrax vaccinations for certain troops.
 
            And with that, I will go ahead and -- (interrupted by computerized message) -- I'm sorry. I wonder if right now we could have a roll call to get an idea -- and as you ask a question after Dr. Winkenwerder has initially given you his statement about what we're going to be doing, I would also like for you to identify yourself so that we can have that on the transcript when it comes out.
 
            So right now, for roll call purposes, would you all go ahead and identify yourselves, please?
 
            Q     Julian Barnes, L.A. Times.
 
            Q     David Kestenbaum, National Public Radio.
 
            Q     Lori Crouch, WAVY-TV, Norfolk, Virginia.
 
            Q     Dee Ann Divis, Washington Examiner newspaper.
 
            Q     Stephanie Heinatz, Daily Press, Hampton Roads, Virginia.
 
            Q     Drew Brown, McClatchy Newspapers.
 
            Q     Gail -- (inaudible) -- Military Times -- (inaudible) -- group.
 
            Q     Breanne Wagner, Air Force Magazine.
 
            Q     (Name inaudible) -- Stars and Stripes.
 
            Q     Admiral Joyce Johnson -- (interrupted by computerized message).
 
            Q     Lolita Baldor, AP.
 
            Q     Kristin Roberts, Reuters.
 
            Q     Sandra Basu, U.S. Medicine.
 
            Q     Pam Hess, UPI.
 
            Q     Chris Lee, Washington Post.
 
            Q     Matt Kaufman, Hartford Courant.
 
            Q     Lisa Chedekel, Hartford Courant.
 
            Q     David Rube (ph), freelancer.
 
            Q     Dr. -- (name inaudible) -- Norfolk.
 
            Q     Jay Lackman (ph), retired military.
 
            Q     Alison Walker-Baird, Frederick News-Post.
 
            Q     (Name inaudible) -- freelance.
 
            Q     (Inaudible) -- for Air Force.
 
            Q     (Inaudible) -- Air Force counterproliferation.
 
            Q     Gil Naito (ph), Bureau of Medicine and Surgery.
 
            Q     (Inaudible) -- Navy.
 
            MR. JONES: Is that everybody? Has everybody identified themselves that's on this -- on the phone call?
 
            Q     This is Sue -- (name inaudible). I'm with the Senate Committee on Veterans Affairs.
 
            Q     Kevin Maurer, Fayetteville Observer.
 
            Q     Brett England, Daily Press.
 
            MR. JONES: Okay, is there anyone else that's come onto the conversation and hasn't identified themselves yet? Okay, thank you.
 
            DR. WINKENWERDER: Good afternoon. This is Dr. Bill -- (interrupted by computerized message).
 
            Okay, who's just joined?
 
            Q     Denise Grady from The New York Times.
 
            DR. WINKENWERDER: Okay, Denise.
 
            This is Dr. Bill Winkenwerder. I'm the assistant secretary of Defense for Health Affairs. Good afternoon.
 
            Q     Thank you.
 
            DR. WINKENWERDER: Today we're announcing the resumption of our mandatory anthrax vaccination/immunization program for military personnel, emergency-essential DOD civilians and contractors, all of those individuals based on defined geographic areas and roles.
 
            This updated policy also allows previously immunized persons against anthrax who are no longer deployed to higher-threat areas to receive their follow-up vaccine doses and booster shots on a voluntary basis.
 
            For the most part, mandatory vaccinations are limited to military units designated for homeland bioterrroism defense and to U.S. forces assigned to the Central Command area of responsibility and to Korea. The under secretary of Defense for Personnel and Readiness will soon issue implementing instructions to the military services for resuming the mandatory vaccination program. The mandatory program is expected to resume within 30 to 60 days.
 
            Now, one set of questions I'm sure you may have is: Why the change in the policy now; has there been an elevation in the threat. Let me say very clearly the answer to that is no. There is no elevated threat situation, nor are there new specific circumstances that have given us reason to make this change and update in our policy. We vaccinate our service members to protect them against deadly diseases, both natural and those potentially spread by terrorists or enemy forces. We take very seriously the potential use of weapons of mass destruction by terrorists. Under the voluntary policy, about -- (audio break) -- percent of our service members in high threat areas, who were contacted about vaccination, followed through and received their vaccination. This rate of vaccination not only put the service members at risk, but also jeopardized unit effectiveness and degraded our medical readiness. Both of those issues are important to me and to our military commanders.
 
            Having said that, a 50 percent acceptance rate is about what we expected --
 
            OPERATOR (?): Someone has joined the conference.
 
            DR. WINKENWERDER: Could you identify yourself, please?
 
            Q     Yes. My name is Todd Furrs (sp). I work at Melvax (sp).
 
            DR. WINKENWERDER: Hey, Todd. Let me continue. Having said that, a 50 percent acceptance rate is about what we expected based on voluntary vaccination programs in the general public. It's clear that, you know, nobody likes getting shots, if they have to, but I think probably the most important reason for the difference we have had between 100 percent acceptance rate for mandatory anthrax shots and a 50 percent rate for voluntary shots is because military members expect that if something is truly important to the mission and if there truly is a threat, that it would be mandatory. So obviously, we've been sending a signal that it's not as important as in fact we believe it is.
 
            Protection against anthrax is important to the mission, and that's why we're returning to a mandatory program for those at higher risk.
 
            I'll say once again, the vaccine is safe and effective. On December 19th, 2005, a little less than a year ago, the Food and Drug Administration issued a final rule and final order stating that the vaccine is effective in preventing against anthrax regardless of the root of exposure. The vaccine has been thoroughly reviewed by eight different review bodies, including the National Academy of Sciences Institute of Medicine. The Institute of Medicine states that the adverse events after anthrax immunization are comparable to those observed with other vaccines administrated to adults.
 
            Finally, let me say that anthrax remains a deadly infection that's been used as a bioterrorism weapon against our own population. The threat environment and unpredictable nature of terrorism makes it necessary to include biological warfare defense as part of our force protection measures.
 
            And with that, let me take your questions.
 
            Q     Dr. Winkenwerder, this is Gail -- (last name inaudible) -- from the Military Times newspapers. I'm wondering -- (inaudible) -- that I've been talking to today -- I'm wondering if you guys are prepared for another legal challenge.
 
            DR. WINKENWERDER: Yes, we're always prepared for any legal challenge.
 
            Q     Do you expect to have to -- (inaudible) -- this program again a second time once you start it back up again?
 
            DR. WINKENWERDER: I don't want to predict what may or may not happen. The vaccine, as I just indicated, has been thoroughly reviewed by several independent outside groups. It was reviewed thoroughly by the Food and Drug Administration initially issuing an order, I believe, in 2004, and that order was challenged. And then, the FDA went out again following Judge Sullivan's decision in October of 2004 and obtained wide comment from all sources and reviewed all the data again and came to the very unambiguous and clear conclusion that the vaccine was safe and that it was effective against all forms of exposure. So in our view, that has definitely settled the question.
 
            Some of you -- let me just answer a question that I'm going to anticipate: Why the delay between that period of time and now? And the quick answer is that there were some follow-up legal issues that were, as I recall, additional meetings of the parties to this case that met and reviewed the matter before the judge in the spring of this year, that that took several months. And then, upon the conclusion of those proceedings, we undertook here within the Department of Defense a full review of all of our vaccination programs -- anthrax, smallpox. We also looked at the matter of potential vaccination for pandemic and avian influenza. And after that review was completed, it was put before Deputy Secretary England, and upon our recommendation, we have decided to move forward with just what I have announced today. We will continue our smallpox vaccination program as well, I might add.
 
            Q     Dr. Winkenwerder, this is Pam Hess with UPI. Can you update us on where you are with the number of doses that you have? I remember that was one of the earlier problems with being able to vaccinate everyone. And what's the status of a second source for the vaccine?
 
            DR. WINKENWERDER: You're correct that that was a concern early on in late 2001, early 2002. I'm pleased to say at this time that the quantity and supply of vaccine is not at all an issue. We have more than enough vaccine doses on hand, and we have no issues or problems with the manufacturer at this point. And so we have a very stable situation in that regard.
 
            Q     Still no second source, though?
 
            DR. WINKENWERDER: There is, as you may know, work that is ongoing through the Department of Health and Human Services for a new and updated vaccine called recombinant protective antigen, sometimes known as rPA -- small "R" then capital "P" and capital "A" -- rPA. And work is ongoing to bring that vaccine to licensure. That's being conducted by the Department of Health and Human Services. We are very much in regular communication about the status of progress of those activities. And should that second source of vaccine become available at some point in the future, then we would certainly look at that as a viable additional vaccine. 
 
            Q     Dr. Winkenwerder, Jeff Schogol with Stars and Stripes. Do you have an estimate of how many troops and contractors need to be vaccinated for anthrax?
 
            DR. WINKENWERDER: I don't have a precise number for you. There are approximately 140,000 troops deployed in Iraq, additional numbers in the CENTCOM area of responsibility, and then there are the troops that are in the Korean peninsula. And I don't have a quick number for you on that -- the 40,000 range.
 
            OPERATOR: Someone has joined the conference.
 
            DR. WINKENWERDER: Could you identify yourself, please?
 
            Q     Excuse me. Luis Martinez, ABC. 
 
            DR. WINKENWERDER: Okay. This is speaking Dr. Bill Winkenwerder, assistant secretary of defense for health affairs.
 
            And so we're probably talking, in the aggregate, in the range of at least a couple hundred thousand individuals. But, of course, people deploying and then redeploying, that number over the next 12 months would certainly be considerably greater than that. I'd say several hundreds of thousands.
 
            Q     And is there any talk about reducing the doses from six doses to three doses?
 
            DR. WINKENWERDER: Yes. We are working with the Centers for Disease Control, and there are studies that are going on that are looking at the possibility of eliminating at least one of the doses. Obviously, that work needs to be reviewed by the FDA, since the FDA sets the license or standard for the number of doses. We're hopeful that within a few months we would be able to look at the possibility of a different route of administration that is intermuscularly as opposed to subcutaneously, and a five-dose schedule instead of a six-dose schedule. That will depend upon the FDA review.
 
            Q     Right. One of the attorneys representing people who plan to challenge the mandatory program in court calls this vaccine "unnecessary, unproven, and potentially unsafe." He wrote an e-mail, quote, "The AVIP is nothing more than a poorly conceived public relations campaign. The perception is that it is currently being implemented to satisfy personal egos and as a result of a lobbying campaign."
 
            How would you respond to that?
 
            DR. WINKENWERDER: I would respond by saying that that's a very irresponsible statement. This is a safe and effective vaccine. It's been reviewed, as I had indicated, by independent, outside reviewers who had no relationship to the Department of Defense, and who had no objective, other than review of the safety and effectiveness of a vaccine.
 
            The other point I would make, obviously a point I hope you would all appreciate, and that is there have been very public, very direct comments made by terrorists about the religious duty to obtain chemical, biological and radionuclear capabilities. 
 
            We still do not know who perpetrated that anthrax attacks five years ago just this month, in October of 2001. The threat is very real and it has not gone away. 
 
            Q     Dr. Winkenwerder, this is Chris Lee at The Washington Post. The anthrax attacks you mentioned happened here on U.S. soil. September 11th was on U.S. soil. Why not vaccinate people here? Why not do mandatory vaccinations of people here? And are you, yourself, going to be vaccinated?
 
            DR. WINKENWERDER: I have not been vaccinated because I'm not in any of the targeted groups to be vaccinated. If I was, I would receive it -- the vaccine without hesitation. 
 
            Just because the attacks were perpetrated here on U.S. soil does not mean that they were perpetrated by U.S. citizens. And I think the FBI has recently spoken to that issue, that they have under consideration the possibility of threat -- of this -- (inaudible) -- been perpetrated by anyone, domestic or foreign. So --
 
            Q     I wasn't implying that it had been done by someone is a U.S. citizen, just simply that the attacks had been here, which would suggest that people here might be vulnerable too, troops here might be vulnerable, and why not have them covered by the order.
 
            DR. WINKENWERDER: Well, some of them will be able to obtain the completion of their schedule on a voluntary basis. It's our judgment that those who are serving in the areas that that's spoken about are at a higher risk because of their location and because of the duties --
 
            OPERATOR : Someone has joined the conference.
 
            DR. WINKENWERDER: -- and because of their duties that they're performing.
 
            Can I ask who's just joined us? (No response.) Can I ask who just joined the call?
 
            OPERATOR: Someone has joined the conference.
 
            DR. WINKENWERDER: Yes. Can I ask who's joined the call?
 
            Q     Yes. Dack Dalwhipple (ph).
 
            DR. WINKENWERDER: From?
 
            Q     From Daupe and Associates (ph), consultant to vaccine companies.
 
            Q     Dr. Winkenwerder --
 
            DR. WINKENWERDER: Thank you.
 
            Q     -- can you elaborate on what changes, if any, have been made to the Adverse Reaction Tracking System, and if that information, given the controversy surrounding the vaccine, will be made available to the public?
 
            DR. WINKENWERDER: We have a very robust vaccine Adverse Event Reporting System. It's an excellent Adverse Reporting System. It was noted for its excellence and for the professionalism of the people who run that program by the Institute of Medicine in their report four years ago. We'll expect to continue that effort.
 
            Let's see here. Multiple echelons of reporting, and certainly we encourage if there are any adverse reactions that are noted by an individual or by his or her medical provider to report them. We know that there will be some local adverse reactions the vaccine has associated with it, as do other similar vaccines; reactions that can occur like local swelling, pain, redness, inflammation, and of course, people may feel malaise or flu-like symptoms for a short period of time. But in all the studies that we've performed and done looking very, very thoroughly at the vaccine, there is no increase in mortality, there's no increase in morbidity, there's no increase in hospitalizations. And all of that has been determined very definitively --
 
            OPERATOR (?): Someone has joined the conference.
 
            DR. WINKENWERDER: -- by very good studies.
 
            Q     Will the tracking information on the new round of shots be made available publicly?
 
            DR. WINKENWERDER: I'm turning to one of our experts on this. The vaccine Adverse Event Reporting data is reported publicly through and with the Centers for Disease Control, as I recall. Yes, that's correct.
 
            Okay. Could I ask who just came on the line?
 
            Q     Hi. This is -- (name inaudible) -- Naval Medical Center Portsmouth.
 
            DR. WINKENWERDER: Thank you.
 
            Q     Thank you.
 
            Q     Doctor, this is Kristin Roberts with Reuters. Can you tell us what disciplinary action faces service members who refuse the vaccine?
 
            DR. WINKENWERDER: Well, our first approach is not to discipline people, but it is to remind them of the importance of the threat, of all the facts about the vaccine and why it is being used. And the decisions, if any discipline is necessary, are performed in a very careful, thorough way, and the most important point, frankly, is that we have had very, very few service members who have refused the vaccine. I wish that you would report the facts because the facts have been misreported from time to time, as I have read over the last two or three years, that large numbers of people refuse. That's simply not true.
 
            That was true in 1998 and 1999, significant numbers, I think that descriptive term might have been fair at that time. In calendar year 2004, we had 10 people who were separated from all the services out of some 700,000 people vaccinated. So, you know, these are very, very small numbers of people who are being separated for refusing. And in 2005, there were none. Zero.
 
            Q     Sir, just to follow up, were there people who were disciplined other than by separation?
 
            DR. WINKENWERDER: Can I ask who's --
 
            Q     I'm sorry. Dee Ann Divis. Just to follow up on the previous question.
 
            DR. WINKENWERDER: Where?
 
            Q     The Washington Examiner.
 
            DR. WINKENWERDER: Okay. We will try to obtain any information to answer your question. I don't have that in front of me right now.
 
            Other questions?
 
            Q     Good evening, Dr. Winkenwerder. Vincent Finlanson (sp) from Scotland here, freelance. Could I ask two questions, please?
 
            DR. WINKENWERDER: Sure.
 
            Q     One, could you tell me who the supplier is of the vaccination?
 
            DR. WINKENWERDER: The supplier of the vaccination?
 
            Q     Yeah.
 
            DR. WINKENWERDER: Emergent BioSolutions is the name of the manufacturer.
 
            Q     I believe that's a private limited company, is it not?
 
            DR. WINKENWERDER: I'm told that it is a privately held company but with plans to issue public shares.
 
            Q     Right. Okay. 
 
            The second question is, you said that 50 percent -- under a voluntary policy, 50 percent of the troops followed through. Can you tell me what other countries have a mandatory program in place?
 
            DR. WINKENWERDER: I'm not aware that any other countries have a mandatory program in place.
 
            Q     That's what I think, as well, yes. That answers my question. Thanks very much.
 
            DR. WINKENWERDER: You're welcome.
 
            Q     Thank you.
 
            Q     Dr. Winkenwerder, sorry, Jeff with Stripes again. You had mentioned that the Defense Department is looking at intramuscular shots as opposed to the current shots. My understanding is that intramuscular shots hurt a great deal. What are you doing to control the pain?
 
            DR. WINKENWERDER: No, intramuscular shots are not necessarily --
 
            COL ROLLAND: It actually reduces --
 
            DR. WINKENWERDER: Yeah, it reduces the --
 
            COL ROLLAND : Swelling.
 
            DR. WINKENWERDER: -- swelling and pain associated with the vaccination.
 
            Q     Dr. Winkenwerder, Julian Barnes here from the L.A. Times.
 
            DR. WINKENWERDER: Yes?
 
            Q     I was wondering, are there any long-term adverse effects that the Department of Defense recognizes as associated with the current anthrax vaccine program?
 
            DR. WINKENWERDER: There have been long-term studies that have looked at that question, 2,000 lab workers since the 1940s, 570 workers at Fort Detrick, Maryland, our Defense Medical Surveillance System of vaccinated personnel versus unvaccinated, and long-term health issues with over 700,000 active-duty service members who have been discharged and the rates of problems with those discharged. And to our knowledge, none of those studies has shown any long-term medical consequence, any deleterious effect of the vaccine.
 
            Q     Dr. Winkenwerder?
 
            DR. WINKENWERDER: (Inaudible) -- the vaccine versus those who did not receive the vaccine.
 
            Q     Dr. Winkenwerder, why did the GAO on May 9th this year state, and I quote, "The long-term safety of the licensed vaccine has not been studied."
 
            DR. WINKENWERDER: I don't know why they would conclude that. I just gave you several long-term studies that suggest otherwise. That wouldn't be the first time that the GAO has made an incorrect statement.
 
            Q     Dr. Winkenwerder, Dave Rube (sp), also a freelancer. You said that reviews had concluded that the vaccine was safe, but would you call it perfectly safe? My understanding is that the Vaccine Healthcare Center, a military center, has been examining quite a number of different kinds of illnesses that might be attributed to the vaccine, they just don't have conclusive evidence. But they talk about muscular dystrophy-related illnesses and other things. 
 
            DR. WINKENWERDER: So your question is?
 
            Q     Well, so are you saying that this is perfectly safe, and that beyond a shadow of a doubt there may not be serious consequences that result, even if, you know, a small percentage of people vaccinated get them?
 
            DR. WINKENWERDER: What I'm saying is that the FDA has said -- the Food and Drug Administration has said, after an exhaustive review, that the vaccine is safe and that it is effective against all forms of exposure of anthrax. And it is, in the conclusions of numerous independent expert groups, safe and effective in the similar way of other vaccines. There is no vaccine, there's no medical treatment, there is no drug for which there has never been a single significant side effect or event noted in not one person. I can't think of a single drug where that has happened.
 
            Q     So the information --
 
            DR. WINKENWERDER: Any drug, whether it's penicillin or --
 
            (Telephone rings.)
 
            Q     Are you there?
 
            DR. WINKENWERDER: I'm sorry. You can -- you can --
 
            Q     Continue. I'm sorry.
 
            DR. WINKENWERDER: You can look at anything that is done in medicine and you cannot say that there's never any adverse effect associated with any particular drug, treatment or vaccine.
 
            Q     So to your mind, then, this issue of safety is completely settled and there are no outstanding issues?
 
            DR. WINKENWERDER: Absolutely it is settled.
 
            Q     Because the Army released information to me that was reported, I guess it was a year ago, saying that I think it was -- I got to remember, because I haven't seen my story in a while -- 400 people over two years, I think it was 2002 -- or 2003 and 2004 were treated at this Vaccine Healthcare Center Network for a range of complications that may have been tied to the anthrax vaccinations.
 
            DR. WINKENWERDER: I'm going to let Colonel Anderson answer, who is with our Military Vaccine Agency.
 
            Colonel?
 
            COL. ANDERSON: Okay. This is Colonel Anderson.
 
            I'm not familiar with what statistic was briefed to you. But the Vaccine Healthcare Center has the role of anybody who has a concern about any adverse event from a vaccine, no matter if it's smallpox, anthrax, even influenza, they can go in there and be evaluated. I don't have their current numbers of how many people they've examined, but it's very possible that people were concerned. A lot of people get a vaccination against anthrax or any other vaccine and later get sick, and they're concerned about if it's due to that vaccine. Most of the time there is no cause and effect from that vaccine, and a lot of times you'll never know. But they do research each and every one of those.
 
            DR. WINKENWERDER: Okay.
 
            OPERATOR: Someone has joined the conference.
 
            DR. WINKENWERDER: Could you identify yourself, please?
 
            Q     This is Jeff with Stripes, sir. I got disconnected.
 
            DR. WINKENWERDER: Okay, thank you.
 
            All right, any other questions?
 
            Q     Dr. Winkenwerder, Julian Bonds here, LA Times. How long does the vaccine last? Will -- between tours in Iraq, will soldiers and Marines need to get second courses of the vaccine?
 
            DR. WINKENWERDER: Well, the current schedule is for an annual booster. And so I think the evidence that the FDA uses is that at least for one year, it's -- in all probability has an effectiveness that goes beyond that period of time. But that is a matter that's currently being studied. And that's part of the -- looking at the dose reduction study and the vaccine series to determine if, in fact, the frequency and the interval of the doses is necessary.
 
            Q     Dr. Winkenwerder, this is Chris Lee again. If we could go back to the subject of how many people refused to get the vaccine. You mentioned in 2004 there were 10. That was also the year that Judge Sullivan put the order in, in October, I believe. And you mentioned in 2005 there were none. But it's my impression that it was either a voluntary program at that time, or certain months it wasn't going on.
 
            DR. WINKENWERDER: Right.
 
            Q     So the last full calendar year that there was mandatory vaccinations, how many people refused?
 
            DR. WINKENWERDER: Well, 2004 would have been that year because it was mandatory through -- at least through the first 10 months of that year, through October. In 2003 the number was 27.
 
            Q     Thank you.
 
            DR. WINKENWERDER: And in 2002, it appears that there was one person. So there were, with the introduction of the program in 2003, obviously a lot of people being educated, a lot of people learning about the vaccine. My guess is that it had something to do with a relative increase there.
 
            But if you look over the 2001 to 2005, other than that 2003, you're talking low single digits for each year.
 
            Q     And I mentioned Judge Sullivan's order. So the FDA ruling in 2005 in December, that's what gave you the legal go-ahead? Or -- I just want to make sure I understand why you're beyond the reach of that case now.
 
            DR. WINKENWERDER: Yeah. It was -- the FDA issued a final rule and a final order, and that is the basis upon which we can act. Out of deference to the parties that were involved in the lawsuit, it is my understanding that there was subsequent -- a subsequent hearing to resolve whatever issues were still (due a ?) discussion at that point, and I think we felt it best to, you know, ensure that that process was completed to everyone's satisfaction before we undertook our review of all our vaccination programs, as I mentioned earlier in the discussion.
 
            Q     Sir, this is Dee Ann Divis with the Examiner. On the numbers that we were just talking about -- in 2004, there were 10, et cetera. Those are active duty only, not Reservists? Or --
 
            DR. WINKENWERDER: They include Reservists.
 
            Q     Okay. And that again, (those are the ?) ones that were separated, right?
 
            DR. WINKENWERDER: That's correct.
 
            Q     Okay.
 
            Q     Dr. Winkenwerder, sorry. Dave Rupe again. You know, you'd mentioned that service people in Iraq would be -- one set would again be receiving the vaccine, but since the war, the Iraq survey group found that Iraq didn't have any anthrax programs going. Is Iraq still a place of concern for anthrax attacks in light of that? Why would it be?
 
            DR. WINKENWERDER: Locations -- well, there are terrorists operating in and around Iraq and in that part of the world. There are people who try to kill American soldiers every day, obviously. That's a higher threat area.
 
            Q     Is al Qaeda one of the particular groups of concern?
 
            DR. WINKENWERDER: Yes.
 
            Q     North Korea?
 
            DR. WINKENWERDER: I don't want to comment on North Korea, because I don't have anything to say about that.
 
            Q     Dr. Winkenwerder, this is Jay Lacklen (sp), a freelancer. The FDA found the unapproved vaccine additive Squalene in five of the first 50 lot numbers of the anthrax vaccine in 1999. Squalene is not an approved substance because it caused sever autoimmune problems in FDA animal experiments. The bioport vaccine product insert lists ailments that occur infrequently after the anthrax vaccination. Many are autoimmune disorders, including inflammation of the brain, heart and spine; strokes; lupus; multiple sclerosis; and erratic heartbeat. Do you see a connection?
 
            DR. WINKENWERDER: No.
 
            Q     Dr. Winkenwerder, this is Denise Grady from The New York Times. Would women have to be given a pregnancy test before they get this vaccination? And if so, do you have to do it every time?
 
            DR. WINKENWERDER: Let me -- we do ask about pregnancy or the possibility of pregnancy before this vaccination and in fact I believe before any vaccination. And my -- we'll have to get you an answer on that. I don't recall that there is a mandatory pregnancy test, but people are certainly questioned about it very directly each and every time.
 
            Q     Okay. Thank you.
 
            Q     Dr. Winkenwerder, Jeff with Stripes again. To clarify -- is this for service members who are serving 15 days or more on the Korean peninsula or CENTCOM AOR?
 
            DR. WINKENWERDER: That's correct.
 
            Q     And will this vaccine be administered to troops both about to deploy out of theater and troops on the ground in theater?
 
            DR. WINKENWERDER: Well, if they're within a very short period of time to redeploy, I suspect that the consideration would be given to not vaccinating those people on a mandatory basis if they're within a very short window of redeploying, because it would not make a great deal of sense to do that. For those deploying yet, they would see the vaccination within 60 days prior to deployment.
 
            MR. JONES: Okay. Any other last questions?
 
            Q     Yeah. Vince Tomooson (sp), freelance again. Just going back on a point previously. I'm puzzled as to why the contract for the production of the vaccines is currently entrusted to a private limited company.
 
            DR. WINKENWERDER: Why is it entrusted to them?
 
            Q     Yeah.
 
            DR. WINKENWERDER: Most of the vaccines made in the United States -- in fact, I think all of them -- are manufactured by private companies.
 
            Q     Yeah, but that then -- doesn't -- that causes the (protein ?) problem, does it not, where, you know, they don't have to report fully on what -- on the results and what they're doing. I mean, I don't understand why it's not a public company.
 
            DR. WINKENWERDER: Well, yeah, it's an FDA licensed vaccine. The FDA regulates all vaccines and drugs and products of that nature, and sets forth certain reporting requirements for safety and effectiveness of those products.
 
            In our case, in the anthrax vaccine, we go beyond that. The adverse reporting systems and surveillance systems that I've talked about today are not required by FDA. These are things that we do because we believe that they're the right thing to do, and we felt it important to demonstrate beyond any doubt that the vaccine is safe and effective, just as we've described it.
 
            Q     Yeah, but this is a private limited company. Would it not be better with a public company? You say the area -- the plans to issue --
 
            DR. WINKENWERDER: I don't -- (audio break) -- the status of a company, whether it's privately held or publicly held, is a factor in the FDA's decision -- (audio break) -- talk to them. But I don't think that that factors into their thinking about -- the accountability to the FDA does not (differ ?) -- (audio break).
 
            Q     Okay.
 
            Q     Kristin -- I'm sorry, this is Kristin Roberts with Reuters again. Is there any discussion or thought about expanding the population of service members who would be vaccinated if supplies would allow? So beyond the CENTCOM area, beyond Korea.
 
            DR. WINKENWERDER: No, not at this time. We don't see a need to expand the program beyond the groups of individuals that I've spoken about.
 
            Q     This is Gail Petrich (ph) from the Military Times newspapers again. You mentioned the procedures as far as vaccinating members of the military, but what's the plan for civilian contractors and civilian DOD employees?
 
            DR. WINKENWERDER: Well, if the civilian contractors are deploying to these areas and they're mission-essential -- and we have definitions for who meets that criteria -- then they are included in the vaccination program. 
 
            Q     As physical --
 
            DR. WINKENWERDER: As far as civilians go who are not mission-essential or who are not in those areas, then they are not subject to the terms of the program.
 
            Q     And if those civilians -- employees and/or contractors -- don't want to take the shot, are they not going to those areas, then? Would they not be permitted?
 
            DR. WINKENWERDER: The -- if a civilian refused to take -- who is a mission-essential contractor refused to take the vaccination?
 
            Q     Mm-hmm. Or a DOD employee.
 
            DR. WINKENWERDER: Or a DOD employee? I don't know that we've encountered that, to my knowledge.
 
            Any other questions?
 
            Q     Just to follow up on that, you must have, if it's a mandatory program -- this is Dee Ann Divis with the Examiner -- what is the plan for those who decline? And is it different for the DOD employees and the civilian contractors?
 
            DR. WINKENWERDER: The plan is always to provide education to ensure that people understand that this program is for their safety and it's for their protection. And as I said, when those efforts are undertaken in that way, we find that there are an extremely small number of people who at that point decline to take the shot. At that juncture, for a military person, then the supervisor or the commander would get involved, and it would be resolved like any other similar matter. To refuse to follow a lawful order -- that's what it is.
 
            For a contractor or a civilian, as I said, I'm not aware that we've had any refusals among that group of people. So I don't want to speculate as to what the contractor's supervisor may or may not choose to do or be directed to do.
 
            Q     Dr. Winkenwerder, Jeff with (Stars and) Stripes. Can you elaborate on what legal ramifications service members face if they do fail to get the shot? For example, do they face confinement, loss of rank, loss of pay?
 
Q     Just to follow up on that, you must have, if it's a mandatory program -- this is Dee Ann Divis with the Examiner -- what is the plan for those who decline? And is it different for the DOD employees and the civilian contractors?
 
            DR. WINKENWERDER: The plan is always to provide education to ensure that people understand that this program is for their safety and it's for their protection. And as I said, when those efforts are undertaken in that way, we find that there are an extremely small number of people who at that point decline to take the shot. At that juncture, for a military person, then the supervisor or the commander would get involved, and it would be resolved like any other similar matter. To refuse to follow a lawful order -- that's what it is.
 
            For a contractor or a civilian, as I said, I'm not aware that we've had any refusals among that group of people. So I don't want to speculate as to what the contractor's supervisor may or may not choose to do or be directed to do.
 
 
            DR. WINKENWERDER: Well, I'm not a lawyer, and I'm not here to talk about that particular issue today. If there's a specific question, if you would submit it to us, and we'll try to get you other information on it.
 
            Q     Dr. Winkenwerder, if terrorists are a threat concern for this sort of attack, then why not have all DOD personnel, not just the ones in these specific areas? Why not vaccinate all DOD personnel?
 
            DR. WINKENWERDER: Because in our judgment, the persons that we are now vaccinating are the persons who are at highest risk. (Technical difficulty.) I'm sorry. Have we just been interrupted again?
 
            Q     No, that's okay. I mean, is it a cost issue or a supply issue?
 
            DR. WINKENWERDER: It is neither a cost nor a supply issue. It's an issue of the relative risk for those individuals and the optimal way to provide around-the-clock protection for them. You also have antibiotics. We can use antibiotics to treat people, and antibiotics are effective in people who have been (exposed ?). And should we have a situation here in the United States, we would be prepared to use antibiotics, and we would also be prepared to use vaccine if we felt that that was the appropriate step to take at that time.
 
            We did have an anthrax scare, if you will, a potential exposure on a detector system here about a year and a half ago, and we treated at that time, not knowing the final result, several hundred employees in the Pentagon with antibiotics as a preventative and protective measure.
 
            Okay. I think --
 
            Q     Dr. Winkenwerder, sir, no more questions directly on anthrax. This is Matt Kaufman with the Hartford Courant. I wonder if I might ask your thoughts on the legislation passed in Congress recently enhancing mental health screen in the services, sir, members of the armed forces.
 
            DR. WINKENWERDER: I'm just not taking any questions on that issue today.
 
            Q     Something you'd be amenable to talking about --
 
            DR. WINKENWERDER: Sure. If you'd like to talk to us separately on that, we'd be glad to work with. Contact Cynthia Smith from our Public Affairs Office.
 
            Q     Okay. I appreciate that. Will do.
 
            DR. WINKENWERDER: Okay. Terry.
 
            MR. JONES: All right. If anyone does need to do any follow up, they can do that with Cynthia Smith or myself, Terry Jones. I'm the guy that sent out the original e-mail, so my information is on there, and most of you already have Cynthia's.
 
            So we thank you for your participation today, and we will have the transcript posted hopefully by tomorrow morning on Defenselink. So you can look for it there. Thanks again.
 
            Q     Thank you, Mr. Secretary.
 
            Q     Thank you.
 
            DR. WINKENWERDER: Thank you.
 
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