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Expansion of the Anthrax and Smallpox Immunization Programs for DoD Personnel

Presenters: William Winkenwerder Jr., Assistant Secretary of Defense for Health Affairs; Brigadier General David Rodriguez, Deputy Director for Operations, J-3, Joint Staff; Bryan Whitman, Deputy Assistant Secretary of Defense for Public Affairs
June 30, 2004 11:10 AM EDT

            MR. WHITMAN:  Good morning, and thank you for joining us today.


            Today we're -- the department is announcing a decision to expand the anthrax and smallpox immunization program for DOD personnel.  This decision is based on the success that we've had with this important force protection measure, and the continued threat of biological agents.  Anthrax and smallpox remain two of the top biological warfare threats to our forces, and vaccinations remain a safe and reliable way to protect our service members.


            Today we have with us Dr. William Winkenwerder, who is the assistant secretary of Defense for Health Affairs.  He is joined by Brigadier General Rodriguez, which I think all of you know, who will be here to address in an unclassified way the threat conditions that make these programs necessary to preserving our combat strength.


            So with that, Dr. Winkenwerder.


            DR. WINKENWERDER:  Thanks, Bryan, and good morning.


            The policy update that we announce today further ensures the continuity of our mission, essential duties to the country.  The threat, as Bryan said, to our personnel continues, and it's important that we maintain our ability to operate in crucial areas.


            When we announced the resumption of the anthrax immunization program in June 2002 and the initiation of the smallpox vaccination program in December of 2002, we said that we would review our policies for these two programs periodically.  We recently completed such a review.  And in light of our successful implementation of our anthrax and smallpox vaccination programs, with an increased amount of vaccine available, particularly for anthrax, we will now vaccinate personnel assigned to selected units in the U.S. Pacific Command, additional personnel serving in the U.S. Central Command and selected other groups of individuals.


            We'll vaccinate service members who are assigned or deployed for 15 days or more.  That was our existing policy.  We'll pursue vaccinations, subject to appropriate personnel and contractor procedures, of emergency-essential civilian employees and comparable contractor personnel in the specified geographic areas.


            We continue to reserve a portion of the anthrax vaccine for stockpiling by the Department of Health and Human Services, and Homeland Security, to use in the event of a domestic emergency.


            And let me just say this about our vaccinations and how we view them.  We view vaccination as the best around-the-clock protection we can offer our personnel.  It's a layer of protection in addition to antibiotics, detection equipment, surveillance, and protective clothing and equipment and the like.  And importantly, it also is in addition to what we can learn from intelligence.


            We continue to work aggressively with the Department of Health and Human Services, using a new federal coordinating committee and taking advantage of the bioshield legislation recently passed to prioritize and develop new and better vaccines and medical countermeasures for biological threats to civilians and military personnel.  We know that the threats of anthrax and smallpox are very real and very serious.


            If exposed to anthrax, you're likely to die -- I think most of you would know this -- if you do not receive treatment promptly. Anthrax is in particular an attractive weapon in that it's highly lethal, easily spread in the air over a large area, easily stored, and dangerous for a long time.  Some of our adversaries we believe possess anthrax.  Some of our defense personnel are at higher risk because of this.


            Smallpox is also an attractive weapon due to its contagious characteristics.  It's also deadly.  Once thought to be eradicated, some of our adversaries may possess this virus, and that places our personnel at risk of exposure.  If an outbreak occurs, we need our personnel to be able to do their jobs.


            Our responsibility to all of our service members is to do all we can to protect their health and safety.  Having effective vaccines that are safe offers us a tremendous advantage for protecting our people.  Just knowing our personnel are protected can create a deterrent for our adversaries' use of these weapons.  We'll begin vaccinations for individuals assigned or deployed to these areas that I mentioned in the very near future.


            And with that, I'm glad to take your questions.


            Yes, sir?


            Q     Could you be more specific about who and what areas?  Are these people deploying to the Korean Peninsula, for example, that will receive --


            DR. WINKENWERDER:  The additional personnel will include those selected areas within the Pacific Command, including those in the Korean Peninsula, yes.


            Q     Can you tell me an estimate of how many more U.S. service personnel are going to be getting these shots with this announcement? And previous to this, have U.S. forces on the Korean Peninsula been getting these shots, or is this the first time?


            DR. WINKENWERDER:  This will be the first time for those forces on the Korean Peninsula.  I don't have precise numbers for you in terms of the aggregate number of additional personnel.  It's into the tens of thousands.  But of course with rotations of forces occurring at periods of time, actually that number will increase.


Clarification from DoD: [The initial Anthrax program announced in 1998 did include U.S. Forces assigned to the Korean Peninsula. This is the first time the anthrax vaccination program has included U.S. forces assigned to the Korean peninsula since the program was resumed in 2002.]


            Q     Could I just follow up?  In giving these vaccinations to our forces on the Korean peninsula for the first time, does this reflect the Pentagon's belief that North Korea possesses and may be willing to use biological weapons, including the two agents for which these vaccinations are given?


            DR. WINKENWERDER:  Well, I'm not going to comment on the intelligence information or speculate as to the answer to your question.  We do have General Rodriguez here today with us, who certainly thinks a lot about those kinds of issues on a day-to-day basis, and I'll ask him to respond.


            GEN. RODRIGUEZ:  It's a combination of things.  You know, obviously, suspected capabilities information, as well as the capability to make this anthrax quickly.  It's not that relatively difficult to do it.  So it's a combination of all those things that led us to say that was a higher threat area.


            Q     What's your first name, please, sir?


            GEN. RODRIGUEZ:  David.


            DR. WINKENWERDER:  Yes?


            Q     I have two questions about this.  Number one, what is the cost, and how are you budgeting for this?  If the '05 budget is already in the hole, would this come in some sort of a supplemental? And also, overall health care costs in general seem to be increasing. Can you speak a little bit to how that's impacting the larger DOD budget?


            DR. WINKENWERDER:  Well, the additional costs that we expect will be associated with the implementation of these changes are not substantial, certainly, relative to our overall Defense health budget. Our total budget is roughly in the area of $30 billion.  And so these changes are into the tens of millions of dollars, and so would not create any strain in that respect.


            Q     So would you include that in a supplemental to get that tens of millions, or can you transfer that from your other accounts?


            DR. WINKENWERDER:  There's sufficient funds that have already been allocated that are in the 2004 and 2005 budgets to pay for these programs.  We have an inventory of both vaccines now, as I mentioned, because of increasing supplies.  So that's already been manufactured and procured, and we have it in stockpiles and we're able to use it.




            Q     I have a follow-up to Will's question, the second one.  You said under the new program -- if I understood you correctly, sir, you said under the next wave of vaccines about tens of thousands of individuals will be, that's additional to how many were?


            DR. WINKENWERDER:  To date, we have -- since of June of 2002, have vaccinated over 750,000 personnel for anthrax.  And since December of '02, have vaccinated over 625,000 personnel against smallpox.  Let me just add to that:  since -- because some people were vaccinated, starting in 1998, against anthrax, some of those people obviously are still in the services; so we've, in the aggregate, vaccinated about 1.1 million people against anthrax.


            Q     The smallpox vaccine that is administered to service personnel and selected civilians, does that differ in any way from the smallpox vaccine that I can get as a civilian outside of it?


            DR. WINKENWERDER:  No, it's the same vaccine.


            Q     You know, there are suggestions that that doesn't work.


            DR. WINKENWERDER:  Doesn't work against?


            Q     Smallpox.


            DR. WINKENWERDER:  I'm not aware of any such suggestions.


            Q     Okay.


            DR. WINKENWERDER:  The science says that it works.


            Q     Okay.


            DR. WINKENWERDER:  Yes?


            Q     The memo that came down also talks about -- or offering the vaccine to family members, dependents and then -- and you mentioned essential personnel.  Who deems who's essential?  And the offering, is that, then, a volunteer basis for the dependents?           


DR. WINKENWERDER:  It is offered on a voluntary basis to family members and dependents.  The emergency-essential contractor personnel is a determination that's made at the local level in the field.


            GEN. RODRIGUEZ:  By the chain of command at a local level in the field, for the determination of essential personnel.


            Q     Is it the first time that dependents will be given -- (word inaudible) -- and --


            DR. WINKENWERDER:  They were offered -- this is just a continuation of the basic structure of policy that we've had in place.   The only change is the groups of individuals that are now included in that policy.




            Q     In the CENTCOM region, who is going to be -- you know, who are the additional people who are going to be vaccinated there?


            DR. WINKENWERDER:  Well, just would suffice to say, it will include all personnel in the CENTCOM area of responsibility.


            Q     And up until now it's been only military personnel?


            DR. WINKENWERDER:  No, there were certain areas of the Central Command that had been -- for which the personnel, the troops -- military personnel had been vaccinated.  This now will include all personnel in the Central Command.


            Q     Can you be more specific about, you know, which personnel were vaccinated before?


            DR. WINKENWERDER:  I'd prefer not to.




            Q     And is it military and civilian?


            DR. WINKENWERDER:  Civilian is essential contractor personnel.


            Q     Like Iraqi civilian guards and stuff like that?


            DR. WINKENWERDER:  Yeah -- U.S.


            Q     Well, I mean, talking about civilians also involve the Iraqi security forces and stuff like that in the --


            DR. WINKENWERDER:  No, this program will not be applied to Iraqi forces.




            Q     When you do these reviews, do you look at -- are they basically to look at where the threat is or just because you have more vaccine?  Just give us generally what goes into this.  So possibly more troops in the future could --


            DR. WINKENWERDER:  It's a combination of factors.  I think again for the threat I'll have General Rodriguez speak to that.  Actually, I believe Director Tenet spoke to this issue earlier.


            GEN. RODRIGUEZ:  Right.  He spoke about it.  But yes, for us it's a periodic review of the threat and, like I said, the intelligence information, known capabilities or potential capabilities for the threat piece of it.


            Q     So how has the threat changed?


            GEN. RODRIGUEZ:  The threat has not changed.  In this case here, they did a review.


            (To Dr. Winkenwerder)  Do you want to handle that part --


            DR. WINKENWERDER:  Right.  Well, I think that's the bottom-line message, is the threat condition, we believe, has not changed since the point at which we implemented these programs earlier, and with the additional availability of vaccine and consideration of other areas of the world for which we wish to provide that additional layer of protection, we're taking these steps.


            Q     So in this case it was just that you got more vaccine. Nothing changed in terms of the threat.


            DR. WINKENWERDER:  There is no substantial change to the threat situation.  Again, I'm going to let General Rodriguez -- you may want to just quote what Director Tenet had said back in --


            GEN. RODRIGUEZ:  He talked about the intent with al Qaeda in the pursuit of this as being one of their higher biological weapons programs that they were pursuing and everything.


            Q     Is the eventual goal to have all service members vaccinated?  And if that is the case, why offer it to dependents before other service members?


            DR. WINKENWERDER:  Our approach is a threat-based approach and an approach that looks at the capabilities and missions we believe are important to preserve.  We currently do not have a policy direction that says we will vaccinate everyone.  We, as a matter of fact, plan to continue to review worldwide circumstances and situations, threat information, availability of these vaccines, possibly in the future new vaccines.  And so our policy is meant to adjust to the situation over time, and that's what we're doing here today.




            Q     What are the latest sort of rates of adverse reactions to both these vaccines?  And do you have any information or numbers on people who have refused to take them?


            DR. WINKENWERDER:  The adverse -- let me take them separately.


            Events or adverse reactions for anthrax vaccine are very similar to other comparable vaccines.  There are local reactions that most people -- or not most people, a significant number of people -- let's say 30 to 60 percent -- get, like swelling, redness, a little inflammation at the site of injection.  Some people get a little fever, malaise, don't feel so well for a few days, and that happens in 20 to 30 percent of people.


            There have been studies.  We've studied the whole issue of adverse events for both of these vaccines.  And the Institute of Medicine of the National Academy of Sciences issues a very comprehensive report in March of 2002 specifically on the anthrax vaccine, and concluded in that case that there were no serious adverse events or long-term adverse events associated with the -- or death -- associated with the anthrax vaccine.


            Now to the case of smallpox vaccine, we know more about that because it is the same vaccine that was used in the United States for children and adults, young adults, principally in years past.  We published a paper in the Journal of the American Medical Association that really serves today as the principal knowledge base about the adverse rates and reactions to the smallpox vaccine.  Generally speaking, people have, again, a little inflammation at the site, redness, swelling, may feel a little malaise, not feel so great, sometimes low-grade fever.  The rate of serious adverse events associated with smallpox is very low, but there is a real chance of that.  It's at a low probability.


            But fortunately, we have had very, very few of those kinds of events and principally, we believe, because we followed people very carefully, to intervene if there were any such signs of that kind of reaction.  And also we've educated people and screened out individuals who might be at higher risk for adverse kinds of problems.


            Q     So will you do that with the soldiers who will be undergoing this and screening out?


            DR. WINKENWERDER:  Oh, yes.


            Q     And if so, if you find someone whom you feel may have an adverse reaction to, say, smallpox, what happens to that person in a unit that may have to be deployed there?


            DR. WINKENWERDER:  They are still deployable, but if they have a medical exemption, appropriate medical exemption, obviously it would not be appropriate to give them the vaccine.


            Q     But they would still be deployable with the rest of the units in the area?


            DR. WINKENWERDER:  That's correct.




            Q     Sir, what happens to a service member who declines to get either one of these vaccines?  And also, on the CENTCOM, I know that you don't want to discuss particular locations where people are getting shots, but can you say the percentage of U.S. forces in that region who currently have it and then what it will be after this program?


            DR. WINKENWERDER:  Right.  Your first question is what --


            Q     What happens if somebody declines --


            DR. WINKENWERDER:  Declines.  Well, we spend a lot of time educating people, certainly about the threats and, more importantly, about the vaccines themselves, the medical science and the facts.  And in fact, if any of you were embedded reporters, I know some people received vaccines, and hopefully you got a very thorough education when you went through that.  And that's the same education that every service member received.  I've been vaccinated against smallpox myself, and I, you know, was sat down -- a physician, but I was sat down -- (chuckles) -- and educated for 30 minutes about this and got a very thorough set of information to review.  So that's the first thing.  And we spend time with people.


            The bottom line is, we've had very few refusals that have led to separations from the service.  A rough statistic that I would share is about four people per hundred thousand who have been vaccinated.  So it's a really very low rate.


            Q     But then they still face the possibility of court-martial?


            DR. WINKENWERDER:  I'm not aware of any court-martials in recent months applying to these situations.  I don't know if you --


            GEN. RODRIGUEZ:  No, I'm not either.  It's just like disobeying orders.  It's been ruled a legal order to tell them to take the vaccination, and then the chain of command handles that appropriately. But there have not been recent court-martials like you asked.


            Q     On my question about the CENTCOM region?


            DR. WINKENWERDER:  I can't give you specific statistics. Obviously, with this change as it's implemented, it will include everyone.  It was probably well over half, two-thirds, three-fourths, the majority, the great majority of people, but this now includes everyone.


            Q     Is Korea the biggest group affected, that area?


            DR. WINKENWERDER:  Probably more affected in the Pacific Command than in the Central Command, but it's both areas.


            DR. WINKENWERDER:  Thank you.



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