Tuesday, July 11, 2000 - 1:45 p.m. EDT
(Also participating in this briefing was Marine Corps Maj. Gen. Randy L. West, Senior Advisor to the Deputy Secretary of Defense for Chemical and Biological Protection, Dr. J. Jarrett Clinton, M.D., First Assistant to the Assistant Secretary of Defense (Health Affairs) and Army Col. Randy Randolph, Director of the Anthrax Vaccine Immunization Program Office, Anthrax Vaccine Immunization Program Agency)
ADM. QUIGLEY: Good afternoon, ladies and gentlemen. As many of you know, yesterday Secretary Cohen announced a slowdown of our Anthrax Vaccine Immunization Program. And I know that we spoke with many of you yesterday, had several questions on that topic. And we thought that perhaps a more comprehensive way for you to get as many of your questions answered as we have answers to them today would be to provide three individuals who are very much into this subject.
I think, again, that many of you have met perhaps all of the three people. But we have Major General Randy West, who is the senior adviser to the deputy secretary for Chemical and Biological Defense;
Dr. Jarrett Clinton, first assistant in the Assistant Secretary's Office for Health Affairs; and Colonel Randy Randolph from the actual AVIP program office, with the Army being the executive agent of that program.
I will ask all three men to come forward here to be on the dais. And the person that -- and because I know you, I will call on you to ask your questions. Please be specific, if you will, as to which of the three that you wish to ask the question of, if you know. Just to go back over for one second there: General West, questions on the overall architecture of the program, operational issues, threat issues -- those are the particular areas of expertise for General West. Dr. Clinton is the health issues, the medical issues person to ask specific medical questions of. And for the program specifics, Colonel Randolph would be the one that works that issue every day. And if you're not quite sure, then the three men will decide amongst themselves which to take it.
And we'll ask the principal speaker to position themselves here in the middle of the podium for cameras and for clarity of sound.
Gentlemen? (Speakers take position.)
Okay. There's no prepared statements. Secretary Cohen's statement that was out yesterday -- we'll let that stand as the start point. So you'd take your questions, please.
Q: Yes. I'd like to ask the general -- I believe you-all said last week that you have been using around -- about 4,500 doses a day. Is that right?
GEN. WEST: Well, depending on whether you figure it on a calendar day or a work day, but the usage rate per month has been running about 75,000 per month.
Q: And what will that be reduced to?
GEN. WEST: We would reduce that to a number that would be around 14,000 per month.
Q: And how many -- how long do you think it ought to last you at that rate?
GEN. WEST: The way we plan to execute the program would be to provide protection to the persons that are shore-based in the high- threat areas. If we use it in that manner and the rate remains at about 14,000 per month, we have enough vaccine to last us from six to 10 months.
Q: And is that the vaccines that are already approved, or assuming that you will get the vaccine that you're testing?
GEN. WEST: That's vaccine that's already approved, certified safe and effective; has passed purity, has passed sterility, has passed potency, has been released by FDA, and is either already in one of our clinics, ready to be used, or is in storage at BioPort ready to be shipped.
Q: Will all those --
Q: Just one more.
Q: I'm sorry. Just one. Could you be a bit more specific about the areas you're talking about? Are you talking about South Korea and the Gulf?
GEN. WEST: We're talking about Southwest Asia and the nine countries that we currently have people based in, and also Korea.
Q: All right. Thanks.
Q: Will all those who started getting shots continue with the shots here if they're back in the United States?
GEN. WEST: At this time we do not plan to continue shots in the immediate future for those persons that have been in the high-threat area and have returned to the United States or to another safe area where the threat is not classified as "high."
We want to continue those protocols, and as soon as we're able to reestablish the supply with safe and effective vaccine that we've got total confidence in, then we'll re-begin those protocols and finish everyone's six-shot series.
Q: Doesn't the FDA require the six-shot regimen?
GEN. WEST: The six-shot regimen is required by FDA to provide full protection. If you have had less than six shots and you stop taking the shots, there's no damage or no harm to the individual. But what you forego is the additional immunity protection that you get by finishing the series. It's our very strong desire to get all of our servicemen and -women six shots, but the simple fact is right now we don't have the supply that allows us to continue all of those protocols and simultaneously provide vaccine protection to the people that are on their way to the high-threat areas to serve in the immediate months ahead.
Q: And one last one: Do you know how many people started the six-shot regimen that you'll postpone now?
GEN. WEST: We have 455,378 people that are -- that have stated the protocols.
They've received about 1.8 million shots; 56,725 of those have received all six shots. So if you subtracted that number out and then subtracted out about 36,000 people that are on the ground there today, that would be the number of people that have started the series and returned to a safe area.
Q: Is there any timeframe in which a person has to complete the six shots? In other words, can they have two shots, revisit it a year later and get four shots?
GEN. WEST: There's a package insert that specifies how the shots should optimally be given. And the first -- you get your first shot, two weeks later you get your second, two weeks later you get your third, and then the fourth, fifth and sixth shots are six months apart. We try to stay on that protocol as close as we can. And we have, in fact -- not graded, but we have tracked how well our units have done on timeliness since we began this program, and that's the way we would like to continue to do it. And if we had reached approval for new production and had an unlimited supply right now, that's the way we would do it. We are --
Q: Just to clarify. The regimen is over 18 months with yearly boosters, is that right?
GEN. WEST: That's correct.
Q: If a person takes the first two shots and then has to wait for a year or even 18 months before getting his third shot, does the person have to start all over from shot one?
GEN. WEST: Dr. Clinton, would you like to take that one?
DR. CLINTON: We have discussed this with the FDA and advised them that we plan to follow the Center for Disease Control's expert group on this issue. It's called the Advisory Committee for Immunization Practices, which has a statement which states you do not need to re-start the whole series. Rather, you just pick up where you were. So, indeed, if an individual had two shots, didn't have access to the third, waited six months, then they would start the third and go right back on the schedule again. That's what we do commonly with other vaccine shortages when they occur in the United States, and that's what we plan to do here.
Q: Can you help us with the math, general, on roughly 35,000, 37,000 in Korea. How many boots on the ground, so to speak, in the nine countries in Southwest Asia do you feel need the full six shots? How many people are going to be fully covered?
GEN. WEST: (Off mike)?
DR. CLINTON: I do. There are approximately 10,000 in the high-threat area of Southwest Asia with boots on the ground, as you term it, that we would want to protect at greatest risk.
Q: And the number in Korea is 37,000? That's it?
DR. CLINTON: You're approximately right.
Q: And you're not going to cover Okinawa, which would be the first guys in? They're off your charts now?
DR. CLINTON: We are going to protect those at highest risk on the peninsula in Korea.
Q: And TDYs who come through for a two-week assignment in those high-threat areas, they will not get it. Right?
GEN. WEST: There are a couple of specifics left in the Secretary's decision process that we don't have and haven't discussed with him yet.
He was briefed on the various alternatives before he left for China, and we gave him papers to study to make his decision. He was able to talk to the chairmen before he left and we've also talked with General Schwartz. Our second affected CINC, General Franks, will be coming in tomorrow for a meeting with the DEPSEC, and then after the deputy and the secretary talk again, we'll have the rest of the specifics. So there are a couple of things that I wouldn't be able to tell you today, because I'd be taking his prerogatives, or making assumptions, but about 80 percent of the solution is in place.
Q: At any given time, the Navy, if they have a carrier task force out there, would have between 5 (thousand) and 8,000 floating personnel, if there is an amphibious group as well. So when those, say, 5 (thousand) to 10,000 floaters come into either the Persian Gulf or off the Korean peninsula, they will not have shots?
GEN. WEST: We would expect those personnel embarked aboard the ships, both Navy and Marine, that are going to be phased ashore, to get the shots. The personnel aboard ship that will not be going ashore will probably be deferred until we reestablish our stockpile.
Q: Most often, the Marines do not embark -- they do not disembark, I should say -- but you will automatically give them the shots if they are out there?
GEN. WEST: The majority of them. There are some people within what we call the MEU, the Marine Expeditionary Unit, that remain aboard ship even when the MEU lands ashore. There are also some Naval personnel, like our SEAL teams and some of the logistics people, that do routinely phase ashore. They would receive the shots, under our plan.
Q: Will this change at all the number of shots that people going to these high-risk areas get before they go there? And is there a standard now for what that is? Is it two shots, three shots, before they actually go?
GEN. WEST: Yeah, the more protection that we can get them before they get there, the better it is. There is not a policy that says how many they have to get, but once a person is assigned, we begin their shot protocols as soon as we can, and then they get them on schedule. Sometimes that's one, sometimes it's three, sometimes it's as many as four, but --
Q: But will this -- will this cause you now to change that in any way, or --
GEN. WEST: We would probably change it a little bit in that we would wait until we were certain than a unit or an individual was going there before we used the vaccine, because we want to keep it available to be sure that it goes into people that are going to be putting their boots on the ground there.
Q: General, one of the centers of the controversy over the anthrax was the Defense Department, last year and even before that, was saying, "We have to give everybody immunization because we never know what may happen, what contingency may arise." Suddenly you're having to do that.
How are you going to explain this internally in the force to avoid some sort of crisis in morale about the program? Are you planning some sort of internal information campaign to the troops?
GEN. WEST: We will have. We'll post a decision, the reasons for it and the plans to handle it as best we can on our website. We'll communicate from the secretary to the service chiefs and the CINCs, and they'll communicate with their people.
But we're disappointed. We wish we were vaccinating the whole force now. We're running about a year behind our planned schedule in this program. We were perhaps a little too optimistic about how long it would take the new manufacturer to pass all of his inspections and receive all of his certification from the FDA and the other people that work with them, and we also thought a little bit more of the supply that had already been produced would become available.
What we have done is meet the secretary's two tenets of the program -- Safety first: safety for my people that are forward deployed in the high-threat areas; and safety of the vaccine before we administer it. So we have not used anything except vaccine that we could place 100 percent full confidence in for safety, purity, sterility and potency. And that has brought us to a situation where we don't have the stockpile to continue the program the way we want to.
Q: You're going to continue to test the batch you're testing now, and when will that be completed?
GEN. WEST: There are about five batches of vaccine that has been made that could still be tested, that was made by the original manufacturer, not by the new manufacturer. Part of the new corporation's learning process and validation process is conducting the potency algorithm for the vaccine. That's one of the things that they're still working on. But once they're able to do that, we may very well be able to test some of the lots that's already been made. There's also some vaccine that they have made that has not been tested because they haven't received licensing by FDA as yet.
When FDA does re-award their license, part of that decision will be whether the first batch of vaccine that can be used will be the vaccine that they watch them make as the final step in that process, or if some of the vaccine that's been produced could be considered. I don't know what that decision will be.
Most likely it'll be the former, and the first batch will be what they make under FDA supervision while they're there as part of the inspection.
Q: Do you -- a couple of questions. First of all, do you in fact have any plans to test those five batches?
GEN. WEST: We have -- the batches are tested by the contractor. BioPort would do the test. It would be overseen by another corporation that's been contracted to provide oversight, called Mitretek. If they were satisfied, then they would submit the data to us, and we would review it. Once we reviewed it, we'd make a decision on whether to submit it to FDA for release.
Q: But have --
GEN. WEST: There is no lot that's right now being tested, and there is no lot before FDA for consideration for release.
Q: Is it not the case that this stuff, you've decided, is generally considered too old and has been on the shelf too long to really realistically test and use? I mean -- (off mike)?
GEN. WEST: There is some vaccine that has an expiration date and would not have a high probability of passing the test. There are some other lots that are newer and would have a higher probability. I can tell you that we don't use any that we're not certain about.
Q: So what is the exact number that you have available, as of today -- that you have available to you?
GEN. WEST: Certified, ready, already approved for release? Something in excess of 160,000 doses.
Q: And if I could just follow up and go back on a couple other points, could you just go back and tell us exactly what has been decided here, and what remains to be decided? What are the still outstanding issues? What's a firm decision, and what's still on the table?
GEN. WEST: Well, what has been decided is that we want to preserve the rest of the vaccine that's available to be used in the high-threat area, for people that are there now, are going to be going there soon. In that way, we will -- we hope not to have to suspend or shut down the program. We would continue it at a slower pace, with emphasis on those personnel that are in immediate -- in imminent danger.
The things that have yet to be decided is things like whether or not persons that are passing through the area for a few days, that are going to be there less than 15 or less than 30 days -- when we began the program, it was a 30-day policy. We later changed it to a zero- day policy, which meant that if an aircraft flew through that high- threat area, and the people disembarked and put their feet on the ground, that they had to be vaccinated before they went there. We're considering relaxing that and going back to a 15- or a 30-day policy. And those kinds of things would make the difference between whether we have a six-month supply or a nine-month supply.
Q: And my last question, then, is what challenge does this pose for you on deployments over the next six to 10 months? Do you have to now start looking around and making sure you have troops that at least have some vaccination? Does it constrain your ability to --
GEN. WEST: To put together a force for the next six months? No, ma'am, because those people will be covered with the vaccine that's remaining. If we go much beyond six months, it could constrain it. It could become more difficult. One of the benefits that we will have gained by running this program since 1998 is that there are 455,000- plus people now that have some protection. There are some that have full protection, and they would need fewer shots. If you had to constitute a Desert Thunder today it would be less challenging to send protected people than it would have in 1998.
Q: General, when do you --
Q: How many are fully protected?
GEN. WEST: Excuse me?
Q: How many are fully protected?
GEN. WEST: Fifty-six thousand, seven hundred and twenty-five.
Q: Why are no lots currently being tested or before the FDA?
GEN. WEST: Because if you -- when you do these tests, if a lot of vaccine is tested and does not pass the test two times, it's removed from consideration for use. Because the manufacturer has not yet worked out all of his challenges in running the tests successfully, we don't want to put the rest of the vaccine at risk of failing with it might be good. We want to keep the remaining lots that have not been tested yet available for test until we know that he has a good potency test program, that the way we're challenging is being done correctly, and that the way we're evaluating the challenge is also working totally correct.
The lots that are available have already been tested for safety, purity and sterility. We know those three parts are good. We do not know for certain that the potency part is good, and we can't test that without putting the vaccine at risk of having an invalid determination.
Q: Do you have any sense when BioPort will be up and running again?
GEN. WEST: We hope that they'll be up and running later this year. They've made significant progress on the recommendations that FDA made on their last visit. They've corrected many of the discrepancies, but they have not corrected all of them. If they remain on schedule, they'll be submitting the last of that data to FDA for consideration sometime during the month of August. If that information goes in on time and is considered by FDA and is found to be acceptable, we should be shipping new vaccine again before the end of the year. But that requires staying on that schedule.
Q: Can I ask Dr. Clinton a question? When does a person become protected to any degree against anthrax? After the first shot? Or do you have to go through the whole series?
DR. CLINTON: After the second, and certainly by the third, you get very high titer levels, and so we interpret that to mean some protection, but it's not sustained; that's why there needs to be a sixth shot. That's how it was designed, to be a sixth shot. So it's one thing to bring the peak up, but we want the peak to come up and stay there.
Q: Now, the first two shots are two weeks apart?
DR. CLINTON: Correct.
Q: And the next shot is six --
DR. CLINTON: It's another two weeks.
Q: Another two weeks. And then the --
DR. CLINTON: It's 0, 2, 4, and then they're in the six-month stages.
Q: Then they're in the six months. So when they get into the six-month stage, they're basically good until --
DR. CLINTON: They're moving and sustaining that antibody level, and then they have the yearly booster.
Q: Do you have any idea how many troops might be protected for up to six months?
DR. CLINTON: I don't have that number on the tip of my tongue. We could run those numbers, but --
Q: Six months is the minimum time you have for administering the vaccine?
DR. CLINTON: Our intent is to get six doses. We're going to do everything we can to get as many doses into the people who are at highest risk at any point in time. That's the driving issue.
Q: My other question is -- and if I can ask this of the general, does this mean that basically there will be no anthrax shots -- and as of when? -- other than in Southwest Asia and Korea?
GEN. WEST: Or people that are designated to go there. Well, that's not totally true. That's how we will use the majority of the vaccine. But the vaccine comes in vials with 10 shots in a vial. Once a vial has been opened, it cannot be shipped. We have some vaccine that's out in the field in over 2,000 places that we will cover and correctly ship to the high-threat areas to be used there during this slowdown period. There will be some vaccine at those sites that we cannot safely ship, so we will leave it there and it will be used until its exhausted. So there will be a few people that came back from SWA or Korea that are due for their fifth or sixth shot that will still get it, even though they're not in the high-threat area. That's just a prudent use of the vaccine that's available so that it provides protection before it expires.
Q: But you wouldn't start someone on a course that you couldn't finish, at this point?
GEN. WEST: No. No.
Q: So in other words, the whole program is basically shut down, except for troops going to Southwest Asia and Korea?
GEN. WEST: That's correct. Except for using the small amounts of stock that's already at sites and already opened.
Q: Did you say the Marine MEUs would or would not be given these?
GEN. WEST: They will be getting the shots.
Q: And who will make the ultimate decision for other shipboard personnel?
GEN. WEST: The commander of the ARG. The people that they've identified that will go ashore as part of the landing shore party and the SEAL teams. It would be a Marine colonel and a Navy captain, most probably --
Q: Okay, it's not a theater-level decision, then?
GEN. WEST: No. The guidance will be specific enough it can be made at the local commander level.
Q: On BioPort's financial condition, you and I talked about that IG report earlier in the year, and both the IG and the DCAA (Defense Contract Audit Agency) worried -- had reports talking about the shaky financial condition of the company.
At this point, is the company in sound financial footing, that there's no problem with a bankruptcy issue?
GEN. WEST: I don't believe there's a problem with a bankruptcy issue, but the company will not be making a profit until they're able to obtain their license and ship vaccine, because the only product that they're making for sale right now is anthrax. There are many customers out there. There are several countries that have asked to procure it, but we are not able to fill any of those orders because, until they re-certify new production, they can't sell any vaccine.
Q: Can you explain why the Pentagon never qualified a second source to go -- like an Eli Lilly, or somebody with a better track record than this fairly new start-up?
GEN. WEST: Well, when we began the program, there was an existing supply and there was one company that had a license. In retrospect, I wish that we would have immediately advertised for a second source. We did not. We recently have. We have also negotiated with the contractor so that that will occur in such a way that the existing license can be used for that second source. BioPort will cooperate with whoever gets that second-source contract, and the FDA tells us that they can probably have that company certified within two to four years.
The reason we didn't do it initially is because we didn't expect to have to wait this long, and we didn't expect to have to suspend the program. So we thought we were on safer ground than we turned out to be. We've decided that it's worth the additional investment. We also have more companies now that has expressed an interest. When we went out with that original bid, we only had two responders, and one of those was a foreign company. So we selected the American company and the company that had the license, and we've been doing the best we can to work with them and the FDA and their other advisors to bring them to new production. But because of the problems we've had and the lessons we've learned, we feel that it's worth the investment to stand up a second source.
Now another part of that is, is since 1998, the threat has only increased. Both the technology and the intent to build these kinds of weapons, that kind of activity, has increased in some of the countries that we're most concerned about. So we think that we need a long- range solution, and if we qualify a second source and they both are producing vaccine, that it provides price competition and it also gives us a safety net if one of them gets shut down.
Q: BioPort's waived its 10-year patent protection -- or, its patent rights -- on the vaccine for the next company that comes in?
GEN. WEST: To cooperate with a second source; not multiple sources, but a second source.
Q: Can you review the bidding on how much money the Defense Department has sunk into BioPort to get it up and running?
GEN. WEST: I couldn't tell you exactly that amount of money. I can get that number for you. But probably this whole program, the investment has been over $100 million.
Q: And secondly, you've indicated that the number of people who are refusing to take the shots has declined, and that the adverse reactions that are being reported by those who are taking the shots, I guess on a per capita basis, have declined. Can you run through those numbers, what you know, how many total people have refused to take the shot, to the best of your knowledge?
GEN. WEST: We've had 351 people that have refused to take the shot and have remained adamant enough about that to receive disciplinary action or be discharged or released from service.
Q: Do you have a breakdown where they're from, what service, what guard or reserve?
GEN. WEST: I don't with me, but I can get that for you.
Q: And the adverse reaction trend line?
GEN. WEST: There have been 848 VAERS (Vaccine Adverse Event Reporting System) forms reviewed as of last month. That's out of 1.8 million-plus shots.
Q: And the way in the past that that has been broken down is some percentage of that has required 24 hours off the job? Is that the -- Doctor, I don't know if I'm --
GEN. WEST: One hundred sixty-three of those have missed a day of work, 38 have been hospitalized.
Q: General, is the anthrax vaccine manufactured anywhere else in the world?
GEN. WEST: It's manufactured two other places in the world right now. Britain has it. They have a vaccine that's similar to ours, in that it uses a protective antigen. They're experiencing similar problems with us and are at about the same point in the program, actually a little bit behind us. They have never had a mandatory program. They had a very limited supply. So they've used theirs selectively, both voluntarily and on a mission assignment basis. But they believe that they have a company that's about ready to be approved for production, and they intend to expand their program. The Russians also have a vaccine. It's a different vaccine. It uses a live bacteria. So we would not be interested in using that.
Q: Would you be interested at all in having a foreign company produce the vaccine? You said there was a bid from a foreign company before.
GEN. WEST: Well, I mean, I think I would prefer to have an American supplier, for a lot of reasons, but there certainly are probably some foreign suppliers that we would be willing to consider as well.
Q: You said you didn't want to put the test, while it's on the shelf, at risk by having them test it twice and then removed from possibility -- being testing -- but you are hoping to test them. So are you asking the FDA, or whomever, for a revised test procedure now?
GEN. WEST: No. What we're trying to do is -- one of the progressive points in qualifying the new company is that they have to take the FDA-specified potency test protocol and run that successfully with no errors in documentation or standardization or quality control. You know, it's a very rigorous and very carefully defined process.
And the standards are in fact tougher today than they have ever been. And BioPort is not the only corporation or vaccine producer that's having problems with that right now. And that's the way we want it. We do not want to use any vaccine that we can't place total confidence in.
Q: That's the other quick question I had. You said that, since 1998, the threat had expanded or changed or grown. That's not so long ago. So can you tell us any more in the last 18 months, how the threat has changed? In other words, have you seen more in the specific area such as Korea and Southwest Asia, or have you seen it grow to be a high-threat beyond those areas? What's changed in the last year and a half?
GEN. WEST: I can't go into the specifics of that here. But I can tell you that, of the people that we have identified that were pursuing the capability, there have been some technology improvements, and there have been some activity increases. There's also been an increase in the number of both state actors and non-state actors that have done things that have prompted our Intelligence Committee to believe they are trying to obtain the capability.
Q: So is part of this because you believe there is a greater terrorist threat, in the last 18 months, of the use of anthrax?
GEN. WEST: No. What I am talking about would be more in the "state actor" category. I mean, I am not -- that whole issue is very difficult to talk about in this forum. I am sorry I can't give you a better answer.
Q: Can I just revisit for a minute the question about naval and Marine forces in these areas?
In Southwest Asia, in particular, I know it's common for ships to pull in and for sailors to get liberty, in places like Bahrain or in Haifa. Are those people going to get the vaccine, just if they are going to be there for a few days? Or are they going to miss the vaccine because their stays are very limited?
GEN. WEST: Well again, that would fall in the area of some particulars that we don't have full definition on yet; that's in that 20 percent. But probably the people that would not be going ashore for an operation or for combat would not receive the vaccine.
If we were worried about the threat, we would have liberty controls and ship movement controls to help answer that.
And Admiral Clinton could probably expand --
Q: I think that's fine.
Q: A question on sort of a different subject: Doctor, you said a minute ago, if I understood right, that after you'd passed the third shot, that the antibodies stabilize; that is, after the first two shots, they --
DR. CLINTON: There's a high level. There's a high level --
DR. CLINTON: -- a level that we're comfortable with.
Q: Okay. But any --
DR. CLINTON: But that's only sustained by the additional shots.
DR. CLINTON: That's why there's a six-shot series.
Q: If it's only sustained by the additional shots, why is it then that after a protracted period with no shots, that you wouldn't have to start over? I mean, I don't quite understand why you could pick up where you left off if in fact what you've just told us, in order to sustain a high level, you have to continue.
DR. CLINTON: I can understand your query on that. I'm only saying that we're turning to the professionals, the Advisory Committee for Immunization Practices, who I think come to the conclusion, based on professional judgment, primarily, that because the body has a memory system about that antigen, as soon as we give them another antigen, it's going to jump up quite nicely. And I don't think there's much more than that.
We've also had earlier series, with DPT shortages in the United States and other vaccine shortages, in which having done it this way, the practitioners were satisfied that the results were the ones that they anticipated and the best way to use a limited resource.
Q: What is the shelf life --
ADM. QUIGLEY: Could we have just one more question, please?
Q: What's the shelf live of the vaccine?
DR. CLINTON: What's the shelf life of the vaccine -- (off mike)?
COL. RANDOLPH: The shelf life is three years from the time of the potency test.
Q: And the lot you tested Friday, the Lot 22, how old was that?
COL. RANDOLPH: Lot 22, I believe, was manufactured in 1993. Last -- well, I can't say. We'd have to get that information back as to its last successful potency test.
COL. RANDOLPH: No, that's when it was manufactured.
Q: Just one last one: One assumes this, since you haven't said otherwise, but do six shots give you a lifetime immunization?
DR. CLINTON: No, it does require an annual booster.
Q: It does require --
GEN. WEST: You must have an annual booster with that six-shot primary serious.
DR. CLINTON: That's true of almost every vaccination. There's some booster series.
GEN. WEST: Just to clarify Colonel Randolph's answer, sir, that the vaccine has a production date, and it has a date to expiration. The date to expiration is the last date that it fully passed a potency test, and a safety and a sterility test.
In the case of Lot 22, we did not submit it to FDA. The FDA did not consider it at all, nor did they make a decision that it didn't pass. As the manufacturer was conducting the test, the test became invalid, so it was suspended and not completed. It is a lot that could be tested again, but again, we're going to be sure that we have a handle on the potency assay approach before we do that.
Q: But that invalid result reflects more on the contractor's ability or inability to do the test properly, or does it reflect on the actual vaccine?
GEN. WEST: I don't believe it reflects on the vaccine. There are several things that could come into play here. You have a potency -- you have an assay of agent that you use to challenge with. Sometimes, over a period of time, the spores in that agent can bond together, and when they count the spores and make up a challenge, it can actually be more potent than it's supposed to. There are lots of other variables in the test, but what we need to do is get the company to have several successful trials at running the potency test so that we're confident that everything is being done right there, and then we can put those other lots at risk.
Q: General West, so what's the bottom line here in terms of if there's a national security crisis in the Persian Gulf or Korea in the next six to 10 months, how much more at risk are U.S. troops?
GEN. WEST: We're less at risk than we were in 1998, because we have 455,000 people that have some protection and we have 56,000 that have full protection. We'll be increasing that number in the coming weeks, even with the limited supply, but we're less protected than we want to be. We want to go to a total force program. We're disappointed that we haven't been able to begin that already, and just as soon as we're able to have a supply that we can place full confidence in, we will embark on that next step.
Q: General, what's the lag time between when BioPort starts manufacturing, FDA approval, and you get the boxes over to the troops?
GEN. WEST: Well, there is almost no lag time once they've received approval, because as part of the approval process, they have to produce their first lot, and after that, they can produce it faster than we will need it. But if they go back with their data in August, the lag time will be from then until December, at the earliest, before we would be shipping.
Q: Just from a chemical or a pharmaceutical standpoint, is every shot the same as the one before, or if I'm getting my fourth shot, is it -- is the composition of that vaccine different from the first?
DR. CLINTON: It's all the same thing.
Q: So it's all the same. So it's not --
DR. CLINTON: Six shots, exactly the same.
Q: -- a situation where you have a problem with the dose in shot number four or shot number five --
DR. CLINTON: No. Same quantity, same vaccine.
Q: So the same stuff, okay.
ADM. QUIGLEY: Thank you, gentlemen.
QGeneral -- can I ask two quick? When would you make a contract decision on the second source? This year or next year?
GEN. WEST: Well, hopefully the decision will be made this year. The Commerce Business Daily announcement I believe was for a 90-day response time. So we'll allow that to run and then see how many responders we have. We have had some corporations call that are interested in that. So --
Q: When did that ad go out?
GEN. WEST: I think it was on the 6th of July.
Q: Which companies? Can you be -- some of the big ones or --
GEN. WEST: I don't know.
Q: You mentioned a British company. Do you know how close they are to production?
GEN. WEST: They are, I understand, very close. I can't tell you within days and weeks, but --
Q: Would the U.S. consider using them as a contingency?
GEN. WEST: We couldn't because their vaccine hasn't been approved by and released by FDA. I mean, we could eventually, but probably that would take longer than getting BioPort into new production.
Q: You haven't heard from the Russians to be a second source, have you? (Laughter.)
GEN. WEST: No. They have not responded.
Q: No phone calls?
Q: One last question, general. What's the status on the shots for Secretary Cohen and the top -- the Joint Chiefs and so forth?
GEN. WEST: Secretary Cohen, all members of the Joint Chiefs, the DEFSEC, myself, the secretary for Personnel and Readiness have all had some shots. Some of them have completed them, and some have not. I've had five. I think Mr. DeLeon has either had five or is up for his fifth --
Q: Is everyone going to continue with their shots? Will they all get -- will you continue with the shots for the top leadership, or will they be suspended?
GEN. WEST: That's in that 20 percent. (Laughter.)
Q: The secretary is still deployable. Is that what you're saying? (Laughter.)
ADM. QUIGLEY: Thank you, general, very much.
And we're just going to pause very briefly here for the rest of the brief. But if -- questions of other subjects. But I have no announcements today, so I'll be pleased to take your questions. Charlie.
Q: What's the status of the analysis of the -- last week's missile shot?
ADM. QUIGLEY: We are no further in the analysis of our data today than we were in the wee early morning hours of Saturday. We put a little bit more out about noon on Sunday -- at 12:30, I guess it was, on Sunday -- that was actually a little bit more detail -- I'm sorry, Saturday, Saturday, about midday on Saturday. But it was really a clarification of what we had initially looked at immediately after the shot.
The stages, if you will, for this are about 48 hours after the shot, then a week, then two weeks, and then about 30 days. So we have said, to have meaningful analysis of the shot, it would still be in the two- to three-week time frame. We still think that looks pretty good. We know what happened. We just don't know -- you know, the exact sequence of events.
Q: Do you know how far down-range the kill vehicle got? And also, is it recoverable, and is it reusable?
ADM. QUIGLEY: No, it's not. The answer to the second part is no, it is not.
I guess the answer to the first, without getting a precise answer, is not very far. It was launched from Kwajalein, a successful launch sequence. But then in the very early stages of the trajectory -- you remember the chart? Or maybe -- and I don't remember if you were here -- the chart had that yellow colored section. And in that yellow colored section of the shot sequence was where the failure occurred. And that was a fourth, maybe, of the way through the trajectory. So not -- very early in the sequence of the flight.
Q: During the briefing, General Kadish had said that he would be getting updates, about every eight hours or so, about the progress of the work. Is there any raw data that you can share with us on the latest of those eight-hour updates? Anything?
ADM. QUIGLEY: Well, there was a four-hour and then an eight-, and then we jumped to a 48-, and then it was a week and two. And so we are past that initial spate of four and eight and 48, and we're into the next. We are not going to be "piece-mealing" the information. We are going to wait now until we have our analysis well in hand and we really do understand what's happened.
Q: Does the secretary still --
Q: So we can expect the next --
ADM. QUIGLEY: Go ahead, Charlie.
Q: Does the secretary still fully intend to make a recommendation to the White House on this before the scheduled shot in October, or is there some question about whether that will be done?
ADM. QUIGLEY: No. The secretary on the trip has said that he intends to make his recommendation to the president within three to four weeks.
Q: We can expect another update next Monday, then?
ADM. QUIGLEY: I don't know. They'll share information, as they have confidence in the analysis, but with no particular schedule. Next Monday puts it about 10 days after the shot. We have said two weeks. I won't make any promises on Monday.
Q: Now you said -- the first was a few hours and then one week?
ADM. QUIGLEY: There was of course that initial -- (snaps fingers) -- you know, minutes after the shot, then about four hours, then eight hours, then 48 hours, and then more analysis in hand at about the one-week, two-week and 30-day point.
Q: So why wouldn't we get a briefing at one week?
ADM. QUIGLEY: Because we're not going to release half-baked data. We want to make sure that we understand before we make any definitive statements as to cause.
Q: Yeah, but, Admiral, you -- I mean, presumably something is going on over this period, there is some analysis going on; right? I mean, it's just that you're not going to tell us?
ADM. QUIGLEY: An awful lot of analysis going on.
Q: Or you're not getting a report to relay to us?
ADM. QUIGLEY: I can only repeat what I said. We'll not release half-baked analysis. We're going to have confidence in the analysis, that we know what it says and that we can explain it to you and others. And I don't anticipate anything to be released before we have confidence in what it is we're seeing.
Q: But I just didn't understand the one week. I mean, after one week, you're going to get something but you're not going to tell us?
ADM. QUIGLEY: That's correct. There is an internal analysis call and a test-gathering plan by the Ballistic Missile Defense Organization on the time gates that I mentioned before. We will not necessarily share those publicly. Much of it is classified data. But we fully understand the desire to understand publicly what went on. We will share that, but only when we have confidence that we've got it right.
Q: Craig, you told us last week, at the briefing on Thursday, that you would let us know immediately when you knew that there had been a hit or had not been a hit. Why was there a delay of about 30 minutes on that on -- I mean how was that --
ADM. QUIGLEY: Well, because we expected -- yeah, absolutely. No, I understand your question. Perfectly fair.
We expected there to be, as I described several times from here, the video link -- okay? -- of a clear picture, an image. And that would be almost self-evident, Charlie, as to whether or not you would see that bright flash, as you did in two shots prior, when you had an intercept and a collision in space.
We did not get the video link, and it was a struggle within the Ballistic Missile Defense Organization to understand what was happening. Eventually there was no video link, of course, so you had to go back to a secondary source, which is the radar data, and make sure you understood what was happening to you before we announced that we had indeed failed to do the intercept.
Q: So you didn't know immediately that there was not a separation?
ADM. QUIGLEY: No. No. And that was a back-up system. You had no video. We were expecting to see video. There was no video, and it was like "what's happening?" And then we had to fully understand what was happening, and then -- that's why the delay. We really expected it to be a visual, instantaneous. It was either going to be a fly-by or an intercept.
Q: There wasn't any telemetry? I mean there wasn't any kind of signal coming back? I would think something as routine as a separation in a missile launch you'd have telemetry that would be telling you --
ADM. QUIGLEY: We had radar imagery and we had other means. But the one we were focusing on for the instantaneous feedback was the visual, and that never materialized. So we had to make sure that we knew what we had before we would announce exactly what happened.
Q: Craig, I still don't understand, because you wouldn't have a visual unless you had an intercept. If you had a fly-by, you wouldn't have any visual. So you're saying, when you say, "We did not have a video link," that something went down with your video link, or you just didn't have a picture because you didn't have an intercept?
ADM. QUIGLEY: We didn't have a picture because we didn't have an intercept.
Q: Not to belabor this, but wouldn't you need to recover that in order to get to the root cause of why it didn't separate?
ADM. QUIGLEY: Not necessarily. We want to take a look at the data that our sensors and systems on hand would have, first, and see what they tell us. Recovering something that small at that water depth is an extraordinarily difficult and expensive undertaking, and if we can get data that will explain to us clearly why didn't that particular step in the process take place, that's a better way to go.
Q: Craig, is it possible that the test scheduled for the October-November time frame could be accelerated to, say, the August- September time frame, to squeeze in another test before the president has to make that decision?
ADM. QUIGLEY: We are currently making no such plans to do that.
Q: Is it just not -- is it just that you don't plan to do it, or is it -- are there technical limitations, that that really can't be done?
ADM. QUIGLEY: Both. The kill vehicle, of course, that we have been using for the test is a prototype. There is another one still being assembled to match that October-November date for the next scheduled test, Flight Test 6. And to accelerate that at this point would be an extraordinarily difficult, very high-risk sort of a circumstance, and for those reasons, we are just not looking at it as a feasible alternative.
Q: You don't have any other kill vehicles already --
ADM. QUIGLEY: No. No. Each is individually built one shot at a time, Chris, at this point.
Q: We were told at the CIA today, this morning, the foreign intelligence -- National Foreign Intelligence Board -- was supposed to meet to review and, presumably, approve the latest classified national intelligence estimate that might include some sort of an update on the missile threat that the United States faces. Can you tell us anything about that and whether Secretary Cohen will be receiving that report, and will he be factoring into to his recommendation? Or can you tell us anything about whether the intelligence estimate of the threat has changed at all?
ADM. QUIGLEY: I'm afraid I can't go into that from here, Jamie. The CIA does have the lead, as you indicated, and I think that is still a work in progress, so I'll have to defer to them on that.
Q: But you confirmed --
Q: You told us last week that the secretary's recommendation would be based on cost and technology. You said the threat and other factors wouldn't enter into that.
ADM. QUIGLEY: Yeah, well, I don't necessarily link the two questions. I kind of took your question, Jamie, as a stand-alone on the National Intelligence --
Q: (Off mike) -- to Jamie's question, I just said, last week, you said that the secretary --
ADM. QUIGLEY: No, those would be the criteria that the secretary will make his recommendation to the president, will be the technical feasibility and the cost.
Q: On Jamie's question, do you know that that meeting took place?
ADM. QUIGLEY: No, I don't. I'd refer you to ICA.
Q: Craig, what actually worked well or performed to standard in the test? What failed was clearly not part of the endemic NMD technology here. There's the radar, the X-band radar, these in-flight update -- (inaudible) -- the warhead. Is there any indication that stuff worked okay?
ADM. QUIGLEY: Well, I can't give you a very comprehensive answer on that, Tony. I remember General Kadish or Dr. Gansler -- I think it was Dr. Gansler, immediately after the test, early Saturday morning, said that the initial readings back from the X-band radar system were very encouraging. But again, this was a pretty abbreviated test, after all was said and done. I have not heard any other specifics on that. And again, we didn't get to the point where the most complex elements of the system, where we really wanted to get the data and understand how it would work, we just never got to that point because of this relatively simplistic failure somewhere back downstream.
Q: Craig, as you review the data from the flight itself, are you also going over with the manufacturer its quality control measures and how it prepares -- you know, checks everything out up to the launch?
ADM. CRAIG: That is certainly an ongoing effort. But I think that we'll probably wait until the analysis is at hand so that we can have a little bit clearer understanding of the cause of failure for that portion of the launch. Quality control with the various manufacturers of the components is always an issue, but in the particulars here, I think we're going to be satisfied at this point to take a look at the data, study it very carefully and see where it leads us.
Q: And if you do find something you believe may have been related to quality control or something along those lines, you would go back to the manufacturer and say, "Can you explain to us how this situation occurred or who was in charge of checking this out" or something?
ADM. CRAIG: We'll try to understand it as best we can and follow every path till we can try to understand it as best we can.
Q: Thank you.
ADM. CRAIG: Thank you.
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