Guest guest Posted March 13, 1999 Report Share Posted March 13, 1999 DOD Briefing on Medical Force Protection, May 22, 1998 Sometimes it is worthwhile to look back at what was said, and unsaid...are they getting ready to develop lots of new vaccines for civilians too? >Q: What can you tell us about any side effects that have been suffered so >far? There have been >some sort of anecdotal reports of flu-like symptoms, some vomiting. > >A: Near as we can tell, we have been unable to relate any but local >soreness kinds of side effects to >the vaccine itself. Certainly there have been people who have received the >vaccine who have a day >or two later come down with a cold or sore throat. That kind of thing, >perhaps even gastrointestinal >symptoms. Nothing that we can relate to the vaccine. > >Certainly, at the time of administration or in the few hours following >that, we have had no serious >side effects. No anaphylaxis, no other kinds of reactions that one might >anticipate. > >Remember, this is a killed bacteria vaccine. It's not a live vaccine, so >you would expect fewer side >effects than, for example, with the typhoid vaccine that gives you a sore >arm and fever the next day, >that sort of thing. > >Q: Could you tell us some of the progress of MBPI and the anthrax facility. >It's shut down at the >moment for renovation. > >A: It is. > >Q: Can you tell us how much DoD is contributing to that renovation, and can >you tell us the future >of the plant, because it's up for sale as I Understand. > >A: Sure, I can cover both of those. > >DoD is paying for the renovation because the fermentation line, or the >production line I guess is a >better term for the public. The production line actually belongs to >Department of Defense. The >equipment there belongs to us. Therefore, we are paying for the renovation >of that particular >equipment. > >The easiest way to explain why I was doing the renovation, and I think that >needs to be clear on >why I was doing it because there's been a lot in the press with regard to >it. We put in the vast >majority of that equipment during or shortly after the Persian Gulf War. To >build the DoD stockpile >I've been running that facility now almost continuously since the end of >the Gulf War to produce the >DoD stockpile. When you look at the amount of time that's gone by, you're >talking six or seven >years that I've had most of those fermenters in production. > >We had reached the DoD stockpile requirement. It made prudent sense to at >that particular time, >having reached the stockpile, to in fact renovate the facility. So we paid >for that renovation. > >Q: How much did it cost? > >A: The renovation's going to cost about $1.8 million, in that neighborhood. >There are some other >figures out there, and that is with regard to something called >refacilitization. To meet the new overall >DoD requirement, because of the number of people we are now going to be >immunizing, I have to >increase the capability at that particular facility. In increasing that >capability, I'm going to double >what they currently can produce. To do that, I will build another >production line, same number of >fermenters, have to put in the associated ancillary equipment. We plan on >doing that between now >and 2004 to meet the DoD requirement. That will come in somewhere around >$15 million to do >that. > >That was the first part of the question. What was the second half of the >question? > >Q: The second half was the future of MBPI, I heard that it was up for sale? > >A: It is in fact... > >Q: ...DoD declined to buy it, was offered it but declined to buy it. > >A: Actually, DoD was not offered to buy it. It is currently under >consideration by the state and the >state is very, very close to making the decision as to who the eventual >owner of MBPI will be. And >I mean very close. > >Q: You talk about a stockpile. I gather that that's disbursed around the >country and around the >world for use as needed? Is that the idea? How are you managing that? And >if there were to be an >attack in the United States, is that stockpile subject to being tapped for >civilian use? > >A: Stockpile requirements, when you work with the FDA, the stockpile is >actually maintained at >Michigan Biologic Products Institute. In a normal process, if you're >producing vaccines or if you're >producing antibiotics, you produce them, they're labeled, they're shipped, >they're used, and they're >usually used before their shelf life. If you're going to stockpile >something, it's going to have to be >tested periodically. > >The FDA asks and requires that if you're going to stockpile it, stockpile >it at the manufacturer who >produced it who in fact can replicate the testing criteria that they use >for original release. So our >doses are stored at MBPI. > >When there's a requirement, as we have now, to immunize portions of the >force, we will then ship >from Michigan Biologic Products Institute to the appropriate location so >that they can administer the >vaccine. > >Currently that vaccine and the stockpile that we have was built for >Department of Defense to handle >a contingency for our soldiers. Has it been used? Has Department of Defense >in fact used some of >the vaccines outside of Department of Defense? Yes. > >Q: So where is supplemental testing being done? Is it being done at the >MBPI facility or are lots >going somewhere else? > >A: Supplemental testing is being done at the MBPI facility, but we have an >independent oversight of >that particular testing that's currently being done. We did that on purpose >because the manufacturer >has to do the supplemental testing. We've asked a team, in fact an >organization called MitreTek to >oversee the testing, to monitor the testing, and then provide us a report >as to the validity of the >testing that's being done. So far we have received back from MitreTek what >I will refer to as lot >release, but which really is approval of the supplemental testing that was >done by MBPI on enough >doses so that we in fact can start the beginning of this plan. We will >finish up supplemental testing by >about November of this year. > >Q: There are six shots in this course, is that right? > >A: Yes. The full course is at 0, 2, 4 weeks, 6 months, 12 months, and 18 >months with yearly >boosters thereafter. The FDA requires that the full six shots be given to >assure full protection, >though there is substantial protection with less than the full series. > >Q: And it's strictly a vaccine. In other words, once somebody's exposed, >this stuff is no good to >them if they have already been getting shots. It's not a remedy, it's not >an antidote. > >A: Oh, I see what you're saying. No, No. It is strictly a vaccine to afford >protection before >exposure. > >Q: Are you happy to continue to do business with them? I'm thinking of the >FDA report, in >particular the one of February of this year, which (inaudible). Real doubts >about their quality control. > >A: Yes, we're happy to do business with MBPI. Second, on the FDA >inspection, the way I try and >classify that, if you've ever seen a Department of the Army Inspector >General Report of an >organization, the 483s which is what you're referring to, are basically the >hand sheets that folks do >on the site. They're the ones, they list all the good, all the bad, and go >into some excruciating detail >for the individual operators who are there. > >What's important is what comes from the FDA and what they have to say about >the facility. That >letter, which I think many of you have seen, paints a very interesting >picture. The first is the strategic >plan that both MBPI and Department of Defense worked on. As they have >stated, they consider >that to be a success. It's doing exactly what it needs to do to keep MBPI >in operation and also to >make it a success in compliance with FDA requirements. Those are key to us, >that letter. The 483? >Many of the comments that are in the 483 are actually questions that are >listed in there specifically >with regard to doing stockpiling. > >Of interest to note, as I mentioned before, usually you produce, you label, >you ship and it's >consumed. Stockpiling is not a normal thing that's done. So a number of the >pieces you saw there >were questions with regard to that. And quite frankly, both the FDA and the >Department of Defense >are building up a knowledge base on how we do stockpiling of fairly >significant quantities of >vaccines. > >Q: It was, just to be sure, it was more than questions, obviously. I mean, >that had, over here on >page nine, they had questions about the contamination of sublots, and then >the amalgamation of >those contaminated sublots into full lots. That was more than a question, >that was a statement. That >was what they found. > >A: In some of the cases what they looked at and part of what they were >looking for was paperwork >that was involved. In one case which is directly referenced in there, but >you can't tell from looking at >it, the individual who did the testing actually contaminated the outside of >it and it was skin >contamination from him. When it was rested, and the paperwork wasn't shown >to the FDA, it was >shown later in that when it's off of quarantine. What it showed was in fact >the individual was the one >that caused the problem, and there was no problem with that particular lot. > >Testing and retesting, paperwork and validity of paperwork are key issues. >In many of those they >didn't see the paperwork. The paperwork has to go back to the FDA for >revalidation of what's >there. We, in fact, have started through that process and so has MBPI. > >A: I would add because, I think, the points that you raise are good ones, >and even with the >clarifications I think it raises some serious questions. Had Secretary >Cohen not insisted on having >that supplemental testing, I think we would have a credibility problem that >we don't because of the >testing. We know that the vaccine that we're administering is not only FDA >approved, but has had >the supplemental testing for safety, for potency, for purity, for >stability, and so we've really been >very fortunate in having that assurance. > >Q: You mentioned that it takes 18 months to get through the whole course, >and you've got about >40,000 troops so far who are in this course of treatment. Are you at a >point yet where you're able >to get ahead of the curve, in Southwest Asia, where forces that might be >deploying six months or a >year from now have begun to get this vaccine so they'll be more fully >immunized? Or are you still >catching up with folks who are already there and already in their exposure, >if you will? > >A: Almost every one who is there... Well, everyone who is there who is >within the window of time >where we give it has begun their immunizations. We have in some cases, for >example in Germany, >actually begun the immunizations on those who were going. That is we >extended it from just doing >the immunizations to those already in theater to groups of those who were >scheduled to go into >theater. The Germany experience, again, was a success as far as us being >able to do that. There are >other places, too, where that's happening. > >It's still limited, though, to those going into the theater, or it was now >until the Secretary made his >decision and signed the memo authorizing it for the full force. > >We now have about 90 days to start up the program, and so, sometime in >August we'll begin >phasing that in to the rest of the force, not just those going to the Gulf. >So I guess that's kind of a >long answer to your question, but yeah, we are ahead of it a bit. > >Q: Anthrax is the one that you hear about a lot. Are there other biological >agents that you guys are >thinking about... > >A: Sure, absolutely. There's plague, there's Q-Fever, there's Tularemia, >there's all sorts of >botulinum, other agents that we worry about. Part of the problem is that we >don't have fully >approved, well developed vaccines from them, so we have programs in place >to try to anticipate >what kind of threat there is. We sort of know that from intelligence >sources. And then to target the >development of vaccines or other protective measures. > >Q: When they come on-line, you'll start vaccinating folks? > >A: I would assume so. That decision hasn't been made and wouldn't be until >it goes through all of >the FDA testing and so forth and so on. > >Q: You don't have vaccines for those, you also don't have antidotes >available for most of them. In >other words, troops are out there now, if these weapons were to be used, >are essentially >defenseless against them. > >A: Most of the organisms that I've mentioned have some kind... Well, first >of all, let me say that >against chemical or biologic, you have to have an integrated program of >detection, protection, and >that's individual protection -- the MOPP gear, the collective protection in >the tight tents and all of >that sort of thing. Most are responsive to antibiotics at some level or >another. Not everything, but >most are. There is for botulinum an anti-toxin and so forth. Actually a lot >of the things have some >vaccines in certain levels of development. Plague, I mentioned actually, >does have an FDA >approved vaccine, and most of the rest of them, something is being done to >try to develop that. > >Q: Anthrax it's 99 out of 100 will die. Do they have the same sort of >potency? > >A: It varies dramatically as to how it's used, how it's disbursed. They're >all very, very different. > >Q: Did you have any plans to start vaccinating against the plague since a >vaccine available? > >A: No, a decision has not been made, and there's a variety of reasons for >that. It has to do with the >assessment of threat, it has to do with the efficacy of the vaccine. > >I believe there are some nations who do vaccinate, although I'm not even >certain of that. > >Q: A question on the tracking system. Where are the records being held on >the immunizations >themselves? For example, on the ships -- the STENNIS, the INDEPENDENCE -- >are records >kept on ship for the immunizations...? > >A: Three ways. Individual keeps their yellow shot record. Those of you in >the military remember >that with some nostalgia, no doubt, that you carry around, keep with your >passport, all of that kind >of thing. The second one is, it's in their permanent medical record that's >maintained at their medical >treatment facility whether it's on board ship or back at Fort or >wherever. The third thing is, >it goes into an automated system. The three services have their own >specific individual systems >which then collectively store the information in DEERS, the Defense >Eligibility Enrollment System. >And then, if a Marine gets a shot at an Army facility, that will go into >DEERS and when the Marine >is put on board ship, then the ship system can pull down that Marine's name >by social security >number or by name or by unit from DEERS and say aha, needs another >immunization. So it's all >centrally stored that way. > >Q: There been no problems so far with that tracking system, as such? > >A: Yeah, there have been some problems. Largely it's worked well with the >usual kind of things. If >you go out in the field, or if a ship is not in contact with the satellite >that can upload, you have to >batch the things, and it takes a few days sometimes for it to get into that >system. But so far -- and >we've looked at this, and we track it very, very carefully -- everyone who >has gotten their >immunization is in the system and we can look at it in near, not quite >real, but near real time. > >Q: Some months ago there was a brief here and we were shown what looked >like a dog tag that >was supposed to be electronically implemented. Is that where it is? Are >those being used now? > >A: No, not yet. These are still in prototype testing. Actually, all of the >commanders in chief of the >various CINCdoms came in with their requirements for what data goes on >this. Based on that we >put a proposal out requesting bids, and five companies bid on doing further >development on this. >We're picking one right now. We intend to begin field testing -- we've done >the prototype. Field >testing on that this summer and deploy it hopefully summer of '99. > >Q: Are you going to stick with a single manufacturer for anthrax? There was >talk of cranking up >(inaudible) at one point. > >A: Yes. Currently, unless someone else wants to get involved in production >of anthrax vaccine. It's >very, very expensive. Anthrax, because of the nature of anthrax, requires >some very specialized >facilities. If someone else were to start up business, obviously we would >be interested. But it would >take five to seven years for them to build a facility, then to have that >facility validated by the FDA. >It's a very long process to build one. > >Q: For each soldier/sailor, now much does this whole course of shots cost? > >A: Under the current vaccine, I'm paying $3.67 a dose, so multiply that >times six. Plus or minus $20 >for the full series. > >Q: Maybe you've already answered, talked about this, but you were obviously >the American >government's expert in making these vaccines and administering them. If we >wanted to go to the >civilian population as some have talked about, have you been approached on >that question? Do you >have any role in that? > >A: No. We've not been approached. There's been some very preliminary people >asking questions >about the joint vaccine acquisition program, would it be capable of >assuming a larger role and a >larger mission. It's a prime systems contract. We would have to take a look >at it. We have to know >what the requirement is going to be. It was set up to meet a DoD >requirement which in the big >scheme of things is very small when we start talking about our whole >nation. So there would be a >number of things that we would have to look at, but no, there's been no >direct... > >Q: It would have to be many, many times as big to... > >A: To give you an idea, though, just to reflect. We have between six and >seven million doses of >anthrax available to us. That sounds like a large number, and sounds like a >large volume. > >The cold room storage facility that I have those doses in, in ten dose >vials, is only twice as big as this >podium right here. When you think about it, it's a liquid, and we're >talking about five mil per shot... >We're not talking about a tremendous amount of vaccine here. In a >pharmaceutical business, seven >million doses is not a lot. In fact there's not a lot of profit to be made >in seven million doses. > >Q: In the event of an anthrax attack on the civilian population would there >be any purpose in giving >people the vaccine in short notice? Would it have any effect at all over a >matter of a few days? > >A: It may well, and there's ongoing research to try to answer the question >as to how late just before >or even after exposure. Will this have value, what's its value in >combination with certain antibiotics. >Anthrax, unless it's resistant, is very responsive to penicillin, for >example, tetracycline, cyprofloxicin. >Some information that some of the anthrax that might have been weaponized >by some nations may >be resistant to antibiotics, though near as we can tell, the vaccine seems >that it would be effective >against various strains of vaccine. I believe we actually talked about that >in a previous briefing. So a >lot of the questions such as that remain, but probably there would be some >value to it. > >Q: Isn't that kind of contingent on medical authorities actually >recognizing the illness as anthrax? > >A: That's why detection is so critical to us, as near real time as possible. > -- Meryl Nass, M.D. Parkview Hospital, Brunswick, Maine 04011 email mnass@... phone (207) 865-0875 fax (207) 865-6975 Quote Link to comment Share on other sites More sharing options...
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