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CDC Telebriefing Transcript

HHS Teleconference On Smallpox Policy

December 14, 2002

AT&T MODERATOR: Ladies and gentlemen, thank you for standing by. Welcome to the CDC/HHS smallpox conference call. At this time, all participants are in a listen-only mode. If you require assistance during the call, please press zero, then star. I would now like to turn the conference over to our host, Mr. Bill Pierce. Please go ahead, sir.

HHS MODERATOR: Good morning. I'm simply going to turn it over to Secretary Tommy G. Thompson.

Mr. Secretary.

SECRETARY THOMPSON: Thank you, Bill, and thanks to Julie, and Tony and Jerry Hauer, and D.A. Henderson, and Bill Winkenwerder for joining with me. Bill Winkenwerder is from the Department of Defense. Everybody else is from Department of Health and Human Services, and we also have Michael Osterholm, a senior adviser, and I thank all of you on the teleconference for joining us this morning, and having us an opportunity to review the decision on smallpox and be able to answer any further questions that you might have.

Before I go on, I'd like to review the basics of the decision.

Under this plan that was announced by the President yesterday, the Department of Health and Human Services is going to be working with state and local governments to form a volunteer smallpox response which will consist of teams who can provide critical services to their fellow Americans in the event of a smallpox attack, and be able to ensure the smallpox response teams will be able to mobilize immediately in an emergency, the health care workers and other critical personnel are going to be asked and we're going to recommend to volunteer to receive the smallpox vaccine.

The Federal Government is not recommending vaccination, as all of you know from the press, for the general public.

There may be some members, however, of the general public who insist on being vaccinated now. Our public health agencies will work to accommodate them, but that is not--and I want to restate and underscore, once again, that that is not the recommendation of the President or of the Department of Health and Human Services at this time.

The Department of Defense and State Department personnel have always been involved in this decision and have worked very closely with us, and the President, as you know, also announced that the Department of Defense will vaccinate, and they've already started, certain military and civilian personnel who are maybe deployed in high-threat areas, and some United States personnel assigned to certain overseas embassies are also being offered the opportunity to be vaccinated.

With the announcement of this decision, it is now our job, in the Department of Health and Human Services, to implement the President's policy.

The key to our success of course is education as well as transmitting of information to you, the press, and you, the press, transmitting to the general public.

We have been working very closely with state public health offices. We've already had teleconferences with all the state public health officers as well as all the governors of the United States.

Key public health and medical professorial associations are also being contacted as we speak, and have been spoken to or will be spoken to in the future.

We are also contacting other state government offices such as homeland security to provide education and planning help on all aspects of carrying out this policy.

We're going to continue to do this. In fact, we'll intensify our efforts in the coming days, weeks, and months. We know that there's going to be some bumps in the road. Some states are going to take longer than others to carry out the vaccination plan. We still have to approve their plans. We expect to do so in the next few days. We'll continue to work with them even as they go forward. To give you an update, we have 49 out of the 50 states that have submitted plans, and at present count, 439,584 individuals have been designated as people that should receive the vaccination.

Now this is a voluntary plan and all 439,584 will not receive it because some of them will turn it down; but hopefully we will get a good percentage of that, and in those cases where we do not have enough, we will be expanding the group to have other individuals designated to receive the vaccination.

The territories, including Puerto Rico, have not at this point in time submitted their plans, and hopefully they'll be doing so very shortly.

We still have to approve their plans but expect to do so, as I've indicated, over the next few days.

This will be a very dynamic process and that is part of the key to its success. We all need to be ready to make changes and adapt to whatever challenges may occur.

Despite the fact we were presented with some bumps along the way, we believe the process is going to be very orderly and safe. As all of you know on this teleconference, we have spent weeks, months, and a lot of extra time making sure that this is going to be an orderly process.

Our highest priority in the next few weeks and months will be working with the states to vaccinate the smallpox response teams and first responders. We do not believe that it will start until after the 24th of January, because that is the date that the immunity portion of the statute, section 304 of the Homeland Security Bill kicks in.

But we will also work to come up with a plan to provide vaccine to those in the in the public who insist on having it, but we, as the President made clear yesterday, are not recommending vaccination for the general public.

We will expect to have a plan how we will do this, late spring or early summer. As a former governor, I can say that states have always been able to step up to the plate and do what needs to be done.

We expect the same in this circumstance and working together we will accomplish our goal of providing protection to our first-line responders as well as the general public because of the vaccination of the first-line responders.

Now Julie Gerberding is on the teleconference, and Julie, I thank you so very much for being with us. She was around the table, the other evening when we had a teleconference like this, a lot of people were, and she has just done an outstanding job at CDC and has done a tremendous job working on this particular project and putting it in order, and I am very proud and appreciative of all the hard work and the effort as well as the ability to get the job done.

So Julie, do you want to bring us up to date on CDC?

DR. GERBERDING: Thank you very much. We certainly appreciate your leadership, Secretary Thompson, and really, the whole team of folks who have worked real hard to put this whole program together.

What I thought I would address in my comments is a little bit more detail on the educational programs that have been underway and now will continue as we have clarification about the smallpox vaccine policy.

We have segmented our target for educational and information programs into several groups. One of the groups that has been especially important is the clinician group, both because we need the clinicians to be able to detect the first case of smallpox or illnesses that look like smallpox, but also now because the clinicians will be important resources for volunteers who are making a decision about whether or not they want to accept the smallpox vaccine.

We have had an ongoing campaign to educate clinicians about smallpox, that we do from CDC in conjunction with experts from a variety of medical professional organizations including the Infectious Disease Society, The Dermatology Society, The Emergency Medicine Society, The Nursing Association, the American Medical Association, and so forth.

These organizations are taking our information and then repackaging it and redeploying it to our individual members and professionals so that it gets widely disseminated throughout the medical community.

In addition, at least 140,000 people have signed on to participate in our educational program called What Every Clinician Needs To Know About Smallpox.

That's available to you via Webcast through our Web cite at CDC. Now we are also moving out into the medical community through videos and CD-ROMs, the educational program that we put out by satellite broadcast last week, which was a very comprehensive two-day program with several modules that target things like how to diagnose an adverse smallpox vaccine event, how to treat it, where to go for help, and how to administer the vaccine and who should and should not receive it.

So those information materials are currently being reproduced. We're making 150,000 copies of those materials this week and the CD-ROM will hopefully be going out some time later this month.

So we're undergoing a fairly extensive campaign to educate clinicians and that is on top of our ordinary procedures for getting information which includes our health alert networking system, our secure FEX program, as well as MMWR and other publications from CDC.

Another very important group now of course are the volunteers or the people who will be asked to participate on the response teams, and then later the folks in the health care and emergency response groups.

Later this week, possibly on Thursday, but I don't want to give you a firm date yet because we still haven't secured the satellite broadcast time, we will be conducting a one-hour program for volunteers with straight talk from a physician about how to assess the risks and benefits of the vaccine and also exactly what will happen if they get the vaccine and what will they need to know about their family's risk and how to care for the wounds that occur, so that they don't spread the infection to others.

So that is a program we will be advertising, probably on Monday when we're able to know for sure the satellite broadcast time.

Finally, and just very briefly, our continued communication with the media. We will certainly be providing updated advisories, briefings as often as we have new information or as often as new information is needed, and the ongoing support of the content material for HHS and CDC and the other federal agencies through out Web site, and the linkages to Health and Human Services and other places.

Finally, we operate a 24-hour-a-day, seven day a week public information hotline that the people in the community can access in either English and Spanish and we're hoping to expand that into additional languages over the next several weeks. * [Clarification: The public information hotline is available Monday through Friday from 8:00 AM - 11:00PM ET, and Saturday and Sunday, 10:00AM - 8:00 PM ET. At other times, callers may listen to recorded messages about public health topics. The numbers are English: 888-246-2675; Espaρol: 888-246-2857; and TTY: 866-874-2646. CDC will be assessing what the public needs are regarding service in additional languages.]

So let me just say one final thing and that is a solid vote of appreciation for the entire public health community. I think as Secretary Thompson has said, the states have stepped up to the plate in the past. They are certainly stepping up to the plate now and we just have enormous confidence that as we take appropriate steps to implement this program, knowing that safety has to be our highest priority, the states will get the job done right.


DR. FAUCI: Yes, I am, Mr. Secretary.

SECRETARY THOMPSON: Tony, how are you, my friend?

DR. FAUCI: Thank you, sir. How are you?

SECRETARY THOMPSON: Do you want to make a few questions, then we'll open it up for questions? Or unless D.A. Henderson's on. He can make some.

DR. FAUCI: I'd be happy to just very quickly reiterate some of the points that we made yesterday at the President's announcement. Julie has again underscored the important of education as part of education is to make sure people understand what we're dealing with, and particularly even since yesterday, I've gotten several questions from people who are quite knowledge and really wanted to get some details about what the vaccine is, and very briefly, we're talking about a licensed Dryvax which is a traditional classical smallpox vaccine that we have used for decades and decades in this country and in other countries, an important vaccine that is highly effective.

That's very important, to make that point. We have 15 million doses in store. We have reexamined those doses in clinical trials and we have shown that the vaccine has maintained its potency even when we diluted out considerably.

So we have no concern that in the couple of decades plus of storage that this vaccine has in fact lost its potency, because it has not.

We will be using that undiluted Dryvax vaccine. Also very key to part of the educational program is for people to realize that this vaccine, as effective as it is, has rare but nonetheless potentially serious adverse events, including 14 to 52 life-threatening adverse events and from 49 to over 900 serious but not life-threatening events, and also one to two people would die per million people, if the historical component of how this vaccine has acted holds true today.

So we need to be expecting that, and not only the smallpox response teams in the voluntary component of the program, but also that underscores the point that the President and Secretary Thompson made yesterday and this morning, that although we have an orderly program to go from the up to a half a million to the then up to ten million individuals who constitute the first responders, it is clear that people [inaudible] the toxicity. This holds true for those people who, despite the fact that we don't recommend that the general population get it, if they do insist that they want to get the vaccine during 2003 or in 2004, they really need to appreciate these toxicities.

If [inaudible] programs will be made available, preferably later on in the spring and summer [inaudible] us the time, and Julie and her team, and the state and local health authorities, to get the primary program underway, namely the smallpox response teams and the first responders.


MR. HENDERSON: Yes. I'm here, Mr. Secretary.


MR. HENDERSON: Doing well; thanks. I'd just like to say a word here, to say that I think it's been--

SECRETARY THOMPSON: D.A., can you talk up a little bit.

MR. HENDERSON: Okay. Can you hear me better now?



SECRETARY THOMPSON: I want to hear that melodious voice of yours, sir.

MR. HENDERSON: Thank you, sir.

I think it's important to stress that we do believe this vaccination program is important. We realize that the risk of smallpox being introduced is low, it continues to be low, but that that problem is that if smallpox were released, it could be catastrophic, and thus I think thee advisory committee on immunization practices assessed this, as various professional groups have assessed it, as the administration has looked at it, as the President has looked at it, I think the unanimity of opinion, that it is important that we have these people who are most likely to care for patients, should the smallpox be released, to have them vaccinated, and so we're solidly behind this and advising all of those who are so designated to be vaccinated, and we hope that the vaccination is never challenged. But these are difficult times for us all.

SECRETARY THOMPSON: Thank you very much, D.A.

Jerry, did you want to say anything before we open it up for the press?

MR. HAUER: No, sir. I think in the interest of time, I think everything's been covered well, so I'll turn it back to you and be available for questions.

SECRETARY THOMPSON: All right. Press, all of the people that you've heard from now are at different venues so just direct your question to whoever you want to answer it and they'll be more than happy and pleased to be able to do so. Open it up for the press.

AT&T MODERATOR: Ladies and gentlemen, if you wish to ask a question, please press one on your touchtone phone. You will hear a tone indicating you've been placed in queue. If you pressed one prior to this announcement, we ask that you do so again at this time. You may remove yourself from queue at any time by pressing the pound key.

If you're using a speaker-phone, please pick up your handset before pressing the numbers. Once again, if you have a question please press one at this time. One moment for the first question.

And our first question comes from the line of Denise Grady [ph] with the New York Times. Please go ahead.

QUESTION: Hi. This would be for anyone who can answer it, please.

We have had some questions from readers about how long the vaccinia can persist in clothing. People are concerned about vaccinated people transmitting the virus to others through clothing. Can you give us an answer on that, please. Thank you.

MR. HENDERSON: This is D.A. Let me take a shot at that. We do know that--


MR. HENDERSON: Okay. We do know that smallpox itself can be transmitted sometimes by people who, from blankets, and to people who are washing the blanket. It can survive on clothing but it probably is only a fairly short period of time.

We have a couple of instances where people were wearing soccer jerseys and transferred it to somebody else and they did get infected.

So that it's probably on the order I would say of not more than a day or two days, but if clothing is soiled, I would strongly advise that it be washed and that one take care if there's material there, to get it washed and not transfer it or let it sit around.

AT&T MODERATOR: Thank you, and our next question comes from the line of Tom Watkins from CNN. Please go ahead.

QUESTION: This is for anybody too. What recommendation are you making to first responders who have spouses or other people who are close to them who are immunocompromised. Should those first responders be vaccinated?

DR. GERBERDING: This is Julie. I think I can address that . We've gotten guidance on this also from the advisory committee on immunization practices, and the bottom line is that if you have a household contact that is in a group that has one of the risk factors for immunization you should not be immunized.

QUESTION: Thank you.

AT&T MODERATOR: Our next question comes from the line of Christie Speag [ph] with CNN.

QUESTION: Mr. Secretary, I'm wondering which overseas embassies are you offering the vaccine to? And I have a second question, is which state hasn't submitted their plan yet?

SECRETARY THOMPSON: The overseas embassies I'm not at liberty to tell you. That is done by the State Department and as of right now they have contacted those embassies and you would have to get that information, if it is given out at all, directly from the Department of State.

We just make the vaccine available to those embassies when they tell us to and through the Department of State.

Secondly, there's one state that has not filed their report as of yet, is Colorado.

QUESTION: Okay; thank you.

AT&T MODERATOR: Our next question comes from the line of Mary McKenna with the Atlanta Journal-Constitution. Please go ahead.

QUESTION: Hi; thanks for doing this briefing.

I'll direct this question broadly. According to the plans, according to what states have said about the plans they've filed with the CDC about pre-event vaccination, the numbers of people who are going to be vaccinated in Phase I in each state vary widely, from 500 in Georgia to about 70,000 in California.

Do you have any concerns that when Phase I is completed, given that you have a moderate amount of uptake on that, that you will have a pathwork of protection across the country that will vary from state to state?

DR. GERBERDING: This is Julie Gerberding at CDC, and I think first of all, we anticipated that states would have very variable plans for many good reasons, and whatever immunization occurs, we are certainly going to be more prepared than we are right now.

We are in the process of reviewing the plans, and I actually met with state health officials in Georgia, and what they presented to us as their initial plan is how they want to get started, but they already acknowledge that they may be expanding their program to include a broader catchment area as they progress through the initial immunization phases.

I think we have got a variety of health department delivery systems and a variety of public health organizations, organizational structure in the fifty states. So the states have really looked at what their particular issues are and come up with I think very robust and flexible plans for getting the job done. We think it's going to work.

DR. OSTERHOLM [ph]: This is Mike Osterholm. If I could just add to that because I've actually been working with many of the states over the last two weeks looking at these plans very carefully and I'd like to reiterate something that Julie said, that in fact these plans really are living documents, and that as further discussions are occurring with the health department delivery systems, often unique to a given geographic area within a state, let alone between states, means that the numbers may change some.

We're not talking about orders of magnitude, but that people are I think in the low states realizing that they may need or want more people to be vaccinated.

Some of the states that have a larger number, we're finding that they're looking at, possibly won't be that high. And so I think that one of the things we have to be careful about is locking in a number right now.

The other piece I would add is that as all reporters on the line are well aware, please be careful about using absolute numbers for states as obviously the populations vary greatly between states, and, in the end, we're going to be looking at this as more of a per population basis.

Finally, I just would like to say that, as Julie pointed out, in some states they are using slightly different models which may very well be the ideal, meaning that the health care delivery system for one state is dominated by one provider.

In those situations, they may need fewer people because more patients will automatically brought to a single catchment, a hospital, or some type of evaluation process, and there will be fewer people that will be needed there to care for those patients than in a situation where they may be in many different locations, and each state really is going to be required to evaluate that, and I think that's happening and I'm quite confident that these numbers look, I think, very, very good for each state.

QUESTION: May I ask a follow-up? Am I on the line still?


QUESTION: Given what you just said, Dr. Osterholm, do you envision, all of you broadly envision that you will end up asking states to vaccinate based on some rate, that so many responders per thousand or 100,000 in the population in Phase I, or a rate for an urban area and a rate for a rural area?

DR. OSTERHOLM: I would never suggest that we're going to do it on a per rate. I think, again, each state, and in many cases local health departments together with the health care delivery system, are in a much better position to know what they need to provide capacity and that will just vary by the very nature of health department delivery systems and public health agencies as we know them in this country. So that at this point I think that the real key message is the state and locals are looking at what do they need to reach capacity to respond to this initial attack, both in terms of public health and in health care delivery, and we should expect differences.

We shouldn't find that to be either a problematic situation or should we in any way try to compare apples to apples and oranges to oranges as such and realize that that's what's going to happen. It's going to vary by each state.

AT&T MODERATOR: Our next question comes from the line of Laura Meckler [ph] with Associated Press. Please go ahead.

QUESTION: Thank you. Actually I have a few questions. I think they're for Dr. Gerberding but anybody who has an answer should feel free to jump in. The first is about stage two of the vaccination program. There are some state and local officials who, as I'm sure you know, who are concerned about the timing of that. How quickly will those vaccinations follow the stage one vaccination?

The suggestion yesterday was almost that they're all part of one big initial vaccination program, and they have some concerns both on logistics and about the time to evaluate the program as it goes.

And the second is about the general public's access to vaccine this year.

Typically, when somebody gets the vaccine through a clinical trial, it's a trial that's testing something specific, such as, you know, a diluted vaccine or a revaccination program.

What kind of program are these people going to be in? Are they testing something in particular or are they just, you know, generic clinical trial or--I know you don't have the details on that yet but do you have any thoughts about it?

DR. GERBERDING: Let me just start by saying that the goal here is, as Secretary Thompson has said, is to implement this policy in an orderly fashion. It's a process, not an event, and certainly not a race. So what we want to do is take care of our highest priority which is those emergency response teams that I think you're familiar with and to make sure that the plans that the states have already submitted to accomplish that are satisfactory and, when approved, that we're ready to do that part of the program by the end of January.

We expect the states--most states will be able to finish that in 30 days or so, some may take longer and that's fine. We want people to do it as safely as they need to to gear up and get the job done right. We haven't issued guidance for the expansion into the larger group of health care personnel and first responders.

We will begin working on that in conjunction with the states and that guidance will go out and states will be given a sensible amount of time to expand their plans to incorporate this larger group of people and when we've gotten that process underway and we have enough licensed vaccine to go forward, we can then expand into the larger population.

I think it would be premature at this time to give you an exact date when that would start but obviously we all recognize that the prudent course here is to do it as safely as we can and as expeditiously as is feasible.

DR. FAUCI: Laura, let me just expand on that a bit because you asked about the clinical trials. It's important for people to understand that there are three potential mechanisms where people might get vaccine in the general public, depending upon the timeframe in which they essentially insist that they want it. Totally underscoring what Julie said, we would hope that that does not occur until the first important component of the program has been implemented.

But nonetheless, let's say in the summer of 2003, someone wants to get vaccine. One of the ways of getting it is to enroll in a clinical trial, but since these are ongoing clinical trials people need to realize that you just can't go up there and say this is going to be the vehicle in which I'm going to get my vaccination.

You have to comply both with the entry criteria for the clinical trial and for what the responsibilities of the clinical trial. Let me give you an example.

There's one trial in which individuals are being vaccinated for the purposes of making vaccinia immune globulin, when you get vaccinated, but then you have your plasma drawn to get vaccinia immune globulin. If that's the trial that you go to, you can't just get vaccinated. You have to be part of that trial.

Also Acambus is going on with some of their clinical trials. They'll be entering into Phase II and Phase III. But with any clinical trial there are restriction criteria. So even though you may not have one of the contraindications such as immunodeficiency, et cetera, for any vaccination, you still might not necessarily qualify for the clinical trial.

For those individuals, and if there are enough of those, which there very well might be, who still want to get vaccinated but can't get into a clinical trial, we will do as best as we can to accommodate, to make a program under an investigational new drug, IND approach, to have those people vaccinated.

Then, finally, if individuals want to wait until 2004, they can then, in a much easier logistic fashion, get the licensed product from Acambis which should be ready by 2004.

QUESTION: Can they just go up to their public health department and say I want one?

DR. FAUCI: No; absolutely not.

QUESTION: I mean in 2004.

DR. FAUCI: Oh, in 2004, the vaccine, if it's a licensed product, and since we said that we would make it available to people who really wanted it, they would be able to do that likely by first going to their physician who then would get the appropriate mechanism whereby that person can get the vaccine to give to an individual in the general public.

QUESTION: So would doctors have it in their office for people who wanted it? Or would they have to--

DR. FAUCI: I'm not sure what the mechanisms are going to be. Perhaps Julie can address that. But that's still far in the future. But nonetheless, Julie, you may know that right now. I don't know.

DR. GERBERDING: As we said yesterday, we are in the process of looking at the options for how we can go about making this vaccine available to the public and Dr. Fauci's described a couple of options. I think we're going to need to really look at the pros and cons and they may not be mutually exclusive. So we'll have to get back to you with those details as we go forward.

SECRETARY THOMPSON: Laura, this is Tommy. It will not be in your doctor's office. We will not be giving up the vaccine out of our custody until we have a plan in place and determine how the vaccine will be distributed. But it will not be willy-nilly handed out to doctors throughout America.

QUESTION: Even in 2004?


QUESTION: Thank you.

AT&T MODERATOR: Our next question comes from the line of Marian Falka [ph] with CNN.

SECRETARY THOMPSON: Laura, that's because of legal, the custody problems, the legalities and all these things. We will retain custody of the vaccine.

AT&T MODERATOR: Our next question comes from the line of Marian Falka with CNN. Please go ahead.

QUESTION: Secretary Thompson, is there a plan being drafted that's going to help compensate either the military or the first responders who have adverse reactions to the vaccine or lose work, or to help at the hospital to have to backfill with workers while the first responders are vaccinated and might be out of work due to the [inaudible] illness that's to be expected from the vaccine?

SECRETARY THOMPSON: What is set up right now, which may be changed in the future, but there are no plans, definitive plans as of this point. Let me explain.

The Homeland Security Bill had section 304 in it which absolved liability to the company that made the vaccine as well as to the doctors, hospitals, and other licensed individuals who are agents of the Federal Government, and as a result of being agents of the Federal Government--and I want to point out here that we will be interpreting the statute very generously to cover as many of these people as possible.

So if there's a minor technicality, we will be doing everything we possibly can to make sure that everybody is under the rubric of being covered by section 304, which means that a person that has adverse impact, because of the vaccine, could sue the Federal Government under the Federal Tort Claims Act.

They would have to prove negligence in order to recover, and that, as many people have pointed out, could be difficult, because if they are agents of the Federal Government and are licensed and are doing everything properly, negligence would not apply.

So then the next step is how do these individuals get compensated?

They will be able to get compensated of course under their own health insurance programs, and most of the individuals in the first category certainly will be people that are covered by health insurance, either by their employer or by their own personal plans.

Secondly, they will also be covered by the state workers compensation laws of the particular state which would pay them compensation. And heaven forbid, if somebody dies, they would be able to receive the wrongful death portions of the workers compensation law put out by the particular state.

The next question you're going to ask me is, Is that fair?, because hospital's workers compensation rates might go up as well as other employers, or the health insurance premiums might go up. The truth of the matter is is that we have not done anything in that regard as of yet, except to point out, quickly, that we have already given the states $1.1 billion. The balance of the money was sent out on June 1st of this year to the states to implement their plans.

We anticipate when Congress passes the next appropriate bills for the Department of Health and Human Services, there will be included in there, almost $1.5 billion, of which about $535 million will be for hospitals, and we will be working with the states in the implementation of their plans, which have already been submitted for fiscal year 2003, to be able to amend those for fiscal year 2004, to be able to take into consideration any further costs that may result as a result of this vaccination program, and we are also looking at the potential of introducing some further legislation.

I'm fairly confident that that is going to take place but at this point in time a decision has not been made on that and there has not been any legislation drafted in that regard . I probably gave you more information than you wanted but I figured I'd give it all to you because I would anticipate other questions following, if I didn't give it all to you right now.

QUESTION: Thank you, Secretary Thompson. I appreciate it.

AT&T MODERATOR: And the next question comes from the line of Steve Sternberg [ph] with USA Today. Please go ahead, sir.

QUESTION: Thank you all for taking the time with us today.

Secretary Thompson, how will the vaccine be paid for?

SECRETARY THOMPSON: Vaccine has already been paid for. Let me tell you what has gone on, so everybody has a complete history of what took place. When I came in as Secretary, we only had 15.5 million doses of what Tony Fauci has described to you as Dryvax. This is vaccine that has been in our inventory since the early '70s. This is the vaccine that was given to you, if you're over the age of 34, and me, when we were growing up, up through 1972, when it was discontinued.

The Federal Government maintained an inventory of 15.5 million doses. Under the previous administration there was an order given out to a company called Acambis, which is a United Kingdom company, to produce 40 million doses of a new smallpox vaccine to be delivered in the year, the latter part of 2004, the early part of fiscal year 2005.

I came in and I had a lot of questions and concerns about bioterrorism, even prior to 9/11, and I brought together people like D.A. Henderson and Tony Fauci, and asked those individuals how we might be bale to work to do something better and get better prepared.

From those conferences, we decided that we would call Acambis in, and then 9/11 came and we negotiated a deal with Acambis that they would, after we put it out with bids, and we have five different companies bid on it, Acambis came back and we renegotiated a contract and expanded their contract up from forty to 45 million doses, and then we entered into another forty to 55 million doses.

Then we entered into another contract with them which they joined with a company by the name of Baxter. So it became Acambis-Baxter 2000, and we put a contract out for them for 154 million doses and accelerated it by expanding it. We accelerated, got a very good deal on it, and so they were to start delivering the vaccine of 209 million doses starting this year.

At the present time, we have taken control of about 65- to 70 million doses of the 209 million doses of Acambis-Baxter 2000 and we probably will not fulfill the Acambis 1000 order because they are working and manufacturing Acambis-Baxter 2000.

So that gives you 15.5 million of Dryvax and 209 million of Acambis-Baxter which will be delivered to us, and which should be completed by the spring of this year. Probably May. We should have taken control of about 209 million doses. It may slip a month or two, but some time the first half of 2004, we will have the 209 million doses.

Then there was a company, Aventis-Pasteur, that contacted us and indicated that they had some other vaccine, it was in liquid form, that was frozen, and they said that they would make us a good deal if we wanted it, and they thought that they had somewhere between 35 and 40 million doses.

I negotiated, personally, a price of $12 million for the purchase of that, because I wanted to have that as an insurance policy. This is vaccine that was manufactured in 1958, in 1959, and could not be licensed because we do not have the substantiating data on it.

But Dr. Fauci has done some studies and tests on it, and it has come out that it is very potent good stuff, and it could also be distilled from one to one to one to five. Actually, if we were in an emergency, it could be distilled one to ten.

They thought they had 35 to 40 million doses. We reached an agreement of $12 million. When we finally got done doing an inventory on it, they had 85 million doses.

We still paid only the price of $12 million, which was basically the price of just packaging it, and it probably goes on the scale of a purchase for the United States, something like I've indicated, maybe a little hyperbole on my side, like the Louisiana Purchase. It is a fantastic deal that we made for the Federal Government.

That 85 million doses is in our stock, in our control, and it can be distilled one to five, and if an emergency happened, worldwide, Dr. Fauci has advised me that we could even protect a lot of people by going one to ten.

So you can see if it was one to five, we're over 400 million doses. We have right now, with the 85 million doses of Aventis-Pasteur, which could go up to over 400 million doses, Dryvax, which can also be distilled one to five, we have 15 million doses which would extrapolate out to 75 million doses, and we have in the process, in the pipeline, 209 million doses of the new stuff, Acambis-Baxter 2000, and so we have plenty of vaccine in the pipeline or in our control to take care of every man, woman and child, plus other people worldwide, if need be.

I've given you more information than you want but I've been dying to give this information because I've been living with it and I wanted to make sure that everybody's got every bit of information that they ever wanted to know on smallpox.

QUESTION: If I could follow up [inaudible] presumably their vaccine would be paid for through the clinical trial and if you initiate--

SECRETARY THOMPSON: The vaccine will be--

[Simultaneous conversation.]

SECRETARY THOMPSON: The vaccine will be given out according to the plan distributed by CDC, and we paid for it, and nobody else will have to do it because it's already been paid for by the taxpayers.

QUESTION: Thank you very much.

AT&T MODERATOR: Our next question comes from the line of Maggie Fox with Reuters News. Please go ahead.

QUESTION: Good afternoon; thanks for doing this. The unions presumably know everything that you've already said about liability and as you know they've already issued, they've nonetheless issued a fairly strong statement condemning your plan, and I'm wondering plan if you feel that their doubts are still justified, or do you think the workers are going to be taken care of? And I also have a follow-up?

SECRETARY THOMPSON: I can't give you any more information than I just have told you. The unions I feel known this information. I don't know if they know it in the detail that I have just given it out. I would hope that they do. I have got a call into Andy Stern, have not had a chance to hook up with him yet but intend to talk to him, the first part of the week, about this, and all I can tell you is is that this is what the law is right now, and I can only conjecturize that there is--you know, with Congress, and if there is a lot of pushback, whether it be by the SEIU union, or states, there could be some further refinements of that in Congress, and I would not be surprised if that did not take place.

MR. : Secretary Thompson, this is Mike [inaudible], if I could just add a piece that might shed some light on this, Maggie. The HHS and CDC has been holding a conference call daily with state and local health officials around the country for the past several weeks, and, initially, when this issue first came up, there were several states that were concerned that workmen's comp which, as you well know, is a state-run program, might not cover that.

I can just tell you that in the past two weeks, we have not yet identified a single state which has refused to cover this program under the workmen's compensation program.

I can't give you an affirmative number to say that all 50 states will but I can tell you that many states have reported that in investigations, they have learned that their state will cover this particular program, and again I would emphasize no state has yet determined that it will not be covered.

So I think that's important information to share with health care providers in each and every state, as to what that means about the fact that they will have a type of compensation coverage as dictated by their state program.

QUESTION: Thanks very much and can I ask, you guys have anticipated that there will be some people who will insist on getting the vaccine even though they're not first responders.

You obviously plan to educate them on the risks they pose not only to themselves but to other people, including other people who may not even know them.

Can you address the issue of what may happen to someone who may be incidentally infected with vaccinia because of one of these people, and incapacitated in some way. Or is it a problem you'll deal with when it happens.

MR. : I walked out of the room. Julie, can you answer that?

DR. GERBERDING: As I understand it, you're asking what actually will happen if someone is injured?

QUESTION: If someone is injured by one of these members of the public, who you guys have said don't do this, but if you insist you can have the vaccination. What if one of them gets the vaccination and incidentally infects someone else who has a severe adverse reaction? What about that person?

DR. GERBERDING: That's one of the issues of concern as we go further out from the core groups, but, first of all, whatever program is available to the public for accessing vaccination, it would come with all of the same information about risks and benefits as well as the care of the wound. In terms of individuals in the community who acquire vaccinia, they would be cared for by whatever mechanisms are currently providing their health care.

AT&T MODERATOR: And our next question comes from the line of Richard Knox of National Public Radio. Please go ahead.

QUESTION: Hi. Thanks very much for doing it. This is really by way of follow-up on a couple of other issue areas that have already been asked about. One of them is liability and compensation.

SECRETARY THOMPSON: Can you talk up.

QUESTION: Yes; sorry. Is this better?


QUESTION: Okay. One of the issue areas is liability and compensation.

Secretary Thompson, you mentioned that you are going to be submitting legislation--

SECRETARY THOMPSON: No, I didn't. That is not what I said, I'm sorry to say. I said that there is a strong possibility as we go through this, that we will have to refine it, but I am not, I did not say, and there is no legislation being drafted as of yet.

QUESTION: All right. Thank you. Is under consideration, is a possibility of drafting legislation. Are you going to be talking about a fund, compensation fund that is modeled after something like the children's vaccine injury fund? Is that part of the--

SECRETARY THOMPSON: That is--I, at this point in time, cannot tell you yes or no on that. I would doubt it.

QUESTION: Are you going to be addressing compensation at all in that discussion?

SECRETARY THOMPSON: Well, at this point in time we are looking at this. As I indicated, when I started out today, that we anticipate there'll be some bumps along the way. I presume the compensation will be one of those bumps that we have to, more than likely will try and have to address. But at this point in time there is no legislation being drafted or has even been discussed in that detail.

QUESTION: Thank you. Secondly, on the question of what's being called Phase II, I'd like to get a clarification of current thinking as to who makes up that potential pool of 10 million people.

SECRETARY THOMPSON: It's going to be a lot determined by states but it will include the overall universe of police, firefighters, EMTs, first responders, other health professionals in hospitals, other public health workers that didn't get vaccinated in the first go-around.

QUESTION: Will it include people who, like in transportation and utilities, who have to keep things going in the event of an attack?

SECRETARY THOMPSON: At this point in time we have not gone that far; no.

QUESTION: And secondly, also along the lines of Phase II, in a conference call with state health commissioners, the other evening, I believe--at least I'm told that you said to them that Phase II would follow on immediately after Phase I, and would, you'd expect it to be completed within 45 to 90 days. Is that still our thinking?

SECRETARY THOMPSON: That's still my thinking but it's also, as Julie Gerberding, who is leading this effort as far as planning, has not developed the plans with the state health departments. It is--logistically, our plan is to continue right on to the second phase, to the first responders, and we're anticipating the first phase should take somewhere around 30 days, knowing full well that some states will take longer, some smaller states--and you mentioned Georgia, which is already expanding, but right now, 500 individuals in their original plan should be able to be vaccinated a lot sooner than 30 days.

So we expect some states to be done sooner. Some states will want to do it a little bit, take a little bit longer, and so we will try and phase that in so that we will be able to have a continuous plan developed that will go right from one to the other, and we will work with the state health departments, and the hospitals, along with CDC to make sure that it's as smooth and as error-free, and as bump-free as possible.

QUESTION: Can I ask just one other thing. I know I'm pressing the limits here.

SECRETARY THOMPSON: You are really pushing it.

QUESTION: I'll shut up if you want me to. But just very quickly, there's some concern about whether you'll really be able to know, if you follow one on immediately after the other, know what the side effect issues in both vaccinees and secondary transmission will have been. Is that an issue?

SECRETARY THOMPSON: I want you to address that to Julie, but I can assure all the listeners that we are going to do a tremendous and a very well-orchestrated job on monitoring this, because not only is it the right thing to do, it also is going to allow us to prepare for future plans and of course help us if we have to go to mass vaccinations.

DR. GERBERDING: This is Julie Gerberding. We are very fortunate in that the Department of Defense and Dr. Winkenwerder, and I think CDC and HHS, have agreed that we want to, from a medical perspective, manage these vaccination programs with full open discussion and sharing of the experience and the medical complications, and we're jointly going to be engaging a group of external experts to objectively participate in the safety reviews, so that we have not only our own internal monitoring but we also have some outside experts who will serve as sort of a data safety monitoring panel, and as we accumulate information, which we intend to do as we go, we will be making that information available, first of all, to clinicians and volunteers, and then of course secondarily to the public.

We expect that the monitoring of the safety of this vaccine will be exemplary and that we will be taking measures far beyond those which would ordinarily be required for a vaccine program.

Those measures will include the follow-up visits of each vaccinee to make sure that they actually had a vaccine response, because not everyone will necessarily have a response to the vaccination, and, at the same time, to monitor for both the minor side effects as well as the more serious side effects through the reporting of the individuals in the study and the overall monitoring that the state and local health departments will be doing in conjunction with CDC.

To that end, we have created special software that states can use to keep track of the people they're vaccinating, and this software can be compiled centrally at the state or at the CDC, so that we can really do an overall job of comprehensively tracking people.

HHS MODERATOR: We have time for one more question.

AT&T MODERATOR: And the final question will come from the line of Larry Altman with the New York Times. Please go ahead.

QUESTION: Yes. These are actually several questions related to the fact that you say that there are a number of Americans who insist on getting vaccinated, even though you're saying that it shouldn't be recommended.

The questions are, number one, do you have any estimates of the number of such individuals? If you're saying that there are numbers, there must be some basis of that from call-ins and from the letters, and so forth, that were sent to CDC. The second is, will children be included in that group, and will they be included in, as those who get insisted, if a parent wants to immunize a child?

And then why are you using the undiluted Dryvax as opposed to using the diluted Dryvax? It sounds that you're putting off the vaccinations for those who insist on it to a later date, because you could use some of the Dryvax for those individuals, licensed Dryvax at the present time. Even though the priority are your health care workers.

MR. : Julie and Tony, answer that.

DR. GERBERDING: I can speak to at least the issue about the children, Larry, and I think Tony will chime in. Right now, the vaccine is not indicated for children. That is not one of the package insert indications, and so we need to do clinical trials of children and Tony's been working on that. Maybe he can comment on where we are with that right now.

MR. HAUER: Larry, this is Jerry. Let me address your issue with Dryvax. As you know, the only licensed product we have right now is the Dryvax, undiluted, so we, at this point in time have to move forward with the Dryvax undiluted.

The diluted Dryvax probably will not be licensed until some time later, probably March or April, at the earliest, at least that's the current plan, and by then we will have one, taken delivery of 209 million doses of the Acambis, so that we have that to pack us up, but more importantly, we'll have gone through, we estimate, somewhere in the area of 5- to 6 million doses of the undiluted Dryvax as part of this pre-vaccination program.

QUESTION: That part's not clear, as to why it would be 5- to 6 million, if you have 500,000 military now, and you're up to 500,000 health care workers, and you would move into Phase II. That could be up to 10 million. But that timing was later. Can you just delineate that.

MR. HAUER: Yes. Sure. First of all, we gave a million doses to the DOD. They are going to be vaccinating about 500,000 people right now. Secondly, we estimate, as the Secretary said, that the first group of people will be somewhere in the area of 4- to 500,000 people, and, again, that number is somewhat dynamic and will change as the actual program begins, because this is people that the states have told us they would like to vaccinate. They now have to approach those people and get them vaccinated. Some people obviously will decide not to be.

So that number will change a bit. The second group of people we estimate to be a universe of 100 million people, including the remainder of health care workers, and all traditional first responders.

That's about 10 million people. Our projection at this point, as the Secretary said, is that probably about half of those people will wind up getting vaccinated. So we'll probably use between 5- and 6 million doses of the vaccine.

But, again, we want to have the rest of the vaccine available in case more people do come forward. So the remainder of the vaccine will then be in the inventory as an undiluted licensed product.

HHS MODERATOR: Any follow-ups then?

QUESTION: On the issue of the children, is Tony there, or--

DR. FAUCI: Yes, Larry. You hear me?


DR. FAUCI: Just to expand a little bit on the point that Julie raised, which is a really very appropriate point, and it gets to the process that we have been going [audio out] files, to get children to be part of the IND, to test in children as to whether or not you could go forward and make that part of a licensure.

You recall when we wanted to go--that there were three separate components of our testing of Dryvax when we were comparing the undiluted, and the components were first, adults who were vaccine naive. Now we're into adults who were previously vaccinated as sero positive. The next natural phase would have been to test them in children. The IRBs that had to have it pass through in order to allow the clinical trials to go in that direction invoked a particular component of a code of federal regulations of IRBs, to ask that they felt that they could not justify on the basis of the risk-benefit to children, that we could go ahead with the trial.

They sent it back to the Secretary, who brought it out for public comment, and the vast majority of the public comment was that people felt that we shouldn't go ahead with that trial, which means that if individuals in the general public, as I alluded to just a few moments ago, several of the avenues whereby they could get vaccine for themselves would be in the clinical trial arena. Since the clinical trial arena has not yet allowed us to test the vaccine in children, then technically, we could not then get the child into the clinical trial.

So there are other mechanisms that you could design, perhaps a special kind of an IND, but in the currently existing mechanisms of clinical trial, because of the concern of letting us even test the vaccine in as few as 20 to 40 children, we could not go forward to allow it to be given to a children given the current situation.

QUESTION: And lastly, do you have any--for anyone--do you have any estimates of how many Americans you think would insist on getting vaccinated at whatever time?

MR. HAUER: I don't think we can tell at this point in time, Larry. You know, we have heard from various people around the country, but I think to do any kind of projection at this time would not be even close to accurate.

DR. GERBERDING: We're doing some focus groups in various parts of the country, and there's clearly some mismatch between people's interest in vaccine and their knowledge about both the benefits of the vaccine, but I think more important the consequences or the side effects of the vaccine.

So the first priority, in that regard, for CDC, is to provide people with the most accurate information that we can, so that if they're thinking about it, they really understand what the decision is all about.

SECRETARY THOMPSON: And Larry, when I--the general focus groups have said as many as 59 percent.

MR. HENDERSON: And I think--D.A. here. WE can also look to the Israeli experience, where, in some settings they've had a very high uptake in medical settings, and in others they've had very poor, and it really depended very much on the leadership in the individual medical settings. So it's pretty hard to evaluate this or guess what it would be on a national basis, let alone even in individual medical institutions.

DR. FAUCI: Larry.


DR. FAUCI: This is Tony. What I was trying to say is that--and it's a point that Julie made very appropriately. We're finding a disconnect between people's desire to get vaccinated and their knowledge of the toxicities. As I was saying, I gave a lecture where I just asked the audience to raise their hand for those who felt they would want to get vaccinated, and I got about the same proportion as the focus groups did.

It was about 60 percent, and I showed some of the slides of the toxicities and adverse events and asked the same [audio out] I think we need to eliminate that disconnect between desire for vaccination and full understanding of what the potential adverse events are.

QUESTION: Okay. What was the rough percentage after you showed the slides?

DR. FAUCI: It was about 20 percent, 15 percent.

QUESTION: So it went down considerably.

DR. FAUCI: Yes. Considerably.

QUESTION: Thank you.

HHS MODERATOR: All right. I want to thank everyone for joining us this afternoon and I want to remind everybody that a transcript of this will be available on the CDC Web site some time later this afternoon.

Thank you very much. I appreciate your being with us.

AT&T MODERATOR: ladies and gentlemen, that does conclude our conference for today. Thank you for your participation and for using the A&T& executive teleconference service. You may now disconnect.

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