Smallpox Vaccine Injury Law Project

CDC Telebriefing Transcript
CDC Smallpox Vaccination Update

January 17, 2003

Link to Original

CDC MODERATOR: I appreciate you all reconvening at 4 o'clock for this important call.

Lots going on here at CDC in regard to our implementing the smallpox vaccination plan. We have with us today Dr. Julie Gerberding, Director of CDC, who will provide you all with some brief comments on the program. With us also is Joseph Henderson, the CDC associate director for terrorism preparedness; and Dr. Walt Orenstein, director of the CDC National Immunization Program.

We'll open with Dr. Gerberding providing some brief comments, and then we will open it up to question-and-answer. Dr. Gerberding.

DR. GERBERDING: Good afternoon, and thank you for allowing me the opportunity to give you some updates on the CDC smallpox vaccination program. I'd really like to begin by reminding everyone that CDC fully supports the decision that President Bush announced on December 13th. We need to prepare out nation for the potential threat of smallpox.

Even before the president made this recommendation, we were working closely with the Department of Health and Human Services, as well as with our partners in the state and local governments and many experts from the medical field and other disciplines, to assert that the government would be able to implement the president's program both rapidly and, most importantly, safely.

The president's decision to recommend that people on smallpox response teams voluntarily receive this vaccine as soon as possible was really based on the need to have a group of responders available very quickly to be able to assist the nation if needed. The urgency and the need for efficient action comes from the fact that we are in fact in a dangerous world, where a terrorist attack with smallpox is possible. We have to be prepared so that we can protect the American people.

At CDC and at HHS, we believe this decision strikes an effective balance between the severe but rare side effects associated with the vaccine and the dreadful consequences that would result from a smallpox attack if we were not prepared.

We received the IOM report last night, and we're carefully reviewing it. After an initial review, four themes emerge, and I would like to comment on our progress in each of these areas.

First of all, the theme of assuring safety. CDC and HHS have taken many steps to implement this program in the safest manner possible. We've trained hundreds of health workers in how to administer the vaccine safely, and these individuals are prepared to train others in the state so that all of the people involved in the vaccine program are able to do this as safely as we can possibly accomplish it.

We also have taken many steps to provide very careful screening of potential vaccinees. These are, really, based on pre-screening and screening at the clinic site, as well as more general information that's being provided to the broad medical community. We think this screening is extremely important, and we have engaged our best experts to provide the best possible screening mechanism.

We also have taken many steps to educate volunteers, health care providers, clinic personnel, and other people involved in the program about contraindications to vaccination, so that people really understand if they have a contraindication or if someone in their household has a contraindication, so that they don't volunteer if there's any doubt about their potential risk.

And finally, we've established the Data Safety Monitoring Board, which consists of objective experts that we believe are fully qualified to assess this program as we go forward. And we have made a commitment to monitor this program in real time so that we can detect at the earliest possible moment any emerging, unexpected, or expected-but-rare problem.

We also want to address a second theme that emerged from the report, and that is informing and educating health care personnel as well as the public. We have literally engaged in countless hours of preparation for this endeavor. We've created numerous educational tools and training programs for public health agencies, for clinicians, and for other categories of health care providers.

This kind of educational program has included in-person, satellite training courses, and webcasts on the proper administration of smallpox vaccine and the monitoring and treatment of adverse events. We also have a CD-ROM available, entitled "What Every Clinician Should Know About Smallpox." We've distributed materials to assist health care personnel so that they can diagnose a rash illness and know the differential diagnosed when smallpox or complications of vaccinia are in the differential. And we've distributed more than 750,000 brochures that present the smallpox algorithm to help clinicians in all kinds of health care settings to be able to diagnose a potential case of smallpox or rule out a potential case of smallpox.

We've also used a public health training network to broadcast many hours of smallpox vaccine educational programming to some 37,000 public health professionals over a two-day training period. And of course that program also continues to be available through webcasting.

We are creating a comprehensive information kit for the persons who may volunteer to receive the vaccine. We have information in this kit that informs individuals of the risks and benefits of the smallpox vaccine and provides a very detailed informed-consent process.

We also have a video that they can observe when they present to a vaccine clinic that is a very targeted message that, again, explains the potential complications of the vaccine, the reasons for considering the program, and also an expression of appreciation for the fact that they are thinking about volunteering.

We have these vaccine information sheets in 14 languages so far. I will have more available as we go forward. We have hotlines available in English and Spanish, and we are preparing a mailing with a number of these materials to 3.5 million clinicians across the United States.

I think it's important to remember that CDC is a leading public health agency with extensive experience in conducting vaccination education, and is very familiar with the process of informing people of the risks and benefits of vaccine. We intend to do this in detail, because we really do want people to be able to make an informed choice. And we want them to have the time and the information they need to make an informed choice.

Of course, to conclude with this issue, we remind you that there's a wealth of smallpox information on the HHS and CDC websites, www.smallpox.gov and www.cdc.gov/smallpox.

A third theme that emerged from the IOM report is the theme of liability and compensation, and I think we recognize that the Homeland Security Bill, Section 304, outlines the liability protections for the companies manufacturing the vaccine, the distributors of the vaccines and others administering the program.

The Department of Health and Human Services is taking every step to assure that we have the kinds of protections that we need to ensure that this program can go forward and we're constantly working to ensure that we have a complete understanding and have completed that understanding to those individuals who are concerned about liability.

We also recognize that individuals volunteering for this program will have concerns about worker's compensation. We are looking at ways to work with all of the involved parties to address issues related to compensation, and keep in mind for at least this first phase of the immunization program, all the people who would be volunteering are in fact workers, so worker's compensation is part of the mechanism that we have to address compensation.

Even though the states may vary in the kinds of coverage or the programs that are available, we are certainly not going to delay this program because of concerns about compensation.

A final theme that really emerged in my interpretation of the report is that of timing, the timing of the clinics, and so on and so forth.

I have some really important and good news to report here. As of approximately 3:00 o'clock this afternoon, about a dozen states have requested that CDC ship vaccine next week. So we will be initiating the first shipments of vaccine to the requesting jurisdictions as early as Tuesday, after the Monday federal holiday, and we think that's a good sign, that clearly states intend to utilize this vaccine and their programs are getting into a state of readiness where we'll be able to go forward and do what we need to do, which is to get this show on the road here.

Each state will be responsible for determining when the vaccination program is ready to go and as I said, we think that this is happening on schedule in many jurisdictions and we anticipate that as individual jurisdictions can initiate their programs safely, they'll take the steps they need to do to implement it as quickly as possible.

Let me just close this commentary by emphasizing what, again, this policy is all about. Protecting the public is our core business and it's certainly our highest priority.

The President's policy really ensures that we can quickly and effectively respond to a smallpox attack. We know that by offering smallpox vaccine to the first responders, these people who will be the public health and the health care workers who would respond to a smallpox emergency, we can strengthen the ability of the public health system, of communities and hospitals to do what they need to do to protect the public.

This is a high priority for all of us in the system and we intend to make this program happen on time.

CDC MODERATOR: Pat, I think we're ready for questions, please.

AT&T MODERATOR: Thank you.

Ladies and gentlemen, if you wish to ask a question please press the one on your touchtone phone.

You will hear a tone indicating you've been placed in queue. You may remove yourself from queue at any time by depressing the pound key. If you're using a speaker-phone, please pick up the handset before pressing the numbers.

Once again, if you have a question please press the one at this time. Because of the response on the call, we request that you only ask one question and if you have a follow-up, please re-queue at that time.

I will call your name. When you hear your name called, please respond with your publication. One moment, please.

Your first question is from Brian Bechel [ph]. Please go ahead.

QUESTION: Hi. I was just going to look down my questions here. I'm wondering if you've addressed any of the problems relating to health care workers who might suffer adverse events and whether they should quarantine themselves from immunocompromised patients after receipt of smallpox vaccine?

DR. ORENSTEIN: [inaudible] the issue of appropriate site care--

CDC MODERATOR: This is Dr. Walt Orenstein speaking, who is the director of our National Immunization Program.

DR. ORENSTEIN: The issue of appropriate site care has been addressed, and what we are recommending is that all health care workers who are vaccinated cover their vaccination sites with a gauze, followed by a semipermeable dressing. They also should cover that with a shirt or some other garment, and they can continue to work.

If they have adverse events that make them sick, clearly, they should stay home until they feel well enough to do it, and if they have certain rashes that can't be covered as an adverse event, then we don't recommend working. Or if for some reason they feel they cannot comply with the vaccination site recommendations they shouldn't work. But we feel that health care workers can work through the vaccination, the vast majority can.

QUESTION: Even with immunocompromised patients?

DR. ORENSTEIN: This has been evaluated by several expert groups, our advisory committee on immunization practices, our health care, infection control practices advisory committee, and we feel with these recommendations, which include a daily inspection to make sure it is properly covered, that they can continue to work.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: The next question is from Tina Hessman [ph] of the St. Louis Post-Dispatch.

QUESTION: Yes. Dr. Gerberding, I was wondering if you could tell us which states have requested the shipment of the smallpox vaccine and how many health care workers you expect to be inoculated with this initial round of shipment.

DR. GERBERDING: That's really a question for the individual states and we're not going to provide that information today.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: The next question is from Ann Kerns [ph], Wall Street Journal. Please go ahead.

QUESTION: Hi. My question was the same as Tina's. And I think it's a little unreasonable to expect us to call 50 states. Could you just tell which states have requested the vaccine?

DR. GERBERDING: We really want the states to be able to announce their own program. This is their jurisdiction and they really have the responsibility, and perhaps the privilege, to take ownership for their program. So that is not something that CDC will be presenting.

CDC MODERATOR: Ann, this is Tom. I think as, you know, the states announce receiving vaccine and they start actually vaccinating individuals, you all can fully expect to get updates from us as to how many people are getting vaccinated and the like. And we plan to keep you all very informed once the program actually gets started and the states have announced that they're starting their own program.

Next question, please?

AT&T MODERATOR: Your next question is from Elizabeth Callidan [sp], CBS News.

QUESTION: Good afternoon. I was just wondering, given what Dr. Gerberding is describing in this extensive education campaign that you have done, what you make of this growing list of hospital systems around the country who are refusing to vaccinate--in the Denver area, the Minneapolis area. What do you make of this? Are they not getting the message, or is there just a very different set of opinions about the safety of this vaccine program?

DR. GERBERDING: Well, we estimated when we envisioned this program that there would be individual hospitals or individual health care workers and public health workers would choose not to participate in the program. That's part of our planning process. Our conversations with state health offices reassure us that we will have the level of preparedness we need to be able to do what this Stage I program is all about, and that is to be sure that we can initiate a mass vaccination program to protect our country if we needed to.

QUESTION: And as a follow-up, then, are the hospitals--are the numbers of hospitals declining what you expected, or are they greater than you expected?

DR. GERBERDING: We have over 3,000 hospitals already who have agreed to participate in this program. So I think we're on target.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from John Sofchek [sp] of the Washington FAQs [?]. Please go ahead.

QUESTION: Yes, Dr. Gerberding, in the IOM discussion today, one of the overriding themes was that implementation of this program should not begin until CDC had been able to thoroughly address all these areas of concern. And now you're telling us today that this vaccine is going to be shipping as early as next week. My question is, is what your telling us, that you believe CDC is going to be able to adequately address all of these issues by next week? Or is it that you don't feel that those areas of concern are worth delaying the start date of the program?

DR. GERBERDING: We are in the process of reviewing this right now, and some of the recommendations, I believe, we've already adequately addressed. So the point here is that we have a step-by-step process, and our preparedness has been ongoing before the IOM report and will be continuing right up until the point that the programs are actually initiated. The same is true at the state level. We all agree that we want to do this as safely as we can, and we all agree that we want to do it as expeditiously as we can. So we respect the input and we will be looking at what specific additional steps we need to take, but the point is the program needs to go forward.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Delthea Ricks [sp] at Newsday. Please go ahead.

QUESTION: Dr. Gerberding, even though you can't tell us which states have requested the shipments, can you tell us, essentially, how many states have requested the shipments? Because you did indicate a time element, which was as of 3 o'clock this afternoon, which is just an hour and a half ago. So can you give us an idea of, essentially, how many states?

DR. GERBERDING: Eleven. As of 3 o'clock.

QUESTION: And that's 11 states receiving shipments that will begin next Tuesday?

DR. GERBERDING: We'll determine the day that they would like to have the vaccine delivered, but we are preparing to ship on Tuesday.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Carrie Fare [ph], Arizona Republic. Please go ahead.

QUESTION: I just want to reiterate what some of the other reporters have said. It's kind of not fair that you're not telling us those 11 states, but I guess we'll do our due diligence and call individually.

I also wanted to ask about the contraindications. You said you're going to set up a monitoring program or system. And I wonder, at what point would you say, gee, the contraindications are too great and we're seeing too many adverse reactions, we're going to discontinue the program. Under what scenario would that occur?

DR. ORENSTEIN: The Data Safety Monitoring Board, one of their major tasks is actually to arrive and help us arrive at those numbers to evaluate what modifications in the program would be needed, depending on the experience to date. And so we will ask them, and they will be meeting shortly to help us in developing what kinds of things we might need to do to modify the program based on our adverse-events experience.

DR. GERBERDING: Keep in mind that we used this vaccine for decades successfully. This is the vaccine that was involved in eradicating smallpox. And so I don't think we anticipate we'll be finding unusual complications, but we are very concerned that the program is administered safely, and so in real time we'll be watching very carefully. We are also working very carefully with the Department of Defense so that we can understand any complications that are occurring there, and we'll be able to use that information as well.

DR. ORENSTEIN: I think the other thing is we also may get information about potential other contraindications based on the adverse events we do see, and we can always make new contraindications if that looks like it should be indicated.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Miriam Falco of CNN. Please go ahead.

QUESTION: Hi, Dr. Gerberding. One of the things that struck me--and I apologize if I missed something off the top; it took me 10 minutes to get into this call--but what's the rush? I don't quite understand. Because what you told us about the workmen's comp covering a lot of the liability issues, that's the same thing we heard a month and two months ago. And given the fact that some of the countries--even Israel, the closest to Iraq, which is saying, yeah, they'll vaccinate more people but they essentially have ruled out smallpox as a serious threat from Iraq. What's the rush? Why not wait until some more of these things have been settled, figuring out who will pay for the HIV test or finding the funding for the HIV test or the pregnancy test so you're weeding out the volunteers who shouldn't participate? Why not wait a--why does it have to happen so quickly?

DR. GERBERDING: Let me just say again, because you probably missed it at the beginning of the call, but the president's decision to recommend this vaccine to the response team was really based on the fact that we need urgent and efficient action because we live in a dangerous world these days, where a terrorist attack with smallpox is possible. Even though the president reassured us that an attack was not imminent, we all know that this is now a possibility and we must be prepared.

QUESTION: But what would a couple of weeks to sort out some of these things or address the issues that were mentioned in the IOM concerns?

Why is it so important to start on the 24th as originally planned?

DR. GERBERDING: Well, let me correct that misunderstanding. There is no rule that says the program has to start in every jurisdiction on the 24th. The states are working to implement the program when they're ready to do it safely.

They are working very hard to do this quickly but they intend to do it safely.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: The next question is from Ceci Connolly, Washington Post.

QUESTION: Well, at the risk of beating a dead horse, I want to also voice dismay, and I'm glad there's going to be a record of this telephone call, over the policy of not indicating which states are requesting and receiving this vaccine.

The whole conversation has been about homeland security and assuring the public of our safety and I think that citizens have a right to know, if and when their states begin.

So I certainly hope that the CDC will reconsider that.

My questions have to do specifically with the IOM report. On page 13, there is a detailed discussion about the informed consent paperwork information and whatnot, and it talks about how the CDC post-event forms made the question of lack of compensation very clear, but not the pre-event. I'm wondering if you can tell us if that's being changed and may we see those?

And there's also a discussion on page 23 of the IOM report in which it talks about a hasty launch may mean insufficiently trained vaccinators and uninformed vaccinees, and if you can address that also.

CDC MODERATOR: Ceci, this is Tom. Before Dr. Orenstein responds, I hear your, you know, concerns about us not handing out or tell you which states are receiving vaccine. But, you know, we don't want to get in front of the states with their own announcement about receiving vaccine so that's why we're doing what we're doing.

Dr. Orenstein.

DR. ORENSTEIN: A couple of things. One, in terms of the current vaccine sheet, which we expect to be out shortly, we do talk about the potential issues with where people might seek care, what is available and what is not, including the fact that we recommend vaccinees check with their employers as to whether workmen's compensation is available to them in their states. In terms of the--

QUESTION: Can I just interrupt for one minute.

Does that paperwork also explain Section 304 of the Homeland Security Act and state clearly that you would have to prove negligence in a federal court, and then you would only receive direct compensation, not punitive damages?

DR. ORENSTEIN: What it currently says is there is no federal program to reimburse you for time lost from work either because of illness due to vaccination or concern about spreading the virus to others.

The employer can tell you if they or worker's compensation will cover these expenses.

The other issue in terms of haste, the, again as Dr. Gerberding said, this program goes forward when the state feels comfortable that it has its employees trained in an adequate manner to provide vaccination services, and so there will clearly be judgments on the part of states and local health departments as to when they feel comfortable that their staff are adequately trained to deliver this vaccine program safely.

QUESTION: But there is really no clear explanation of Section 304 of the Homeland Security? I mean it seems to me, if you really wanted to provide full information, you'd try to decipher that for these poor folks who are about to be vaccinated.

CDC MODERATOR: I think, yeah, Ceci, I think beyond what he's already read to you that's in the form, I mean that's the extent that he can address that question. Next question, please.

AT&T MODERATOR: Your next question is from Monica Conrad, ABC News.

QUESTION: Hi. Just let me also put my voice in this. As far as knowing how many states, we want to get the message out, and be very clear as to what's happening with this program. It'd be very helpful for us to know what states, so we can all be on the same page, and all be very clear as to what is happening.

That said, workmen's comp--what are you doing in regard to workmen's comp? You're talking to the states. I hear that. You're talking to the states about what their rules are.

Does it require congressional legislation? Is HHS or CDC talking with law makers on the Hill about making legislation to help cover compensation issues? What actually are you pursuing in this regard?

DR. GERBERDING: There are a number of steps that are being taken by Secretary Thompson and the Department as well as CDC and again we'd advised the states to get a very firm assessment of what worker's compensation programs in their state will and will not cover, and we're advising that various employers collaborate in this process.

So things are happening, we recognize this is an important issue, we're doing a lot of things, and as we get more specific information we can give you an update.

QUESTION: Does that mean you're not pursuing legislation on the Hill?

DR. GERBERDING: I can't answer that.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Laura Meckler [ph] of Associated Press.

QUESTION: First of all, I'll add my voice to the growing list as well. These are federal assets being given to states and there's no reason why a federal department cannot give that information out to reporters. But having said that, my question deals again with the consent form.

One of the themes of the Institute of Medicine, one of their strongest themes was that people need to understand that they are not getting this vaccine for their own personal protection but they're getting it as part of the public's protection.

I'm wondering if A, you agree with that, that put in such strong terms as they put it, and B, if that's the specific message that you'll be giving to people, both in writing and when counselors are talking to people? That this is not particularly good for you but it is helping with public health preparedness.

DR. ORENSTEIN: This is Walt Orenstein. The current consent form talks about smallpox and talks about the risk and who should be vaccinated and why they might be vaccinated. In that we talk about the importance of public health to hospital and other personnel, generally 18 to 65 years of age, who may have to respond to a smallpox case or outbreak, and that is basically the response issue that we are focusing on in the consent process.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Denise Grady [ph], New York Times.

QUESTION: Thank you.

I also was not able to get into this call, so I apologize if this question was dealt with early on.

My question is the report raised issues about the composition or the way that the data safety monitoring board would be set up and suggested that it should not have such close ties to the government as apparently it is constituted now.

Will you be taking any action in regard to that recommendation?

DR. GERBERDING: You know, there are a number of different models for data safety monitoring that are tried and true and have been used by government agencies for many, many years, and the model that we're using for this program is the model that I think meets the criteria for the data safety monitoring board.

We're looking at the IOM report and we're looking at whether we need to make any changes in our decision, but I think this is a very legitimate approach to data safety monitoring.

QUESTION: Thank you.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Ricky Kemper [ph], Los Angeles Times.

QUESTION: Hi, Dr. Gerberding. As you know, I mean, and as we all know, you all have been working on this for months and months, if not a year, to get all the ducks lined up and to get this program ready to go, and yet just in the last few days we've seen a groundswell of cries for the administration to delay the implementation, to slow it down.

I'm just wondering, clearly, you all think you've done everything you need to do. I'm just wondering what you think is behind these calls.

Is it fear?

DR. GERBERDING: We do not appreciate a groundswell of requests to delay or stop this program. In fact our experience in working with our partners in the state and local health agencies is that people really understand that this is an important aspect of preparedness and while it's taking a heroic effort up and down the entire public health system, we know it's important, people recognize we need to do it, and they are extremely responsive to our request to participate in implementing the President's decision.

QUESTION: Okay. If I just could follow up. I wasn't trying to be rhetorical. I mean, we have the Service Employees Union, we have the American Nurses Association, as well as the Institute of Medicine, essentially asking you all to slow down.

DR. GERBERDING: I think that we have communication with a wide variety of experts and a lot of perspectives on this. Sometimes it is difficult for people who are thinking of this from a totally public health perspective to recognize that this decision is not just a public health decision.

This is an issue of homeland security and an issue of national defense, and I believe that is the context in which the support for this program was developed within the Department of Health and Human Services and within CDC.

We recognize this is challenging for everyone and we are focusing on the safety of the volunteers and ensuring that we really are informing them.

We're taking that very seriously, working with all kinds of people to help make our consent processes understandable.

We're reaching people in multiple media. We have the world experts in smallpox engaged in educating clinicians and the people in the clinic, and I think that we have done a heroic job of getting that kind of information out there, so that the people participating in the program really will have probably more protection and more information than we've provided for almost any other vaccination program.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Tina Hessman, St. Louis Post-Dispatch.

QUESTION: Yes. I was wondering what mechanisms exist for people who may contract the vaccinia virus from someone who has volunteered to take the vaccine, but have adverse reactions from a secondary inoculation?

DR. GERBERDING: This is one of the gaps in coverage that we are evaluating and looking for mechanisms to deal with.

I don't have a specific answer for you right now but this is an area that we are addressing.

QUESTION: So there's no current plan for that?

DR. GERBERDING: As I said, we are evaluating options for addressing this and I can't really go into any more details right now.

CDC MODERATOR: Next question ,please.

AT&T MODERATOR: Your next question is from Steven Russell, San Francisco Chronicle.

QUESTION: Hello, Dr. Gerberding. Just on the matter of the 11 states, there were several things in the IOM report referring to the need for a single voice. I was wondering if in fact the decision to leave it up to the states to discuss whether they're seeking the vaccine or not represents kind of a response to that, that it is no up to the--it is a state issue and not a single CDC policy?

DR. GERBERDING: You know, I think that those of you who have reported on public health issues in the past recognize that CDC never preempts states. We never present news about outbreaks or about any other business going on in states without allowing them the opportunity to present the perspective from their jurisdiction.

This is not exceptionalism in this case, this our policy and the way we always practice, and I think many of you know that.

What I will say about speaking with one voice. We speak with one voice, the Department of Health and Human Services and CDC and the other partners in this effort. Our doctors and scientists have been speaking about public health and scientific aspects of the policy, you've heard us in many different formats. And our nation's leaders, including Secretary Thompson, have been speaking to America about why we need to take this step for this program. So, yeah, I recognize that everyone is eager to have the news about where the program is going, but this issue about the states is the generic way the public health system works.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: Your next question is from Steven Smith, Boston Globe.

QUESTION: Hi. Good afternoon, Dr. Gerberding. As you may know, yesterday the medical staff of Cooley Dickinson Hospital in Northampton, Massachusetts, in the western part of the commonwealth, announced that it is opting out. And I know you've said several times here that you've had support from 3,000-some-odd hospitals, but I have to tell you, I was on a television program this morning with the head of the Massachusetts Hospital Association, who is being inundated with calls from hospitals, with doctors, who are indicating that there is increasing dissent around this program.

And I'm wondering, secondly, as we're seeing hospitals opt out, if the whole notion is providing blanket protection, what happens as we have hospitals drop out and if someone were infected with smallpox and were to show up at a hospital where there have not been vaccination programs, what is the plan when that happens?

DR. GERBERDING: It's very important to understand what the goal of this program is. It is not to ensure that every hospital in the country has vaccinated employees. The goal is to ensure that we have the public health response teams that can go out and assess initial cases and that we have health care personnel in a facility in the jurisdiction that would be able to take care of the first cases, that would have the long-term contact with those individuals and would be in a situation where they could provide care for the first patients until the rest of the public and the health care workers were--the immunization program is initiated.

So as we said before, we have 3,000-plus hospitals that have indicated that their personnel will be participating in the program. We never expected every hospital to participate, and we still remain confident that we will have the level of preparedness we need.

QUESTION: But may I submit, you talk about 3,000 hospitals. And any of us who call an administrator up, and administrator is probably going to say, yeah, we're gung-ho. But I would submit to you that you're losing the docs on this one. I mean, docs, we're hearing in Massachusetts, are beginning to really question this. And this increasingly seems to be reflected across the country. And what happens if you lose the docs on this?

DR. GERBERDING: Well, first of all, our understanding is that we're not losing the docs; in fact, quite the contrary. We have people calling because they want to participate in the vaccination program and their hospital has not been included in the catchment for the planning in that jurisdiction. So I think there's a lot of variability, and we're working very hard to remove the obstacles to the program as we go forward. But we still feel confident that we will be able to have the level of protection we need to initiate a vaccine program for the population if we need it.

CDC MODERATOR: We have time for just a few more questions, please.

AT&T MODERATOR: We have a question from Marian McKenna, Atlanta Journal.

QUESTION: Hi, thanks. In discussing the IOM report this morning, the IOM representative made two points about data collection. The first was they said that in Phase I, they want to be very clear that the CDC is conducting active surveillance of everyone who receives the vaccine. And the second thing they said is that they desire to see a significant pause for data analysis between Phase I and Phase II. I don't think I've heard you address those issue yet, so could you talk about both of those, please?

DR. ORENSTEIN: First of all, we will certainly evaluate the issue of active surveillance. There is a very active adverse-event monitoring program in place already, relying on hospital workers who are inspecting each of these sites on a daily basis for workers to continue to be vaccinated. We will look at what the IOM recommended and see if any modifications are necessary. But we do have an adverse-event monitoring system. And in fact, because we are the ones who control the therapies for a number of these adverse events, we believe a lot of them will get reported to us for that reason as well. But we will look at the issue of the adverse-event monitoring.

What was the second question?

QUESTION: Does the IOM ask in particular for a pause between Phase I and Phase II?

DR. ORENSTEIN: I think we will be continually evaluating this effort, and we have a number of staff who are involved in that, along with outside consultants, as we work toward moving forward.

QUESTION: Is that a no?

DR. GERBERDING: I think there is another point of confusion here that I'd like to take this opportunity to clear up. As we have said all along, getting these response teams vaccinated is what the president asked us to do. But we are including in the broader group, what you are referring to as Phase II, a much more comprehensive group of health care personnel and emergency responders. The priority is to get the response teams vaccinated. Individual jurisdictions may have the initiation of the immunization program for the broader groups when they're ready to do it. So this is not "do Stage I and then do Stage II" simultaneously across the nation. There's going to be some variability here and you need to expect that, because we'll go forward with the larger group as preparations evolve.

CDC MODERATOR: We've got time for one more question, please.

AT&T MODERATOR: Your final question is from Gerald Bertram of the Star-Tribune.

QUESTION: Hi. Last but not least. Two-part question: When do you expect to have Phase I vaccinations under way in all states? And are you getting a sense from the states that you have an adequate number of volunteers who have come forward for the first stage of vaccinations?

DR. GERBERDING: We'll be able to initiate the vaccine programs in all jurisdictions when the states are ready to do so.

QUESTION: Do you have any sense what date that would be?

DR. GERBERDING: We have approved the plans for all states, so their planning has progressed to the level where they have met all the criteria for receiving vaccine when they're ready to receive it. So I don't think we're going to be looking at a long time frame, but again, the goal is to get these programs off the ground and running as soon as it's safe to do so.

QUESTION: Do you have any idea what date you might have these completed in all of the states?

DR. GERBERDING: No, we're not looking at that from that--we're not looking at this from that standpoint.

QUESTION: Okay, and then the second part of the question, are you getting a sense from the states that you have enough volunteers coming forward?

DR. GERBERDING: Yes, we are, as a matter of fact. Just in the initial requests, we have requests for over 50,000 doses of vaccine.

CDC MODERATOR: That concludes our media briefing here.

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