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Smallpox Home
SARS Home

CDC Telebriefing Transcript

Update on SARS and Smallpox Vaccine Program

March 27, 2003

MS. TELFER: Good afternoon and thank you for waiting. I'm Janet Telfer, Acting Director of Media Relations for the Centers for Disease Control and Prevention, and we welcome you to what is becoming a continuing series of news briefings on breaking news and updates related to severe acute respiratory syndrome, or SARS, and smallpox. Today, we're bringing you two topics. First will be severe acute respiratory syndrome. Then we'll break at 12:30, switch speakers, and bring you an update on smallpox.

I want to advise people who are dialing in on the phone that if you're experiencing trouble dialing in, our operators are able to accept a fairly large number of calls at one time, but they can't accept all of the calls at one time, and what we're finding is that people are all dialing in at the top of the hour, and that's indeed what has been causing the delay that some people have been experiencing. So if you can start dialing in a little bit before the hour, that would be helpful. That way we can get everybody through and have you live on the phone for the beginning of the conference.

We appreciate everybody's perseverance with us. We know that we have been bringing information to you very suddenly, and sometimes with last-minute notice, and we appreciate your staying with us and of any receptiveness to this kind of an environment.

Our first briefing, as we said, is an update on severe acute respiratory syndrome, and I'd like to introduce Dr. Jim Hughes, who is the Director of the National Center for Infectious Diseases.

DR. HUGHES: Thank you very much, Janet. Good afternoon, everyone. Thank you for coming and thank you to the others for dialing in. CDC continues to work with the World Health Organization and other national organizations to investigate an ongoing emerging microbial threat, referred to as SARS. This is a major challenge, but is also an excellent illustration of the kinds of threats that microbes can pose and the rapidity with which they can move around the world.

The number of cases of suspected SARS continues to grow, both in the U.S. and worldwide. In the United States today we're reporting 51 suspected cases of SARS. That would be an increase of six cases from yesterday, from 21 states. And increase of one from yesterday. So far, happily, there have been no deaths attributable to SARS in patients in the United States.

Of these 51 cases, 44 are associated with travel to areas where we know transmission is occurring. Five cases are occurring in people who have had contact with people who are ill with SARS, and there are two health care workers who are I'll as a result of caring for one patient with a suspected case.

Internationally, WHO is reporting 1283 suspect or probable cases, exclusive of those from the United States. Now, I've not yet seen today, because of the timing of the conference, the case counts for WHO today. So I would urge you to consult with their website this afternoon for an update on that information. Those cases come from 12 countries and a total of 14 geographic areas that have not changed from yesterday.

There are a total of, the case fatality ratio for cases internationally is 4 percent.

We're encouraged that many of these patients with SARS are improving over time. In spite of that, we know that this is a very severe illness. We know it is causing great concern for patients, for family members, and for health care workers. So, it is quite understandable that people are concerned about this, and I'd like to assure you that we and the World Health Organization and national authorities are doing everything possible to move this investigation forward, just as rapidly as possible.

CDC is participating on teams assisting in the investigation in Hong Kong, in Hanoi in Vietnam, and Taiwan, and in Thailand. We're also conducting very active surveillance and prevention activities in this country, working with numerous partners at the state and local levels of clinicians and public health officials.

We've set up a special investigative team here in Atlanta to focus on international aspects of this investigation, which is quite complicated. And I would refer all of you to the morbidity and mortality weekly report article that's released today and will be available on the web.

For those of you in the room, there's a figure that appears in that MMWR. And what this figure shows is the linkage of many of the cases of SARS, certainly not all, but many of the cases of SARS, to a specific hotel in Hong Kong. When you have a chance to look more closely at that figure, you'll be able to see how patients infected with whatever it is that is causing SARS through their travels moved this infection to other countries. Again, a very vivid illustration of the complexity of the situation, but also the nature of global microbial threat.

Much laboratory work continues here at CDC and in a WHO-supported network of laboratories working worldwide, to continue to try to sort out the cause of this illness. The evidence in favor of this illness being caused by a previously unrecognized virus in the group of viruses known as corona viruses continues to mount. I'm not prepared that we're ready to say it's definitive evidence yet. Much work remains to be done. But the preponderance of the evidence as it evolves here and in other laboratories around the world is consistent with a previously unrecognized corona virus playing an important role.

We have taken action to meet aircraft returning to the United States, bringing passengers to the United States from other parts of the world where SARS is occurring. We're providing disembarking passengers with information in terms of the nature of the illness and what to do if the individuals develop such an illness. This is part of our overall national surveillance effort on the one hand, and reflects our interest in early-case identification, so that proper infection control measures can be implemented.

With that in the way of a quick overview, let me stop and open this to questions, and we'll try and alternate between people in the room and people on the phone.

Let me take the first question here in the room.

QUESTION: Thank you, Dr. Hughes. Betsy McKay [ph] from the Wall Street Journal. I have a couple of questions. One, I'm just wondering at this point, with about 50 deaths around the world, and 13 or 14 hundred people I'll, could you put this outbreak in context for some other outbreak? You know, how large is it compared with other outbreaks? What particularly raises the alarm felt here versus, say, a simple flu outbreak?

Secondly, I understand there is a movement to rename this disease from SARS to CPD, I believe? And or CVP. And I wonder if you could just comment on whether you all have adopted that name, as well. Thanks.

DR. HUGHES: Okay. Thank you. Several questions there.

First, the size of the outbreak. This outbreak is obviously no where near as large as the global epidemic of HIV infection, for example. Nevertheless, it is certainly significant. A number of people have been infected, the case counts continue to increase. This is an infection that certainly is contagious, though it does appear that proper, prudent infection-control products and practices can dramatically reduce the risk of transmission. So, although it's not huge, it's getting bigger and it has the potential to get bigger still if it is not aggressively addressed.

I would take some issue with your comment that influenza outbreaks were simple. Influenza outbreaks are actually quite complicated. And I'll use this to remind everybody that you've heard us and others talk about the stress posed by the next pandemic or worldwide epidemic of influenza. And this is a good example of many of the issues that we would face when the--we will face when the next influenza pandemic begins.

In terms of what this will ultimately be called--ultimately, if we can agree on the virus causing this syndrome, assuming it is a virus, that virus will have a name and the clinical syndrome will have a name. I think we're still learning as we go. Evidence is accumulating. I think--my personal reaction is that any name right now that includes pneumonia is too--that limits the syndrome to pneumonia is too restrictive because at least many of the suspect cases in the U.S. so far don't have evidence of pneumonia. So I would say stay tuned on virus identification, virus name, and syndrome name.

CDC MODERATOR: Given the number of callers on the phone, we're going to take our next two questions from the telephone.

MODERATOR: We do have a question from the line of Seth Borenstein with Knight Ridder. Mr. Borenstein, your line is open if you have a first question.

QUESTION: Yes, thank you so much for taking this. In terms of the growth of the outbreak, there was a lot of hope a week or so ago that it was starting to peter out. And even if you take out the Guangdong numbers, it doesn't seem to be the case. Can you address the issue of whether you think this--whether with the infection control that's out there, do you feel like you're getting a handle on stopping its growth?

And then the other question I have, obviously 50 is a small number in the U.S., but is it unusual that we haven't seen any deaths or extremely critical ill patients, given the mortality rate?

DR. HUGHES: Well, first of all, we're extremely gratified that we've not seen any deaths from this syndrome in this country. Now, remember, we're working with a surveillance case definition. And that case definition in fact is evolving as we learn more about the illness. What the case definition currently lacks is a laboratory component so that we can confirm cases of SARS. When we have that and we're able to test all these suspected cases, my feeling is that some will be confirmed and some will be eliminated. So I know it's frustrating to follow case counts, but you're going to have to bear with us on this.

In terms of changing numbers internationally, there's the potential for swings there in part because of the recent report from China with reference to Guangdong Province, and the number of total international cases increased dramatically yesterday with the reporting of those cases from Guangdong. I would also just remind you that there's a WHO-led international team that we at CDC have two individuals participating in, working with Chinese colleagues in Beijing right now, looking at much of the data that they have developed over the past few months. So I would just say stay tuned, watch the WHO website, watch our website, and you may well see some changes in these numbers in the near future.

MODERATOR: We have a question from the line of Jeremy Manier with the Chicago Tribune.

QUESTION: I apologize. Could I pass and save my question for smallpox.

MODERATOR: Thank you. We have a question from Laurie Garrett with Newsday.

QUESTION: Is anybody talking about or trying to initiate any kind of a case control study anywhere that might begin to answer some questions about transmission and, you know, explain how transmission might have occurred in the hotel, for example.

And the second is, Jim, we've talked about it before; I want to ask you again about these two clusters and then scattered reports across the country of sudden onset pediatric respiratory deaths in American children that occurred in January and February and whether or not CDC is actively investigating any possible link to SARS.

DR. HUGHES: Thank you, Laurie. Let me address the questions in the sequence you asked them. First of all, your question about case control studies is an excellent one. As with any evolving, emerging infectious disease, there are many research questions that are raised immediately. Some are critically important in the short terms; others are critically important in the longer term. But right now, much of the focus is on better definition of the precise mode of transmission of this agent and the risk factors for transmission. So yes, we are working, in the United States particularly, to look at health care workers and household contacts to see if we can better define risk factors for transmission in those settings. Similarly, in the international setting, case control studies and other studies are being organized and are getting under way.

In terms of the clusters of unexplained deaths associated with acute respiratory infections--and there were at least two that we were involved in, going back six, eight weeks ago in the U.S.--severe unexplained infectious disease-like illness occurs not infrequently in the United States and around the world. Many people haven't in the past realized that even with aggressive diagnostic workups for people that die with syndromes that look like they may be infectious, you're often lucky if you find cause in maybe half of the cases. So there are other unknown causes of infectious diseases out there.

When clusters occur, we assist state and local authorities in investigating them when we're asked to do so. We recently did that in two different states. We were able to identify the cause in many of these cases as being influenza, and in one case Group A streptococcal disease.

Now, for those who didn't have an explained etiology, we do have specimens remaining, and as time goes on we will be looking back to see if there was any evidence of this disease occurring in the U.S. prior to early February.

MODERATOR: We have a question from Jennifer Coleman [ph] with KYM-TV. Ms. Coleman, your line is open. Do you have a SARS question?

QUESTION: Yes. I think you touched on this a little bit. I know that right now there's only 51 suspected cases in the U.S., but how are the cases in the U.S.--I mean, I guess I'm just wondering if it's better medical care or if--you know, why there's no deaths at this point reported.

DR. HUGHES: Well, we're concerned that there are as many as 51 cases in the U.S. We're extremely pleased that there have not been any deaths. I suspect in part that reflects early recognition and good clinical management and we continue to urge good, prudent infection-control practices as well. We haven't had very many of these suspect cases having real severe disease, fortunately. Of the 51, 14 have had pneumonia and only one has required ventilatory support with a respirator.

So we're seeing among our suspect cases milder illness overall than people in Asia are encountering. So we're fortunate in that, but I think we're also fortunate that we're well-positioned to provide good clinical care to the patients who need it.

MODERATOR: We have a question from Robert Bazell from NBC News. MR. Bazell, your line is open. Do you have a SARS question?

QUESTION: Thank you. Dr. Hughes, since the emergence of HIV and other than influenza, have you had an emerging infection that you can recall that's caused you so much concern?

DR. HUGHES: Well, there was that one that you recall, Bob, as well as I do, back in 1993, Hantavirus Pulmonary Syndrome. That was a severe, unexplained, acute respiratory disease that was recognized in previously healthy young people on the Navajo Indian Reservation in the Southwest. That was astonishing, to say the least, in a similar way that this current outbreak is astonishing in terms of its complexity and challenges.

These microbes have continually illustrated that they will continue to challenge us. You'll never see better examples than that Hantavirus situation and the current situation to drive home the important points made by the recently issued medicine report on global microbial threat, which points out the critical need to continue to rebuild global response, global surveillance and national and local infectious disease surveillance and response capacity, and to address the many research questions, the training needs, and the communication issues that these challenges pose.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Maggie Fox at Reuters. Miss Fox, do you have a SARS question?

QUESTION: Oh yes. Thanks, Dr. Hughes. The authorities in Hong Kong seem to be a lot more confident than you are that corona virus is to blame. Can you address that and the possibility that the corona virus and the paramyxovirus may be acting in concert?

And also how unusual is it to find samples of both these viruses in tissue?

DR. HUGHES: Okay.

Let me say that I thought I had said earlier that the weight of the evidence, as far as we're concerned, continues to build in support of the corona virus having a causative role in this syndrome. We're not ready to be totally definitive about that? There is more work to do. You have to be cautious. It doesn't do anyone any good to jump to conclusions prematurely when you're investigating a problem as complicated as this.

Labs in many countries now have found evidence of corona virus infection in these patients. That's in contrast to just a few days ago, you may recall when metapneumovirus was clearly the leading candidate. I would say corona virus likelihood is going up; metapneumovirus likelihood is probably going down. We're not willing to take it off the table yet. We keep an open mind in these things. And the possibility of their being some co-infection, at least in some patients, and have that play a role in the overall presentation of this illness has to be kept in mind.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Larry Altman with New York Times. Mr. Altman, do you have a SARS question?

QUESTION: Yes. It was along the lines of Maggie's question. But could you put this in a little more perspective in terms of the evolution of paramyxo and then the subset of metapneumovirus, and then the emergence of corona virus. Can you just outline the steps as how this has evolved over time?

CDC MODERATOR: Jim?

DR. HUGHES: Yes, thank you, Larry.

Actually because Dr. Larry Anderson is here and is an expert in both these groups of agents, let me seize the moment and ask Larry to come up and make some comments.

DR. ANDERSON: Thank you.

It's actually been a very interesting progression of laboratory and clinical and epidemiologic findings. I think some of the early suggestions came from electron microscopic studies, when they noted paramyxovirus-like particles in respiratory secretions. Around that time they also identified evidence of the human metapneumovirus in respiratory secretion specimens in Hong Kong. This virus has also been identified in specimens from some other countries as well.

We pursued that, but continued to look for other agents. A group in Hong Kong and Germany identified some other particles and secretions that were suggestive of probably not a paramyxovirus by size. And we and other groups isolated or found evidence of cytopathic effect in tissue culture material. Our electron microscopist identified corona virus-like particles in this tissue culture material. We then used molecular techniques to look at the genetics of this virus and confirmed that in fact it was a corona virus. And then developed tools to look at additional specimens, and then provided the tools for other laboratories to look at this finding as well.

So that's been the progression. And I think as in any investigation, you develop hypotheses and then test the hypothesis to see if it fits with the clinical and epidemiologic characteristics of the disease, and we're kind of trying to finish up the linking to disease at this point.

DR. HUGHES: So let me just follow on and point out again to remind everybody, this remains a work in progress, and there will continue to be new data and new observations that are important that will be made.

CDC MODERATOR: Next question, please?

MODERATOR: We do have a question from the line of Bob Stein with The Washington Post. Mr. Stein, do you have a SARS question?

QUESTION: Yes. Thank you very much.

I'm trying to get a little bit more information about the 51 suspected cases. First of all, I was wondering, are they all being held, or kept isolated? And if so, is it homes, or in a hospital? And of the five cases that appear to have been the result of close contact, were they all family members, or were they some other kind of contact?

DR. HUGHES: Okay, to get to the second question first. Three of them were family members, and two of them were health care workers. The infection control precautions that are recommended for these patients are in addition to standard precautions recommended for everyone. We call for contact droplet and airborne precautions. And that's being prudent, because the bulk of the evidence suggests that this infection spreads through close contact between patients and others who are unaffected.

We have to keep an open mind here in terms of exactly how this transmission occurs. Whether it's by physical contact or by large droplets that spread over short distances, or possibly through contamination of articles in the inanimate environment that might be handled. And then finally we have to keep open the possibly that this is transmitted at least in some cases by the airborne route. There's no evidence of that today but we are keeping a very open mind in that regard, I assure you.

So patients that are ill with this syndrome are kept on these isolation precautions throughout the course of their hospitalization. And because we just issued, last night, some additional infection control guidance, and because Dr. John Jernigan from our Division of Health Care Quality Promotion is here with us today, let me ask John to come up and just briefly comment on that one specific aspect of your question. John?

DR. JERNIGAN: Sure, Jim. We issued some guidance last night to hospitals in the United States on some more detail on how to handle infection control procedures in the hospital, and specifically how to handle health care workers who may have been exposed to patients while they were taking care of them. And we have no reason to believe that people can transmit this disease when they don't have symptoms. So what we've recommended the hospital, since they close track of health care workers who are caring for SARS patients, and do surveillance and touch base with the very frequently to make sure that they don't develop signs of illness. And if in fact they do develop signs of illness, we are recommending that they probably should not be taking care of patients in the hospital.

We are not excluding, not recommending exclusion from duty if people do not have respiratory symptoms. Again, the weight of the evidence that we have so far suggests that the infection cannot be transmitted from asymptomatic people. We are monitoring that situation closely and we are in close collaboration with our international folks who have had a lot of experience. And the bulk of the evidence suggests that as well.

To date, all the patients with SARS in the United States have been either in persons with history of foreign travels, or transmission with close contacts. And so we're pretty comfortable with those recommendations that we put out last night for health care institutions.

CDC MODERATOR: Given that we have two important topics to cover today, this will be out last question on SARS.

MODERATOR: We do have a question from the line of Qeta McPherson [ph] with Star Ledger. Please go ahead.

QUESTION: Thank you.

My question concerns the investigation itself. I was wondering, Dr. Hughes, for my readers who are not scientists, what tools do you have at your disposal this time that you didn't have when the AIDS was breaking out, and maybe even more recently? And does this reflect an investment that's more towards bioterror precautions?

DR. HUGHES: Thank you. I thought you were going to ask, perhaps, what tools do we have today that we didn't have back in 1993 when we encountered the Hantavirus situation. But you went way back 23 years ago to the recognition of HIV infection. And you might recall that it took three or four years to identify the cause of that syndrome. So keep that in perspective.

We have much more sophisticated tools today at the national level and at the state level and in clinical laboratory settings to diagnose infections disease as compared to, certainly, the situation 23 years ago. We've made dramatic progress. The Institute of Medicine report that I mentioned points that out, but it also emphasizes the fact that we need a much broader array of diagnostic tests. In many cases of pneumonia, a positive agent is only found in roughly 50 percent. And many of these tests that do exist take a long time to conduct.

One of the major problems that we're facing nationally and globally now, if you move SARS, is the problem of antimicrobial resistance. I mention it because it's a big problem for clinicians and public health officials. But it also is one that illustrates why it's so important to continue research to develop rapid, sensitive, specific diagnostic tests that can be used both in clinical and public health settings.

So yes, we have better tools today. We don't have all the tools that we need to sort these things out as rapidly as we need to. And we don't have all the highly trained people with the range of skills needed to address these issues that we need as well. So keep that in mind.

Let me stop there. Thank you all very much for your continuing interest, and again, I ask you to stay tuned.

CDC MODERATOR: Thank you very much, Dr. Hughes. We're now going to give you just a moment to switch files from the SARS to the smallpox. While you're doing that, let me thank you again for joining us today. I know we had several people on line who were unable to ask their SARS questions. Please, call the Media Relations Office upon conclusion of this broadcast, and we will assure that you're connected with somebody to have your question answered if it was not answered in the telephone briefing that we just concluded.

We are going to also repeat for those people who were frustrated by not being able to get on the line immediately the caution that, while our operators do have plenty of capacity, they don't have capacity enough to handle 50 calls at once, and that's how many came in at 11:59 today. So we appreciate your promptness. If you can bear with a little bit more music, please try to dial in a little bit earlier and we will get you through as rapidly as possible.

Now it's my pleasure to introduce the head of our National Immunization Program, Dr. Walter Orenstein, do give you an update on smallpox.

DR. ORENSTEIN: Thank you very much, January, and good afternoon.

First of all, I'd like to say that we are deeply saddened by the reports of deaths of two of our health care colleagues after smallpox vaccination. Our thoughts are with their families. They were valued members of our health care community, and their families can rest assured that we at CDC will be working closely with our colleagues in the states and other outside scientific experts to try and determine the possible reasons for their deaths.

Smallpox vaccine safety remains a top priority for CDC and we are committed to the safety of individuals involved in this program. We will continue to carefully monitor the safety and will update our partners, the public, and vaccine recipients whenever we have a concern about potential health issues that can affect their lives.

Between January 24th and March 21st, smallpox vaccine was administered to 25,645 individuals. These are health care workers and public health workers in 53 jurisdictions around the country. This is part of our effort to prepare the United States for a smallpox attack, should it ever occur. Seven cases of cardiac adverse events have been reported among civilian vaccinees since the beginning of the program. Of the seven cases reported to CDC, two are cases of inflammation of the heart, the membranes around the heart--so-called myopericarditis--and five are the result of coronary artery disease. This includes two cases of angina and three cases of heart attacks, two of whom have died. In addition, there are 10 cases of myopericarditis, or inflammation, reported among military vaccinees.

While available evidence suggests that vaccines may be playing a causal role in inflammation of the heart or around the heart, it is not clear whether the other cardiac events are causally related or coincidental and would have occurred anyway. We are actively investigating whether there is any association between smallpox vaccination and these other cases. If our investigation shows the precautionary measures we have adopted--which I will mention in a moment--should become permanent, or if there are other reasons for change, we will take immediate action.

CDC has taken the following actions.

We have recommended that persons with histories of heart disease be temporarily excluded from vaccinations until more extensive evaluation and review have taken place. We have been in contact with the states and informed them of what we are doing.

We have developed interim screening criteria and an addendum to our vaccine information statements and fact sheets, which we are sending to the states.

We have sent staff to states where deaths have occurred to collect more detailed information, and we will continue to work with states to refine our information and make further recommendations.

Our Advisory Committee on Immunization Practices, supplemented by members of the Armed Forces Epidemiological Board as well as cardiology experts and other experts will meet on Friday, and we hope to accomplish the following:

One, to determine which group should be deferred for vaccinations. What are the best ways to screen for conditions in the setting of a vaccination clinic, and what further studies are needed to determine if there is a causal relationship. Our preliminary discussions with some of our experts have reinforced that we should continue the program with the exclusion criteria that I mentioned.

I'd be happy to take any questions. Thank you.

CDC MODERATOR: We'll start with a question from the floor. Seeing no hands, let's move right to the phone because we know there are several people in queues. So again, if people on the floor have a question, please indicate and we'll be sure you have the opportunity to ask.

MODERATOR: We have a question from Jeremy Manier with Chicago Tribune.

QUESTION: Thanks very much. What efforts are being made to reach people who have already been vaccinated who might have preexisting heart conditions, and what effect might this have on the larger effort? I know the vaccine effort has not gone as quickly or as--and as widespread as had been hoped. Might this slow down the effort somewhat?

DR. ORENSTEIN: Let me take the first question first. In terms of notifying people, we are doing a number of things. One, we're holding media briefings, we're getting the--trying to get the word out in a variety of fashions. We're getting the word out to our partner organizations, our physician organizations. We've put out a Health Alert Network. And we're getting information out to the states so that they can use to inform people who have already been vaccinated that should they develop any symptoms of heart disease, such as shortness of breath, chest pain, or symptoms like that, that they immediately consult their physician.

In terms of what this will do to the program, we are working to try to maintain the program. The vast majority of people would not be included in the risk factors that we are currently recommending be used to exclude people from the program. We are developing materials for that. And we certainly feel the need to continue our efforts to try to improve our preparedness against smallpox. How well we do will depend on how health care workers themselves, as well as the states, evaluate the information that we're presenting.

MODERATOR: We have a question from John Barman [ph] with Bloomberg News.

QUESTION: Thanks for taking my question. I know you're often loathe to give this kind of information, but what can you tell us about the second health care worker? Can you tell us at least the state of the health care worker?

DR. ORENSTEIN: At the moment, we cannot tell you the state because we are concerned about identifiers. However, we do know a number of the states have made press releases, and I would not be surprised if that happens in this case.

What I can tell you is that the individual was a 57-year-old female who developed her heart attack approximately 17 days after vaccination, collapsed, was resuscitated, but not for a period of about 20 minutes or so, and has subsequently died. We know that this individual, who was a female, had a previous cardiac catheterization. At the moment we're not clear what the rationale for it is. We know she had a previous history of hypertension, and we know that she had, during the cardiac catheterization, other evidence of perhaps underlying arteriosclerotic heart disease, which is based on having what's called a transient ischemic attack during the episode.

I need to emphasize, again, what--the points I've made. While the evidence is somewhat suggestive that vaccine is playing a role in the mild pericarditis, the inflammation side of this, particularly based on the military data, the data that we have on the civilian side, from the heart attacks and from the cases of angina, the numbers we have, at least to date, are within what we might have expected by chance alone.

So that this very well could be coincidental illnesses and we will be trying to determine whether there is a causal role, but we are trying to, again, be precautionary, by excluding those at the very highest risk of having underlying heart disease from vaccination at this point.

QUESTION: A question from The Wall Street Journal. Can you tell us anything more about these ten cases in the military, their ages or risk factors--

DR. ORENSTEIN: I think, one, it would be best to talk to the military about those cases. What I can tell you is that all of them are primary vaccinees, meaning they've never been vaccinated before. So that gives you a picture that they're generally a younger population than in the civilian side. On the civilian side, what we can say is that roughly two-thirds of our civilian vaccinees are over 45 years of age, which is very, very different than the military population.

In the military population, they have not seen any cases in about a 100,000 revaccinees. So it's been only in their first vaccination group that this is occurring, which makes sense from a biologic perspective, because it's the first vaccinations in which you expect the maximal viral replication and where you might expect to see some kind of increased inflammation.

In the civilian side, again, we really don't have solid data on causation and based on the numbers of deaths at least, this is within what we might expect in a similar population of this age.

CDC MODERATOR: Our next question is from the phone.

MODERATOR: We do have a question from the line of Laura Meckler with Associated Press. Please go ahead.

QUESTION: Thank you.

I have two questions related to the inflammation cases. First, do any of the people on the civilian or the military side, are they still having problems or have they all recovered? Could you just tell us something about their condition.

And secondly, the screening provisions that you've put into place, as I understand it, would not do anything to prevent these cases because the sort of history of heart disease, as I understand, is not related to inflammation of the heart. So what can be--if I'm right about that--what can be done about trying to prevent these inflammation cases?

DR. ORENSTEIN: Okay. First of all, we know that all cases in the military have completely recovered. They were not that sick and they are going, as far as I know, are going about their regular duties.

In terms of the physician [?] population, I have preliminary information but I'm concerned I don't have adequate information to say whether they're recovered or not. My belief is that they have also recovered fully. In terms of screening for risk factors for myocarditis and pericarditis, that's part of what we will be talking about when we discuss with cardiologists, and others, whether there are risk factors that we can use to exclude people. We do not at the moment have such risk factors.

On the other hand, there are clear risk factors for coronary artery disease and that's why we have made the recommendations that we did, to try and pick out the risk, highest risk factors for coronary artery disease.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Maryn McKenna with the Atlanta Journal-Constitution. Please go ahead.

QUESTION: Hi. Thanks for doing this.

My question relates to the ruling out potential vaccinees if they have a known history of heart disease.

Dr. Orenstein, given that the two deaths were both in women, that women have, that the health care population is more than 50 percent female, and that women tend to be underdiagnosed with heart disease compared to men, do you have any concerns that a known history of heart disease won't be sufficient to screen out people who might potentially be at risk of ischemic responses to vaccination?

DR. ORENSTEIN: Thank you. It's a very good question, Maryn. Clearly, if we look at all known risk factors for coronary artery disease, we would potentially get to very, very large numbers of the population, and we would, in essence, be very--very difficult to enhance our preparedness.

What we've tried to do is pick out people with the very highest of risk factors, in the absence, at this point, of any known causal relationship.

The issue of women is a very important one. Women are not only disproportionately represented in the cases. They're disproportionately represented in the vaccinees. About two-thirds of the vaccinees are women, and women make up a larger proportion of the health care worker task force, and this may in part explain why we're tending to see more of these cases in women, and one of the things that we will be consulting with cardiologists over the next days to weeks is to see whether there are other risk factors and other issues we ought to be doing for evaluation.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Marilyn Marchone [ph] with Milwaukee Journal. Do you have a question on smallpox?

QUESTION: Yes, I do. Dr. Orenstein, I understand you're mostly talking about adverse events but some of us just finished a conference call with the Institute of Medicine and there's a great deal of confusion about whether Phase II is starting with other emergency responders.

Has CDC made any determination about beginning Phase II smallpox shots, and if so, are states free now to begin?

DR. ORENSTEIN: We are planning to issue guidance by mid April on further vaccination against smallpox. Certainly states, at this point, are free to increase their vaccination target populations as they feel important, but we will be issuing guidance by mid April on this.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Rachel LeClerk [ph] with the Associated Press. Do you have a question on smallpox?

QUESTION: Yes. This is getting back to the second death being reported here, this woman from St. Petersburg. Any sort of timeframe on determining the connection between her prior heart problems and the vaccination?

DR. ORENSTEIN: It's hard to give an actual timeframe. Clearly, we have epidemic intelligence service officers in both locations where the deaths occurred, to try and collect more information and ideally specimens that will allow us to look for virus, if it happens to be in the heart tissue, to look for signs of more diffuse inflammation, if inflammation is an inciting event for someone with underlying heart disease for a heart attack, and that will take some time.

I really can't tell you at this point. We do have involved a variety of people in this, including cardiac pathologists. We have our virologists here, at CDC, and others, to try and look at this.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Kerry Fursnyder [ph] with Arizona Republic. Do you have a question on smallpox?

QUESTION: Yes. [inaudible] vaccinations were stopped in 1972, were there ever any reported problems among children or adults receiving the vaccine in terms of cardiac issues?

DR. ORENSTEIN: The greatest experience with regard to cardiac issues came from Europe, where there were reports of myocarditis and pericarditis in the past, but not with the strain of vaccine that we use in the United States, the New York City Board of Health strain.

There are always case reports of different things, but certainly heart problems were not an accepted, or scientifically accepted adverse event of smallpox vaccine with vaccine use in the United States.

In terms of the issue of coronary event and smallpox vaccine, that too was not an accepted adverse event. Certainly, there may be occasional reports of this but not enough to support a role for vaccine causing any of these events.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Helen Chickering with NBC News. Do you have a question on smallpox?

QUESTION: No; thank you.

MODERATOR: We do have a question from Ceci Connelly with the Washington Post. Do you have a question on smallpox?

QUESTION: Yes; thank you. Doctor, earlier, we were on a conference call with the chairman of the IOM advisory committee and its report coming out today, and they continue to express concern about having enough of what they describe as a pause, to evaluate, say, how your Phase I is going. Their initiate desire was before you moved into Phase II. It seems that now we're, in some respects, already in Phase II while still operating in Phase I.

I'm wondering if you can respond to some of the IOM concerns about the lines of the Phase II potential population is very different from your Phase I target population and so in terms of public health, is it really wise to begin vaccinating police, firefighters, EMTs, without giving guidance in terms of information packets, consent forms, what kind of education and training you might need?

It seems that so much work went into the preparation for Phase I and now we don't really see any, and we're in the middle of Phase II.

DR. ORENSTEIN: I think those are good points. In terms of the information packet, our intent would be to use the same kinds of information packets that we are currently using, which gives people quite a bit of detail, as you know, on a variety of issues with regard to smallpox and smallpox vaccine safety.

We are also in the process of developing revised forms, which we're working with our states on.

We plan on distributing guidance with regard to program expansions in mid April and so that guidance will be used, I presume by the states, in developing the ways they will move into Phase II.

Some states and areas have already selected as part of their initial response teams a number of the staff that might be suggested for vaccination in Phase II, such as security workers who might need to keep order for clinics and other kinds of events.

And so again, we are concerned, we are evaluating as we go. An example of that clearly is what we're doing with the cardiac disease in this program and trying to get information out as quickly as possible to people.

So we are not recommending a pause, but because of the concerns of the need to get prepared, particularly with the other events going on in the world at the moment.

CDC MODERATOR: Next question, please.

MODERATOR: We do have a question from the line of Richard Knox with National Public Radio. Do you have a smallpox question?

QUESTION: Yes. I do.

Thank you for having this. It's really following on Ceci's question. Because of the greater definite evidence for some kind of inflammatory process with the vaccine, is there some reason to do a pause now before moving to a broader first responder population, while that can really be worked out, because, after all, you may have a lotta people in that population who would worry about their risk for that.

Also, I wonder whether, in your deliberations about the guidance for that and for Phase I, you are considering whether to recommend explicitly that people be vaccinated for this pre-vaccination effort, only if they've had prior vaccination to minimize that.

DR. ORENSTEIN: First o fall, what we have done with regard to myocarditis and pericarditis, is we will be discussing over the next several days, with a variety of experts, what should be done with regard to those cases.

In the meantime, we do feel that clinics that are scheduled should go on with the new information which we have recently distributed to the states.

Your second question was on--can you review the second question again, or your second part of it.

CDC MODERATOR: Let's go on to the next caller.

MODERATOR: We do have a question from Debosiya Ricks [?] with [inaudible]. Do you have a smallpox question?

QUESTION: Yes. I do. It's Delphia [?] Ricks. My question is in the meetings that you'll have over the next several days, are these open to the public and will you be releasing any information whatsoever regarding any of the results that come of it?

DR. ORENSTEIN: I think I remember the second question, if I could answer that first. The issue of should we focus vaccine solely on persons with revaccination, based on the information from the military, which suggested that the myocarditis and pericarditis was only in first-time vaccinees, we have actually put out recommendations in the past, that where feasible, health programs should focus their vaccination program on revaccinees, and so you can tell from the age group of the serious cases of heart disease, that is, the heart attacks and the angina cases, they're all in an age group where they most likely had had prior vaccinations.

So at the moment, I don't think we're prepared to try and limit it only to revaccinees, until we understand a little bit more about what's going on, simply because we're moving into a more at-risk age group, and in fact the data from the military suggests that the cases of myocarditis and pericarditis were all very mild and all followed by full recovery.

In terms of the meetings, we do have a meeting on Friday, which is our major meeting with our Advisory Committee on Immunization Practices, supplemented by the Armed Forces Epidemiological Board. That will be an opening meeting and we will be putting information up on how media and others can get access to it.

CDC MODERATOR: Out of deference to Dr. Orenstein's schedule as well as your own, this will be our last question.

MODERATOR: We do have a question from the line of Marcus Franklin with St. Petersburg Times. Mr. Franklin, do you have a smallpox question?

QUESTION: Yes; thank you.

Doctor, is there any timetable here with regard to when you'll be making the determination as to whether the death of Virginia Jorgensen [ph] here, in St. Petersburg, is in fact related to the vaccination?

DR. ORENSTEIN: We have no timetable. We clearly are working as quickly as we can. It will depend on the quality of information we have and, perhaps more importantly, the information we get on other cases, because to make decisions on a single case can be very, very difficult.

What needs to be seen is patterns or unusual patterns, help in trying to differentiate that this is different than other kinds of events, and so it's not just simply an investigation of the death of the 57 [?]-year-old female but it's also the overall investigation that takes place and the collection of information on cases that haven't died but who have significant cardiac events, again, all of it put together to see if we have a pattern. Thank you.

CDC MODERATOR: Thank you, Dr. Orenstein. because of the importance of this issue, as Dr. Orenstein mentioned, the Advisory Committee on Immunization Practices, or ACIP, is meeting tomorrow and we are trying to set up an open listen-in line for reporters, so please watch for a media advisory on that. This concludes our briefing today. Thank you for staying with us.

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