Smallpox Home

CDC Telebriefing Transcript

Update on Smallpox Vaccination Program

March 25, 2003

MR. SKINNER: Thank you, Mary, and thank you all for joining us this evening where tonight we are going to provide you with a brief update on the smallpox vaccination program and really take time to inform you of some important developments in regards to some adverse events possibly associated with the smallpox vaccine.

I'm going to turn the program over to the Director of the Centers for Disease Control and Prevention, Dr. Julie Gerberding, who will give you just a brief update on where we stand. And then we'll certainly open up the floor for question and answer.

Dr. Gerberding, go ahead.

DR. GERBERDING: Thank you.

As you know, CDC has been involved in supporting the civilian smallpox vaccine program for the past several weeks, and when we started this program we made a commitment that we would put the safety of the individuals involved in the program first, and we would do everything we could to monitor the safety of the program in real time, and update the public as well as vaccine recipients and the partners in this endeavor, whenever we have a concern about a potential health issue that could affect the vaccine safety.

We have received several reports of cardiac-related problems among the 25,000 or so people who have been vaccinated in this program. There are seven of these reports that we are going to concentrate on this evening. These reports include three patients who have sustained myocardial infarctions. One of these patients has died, and the other is on life support.

We also have described two cases of angina, or chest pain, and two cases of myocardial or pericardial inflammation. Five of the seven cases have already been reported in the MMWR as part of our ongoing effort to provide updated information. And we have also presented these patients to our Vaccine Program Safety Monitoring committee, which is a subset of the ACIP, or the Advisory Committee on Immunization Practices that is charged with responsibility for looking at the safety of the program.

The Advisory Committee met on Thursday and Friday of last week and had evaluated six of these seven patients at that point in time, and has provided some verbal feedback, suggesting that we needed to be taking a closer look at a potential association of cardiac events with the vaccine program. But at that point in time there was no indication to change the program.

However, over the weekend we learned that an additional patient had died, and today we learned that the cause of death in this patient was indeed a heart attack related to coronary artery disease.

And I want to say a few things about the five patients who have had the coronary artery disease related complications, the three with MI, and the two with angina. All five of these patients have very clear defined risk factors for coronary artery disease that is known in their medical history, and are people who would medically be considered to be at perhaps increased risk of these conditions, based on their past medical history.

We also recognize that in the past vaccination programs for smallpox before the design was eradicated, we didn't have a lot of experience vaccinating older people, although we did have some experience because travelers, for example, to parts of the world that still had smallpox underwent vaccination. And there is no known association throughout that experience with any kind of cardiac events associated with immunization.

But we acknowledge that we don't have a lot of epidemiologic or scientific information about the relationship between vaccine and cardiac illness in persons who are older and who were not involved in the childhood immunization program where we had the most experience in the '60s.

So what we know right now is that we have seven patients with what looks like coronary artery disease and two additional patients that have inflammatory conditions that have affected the heart. One of the patients, the patient with myocarditis, was very carefully evaluated a few weeks ago, and deemed not to have an illness related to the vaccinations, since they were ill before they were vaccinated. But we're including that individual in this list just for the sake of completion. The other individual had a mild case of what was probably pericardial inflammation, an experience consistent with what we understand might be a condition in other people who are being vaccinated for the first time.

We are doing several things. And I wanted to sort of outline for you how we are responding to this information. As I said, safety is our priority, so as a precaution we are taking a number of steps until we can have more information to help us determine whether or not the vaccination has any relationship at all to the onset of illness in these individuals.

We learned about the patient who died over the weekend on Sunday. As I said, yesterday I convened the various experts at CDC to review information about this patient and make sure we really had a clear understanding. We conferred with health officials in the involved state. We notified our vaccine safety working group. And we also conferred with the Department of Defense to learn if they were seeing any similar problems in their vaccine program among older people who might be at risk for coronary artery disease.

We also sought input from experts in cardiology and coronary artery disease, and then we notified yesterday afternoon the Department of Health and Human Services, and developed a plan for the next 24 hours of the steps that we would take to further evaluate this situation and determine what if any changes might be necessary in our vaccination program.

So, we have taken several of those steps, including another consultation with experts from FDA, and other components of Department of Health and Human Services, Dr. Fauci from the NIH, and so forth. And at 4:30 this afternoon we brief Secretary Thompson, and Secretary Thompson made the decision that we would make a change in the vaccine program.

And what we are doing in the program right now is certainly not stopping the program, because we recognize that this is still critically important to our preparedness capacity. But we are taking a precautionary step of adding a temporary medical deferral to the vaccination program for persons who have been diagnosed with serious heart disease.

The serious heart disease that we include in this deferral include conditions that involve either coronary artery disease or myocardial disease such as angina, a history of a heart attack, congestive heart failure, or any kind of cardiomyopathy, or a physician diagnosis of coronary artery disease.

And so we will be making some tools to help our state and local health agencies who are involved in the vaccine program be able to screen, using a simple tool to identify people who might fall into these categories, in asking that they defer vaccinations until such time that we have more information to decide whether or not it is safe for them to continue to be included in the program.

We will also be convening an expert panel of cardiologists and immunologists, who may have expertise and can help evaluate the biological possibility of the association between vaccination and cardiac toxicity.

And we will be doing some scientific evaluations to determine whether or not epidemiologic evidence suggests that deaths in this population of vaccinees are occurring at a rate that is higher than we would expect from age-matched people in the health care population who are not undergoing those vaccine programs. That is going to take us a little bit of time and we didn't want to make to make a deferral in the program while we sorted that out. So we decided to go ahead and take this precautionary step until we get additional information and input from a broader variety of experts.

We are also continuing the overall vaccination program. Certainly we are a time in the history of our country where the potential for terrorism has probably never been higher. And we recognize that we must continue to be prepared to deal with a threat of smallpox in our nation. And so we are going to continue the program.

But we're also going to continue the program with the caveat that safety still is a high priority for us. And we will continue to monitor people who are volunteering for the program, and as we did in this case, in very fast order identify potential hazards or threats, draw them to the attention of our advisors and experts, and take precautionary action when necessary to protect the safety of the volunteers.

We appreciate your being here tonight. This was not something that we started out to do this morning in the context of SARS and everything else that's going on at CDC. But when we made a decision like this, we wanted to first let the health officers know and then communicate this evening. This will also help ensure that tomorrow as our vaccine clinics get scheduled, that we'll have people ready to initiate the screening process, and make sure that we're taking all the steps we need to take.

We'll also make our clinician hotline services available to people who are concerned about the risk if they've been recently vaccinated, or they're considering vaccination, and take additional steps to provide information to people interested in vaccine, so that they have all of the information that we can put in their hands to help them make an informed and fair choice.

So thank you.

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

MODERATOR: Thank you. Ladies and gentlemen, if you do wish to ask a question, please press the '1' on your touch tone phone. You will hear a tone indicating you have been placed in queue. If you pressed '1' prior to this announcement, we ask you please to do so again at this time. You may removed yourself from queue at any time by pressing the pound key. If you are using a speaker phone, please take off your hand set before pressing the numbers. And once again, if you do have a question, please press the '1' at this time.

MODERATOR: The question comes from the line of Monica Conrad, ABC News. Your line is open.

CDC MODERATOR: Monica?

[No response.]

MODERATOR: Her line is open.

CDC MODERATOR: Next question, please.

MODERATOR: And the next question comes from the line of Anita Manning with USA Today. And your line is open.

QUESTION: Thank you. Can you hear me?
CDC MODERATOR: Yes. HI, Anita.

QUESTION: Hi, Tom.

Dr. Gerberding, you mentioned that there were three patients with, I'm scrolling back up, myocardial infarction. One died and one was on life support. What about the third person? And can you give us any detail about these people? Their ages? Their states? Anything like that. Their genders?

DR. GERBERDING: I'm not going to provide information about the location of the patients. The initial patient was diagnosed with coronary artery disease and has been hospitalized, but is no longer in the hospital.

QUESTION: Okay.

DR. GERBERDING: Both that patient and the person who died over the weekend will be included in the MMWR report this Thursday.

QUESTION: Thank you.

CDC MODERATOR: Next question please.

MODERATOR: The question is from the line of Larry Altman of New York Times. And your line is open.

QUESTION: Yes. Dr. Gerberding, can you provide something about the age and the gender of those patients. And the reason I ask is the stage of the vaccination program as I understand it is now in health care workers first responders. So one would assume that these are relatively younger patients, or younger people who became patients, and not the general population at large. But could you clarify this? Because that seems like an important point for the public.

DR. GERBERDING: Thank you. Yes.

First of all, let me address that women are over-represented in the health care workforce and women are over-represented in our vaccine population. The three patients that have sustained myocardial infarctions are all women, and they are all in their 50s. And I think that's, you know, an explanation for that has to do with the denominator as well as the factors that you mentioned.

And I would just stress again that all of these individuals had very clear risk factors for myocardial disease. So we are not talking about people with no unknown reasons to have ischemic disease. And that's why we cannot necessarily ascribe any relationship of vaccination to these events. It could be entirely coincidental. But until we know that for sure, we're taking this precautionary step.

QUESTION: But ballpark, how long an interval between vaccination and the events? The adverse events?

DR. GERBERDING: It's actually very variable, and there's a lot of complexity in describing each individual case history, which I'm not prepared to do right now. But basically the intervals varied from five days to 17 days.

QUESTION: Five days to 17 days. And all the individuals you're talking about a health care workers?

DR. GERBERDING: I don't know that for a fact. I don't have their occupations. But they would be members of smallpox response teams. So they would be either public health personnel or health care personnel.

QUESTION: Uh-huh. Okay.

CDC MODERATOR: Thanks, Larry.

Next question, please.

MODERATOR: The next question is from the line of Laura Meckler with Associated Press. And your line is open.

QUESTION: Thank you.

I have a couple questions. [inaudible] and forgive me if I ask you to repeat yourself. Are all seven of these have a history of some sort of heart disease or some sort of heart problem?

DR. GERBERDING: Let me talk about the patients who have had the kind of heart disease that we would refer to as ischemic heart disease. So the three heart attacks in the patients with angina. All of these individuals have had a history of factors that are associated with an increased risk of coronary artery disease. The two patients that had the myocarditis and the patient with the pericarditis are individuals who do not have a history of coronary artery disease risk factors. Not surprising since neither of these conditions are associated with those risk factors.

QUESTION: Okay.

And when you went to the Pentagon to ask them what their experience had been, I know of at least one case that the Pentagon reported of, of a heart association. But what did they tell you?

DR. GERBERDING: You know, I'm not going to speak on behalf of the Pentagon. I think we'll look forward to getting that information directly from them. But basically, what we've learned from their experience is that they have two basic populations of people: people who are young, healthy, primary vaccinees, and people who are a bit older and have been vaccinated in the past. And their experience so far has not documented the coronary artery disease events that we're concerned about here.

QUESTION: They have not found the same thing that you found?

DR. GERBERDING: So far.

QUESTION: Okay.

CDC MODERATOR: Next question, please.

MODERATOR: The next question comes from the line of Brendan O'Connell with WTTG in Washington. Your line is open.

QUESTION: Thank you for your time. I just wanted to clarify, because I've been on the phone, AP wires, and [inaudible] the story. They say the woman who died here Maryland was vaccinated on the 18th and died five days later on the 23rd. Is that consistent with your information?

DR. GERBERDING: I'm not prepared to provide the specific dates or details. I would really like to defer the specific information about the patient to the health department, and I'm not sure that they've issued their press information yet, because they're working with the family in the situation.

QUESTION: They're actually the one to quote in here, the state health department, Maryland State Health Department.

CDC MODERATOR: Do you have another question?

QUESTION: No.

MODERATOR: Okay. The next question comes from the line of Richard Knox with NPR. Your line is open.

QUESTION: Yes. Hi. Thanks.

Can you say at this point what you think the hypothesis might be about what may, if anything, what may be causing this? I mean are you entertaining an inflammation hypothesis that might tie these things together? Or just what's on the table?

DR. GERBERDING: I think the first hypothesis is that this is not causally related. And that's the null hypothesis in this case that we're working from. But I think there is also at least biological plausibility that when you have a viral infection which is basically what happens when you issue the vaccine, that there could be inflammatory response that in some unidentified way exacerbates pre-existing coronary artery disease or inflammation. And that's why we're convening the expert cardiologists and immunologists tomorrow to really make sure that we pull together all the information that would bear on this, and get their advice and input about the plausibility of this association and what if anything we can do to define it or identify it more clearly.

QUESTION: As a follow-up, that does lead to what I was going to ask about what are you going to be doing to try to nail this down one way or the other?

DR. GERBERDING: Well, again, the first step is get input from people. There are situations that often come up in public health where you see an adverse event or you see any kind of an event, a temporal association to an intervention. And there's a whole science around trying to determine whether it is by chance alone or whether it is in fact directly attributable.

But the first step, really, in addition to getting expert advice is to really do a much more thorough assessment of the cases of these events so that we are understanding all of the details that might have a bearing on the risks in these individuals, and ascertain that the information we've gotten so far is in fact correct and reliable.

We will also be considering ways to identify the expected frequency of these events in a comparable population. We have a number of coincidental populations with people under study for a variety of reasons and some of these studies to ascertain risk factors for cardiovascular disease and would be sources where we could identify the incidence of events in populations that might be fair control groups, if you will, for the vaccine recipient.

And then there is some detailed research type studies that we can do, but we would of course want to design those with input from vaccine volunteers and the IRB and other resources that would really put them more in the research category.

All of those types of actions will take time, and we are not going to get information or answers or clues from them without a great deal of investigation. And again, I just am stressing that that is why we are taking the precautionary steps tonight, because we have decided with Secretary Thompson's leadership to err on the side of asking this particular group of potential vaccine volunteers to defer for now, until we do have the information that would reassure them of the safety of the program.

CDC MODERATOR: Next question, please.
MODERATOR: The next question comes from the line of Elizabeth Cowan with CNN. And your line is open.

QUESTION: Hi, Dr. Gerberding.

Did these seven patients have any other reaction to the inoculations? Anything that was at all, came that your attention, anything at all abnormal?

DR. GERBERDING: No. As far as we know, the vaccine per se was administered in the normal way, and there were other related adverse events. But that will be one of the things that we will be checking on when we do a more thorough evaluation.
QUESTION: And as a follow-up, can you go through again the three? The one that died, the one on life support, and the one who was released from the hospital. What were their exact heart trouble history?

DR. GERBERDING: I'm not going to give that in great detail. But I'll just describe in general, the heart conditions included in these individuals factors such as poorly controlled diabetes, hypertension, hyperlipidemia, obesity, prior history of chest pain and angina, tobacco use, hypertension, possible history of a stroke, on hypertension medications, and diabetes and other of the known risk factors. I don't have information about family history or obesity in these individuals and some of the other risk factors I'm not mentioning may or may not be present. That's another aspect of the medical history that we'll review in more detail when we are evaluating the patients.

QUESTION: And these are not things that would have made them ineligible to get the inoculations? In other words, if someone is HIV positive, they can't get it. But all the things you just listed, you're still okay to get it?

DR. GERBERDING: Now, there are many medical conditions that, as you know, are contraindications to vaccination, and what we're saying right now is that we're going to add coronary artery disease or myocardial disease to the list of medical conditions that would be reasons to defer vaccination at this point in time.
QUESTION: Okay. Thank you.

DR. GERBERDING: Also I want to stress that we're talking right now about the pre-event vaccination program. And should we have a smallpox attack, we would have a very different set of expectations about who would be vaccinated, because if the threat is eminent, then we would want people that err on the side of protection.

CDC MODERATOR: Next question, please.

MODERATOR: The next question comes from the line of John Lauerman with Bloomberg News. And your line is open.

QUESTION: Thanks for taking my question.

Are you going to be issuing any kind of an alert for people with a history of heart disease who have already received the vaccine?

DR. GERBERDING: Yes. We're going to be taking a number of steps, preparing things as we speak. And we'll be putting them out tomorrow and the next couple of days. Certainly, we'll get something up on the internet very shortly.

We're also creating tools for health departments.

We're counting on you to help get the word out through the media. And we have some suggestions about other means that we could more directly interact with recent vaccinees. As you know, people who are vaccinated return to have their vaccine take evaluated seven days after the immunization, and that's an ideal opportunity to let them know that there is an additional concern, and if they have any symptoms or worries, to consult with their medical provider.

QUESTION: And this is a follow-up.

Is there any estimate of how many people might become ineligible for the program?

DR. GERBERDING: We are trying to make an assessment of that. And right now we can really base our estimates on what we know about the general population. But certainly, given the distribution of ages and the relatively good health of employed people, we are expecting this to be certainly less than 10 percent of vaccine recipients. And some have said less than 5 percent.

QUESTION: Thank you.

CDC MODERATOR: I think we'll take two more questions, please.

MODERATOR: The next question comes from the line of Mary McKinna with Atlantic Journal [inaudible]. And go ahead, please.

QUESTION: Hi. Thanks so much for doing this.

Dr. Gerberding, I wanted to ask. You said that the temporary deferral will be aimed at people, I'm just scrolling up here to make sure I get your words correct, for people who have already been diagnosed with serious heart disease, conditions, coronary artery disease, myocardial disease, angina, history of heart attack. My question is heart disease of all kinds tends to be underdiagnosed in women. And you said that the health care worker population tends to be slanted more toward women. So, I wonder what you folks are thinking about that potential vulnerability at this point?

DR. GERBERDING: Well, I think that's one of the reasons that we're going to get our experts in cardiology together tomorrow. Because, you know, in the world of cardiac risk assessment, there are already a number of proven tools for identifying who is at increased risk for a cardiac event such as a heart attack. And so we really want to get their input. And the conditions that we define tonight are those that we're prepared to work with first thing in the morning. But we know that this may evolve, or be revised as we get better input from the experts.

So for the first step, we will certainly be addressing the concern you raised, as well as a number of other concerns as we try to make a sensible implementation strategy.

QUESTION: Can I ask a follow-up?

CDC MODERATOR: Yes.

QUESTION: Following up on that, I've heard just sort of anecdotal reports from a number of states that it has been older people who have tended to step up for a vaccination, first because they are not primary vaccinees, and therefore they think they'll have lesser reactions. And also because they want to inspire their staffs, whether they're medical staff or public health workers. Would you consider doing anything along the lines of discouraging senior staff to step up?

DR. GERBERDING: I don't think that we are prepared to take that step in this point in time. We did have some discussions about that today. But again, we'll defer to the expert input that we anticipate receiving from people who are the most credible in the world of cardiac risk assessment.

CDC MODERATOR: Okay. Mary, we'll take one final question, please.

MODERATOR: All right. And the final question comes from the line of Laura Meckler with AP. And your line is open.

QUESTION: I just wanted to ask a follow-up. And that is obviously, you guys have been working hard to get people to participate in this program. Are you at all concerned that these reports will, you know, dampen enthusiasm for it beyond whatever is out there already?

DR. GERBERDING: I think that there is going to be some questions and some concerns. And what we would like to emphasize is that as we promised, we would try to evaluate the safety of this program as we go forward, and when we have any question of a doubt, we will act quickly to take steps that assure people that we're watching out for them, and that we want their safety to be our priority.

I think a population of people that we hope will continue to participate on the smallpox response team is a very broad cross-section of the health care delivery system and the public health community, and that the vast majority of people who would be considered for this program would not be affected by this deferral. It just is another medical condition, nonetheless.

And every time we put something on the list of medical conditions that constitute a basis for deferral, we recognize that it does decrease, to some extent, the population of people who are willing to volunteer. But it's a balance. And I think, again, we want to err on the side of safety.

QUESTION: Thank you.

DR. GERBERDING: Let me just close by again saying that while we're putting a lot of detail around why we are taking this step tonight, we don't know that these events are associated with vaccine. Coronary artery disease is a very common condition in our society, and people who have strong risk factors for coronary artery disease do develop angina and have heart attacks all the time. So we cannot say that what we've observed in these vaccine volunteers is a greater frequency of this problem, greater than what we would expect under other circumstances. But we will certainly do everything we can to get to the bottom of this issue.

Safety really is important. It's a priority for this program. And we are going to continue the program with that in mind, as we help prepare a nation for a potential bioterroism event.

I really thank you for joining us, and we will certainly do everything we can to keep you up to date and informed as this vaccine program evolves, and we learn more about the specific reason that we contacted you tonight.

So thank you.

CDC MODERATOR: Thank you all for joining us. And Mary, I'd like to make a note that the phone company will make available for replay at midnight tonight, a replay of this call. And folks can call in to 1-800-475-6701. The access code would be 680-050. And we at CDC will have a full transcript available early in the morning.

So thank you all for joining us tonight.

MODERATOR: Ladies and gentlemen, that does conclude your conference for today. Thank you for your participation in this teleconference service. You may now disconnect.

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