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CDC Telebriefing Transcript

Update: Smallpox Vaccination Program

February 27, 2003

CDC MODERATOR: Good afternoon, everyone, and thank you for your patience. We were waiting a few more folks to get on the line so everyone could hear the telebriefing.

Welcome to the Centers for Disease Control and Prevention's telebriefing update. Today's briefing will discuss this week's Morbidity and Mortality Weekly Report article on Smallpox Vaccination Adverse Events. The article will be posted on our website later today.

I ask that you limit your questions to CDC's reporting of smallpox vaccine adverse events on today's briefing. If you have other questions regarding the smallpox vaccination program, please contact the main CDC Press Office.

A full transcript of today's briefing will be available on CDC's website after 4 o'clock Eastern Standard Time today.

Now, I'd like to introduce Dr. Eric Mast, who is an immunization expert at CDC. Eric is spelled E-R-I-C. Mast is M--as in Michael--A-S, as in Sam--T, as in table.

Dr. Mast will begin with a brief statement and then take your questions.

Dr. Mast?

DR. MAST: Thanks, Von.

Good afternoon. We wanted to share information with you concerning two adverse events that have occurred from the civilian smallpox vaccination program and are being reported in the Morbidity and Mortality Weekly Report today.

One of the adverse events, generalized vaccinia, has been previously associated with smallpox vaccine, while the other, angina or chest pain, is not known to be causally associated with smallpox vaccinations.

I want to remind everyone on the call that an important goal of the smallpox vaccination program is to maximize protection and minimize risk for all vaccinees. Vaccine safety is a high priority. We have known from the outset that vaccine reactions will occur after a smallpox vaccination and that some of these reactions may be moderate to severe or potentially life-threatening.

In collaboration with state and local health departments and hospitals, we are actively tracking all vaccinees to determine if they require medical care, either outpatient visits or hospitalization after vaccination. To date, our tracking systems have been successful in identifying patients with moderate to severe or potentially life-threatening adverse events after vaccination.

In addition, we are tracking vaccinees to determine if there is any transmission of vaccinia to their contacts.

Since we are asking clinicians to report any type of unusual medical event that occurs after vaccination, we know that there will be a wide range of illnesses that are reported, and we need to recognize that some of them may be caused by the vaccine and some of them may not be. Regardless of which group they fall into, we are investigating all of the moderate-to-severe events, both to verify the diagnosis and to assess the clinical course and outcome of the patient.

In addition to CDC investigating all vaccine adverse-event reports, there is also an external independent body, a working group of the Advisory Committee on Immunization Practices that reviews all reported vaccine adverse events on a weekly basis.

This group also makes recommendation to CDC about whether further investigation is needed to identify a causal relationship between the vaccine and an adverse event and also whether the number of adverse events previously known to be caused by the vaccine is higher than expected.

I would next like to briefly review for you the report that's in the MMWR this week. During January 24th to February 21st, 2003, smallpox vaccine was administered to 7,354 civilian health care and public health workers in 40 jurisdictions. No potentially life-threatening events previously known to be caused by smallpox vaccination have been reported.

Today, in MMWR, we focus on two adverse events that have been reported. Note that our policy is to protect patient confidentiality, so that only a basic description of the individuals will be released by CDC.

One moderate-to-severe adverse event was reported. This was a suspected case of generalized vaccinia in a 39-year-old woman, and further details on this report are available in the MMWR report.

The other serious adverse event that was reported was angina or chest pain in a 60-year-old man with a history of hypertension and a family history of coronary artery disease. Angina is not known to be associated with smallpox vaccination.

Finally, I want to reiterate that surveillance for adverse events during the civilian smallpox vaccination program is ongoing, and I would like to give you some background information on how adverse events are going to be regularly reported in the MMWR.

Potentially life-threatening and moderate-to-serious adverse events are classified on the basis of evidence in support of the reported diagnoses. For probable cases, other causes are excluded and supportive information is available. Events are classified as suspected if they have clinical features compatible with the diagnosis, but either further investigation is required or additional investigation of the case did not provide supporting evidence for the diagnosis and did not identify an alternative diagnosis.

In general, case vignettes will be provided in the MMWR when potentially life-threatening, moderate-to-severe or other serious adverse events are first reported.

We also are reporting other nonserious events, and these events are usually mild, but we need to recognize that these events are going to be reported through passive surveillance and are expected to be underreported. For these nonserious events, we will provide the total number of cases reported and a description of the most common signs and symptoms reported by these patients.

Thank you.

CDC MODERATOR: Thank you, Dr. Mast.

We now will take questions and answers from the audience.

AT&T OPERATOR: Thank you.

Ladies and gentlemen, if you wish to ask a question, please press the one on your touch-tone phone. You'll hear a tone indicating you have been placed in queue, and if you pressed one prior to this announcement, we ask that you please do so again at this time. You may remove yourself from queue at any time by pressing the pound key, and 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.

And our first question comes from Maggie Fox with Reuters. Please go ahead.

QUESTION: Hi. Thanks very much. Can you tell us when and how you will determine that this one patient with generalized vaccinia, suspected generalized vaccinia actually has it. How do you go about determining that?

DR. MAST: Well, this is a case--we're classifying this as a suspected case because the patient has signs and symptoms that are characteristic of generalized vaccinia. Specifically, they have a pustular rash. We will be able to further characterize that case based on laboratory findings and there's virological testing of the patient that's in progress, and we'll be able to classify the patient more once we have those tests.

In addition, we can determine how the rash progresses and use that to better characterize the patient in terms of determining whether it's a probably case or a confirmed case of generalized vaccinia.

If we isolate virus from the lesions it will be a confirmed case. If we don't isolate virus form the lesions, it will remain either a probably or a suspected case.

QUESTION: And is she otherwise ill? Does she have a fever or anything like that?

DR. MAST: She's being treated as an outpatient and her rashes are resolving at this point in time.

QUESTION: Thank you.

CDC MODERATOR: Next question, please.

AT&T MODERATOR: And we have a question from Cici Connolly with Washington Post. Please go ahead.

QUESTION: Thanks, and I apologize if some of this information is in the MMWR, although I don't believe we have that document yet. Can you be a little more specific in terms of when each of these events was reported to CDC and was that immediately or was there a lag? Can you also help us in terms of--I realize you have patient confidentiality concerns, but what state or jurisdiction? Are they hospital workers, state public health employees?

And I think the very obvious question is: Do they have health insurance that covers the care?

DR. MAST: I can give you a few more details about the cases since you don't have those in front of you. The 39-year-old woman with generalized vaccinia was reported to CDC in the past week. All these cases are cases that are reported to CDC in the last week.

QUESTION: Well, can you be a little more precise since the postings on your Web site keeps changing.

DR. MAST: This is the first, these are the first reports of moderate to severe or life-threatening adverse events that have been reported by CDC. In our last report, which was last week, there were no moderate to severe, or life-threatening cases that were reported. So these are the first--

QUESTION: Okay. So that was eight days ago. Can you be a little more precise.

DR. MAST: All I can say is that they were reported in the last, during the last week to us.

QUESTION: During the last eight days. That's all you know.

DR. MAST: Right.

QUESTION: And were they reported immediately?

DR. MAST: We're asking vets that life-threatening and moderate-to-severe cases be reported to CDC within--well, life-threatening ones that require vaccine immune globulin be reported immediately and those that are moderate to severe be reported in, within 48 hours.

These ones were reported to CDC in a timely fashion. Let me give you a few more details about the cases.

For the generalized vaccinia, nine days after receiving smallpox vaccination the patient reported increased pain at the vaccination site, malaise and headache. The following day, she developed a rash on her chest and back which progressed to scattered pustules by day twelve, post-vaccination.

She was treated as an outpatient and by day 15 the rash was resolving. There are specimens from the pustular lesion collected and sent for virologic testing and the results of these tests are pending.

The other serious adverse event, angina in a 60-year-old man, with a history of hypertension, a family history of coronary artery disease, for this patient the individual had a onset of chest pain while exercising four days after smallpox vaccination and reported to an emergency department. Angioplasty was performed and he was discharged after a two-day hospitalization.

In terms of the states where these occurred, we cannot release that information but the states in question are also investigating these and we expect that they will be releasing their own report, and we don't know the insurance status of this, either of these individuals.

CDC MODERATOR: Can we have our next question, please.

AT&T MODERATOR: And we have a question from John Lowerman with Bloomberg News. Please go ahead.

QUESTION: Hi. Thanks for taking my question. I'd like to know how you would establish--what would you be looking at to establish any kind of a link between smallpox vaccination and the 60-year-old man who underwent angioplasty? That is, is there any connection that you do suspect and how would you establish that connection? And then I have one more quick question after this.

DR. MAST: Well, angina is not known to be associated with smallpox vaccination. It's never been previously reported to be associated with smallpox vaccination. So it's unlikely that it would be associated with smallpox vaccination.

If there were more cases of angina that were reported, we could do controlled investigations to assess whether there was a causal relationship between vaccination and angina or any other events, unusual events that occurred after vaccination. But it's difficult to do that based on a single case.

QUESTION: So you can't look at like sort of inflammatory markers or anything like that to--

DR. MAST: With a single case you couldn't look at causal relationships. If you could isolate virus from a particular organ, for example, so if there was--if there's virus isolated that was pathologically related to the diagnosis, then it could be causally related.

QUESTION: And you won't be doing that? Or you will?

DR. MAST: In this particular instance, no.

QUESTION: Okay. So you'll look at it from a epidemiologic point of view, solely?

DR. MAST: For this particular case, we'll look at it just from an epidemiologic perspective. For other types of cases, we may be able to do virologic studies, but for this one, because the patient's, you know, recovered and is home, you'd have to do invasive studies to be able to do that and we don't plan to do those.

And the clinicians who are caring for the patient would not do those.

QUESTION: Okay, and then the other quick question is, Can you tell us what kind of health care workers either of these people were?

DR. MAST: I don't have information on that.

QUESTION: Okay; thank you.

CDC MODERATOR: Thank you, Dr. Mast. Our next question, please.

AT&T MODERATOR: And we have a question from Miriam Falco with CNN. Please go ahead.

QUESTION: Hi. I hope you can hear me. I'm in a very loud place. My question is both these two incidences were people old enough to have been vaccinated the first time.

Did you have any of these nonserious adverse events amongst first-time vaccinees, or were among these 7,000-plus health care workers and civilian volunteers, were they all people who had already been vaccinated once before?

DR. MAST: These two cases occurred both in persons who were previously vaccinated. I don't have information on the proportion of the 7,000 vaccinees that were previously vaccinated.

CDC MODERATOR: Thank you, Dr. Mast.

Our next question, please?

AT&T OPERATOR: We have a question from Bob Roos with CIDRAP News. Please go ahead.

QUESTION: Yes, thanks.

With regard to the woman who had the suspected generalized vaccinia, the report mentions the other symptoms such as malaise and headache. I wondered if those have continued and also did she miss work because of her case?

DR. MAST: Her symptoms are resolving. That's the only information that I have. I don't have any information on whether she lost work or not.

QUESTION: Thank you.

CDC MODERATOR: Thank you, Dr. Mast.

Our next question, please.

AT&T OPERATOR: We have a question from Laura Meckler with Associated Press. Please go ahead.

QUESTION: Thanks. I hope there's not too much background noise here because I'm also in a loud place.

Two questions. One, how were these cases reported? Do they come through the monitoring system that you set up? Do they come from the public health departments in those states? If you can give us more information about that.

Secondly, do you know whether this woman may have a permanent rash, a scarring from her generalized vaccinia? Do you know that yet?

DR. MAST: To answer your second question, yes, we don't know yet. Her rash is resolving, but it's not yet fully resolved, but she has a relatively mild case of generalized vaccinia, so it wouldn't be expected based on that presentation to have any scarring.

In terms of how these cases reported, basically, there's two main ways that we get cases. One is directly through the Vaccine Adverse Events Reporting System, which is a system that is maintained by CDC and the Food and Drug Administration whereby clinicians submit reports to the system either electronically or paper forms. One of the cases came directly through that reporting system.

The other way that we have to get reports through was set up specifically for the smallpox vaccination program is a clinician information line, which is a 1-800 number that provides clinicians with information about smallpox vaccination and smallpox vaccine adverse events and also provides assistance to clinicians for reporting adverse events. One of the calls came from a clinician to the clinician information line.

These cases are both also being investigated in collaboration with state health officials.

QUESTION: And which was which? Which case came from--

DR. MAST: The generalized vaccinia case came through the clinician information line, and the angina case came through VAERS.

QUESTION: You may have said this. Were you able to tell us what sort of workers they were; if they were hospital workers or public health workers?

DR. MAST: No, I don't have that information.

QUESTION: Is that information available from CDC later in the day or any other way?

DR. MAST: It's not information that we collect as part of our investigation.

QUESTION: You guys don't know; is that what you're telling me?

DR. MAST: It's not information that is important for our investigation of the case, so it's not information that we, in general, collect as part of the investigation of adverse event reports.

QUESTION: Well, I would be shocked if you don't have that information, and I'll be calling later to see if I can get it.

DR. MAST: Okay.

CDC MODERATOR: Thank you. Our next question, please.

AT&T OPERATOR: We have a question from Steven Smith with the Boston Globe. Please go ahead.

QUESTION: Hi. Good afternoon. I actually had three questions.

I was wondering, Dr. Mast, if you could describe the level of concern at CDC regarding these reports. If you could expound a little bit regarding the specific kind of treatment that the 39-year-old woman received, what CDC's response was. Did you send in a Rapid Response Team to investigate either or both of these?

Lastly, if you can talk, since these are health care workers, and especially regarding the 39-year-old woman, whether there is concern about or knowledge of potential exposure to patients or coworkers.

DR. MAST: Regarding the treatment the patient received. The patient was treated with antihistamines as an outpatient. That's the only treatment that she received.

We don't have information on whether this is a public health worker or a health care worker. We can find out that information, if people would like to have that information, but we don't have that right at the present.

And then, I'm sorry, in terms of the CDC's response to this investigation, both of these cases were investigated by state health departments in consultation, with phone consultation by CDC. In one of the cases, there was an EIS officer, who's stationed in Florida, who assisted with the investigation.

QUESTION: And if you could describe the level of concern and also returning to this issue of what kind of jobs these people had, I mean, are you looking into the potential, say, that the 39-year-old woman with generalized vaccinia may have exposed a patient population?

DR. MAST: We are concerned about all adverse events that occur, and we do intensive investigations of them because of that. We're obviously concerned about any situation in which these, or any patients, could transmit vaccinia to contacts.

In the case of this generalized vaccinia case, there was no indication that any of the contacts were a particularly high risk of transmission.

CDC MODERATOR: Thank you, Dr. Mast.

Next question, please.

AT&T OPERATOR: We have a question from Vicki Kemper with the L.A. Times. Please go ahead.

QUESTION: Dr. Mast, my question is actually about the nonserious adverse events that have been reported. The number seems extremely low, and I was wondering, first of all, if that's also your sense and, secondly, if that raises any concerns about the value and the accuracy of the reporting system up until now.

DR. MAST: As I mentioned, there have been 23 nonserious adverse events reported. I also mentioned that we expect nonserious adverse events to be underreported because they are reported through a passive reporting system.

We're doing active surveillance on all moderate-to-severe or life-threatening events, but for the nonserious adverse events, we're relying on passive surveillance at the present. But in order to get the most accurate rates of these nonserious adverse events possible, we're also conducting a survey of approximately 10,000 vaccinees at 10 and 21 days after vaccination to get more information about how frequently these nonserious adverse events actually occur.

So I think our surveillance is very good. It's working, in terms of tracking the active surveillance system. I think it's very good at identifying any moderate-to-severe or life-threatening events, but for the mild events, we're relying on other methods to get accurate information about those.

QUESTION: And in terms of the survey of the nonserious events, has that already begun?

DR. MAST: No, we expect that to start sometime in the next month or so.

QUESTION: Okay. Thank you.

CDC MODERATOR: Thank you, Dr. Mast.

Next question, please.

AT&T OPERATOR: And we have a follow-up question from Ann Carrns with the Wall Street Journal. Please go ahead.

QUESTION: Hi. This is actually my first question, not a follow-up.

But anyway, the State of Florida put out a statement this morning saying that they are reporting three adverse events, including a suspected case of generalized vaccinia and a patient with chest pains.

So just to avoid confusion, since they are releasing this, are these the two reactions that you're reporting in the MMWR?

DR. MAST: Yes, these are the same cases. The one additional case that we're not reporting was reported after the MMWR deadline, and so it's not included in our report.

QUESTION: So these cases you're discussing both occurred in Florida.

DR. MAST: Yes, they did.

QUESTION: Okay. Thanks. That helps.

AT&T OPERATOR: And we have a question from Ceci Connolly with the Washington Post. Please go ahead.

QUESTION: Well, to follow up on that then, if there is at least this one additional case out of Florida that is not in the MMWR, can you tell us a little bit more about that one, and also are there others that you're aware of that will not be in today's MMWR?

DR. MAST: I can say that we have a 1-800 number that is available on a 24-hour basis to clinicians, and we have adverse events under continually surveillance. So we are investigating all adverse events as they occur.

QUESTION: Well, perhaps then I should rephrase the question.

Are you investigating any other adverse events that we should be aware of?

DR. MAST: Our general policy, in terms of conveying information to you, in the most transparent and accurate way that we can, is to provide a cut-off date for the time that we report cases so we can have the most up-to-date information reported in MMWR and reported to you.

So that's how we have laid out kind of a standard way to report information, on a regular basis, to you in a transparent way that we can provide the most up-to-date information about cases. There are always cases that we are investigating. That's because we're providing a service on a 24/7 basis. But we want to be able to provide you the most up-to-date accurate information that we can.

QUESTION: Well, but since as Ann pointed out, Florida has now made this announcement that they're dealing with the three and you've given us detailed information on two out of the three, is it not possible for you to tell us a little bit more about the third?

And, again, since we're all on this call and we're acknowledging that you're, there's at least one more out there that you're investigating, are there others that you are currently investigating?

DR. MAST: The one that, from Florida, that has been reported is a acute gall bladder inflammation in a patient that was hospitalized after vaccination. We heard about this case yesterday evening, but it has not yet been officially reported through to the Vaccine Events reporting system. So that's all the--it's under investigation and that's all the information that we have about it.

CDC MODERATOR: Thank you, Dr. Mast. May we have our next question, please.

AT&T MODERATOR: We have a question from Miriam Falco, CNN. Please go ahead.

QUESTION: Hi. I want to address the small number of volunteers in the first place. You mentioned, just a minute ago, that you'll be conducting a survey among the 10,000, or among the number of 10,000 vaccinees, and you're not even there yet and it's been a month.

Can you address the fact that there's such a slow--it's not moving any quicker to [audio blip] vaccinations, for the goals that have been set both by Secretary Thompson and the CDC?

CDC MODERATOR: CDC has covered that issue during previous briefings and if you wish to discuss the issues around policy associated with this program, we ask that you call the press office to arrange a specific interview to address that question. But today's telebriefing, we're focusing just on the adverse event issues.

QUESTION: Right, but you just mentioned that your surveys that you're conducting are based on 10,000 vaccinees, and so in my opinion, if I understood you right, you can't even start that yet cause you haven't reached that yet. So that does, in some way, impact the adverse events reporting, does it not?

DR. MAST: Well, we would like to do that survey among 10,000 people and it's been designed to collect that information among 10,000 people. We expect that survey to start within the next month or so, and it will collect information until there's 10,000 vaccinees. If there's not 10,000 vaccinees, the survey would collect information on less than 10,000 vaccinees.

QUESTION: But is that informa--

[Simultaneous conversation.]

DR. MAST: [inaudible] there will be enough vaccinees to collect that information on.

QUESTION: But is the fact that it's moving so slowly impacting you in collecting important information that you need? Is some information not being reported to you because you might uncover it through the survey, because you've only come up to seven thousand volunteers?

DR. MAST: No, the nature of the program and the number of people vaccinated is not impacting our ability to do adverse events surveillance, and we're gathering--we're basically gathering information as we go along, and I think part of the reason that the vaccinations have been relatively [unintelligible] number of people vaccinated is because of the screening considerations and the desire to make the program as safe as possible.

CDC MODERATOR: Okay. Let's--

QUESTION: Well, if I may do one more follow-up, and not to be extremely skeptical, but it's odd that all the adverse events that you are reporting come from just one state when you have told us that 40 jurisdictions have been vaccinating.

Could it be that the reporting isn't happening as you hoped it would, and thus, there are a lot that aren't reported yet?

DR. MAST: There ma be events that have not been reported yet. In terms of our active surveillance, we have a system in place such that all vaccinees will be asked at the time of follow-up whether they had a vaccine adverse event that required either hospitalization or outpatient care. So we expect that information on adverse events will be collected on all vaccinees within the time frame. They won't necessarily be reported immediately but we are asking that the events that are life-threatening and moderate to severe be reported in a timely fashion.

But we have a mechanism in place to collect information on adverse events on all vaccinees.

CDC MODERATOR: Thank you, Dr. Mast. Our next question, please.

AT&T MODERATOR: We have a question from Steven Smith with the Boston Globe. Please go ahead.

QUESTION: Dr. Mast, I wanted to follow up again regarding the case of the 39-year-old woman and any potential exposure to patients.

Can you talk about whether anyone she came in contact with has been made aware of her case and whether any of those people are being reviewed for potential exposure.

What was the response--I'm assuming from the, as you may to may not be cognizant of it, of the Florida Department of Health in this regard, to assure that there was no exposure?

DR. MAST: Yeah. I'm not aware that that patient put anybody else at risk of exposure but we are investigating that and I'll get back to you with more information about that.

QUESTION: Does that include family contacts as well? Do you know anything about her family?

DR. MAST: No. I don't know anything about her family.

CDC MODERATOR: Thank you, Dr. Mast. Our next question, please.

AT&T MODERATOR: We have a question from Erin McKenna with Atlanta Journal & Constitution. Please go ahead.

QUESTION: Hi; thanks for doing this. Dr. Mast, to turn for a minute to the telephone survey you're going to do of 10,000 vaccinees, could you give us a bit more detail about how you're going to do that. I ask because for some of the vaccinees, at least certainly day ten has already passed, and for some of them day twenty-one will have passed as well.

So it sounds like you're going to be getting retrospective information rather than real-time information and I'm wondering how that's going to work.

DR. MAST: That will be a survey of 10,000 vaccinees that will be conducted at ten and twenty-one days after vaccination. It will be collected in a prospective way, when, after the survey starts. There's eight jurisdictions that have agreed to participate in the survey and we expect it to start in about a month.

QUESTION: So just to clarify. None of the people who've been vaccinated so far, and none of the people who are going to be vaccinated in the next month before this starts, are going to be included in that survey?

DR. MAST: That's correct. It's a survey of 10,000 people and those 10,000 people are expected to be representative of the whole group of people that's vaccinated.

I also have some information for you on the 39-year-old patient with generalized vaccinia, that we've been able to obtain.

The patient is a nurse. She missed some work but we don't know how many days of work that she missed, and at this time there's no concern evidenced that there's any other, any patients at risk of transmission.

CDC MODERATOR: Thank you, Dr. Mast. Can we have our next question, please.

AT&T MODERATOR: And we have a question from Ann Kerns with The Wall Street Journal. Please go ahead.

QUESTION: Hi. I'm just a little confused about the difference between the survey that's being done and the active surveillance for adverse events. So are they one and the same? Or if not ,how are you actively following up with the vaccinees? Are you calling them on the phone? How does that work?

DR. MAST: There are two different things. For active surveillance, there's a whole process that's in place for active surveillance, and for active surveillance we're collecting information on moderate to severe and serious life-threatening events.

The process that's involved in active surveillance is when the person goes to the vaccination clinic, they get a unique identifying number assigned to them and there's information that's collected about them.

Then they go for follow-up for their vaccination site monitoring, to look at their vaccination site on a regular basis, and these vaccination site monitors assess, on a regular basis, the vaccination site.

They'll assess whether the person actually had a vaccine take, or a response to vaccination, and they'll assess any adverse events associated with the vaccine.

QUESTION: Okay. So--

DR. MAST: I just had--let me just finish, if I can.

QUESTION: Okay.

DR. MAST: And then at the time that the vaccination follow-up is completed, all vaccinees will be asked, with a questionnaire, whether they had an adverse event that required them to be hospitalized or required outpatient care.

We'll be collecting information on all of those adverse events. So that's basically what active surveillance is. In addition to that, there's a survey of 10,000 vaccinees that's being done to collect information on the nonsevere adverse events. So for the 10,000 vaccinees, the primary objective of that is to collect information on the nonserious adverse events.

QUESTION: I see; okay; thanks. And I apologize if this has been answered already. So this woman with generalized vaccinia, was her rash seen during this active surveillance period or did she just go to the hospital herself? Do you have any information on that?

I mean, was she diagnosed at one of these follow-up visits?

DR. MAST: I don't have information on whether she was diagnosed based on a follow-up visit.

We received a call from her clinician.

QUESTION: Okay.

CDC MODERATOR: Thank you, Dr. Mast. Can we have another question, please.

AT&T MODERATOR: And we have a question from Laura Meckler with Associated Press. Please go ahead.

QUESTION: Hi; thanks again. Just to follow up on what we were talking about earlier, about whether there are other cases being investigated. Sort of in the spirit of trying to get the most up-to-date information, could you tell us if there are any other cases that you would classify in the same way as you're classifying that third Florida case which is you've gotten a report of something and you're still looking to see if it really is a reaction to the vaccine?

DR. MAST: I can't say that right now. I can say that we're providing you the most up-to-date information and in order to do that we have to--most updated and accurate information. In order to do that, we need to establish a cut-off of when cases are reported to us and when we convey that information to you.

QUESTION: Well, if you know it right now you can tell us. I mean, I know there's a cut-off for MMWR but if you have other information, you know, I don't understand why you wouldn't share it.

DR. MAST: Any events that we're looking in--any events that we may be looking into, we don't have enough information about them to convey that information to you in an accurate way. We want to make sure that the information we're providing is accurate.

We're actively investigating cases but the cases that we investigate, many of them turn out to be nonadverse events, and so we want to make sure that we're not providing bad information to you as well.

QUESTION: But I mean, for instance, the case of the gentleman who has a heart condition. That is most likely not a real adverse event but you're reporting that to us, so I guess I'm a little confused.

DR. MAST: That's a real adverse event, is a person who had a diagnosis and we wanted to make sure that we accurately reported that--accurately had information about that diagnosis. Actually, that case was reported yesterday as a myocardial infarction based on the information that we had, and was reported to the ACIP as a myocardial infarction.

Subsequently, we obtained information that the patient actually did not have cardiac enzyme elevations and so was not classified as a myocardial infarction. He only had angina. So that's the kind of information that we're conducting to verify the diagnosis in these patients, and that's being done on an ongoing fashion. We basically want to be able to do that type of investigation to convey to you the most accurate information that we can.

CDC MODERATOR: Yes, and we'll take our final question of the afternoon, please.

AT&T MODERATOR: And that comes from John Lowerman with Bloomberg News. Please go ahead.

QUESTION: Yes. One thing I wanted to clarify, which is that the gall bladder infection, that there's no history of gall bladder infection in vaccinated people, is that the case? Or is there any sort of possible linkage, known linkage there?

DR. MAST: This is a gall bladder inflammation.

QUESTION: Inflammation, rather.

DR. MAST: Inflammation, and there's no evidence of infection, and gall bladder inflammation has never been previously associated with smallpox vaccination.

QUESTION: And one more thing. The MMWR says the nurse was treated with antihistamines?

DR. MAST: Right.

QUESTION: Is that the sole treatment she received and do you know which antihistamine she received?

DR. MAST: She received antihistamines and I don't know which antihistamines she received.

QUESTION: Okay; thank you.

CDC MODERATOR: I want to thank everyone again for this afternoon's briefing and attendance, and remind everyone that a full transcript of today's briefing will be up on the CDC Web site later today. Thank you all. Have a good afternoon.

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

Listen to the telebriefing

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URL: http://www.cdc.gov/od/oc/media/transcripts/t030227.htm

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