U. S. Department of health & human services




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than the average age quoted for the population, but as

youve noted, even finding out what the average age

for the population is is very, very difficult to know.

The concern was possibly most stimulated

by the fact that in the reported cases the vaccination

occurred, had occurred in most of these cases about a

week prior to the report. Of course, theres also the

bias that anything that happens in closer association

to vaccination is likely to be associated with the

vaccine, even if its a random event.

So, I apologize for not being able to give

you the exact data, but they really arent available

even for the normal population.

DOCTOR DAUM: Doctor Karzon, please.

DOCTOR KARZON: The pathogenesis of this

illness is not fully understood. Is there anyone

looking at the microbial flora in known cases that are

diagnosed?

DOCTOR CARBONE: There may be investigators

out in the scientific community looking at that, but

from our point of view Doctor Breimans group, the

multi center working group, thats one of the

approaches thats going to be taken, to review the

cases and look for associated  for example, there is

a report in the literature in children where theyve

looked for Rotavirus in childrens intussusception and

actually found adenovirus also present in the majority

of those children, as well as adenovirus present in

children who have intussusception and no Rotavirus

present.

So, that is absolutely a very important

question, and that will be addressed.

DOCTOR DAUM: Doctor Snider, then Doctor

Kim.

DOCTOR SNIDER: Dixie Snider, CDC.

I just wanted to point out to everyone

that this case control study is a massive undertaking.

It requires hundreds of people. Its consuming time

of most people in the National Immunization Program,

and, thank goodness for all the people that CDC has

stationed in the States, and for all the state health

departments and other health care provider

organizations that are helping out with this

investigation.

I know it sounds like a long time to the

end of October before we finish up this study, but it

is a massive job trying to track down all these cases,

and then the four controls per case to get the

information thats needed.

So, I just wanted people to be aware that

lots of effort is being put into this, lots of

resources, to try to get the answers as quickly as we

possibly can.

DOCTOR DAUM: Kwang Sik.

DOCTOR KIM: Doctor Kim from Los Angeles.

My question was partially answered by

Doctor Snider, however, just looking into the numbers

that you presented, rate of intussusception was about

one per 10,000 before licensure, you know, in your

document, which means that if you immunize 1.5 million

than you anticipate about 15 cases. So, the question

comes up, is that what is the interpretation before

licensure, which is one per 10,000 versus, you know,

after licensure, which is 15 per 1.5 million, what is

the  what made your interpretation somewhat

different, I guess, in terms of looking for numbers?

DOCTOR CARBONE: Let me rephrase that to

make sure I understand. What you are saying is the

rate after licensure isnt very much different from

the rate prior?

DOCTOR KIM: No, its the same.

DOCTOR CARBONE: Right, its the same from

the rate prior, and, therefore, why were we concerned.

One of the reasons we are concerned was

because the information  we feel that in many ways we

appropriately stimulated a public concern about many

of the adverse events of this vaccine to the label,

thats normal, you put in the label adverse events.

Physicians read that and, hopefully, patients have

access to this information as well.

Therefore, one concern is that when people

find an adverse event following a new vaccine it gets

reported at a very high rate. However, we still

assume that because of the passive reporting system,

as few as five percent or ten percent of the cases

will actually be reported. Therefore, when we see a

rate in a passive reporting system that equals the

expected rate, we become concerned and investigate

that.

Did I answer your question?

DOCTOR KIM: Yes.

DOCTOR CARBONE: Thank you.

DOCTOR DAUM: I actually have a question.

Im very impressed at the response that

the entire vaccine community has made to this issue,

the speed with which everyone from CDC, to FDA, to

manufacturer, responded by picking this up and acting,

and Id like to know whether you think theres any

precedent for responding at this kind of speed, and

whether this is  I think its something that

everybody should sort of take a bow for and really

feel good about how the system appears to be working.

I wonder if youd like to comment on that.

DOCTOR CARBONE: The only thing Id like to

say is that I think it just reflects the concern that

we have in doing the regulation and putting out a safe

and effective product. And, it simply was what we

felt the right thing to do.

DOCTOR DAUM: How will you address, lets

say that the case  lets take the worst case, and the

case control studies establishes causality, how will

FDA, or other agencies for that matter in your

opinion, view testing of future Rotavirus vaccines

with respect to rare side effects?

DOCTOR CARBONE: I think thats a terribly

sticky wicket problem. Obviously, thats a $64,000.00

question, and I think that one of the big problems we

are dealing in this is this massive, vast lack of

information, even about intussusception as a disease

itself. And, I think it makes sense that if we find

out what causes intussusception, or at least get a

handle on some mechanism, what the relationship

between infectious agents are and intussusception,

that, perhaps, a vaccine could be designed to

specifically avoid the problems.

But, it is a vast ranging problem,

including even oral delivery of vaccines at all, if

theres other association.

I cant really make any specific comments

about plans, not knowing what we are going to find

down the road, except we are considering the

possibility from all directions, in our laboratory we

actually have a very talented young scientist, Doctor

Atreya, who of his own volition developed a Rotavirus

lab to start looking at adverse events about a year

and a half ago when we were investigating the vaccine,

and hes made some good headway. There are many

people, obviously, at the CDC, Doctor Snider was

talking about the effort, and in the larger community,

so because this problem has finally risen to the

surface, and we have many different ways to

investigate it, I think that  I actually am very

hopeful that a mechanism will be found and a way to

protect children against Rotaviral diseases will come

around. Its not particularly obvious right now

because we dont have enough information.

DOCTOR DAUM: Doctor Estes.

DOCTOR ESTES: I think many people have

raised the question about whether this has been a

problem with the live oral polio vaccine, which is

probably the oral vaccine that we have the most

experience with. And, can you comment on that, or at

least let us know whats being done to look at that?

DOCTOR CARBONE: Thats actually being

looked at very intensively. The data on this are

very, very preliminary. The polio in the intestine

causes a very different type reaction and a very

different location of reaction than Rotavirus does.

However, there is some hints in careful, careful study

that there are a few cases that may have been

associated with polio virus vaccine, but its very

preliminary, I stress association rather than causal,

but there are several groups that are looking very

intensively at that and other orally delivered

vaccines.

DOCTOR DAUM: If there are no other

questions, Ill just make one final comment, and that

is that outside of the United States in developing

countries this disease is an even greater impacter on

pediatric ill health than it is in our country, and it

would be crucial to clarify this issue so that we can

deliver the vaccine to children in developing

countries once the safety issue is clarified.

And, with that, I will step down and turn

the floor back to our erstwhile Chair.

CHAIR GREENBERG: Thank you.

And now, we will move into Session 4,

which is a briefing on selected individual research

programs, and for an introduction we have Doctor

Thomas Hoffman.

Doctor Hoffman, this session moves along

reasonably quickly, so 

DOCTOR HOFFMAN: My name is Thomas Hoffman.

Im the Acting Director of the Division of Allergenic

Products and Parasitology.

Im going to depart slightly and introduce

each of the two presenters in turn, rather than

introduce both at this time as it is on the program.

The first person that youll hear from is

Doctor Richard Kenney. Doctor Richard Kenney, Rick

Kenney, came to CBER as a Senior Research Investigator

in 1995, after completing a fellowship in infectious

disease at NIH, and taking further training in

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