U. S. Department of health & human services

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providers, but certainly I think it would be

appropriate for parents to request the Thimerosal free

product for that particular age group.

But, I mean, there is a caveat with that,

in that if there is none available, and you have a

mother whose status you dont know, or who is known to

be hepatitis B surface antigen positive, you dont

want to have that infant become infected with

hepatitis B and have the high risk of cirrhosis or

cancer. So, you know, there you take the greater risk

by not vaccinating with a Thimerosal containing


CHAIR GREENBERG: Any other questions?

DOCTOR FAGGETT: Harry, just one other


Back to Dixies point, I think this brings

up the issue of making sure that whatever information

that pediatrician or family practice doctor has to

tell the parent is accurate and up to date. The NMA

fully agrees with AAP position, but we really need to

look at how we are informing the information we are

putting out there, because thats back to the question

of inventory, to raise parents expectations that they

can get it and not have the inventory, I think, does

not serve anybody well.

CHAIR GREENBERG: Well, I think those

comments are excellent. I would just like to say for

everybody who was not at the two day conference that

I think the FDA, and the AAP, and other bodies, are to

be commended on trying to bring order to what is

inherently a very complex database, and it is not

critical to really understand this in scientific

terms, and it is not  there is conflicting scientific

data that on the face of it looks like it was obtained

correctly as to the risks, and theres clear cut

advantages. So, I think the FDA is to be commended,

as is Merck for moving very rapidly for eliminating

Thimerosal in a product that is not needed.

On the other hand, for sure a mother who

is infected with hepatitis B virus, that infant should

be vaccinated, and thats a clear risk that we dont

want  that we want to deal with.

Id like to thank you, Bill, for updating

us, and now we are now still ahead of time. Id like

to move on to our next agenda item, which is Doctor

Andrew Lewis, there he is, and Doctor Lewis is going

to update us on the cell substrate workshop. I think

you all remember that I guess it was last year Andy

spent some time bringing us up to date on the very

important topic of cell substrate selection.

DOCTOR LEWIS: Thank you, Doctor Greenberg.

Just to introduce myself, Im Andrew

Lewis, in the Office of Vaccines, Division of Viral

Products, and Im going to attempt to review for you,

in fairly cursory detail because theres a huge amount

of information that was presented, the cell substrate

meeting that we had last week, mid Friday afternoon,


I think the beginnings of this meeting

started before this committee on November the 19th

last year, when we presented or introduced the topic

of using aplastic cell substrates for viral vaccine

development and manufacturing to the committee.

Keith, can I have the next overhead,

please? Just to review very briefly for those of you

in the audience and on the committee who were not

present at that meeting, the motive antifactors that

are driving the Center for Biologics to consider using

neoplastic cell substrates for viral vaccines include,

very importantly, development of whole virus, the

traditional vaccines to HIV, and in addition several

other things are very actively involved in generating

this need.

Bioengineering approaches to viral

attenuation are creating large opportunities to

develop vaccines that had not been available to us

previously. Emerging viruses, such as the Hong Kong

influenza H5N1 flu strain, and now I think more

recently H9 and 5 flu strain may require rapid

attention. Progress in understanding carcinogenesis

has been very rapid in the past decade, and along with

that our ability to detect and identify adventitious

agents. And finally, we have a very successful

experience since the late 1980s with using highly

purified biologicals that were made and actually

derived the neoplastic cells.

So, based on these factors, there is

increasing interest and need to use neoplastic cells

to develop traditional vaccines.

Now, as a result of our presentation

before the committee last year, several things

evolved. First, we were going to develop a document

outlining issues. We were going to hold a workshop on

those issues and on this document, and I think these

are the first two things that we have accomplished,

and were at this stage in implementing the approach

that weve outlined on this overhead.

The document, we estimated last year it

will take us about six months to put together. We had

the document ready, I think, some time in May for

internal review, and then it went out to the people

who were going to be addressing the topic in July.

And so, that document sort of formed the basis for the

agenda for the meeting, and Ill have a little bit

more to say about that.

The title of the meeting was, Evolving

Scientific and Regulatory Perspectives on Cell

Substrates for Vaccine Development. The meeting was

sponsored jointly by the Center for Biologics, the

International Association for Biologicals, and the

National Institute of Allergy and Infectious Diseases,

the National Vaccine Program Office, and the World

Health Organization.

The goals of the workshop were two in

number. First, to identify the concerns and issues

that were associated with using neoplastic cell lines,

and then to identify approaches to determine the

levels of risk that might be association with those


The meeting was organized around the

following scheme. The first session was to introduce

the cell substrate history and to review the

milestones in cell substrate development over the past

50 years, and then following that review process to

present the CBER draft proposal as it formed the basis

for the need for the meeting, number one, and for the

organization of the session. The other sessions were

then organized around the concept of issue

presentation, each specific session followed by a

panel/audience discussion about issues, and we

proceeded through that on that through the three and 

a half days of the workshop, with one exception, that

was a session on Thursday night designed for people to

present late breaking information and miscellaneous

topics that the speakers and people who had been

contacted to participate in the meeting felt like that

they would be able to  that would be of interest to

the audience.

I wont have anything more to say about

that session, as it was a composite of a lot of topics

that were germane, but that really did no get involved

in the business of the panel discussions to any

significant degree.

Now, the topics of cell substrate history

were reviewed very nicely by Doctor Elwyn Griffiths,

and Bill Egan, and Leonard Hayflick interacting during

the first three presentations Tuesday evening, and

following that Doctor Phil Krause and I took about an

hour of the sessions time to present the approach

that CBER had put together, based on the presentation

that was made before the committee last November.

And, that approach was developed in this document.

The document is on  will be on the CBER

web site very shortly, and copies of it will be made

available to those people who are, in fact, interested

in receiving that.

As I said, we distributed copies to the

speakers and the session panel chairs who were going

to be addressing the contents of the document during

the course of the workshop.

The table of contents, very quickly,

includes these particular items. I think it covers

some 25 or 30 pages, and we took the suggestions of

the Advisory Committee to  and expanded on the

approach that we presented before you last November,

and I think based on the comments that we got it is

reasonably comprehensive.

The gist of the document revolves around

the concerns that were outlined again for the

committee last November, and just very quickly for the

audience and to recapitulate a bit. Its two

comprehensive  its too extensive to be presented on

one slide, but the concerns as we have identified them

represent tumor cell contamination, adventitious agent

contamination, cell DNA contamination, cell protein

contamination, viral viral and viral cellular

interactions. The represent the generation of

recombinants or reassortants, or  of the transduction

cellular genes that might take place when vaccines are

produced in the aplastic cell substrates. And then

finally, the issue of genomic instability.

So, this particular  the sessions of the

workshop were organized around the concerns that were

listed in this paper. I think youll see that as we

go through the sessions. And finally, we tried to

bring the CBER folks together with an algorithm which

we are calling a defined risk approach algorithm, and

in this particular algorithm we are attempting to

develop a systematic way of getting at the levels of

concern or the levels of risk, however you want to
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