U. S. Department of health & human services




НазваниеU. S. Department of health & human services
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some of the limits for these other vaccines regulated

by OVRR.

Thank you very much.

CHAIR GREENBERG: Thank you, Doctor Pastor,

and in the interest of time there wont be any

questions from the committee, but thank you very much.

We are now going to move on to the session

that you all love, the open public hearing piece, and

at this point I ask the audience whether theres

anybody that wishes to address the committee.

Im told that there is one person that has

identified themselves previously, Doctor Michael

Young, the Chief Science Office from Medeva, is that

correct? Okay. And, Im told that you need about

five minutes, Doctor? Okey dokey.

DOCTOR YOUNG: Good afternoon.

As the Chief Scientific Officer of Medeva,

the UKs largest vaccine manufacturing company in

worldwide vaccine research since our acquisition of

the Wellcome vaccine products and R&D in that area, I

feel its appropriate for the committee to at least

hear something from an industry perspective going back

to the meeting two or three days ago on the whole

question of cell substrates. This is a crucial issue

for anyone responsible for R&D and R&D investment.

Im sure that it is clear to you all, it

was very worthwhile to attempt to get consensus

between, on the one hand, government agencies,

government bodies such as NIH, such as NIBC, Paul 

Ehrlich and others, as well as academia, and, indeed,

the industry, and the agency is, I believe, to be

commended on that.

It is important to look at risks, as has

been said. Its also important to look at benefits,

and Im sure I neednt remind this particular

committee that vaccines have been undergoing quite

some reconceptualization and broadening, seeing them

both, on the one hand, as prophylaxis, and in that

sense prevention of disease, and on the other hand as

immune modulators, and to some degree treatment of

infectious diseases. So, the roles are shifting with

time.

For those of us attempting to invest and

decide on investments in these areas, one of the most

important things for us is to know what it is we are

trying to aim at, what consensus is amongst agencies

as to what we should be doing, and its particularly

important to hear those consensuses reviewed and

endorsed by a committee such as this, when, indeed, it

comes back to you.

I would, indeed, point out that when the

study is done a great deal of work has clearly gone in

before, I hope the committee will give it clear

recognition, and I believe that the agency, FDA in

this particular case, is to be commended on making the

effort to push for this. I hope the committee

understands just how much is involved in that.

Thank you for your time.

CHAIR GREENBERG: Do committee members have

any questions of Doctor Young?

If not, thank you, Doctor Young.

Is there anybody else in the audience who

wishes to address the committee?

Let the record show that Ive stared down

the audience and nobody seems to be raising their

hand.

If thats the case, I am going to

recommend that we take a break now, end the open

public hearing, and Im told that several of the

committee members have yet to check in, so what I

think I will do is, let me just look here, I think we

will get back on track, and can people check in in a

half an hour? So, Id like people back here at 3:45,

to start again promptly at 3:45. At that time, well

start our closed sessions, and, in fact, Doctor Daum

will start that session because I will be not in the

room.

EXECUTIVE SECRETARY CHERRY: Yes, and we

will be in closed session, so at this time Im afraid

well have to dismiss the audience.

(Whereupon, the open session was concluded

at 3:16 p.m.)


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