U. S. Department of health & human services




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but if somebody is here from Merck that knows that

answer?

DOCTOR FAGGETT: We had a meeting in Vegas

in August, it was a fact that it is very confusing to

our patients and parents, and I dont know if you

emphasized the fact that in our present situation we

need to really also be cautious about vaccinating

premature, low birth weight infants. I mean, that was

another issue that was brought up.

So, those are two issues that we need to

have some clarity on. Would the Merck vaccine be used

on low birth weight and pre term infants as well?

Thats going to be another 

DOCTOR EGAN: I think that may be in the

MMWR article but Im not sure. Dixie, do you know how

thats addressed in the MMWR?

DOCTOR SNIDER: I dont recall that we

addressed the low birth weight issue. Its clear that

for a while, Walter, were going to be in a position

of having both Thimerosal preservative free vaccine

and Thimerosal containing vaccine on the market, and

these guidelines basically are saying, lets give

preference to the younger children for the Thimerosal

preservative free, and use the Thimerosal containing

products for the older children and adults, because

there will be both, and there will be supply problems

initially.

I cant speak as to what the supplies are,

but I know that Merck is working very hard to make as

many doses available as they possibly can safely, and

it shouldnt be too long before we move to a situation

where we  one thing I didnt mention is that Smith

Kline Beecham is also in the process of making a

preservative free, their hepatitis B vaccine

preservative free, so we are in an interim period now,

hopefully, well get to a period where we have no

hepatitis B vaccine that contains Thimerosal.

As far as low birth weight infants are

concerned, I dont think that this last MMWR addressed

it. There certainly is greater concern with low birth

weight infants, premature infants 

CHAIR GREENBERG: Excuse me, can you speak

a little closer to your microphone?

DOCTOR SNIDER: There is greater concern

with low birth weight infants, with regard to mercury,

and theres been a lot of discussion about what to do

about those infants. I think the fact that we now

have preservative free vaccines available should help

alleviate those concerns.

CHAIR GREENBERG: Doctor Huang?

EXECUTIVE SECRETARY CHERRY: Before we go

any farther, would all of you hold your microphones a

little close, because theres a buzz in here and I

think people in the audience are having trouble

hearing.

DOCTOR HUANG: As a point of information,

is there a cost difference to the consumer between

Thimerosal free and Thimerosal containing vaccine?

DOCTOR EGAN: I dont know how they are

being costed. Im not aware that theres any change

in costs to the CDC for their NIP program.

DOCTOR HUANG: Is there a difference

between single and multi dose vaccine?

DOCTOR EGAN: Yes, I mean, general single

dose presentations are more expensive. But, you have

to know that all of the single dose presentations of

hepatitis B, for example, contained Thimerosal as

well, and this was so that there would be a single

formulation that the manufacturers would have that

would go either into single dose vials or multi dose

vials.

CHAIR GREENBERG: Doctor Daum?

DOCTOR DAUM: Close enough to the

microphone, I hope.

The American Academy of Pediatrics, at

least currently, does not have a recommendation for

immunizing newborns less than two kilos, so I dont

know whether that situation is going to change with

Thimerosal free, but I think it probably will have no

impact on that situation.

I think that it should be noted somewhere

during this discussion that this is going to have some

impact on places where money is more scarce than it is

in the United States, because it really is the end of

multi dose vials if other countries decide that they

want to remove this preservative from their products

as well. And, this was an important point, I thought,

raised at the NIH workshop by people concerned with

health care beyond the United States.

I would be a little remiss, I guess, if I

didnt comment on the Academy of Pediatrics and the

Public Health Service, the speed and the aggressive

nature of changing the recommendation so quickly. It

seemed that FDA had set in motion a fairly orderly

review of Thimerosal containing products, and it

seemed that plans were going forward to decrease them

in products or to eliminate them.

Thimerosal has been around and used for a

long, long time, and one wonders what the need was to

act so quickly, an issue this urgent, reversal of

direction, which I think did confuse a lot of people.

At the workshop, Barbara Watson from

Philadelphia commented that at her hospital there was

at least three children that she knew of that were

born to serotype positive mothers, who were not

immunized at birth because it was believed that this

vaccine shouldnt be used in that context incorrectly.

I also, one more comment and then Ill end

with a question for Bill. I also think it might be

instructive for people to know that there are other

impacts, it turns out, of changing or deleting that

birth dose, which, again, made me concerned about the

speed with which the recommendation was changed. We

have a paper in press at JAMA which will be coming out

the first week in November, which documents in the

inner city of Chicago that that birth dose, first dose

of hepatitis B does something very positive to people,

that it makes it more likely that they are going to

end up at two years of age up to date with all of

their shots.

If you stratify our inner city population

by those who received that first dose and those who

didnt, at two years of age theres an impressive and

statistically significant difference in who is up to

date for all shots, DTP, IPB, everything. So, I view

the suggestion to postpone that first dose with some

special concern, perhaps.

And, I want to end with a question, Bill,

if you dont mind, after all those comments, is how is

FDA viewing manufacturers applications to just remove

the Thimerosal? It sounds like you went very quickly

with the Merck product, but can a vaccine thats been

licensed, safety and immunogenicity profile in place,

turn around and remove the Thimerosal and theres an

assumption that everything else would stay the same.

Is that the approach, or is there some other?

DOCTOR EGAN: Yes, well, thats a very

complicated question, and one that Doctor Baylor tried

to address as best he could during the Thimerosal

workshops. For a more complete answer, I would refer

people to that when it becomes available on the web.

There are a lot of issues. It depends

whether Thimerosal is in the product or whether its

contained in the diluent for the product.

What the expectations are and what data

may already exist from the manufacturers with regard

to stability, it does not mean that Thimerosal per se,

you know, lengthens the stability or decreases the

stability of the hepatitis B vaccine at least, and

there are some data that do address that. I mean,

certainly, although not perfect, theres data, for

example, on Comvax, which is a Thimerosal free

preparation, and, you know, the hepatitis B component

is not adversely impacted by not having Thimerosal in

that preparation.

There are many other issues, for example,

if usually puts material in single dose presentations

with a preservative, then the issue of, you know, the

ability to manufacture and to put material into

single dose preparations without a preservative, you

know, and maintain sterility, that has to be assessed,

because the last thing you want is, you know, material

thats no longer sterile.

For some of the other vaccines, how

crucial they may, for example, in influenza

manufacturing to maintain some Thimerosal during the

manufacturing, I think well have to look at that.

So, it becomes an awfully complicated situation, Merck

being one of the simpler.

CHAIR GREENBERG: Any other  Ms. Fisher?

MS. FISHER: Thank you.

Well, I think the FDA acted very prudently

in asking the manufacturers to take the mercury out of

the vaccines at this point, as there is accumulating

evidence, for example, the study in the American

Chemical Society here this month that mercury can

circumvent a blood brain barrier that usually prevents

such toxins from entering the brain.

As the mercury free vaccines are coming

out, and we also will have the vaccines that have

mercury in it, hepatitis B vaccines, should consumers

be asking, Doctor Snider, should consumers be asking

their pediatricians for the mercury free vaccine,

especially for premature infants and two month old

infants?

DOCTOR SNIDER: I think if you look at the

MMWR, hopefully, the impression you will come away

with is that we are urging providers and parents of

infants who are to receive the birth dose to receive

the Thimerosal free product. So, I think we are,

although I think we addressed our MMWR primarily to
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