Using Chicken Vaccine On People Debated

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CTV,

Canadian Press

May 15, 2006 8:30 AM ET

Officials mull using poultry vaccine on people

TORONTO -- Is what's good for the goose good for Mr. and Mrs. Gander? Public

health authorities exploring the possibility of protecting people against an

influenza pandemic with vaccine produced for poultry say " Maybe. "

The World Health Organization and others are studying whether it would be

possible to tap into the global agricultural vaccine production capacity to

help bridge the enormous gap between the amount of human flu vaccine the

world can produce and how much would be needed in a severe pandemic.

While the idea of giving people vaccine produced for poultry may seem, well,

for the birds, the proposal - advanced by eager agricultural

vaccine-makers - hasn't been dismissed out of hand.

" I think it's something that does merit consideration, " says Dr.

Goodman, director of the U.S. Food and Drug Administration's Center for

Biologics Evaluation and Review. (Vaccines are considered biological

products.)

Goodman and others would rather not have to resort to this option, hoping a

pandemic is far enough off and new investment in novel production methods

and facilities is sufficient to vastly expand output within the human

influenza vaccine sector.

But given the current limited vaccine capacity, all sorts of options would

have to be on the table if a harsh pandemic were to strike soon. And

harnessing agriculture vaccine production is one of them, Goodman says.

" I would say our goal would be to keep an open mind about possible

approaches in an emergency, " he said in an interview from Washington.

" For a medium-to long-term approach, certainly enhancing the capacity and

use of the human vaccines in my mind would be the first priority. . . .

(But) in the short-term emergency point of view . . . I think it is wise to

look at all possible approaches and alternatives. "

Canada is unlikely to need to explore this option. The country has a

long-term contract for pandemic vaccine to be made at a production facility

located in Ste-Foy, Que.

But most other countries, including the United States, currently don't have

enough domestic production capacity to be able to vaccinate their citizens

during a flu pandemic - hence the outside-the-box exploration of options.

Experts say the agricultural vaccine sector's greatest potential for humans

lies as a possible source of antigen (vaccine-ready virus) for live

attenuated vaccines such as FluMist, the inhaled vaccine produced by

MedImmune Inc., headquartered in Gaithersburg, Md.

That's because antigen used in live attenuated vaccines is not put through

the investment-intensive purification and sterilization processes used in

the manufacture of inactivated (killed virus) vaccine, the type contained in

flu shots.

The production processes for live attenuated vaccine and agricultural

vaccine are quite similar, says Dr. Klaus Stohr, the WHO's special adviser

on influenza pandemic vaccine development. So are the criteria - known as

good manufacturing practices - set down for production of agricultural and

human flu vaccines.

" So theoretically - theoretically - it's conceivable that this antigen, and

there's a lot of antigen produced by the agricultural vaccine makers, could

with much less investment be transformed into live attenuated vaccines, "

Stohr says.

A MedImmune executive says the company doesn't yet know what to make of the

idea, raised at a recent meeting in Geneva hosted by the WHO.

" We're just beginning to discuss this in MedImmune and we really haven't

looked into it to be able to understand what that would mean, " says Kathleen

Coelingh, senior director of scientific affairs.

" We're not ruling anything in or anything out. "

Goodman says companies which make inactivated flu vaccine might also be able

increase their output by processing some antigen produced by agricultural

vaccine makers.

But Stohr says human flu vaccine makers carefully match their antigen

production to their capacity to purify, sterilize, bottle and label,

suggesting these essential downstream steps create a bottleneck around which

there is no easy or inexpensive route.

Dr. Fedson, a retired vaccine industry executive, says there are

hitches that may limit the ability to use antigen from agricultural sources

to vastly increase the output of live attenuated vaccine as well.

FluMist, for instance, currently must be kept in a freezer until it is

administered - a factor that might limit its usefulness in some parts of the

world. As well, individual doses come pre-packaged in an inhaler, raising

questions about whether adequate numbers of additional inhalers could be

made and whether MedImmune or another company could expand capacity to

package mass numbers of extra doses.

Modifying the delivery mechanism so that the vaccine is given in the form of

nose drops could get around that potential bottleneck, Fedson says. (The

Russians have been using live attenuated vaccine delivered this way for at

least two decades.) But changing the vaccine would require regulatory

approval.

Still, Stohr insists that with few options for rapidly and affordably

increasing human flu vaccine production capacity, the notion of exploiting

agricultural antigen sources is worth further study.

" There are so many things which we have seen may not work out quickly or

will cost too much, " he says.

" But here we have an option which has not been fully explored which has a

good chance or which has a greater chance of success. And if it succeeds, it

would make a profound contribution to the efforts to fill the pandemic

vaccine gap. "

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Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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