Worries over swine flu vaccine bottling capacity

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Worries over swine flu vaccine bottling capacity

Updated Thu. Aug. 20 2009 8:37 AM ET

The Canadian Press

TORONTO -- The production capacity of GlaxoKline's flu vaccine plant near

Quebec City isn't likely to delay efforts to vaccinate Canadians against swine

flu this fall, the head of the Public Health Agency of Canada said Wednesday.

Dr. - said by the time Health Canada has licensed the product

in November, there ought to be between 10 million and 15 million doses of

pandemic vaccine ready to be shipped to provinces and territories.

He said at that point, it is unlikely local authorities will be able to put

vaccine into arms faster than GSK will be able to replenish the supplies.

" We will have the vaccine we need in a timely way, at least in terms of our

ability to deliver it, " - said in an interview from Ottawa.

Canada has ordered 50.4 million doses of pandemic vaccine from GSK. It's not yet

clear whether people will need one or two shots, but the vaccine order is large

enough to give every Canadian one shot (and some a second) or 75 per cent of

people two shots.

It remains unclear how many Canadians will actually roll up their sleeves when

the pandemic vaccine is ready.

Polling commissioned by the government suggests fewer than two-thirds of

Canadians anticipate getting vaccinated against the virus. Just under one-third

of Canadians got a flu shot in 2008 to help them through last winter's flu

season.

The Ste-Foy, Que., plant can produce more vaccine than the facility can bottle

in a timely manner. That last step in the process, called fill and finish, is

the bottleneck in vaccine production.

GSK plans to export vaccine in bulk to be filled and finished outside of Canada

and then sold to other countries.

But those exports won't jeopardize or delay Canadians' access to pandemic

vaccine, - said, noting Canadian government investments in the plant

over the years have helped build up the additional capacity.

The facility can fill and finish roughly 3.5 million doses of vaccine a week

once production reaches that stage. In the case of vaccine against the new H1N1

virus, fill and finish operations should begin in October -- several weeks

before the vaccine is expected to get regulatory approval.

Once the regulatory body, Health Canada, gives the vaccine its seal of approval

there will be weeks worth of output to distribute across the country. As that is

used up, additional vaccine will flow out of the plant at the same rate.

" The vaccine should not be the limiting step at that point, " - said.

Canadian officials explored the possibility of trying to speed up delivery by

having some of the fill and finish work done elsewhere, he admitted. But GSK's

plant is the only flu vaccine production facility in Canada.

That left only two options: using the facilities of another type of vaccine

manufacturing plant or shipping bulk vaccine out of the country to another GSK

facility to have work done there.

- said it was concluded the latter option wouldn't save time. And the

former might have solved one problem and caused others. For one thing, that

would have meant the work was done in a plant without a licence to product flu

vaccine. And it would have interrupted production of essential childhood

vaccines.

" The actual (extra) volume that it would accomplish is not large. Wouldn't

actually add much to that total... And certainly given the time frame, it

wouldn't make a difference to when it arrives in people's arms, " -

said.

He said it might add an extra million doses a week, but added at that point

vaccination efforts wouldn't be able to keep pace with the delivery of vaccine.

" It just makes no sense given that it won't confer an advantage. Why would you

go through all that and then also offset or risk the child vaccine production? "

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