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Companies poised for swine flu vaccine drive

Published on 29/05/09 at 05:07pm

Pharmaceutical manufacturers now have access to the swine flu seed virus that can be used to start full-blown production of a vaccine.

But companies are still awaiting the go-ahead from public health agencies.

The seed virus has been developed by the US Centers for Disease Control and Prevention (CDC) and sent to various drugmakers, including Sanofi-Aventis and GlaxoSmithKline.

The CDC has given the green light to two versions, one made via conventional vaccine methods in chicken eggs and the other based on a reverse genetics method developed by AstraZenecas MedImmune unit.

Sanofi Pasteur, the vaccines subsidiary of Sanofi-Aventis, said it would start work on developing the seed virus into a working seed, achieved by repeatedly incubating the virus under specified conditions in order to acclimatise it to a production environment.

This process, known as passaging, is expected to take two weeks to complete, and the "working seed" produced will have to be certified by the US Food and Drug Administration (FDA).

Once that is done Sanofi Pasteur said it "will be prepared to begin industrial production as soon as directed", adding that it would be able to produce its first batches "within a few months".

$1 billion federal contract

Sanofi is among a group of companies that are the recipients of a $1 billion contract awarded by the US Department of Health and Human Services to manufacture vaccines against the H1N1 flu strain.

The funds will be used for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile, as well as for clinical studies that will take place over the summer.

Sanofis share of that contract - worth around $190 million - provides for the production of the bulk vaccine antigen and related activities, such as trials to establish the required dosage.  

GSK has not disclosed the value of its contract but will also provide vaccine antigen as well as its proprietary adjuvant system AS03 which is used to boost immune reactions to the antigen.

Meanwhile, Australian pharmaceutical manufacturer CSL says it could have its own version of an H1N1 vaccine available in as little as eight weeks as it started work on developing a vaccine from a virus sample secured in the early days of the Mexico outbreak.

CSL already has a $180 million-order from the US government for its vaccine, and says the Australian government has also placed an order for 10 million courses.

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