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Pharmaceuticals

Preparing For Swine Flu

Vaccine procurement ramps up as virus gains ground

by Ann M. Thayer
July 20, 2009 | A version of this story appeared in Volume 87, Issue 29

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Credit: Novartis
A Novartis worker inspects an H1N1-vaccine-containing syringe during the filling process.
Credit: Novartis
A Novartis worker inspects an H1N1-vaccine-containing syringe during the filling process.

One month after the World Health Organization called the outbreak of influenza A (H1N1) a global pandemic, the total number of confirmed cases now exceeds 98,000 in more than 120 countries, with about 440 deaths. The pandemic designation is in recognition of the virus's rapid spread and not the moderate seriousness of the disease.

"The H1N1 pandemic is unstoppable, and therefore all countries will need to have access to vaccines," said Marie-Paule Kieny, WHO director of the initiative for vaccine research, in a press briefing last week. The organization also recommended that countries immunize their health care workers first when a vaccine does become available.

In turn, countries around the world have started committing funds to buy vaccine ingredients. The U.S. Department of Health & Human Services, for example, announced last week that it would spend another $884 million on top of more than $900 million it pledged in May for bulk supplies and clinical trials (C&EN, June 1, page 6).

Under pandemic preparedness contracts set up in 2004, HHS will place orders for vaccine antigen (the active ingredient) and new oil-in-water adjuvants (to boost the immune system) from Sanofi Pasteur, Novartis, GlaxoSmithKline, CSL Biotherapies, and MedImmune.

Nearly $980 million will be paid to Novartis alone. In mid-June, the company produced its first batch of H1N1 vaccine using a wild virus strain in a new cell-culture process. At the time, Novartis also said it was close to completing the first batch using a modified virus that health agencies had provided.

Vaccine makers have found, however, that the viral strains are generating only 25–50% of normal yields, Kieny said. Although there is enough antigen for clinical testing, WHO's lab network is hunting for more productive strains. And until better data on yield and dosages are known, Kieny would not predict exactly how soon vaccine could be readied or how many billions of vaccine doses could be made.

Preorder contracts between vaccine makers and countries including the U.S., the U.K., France, and Australia have raised concerns about vaccines being shared equitably with low-income nations. For its part, Kieny said, WHO is "trying to ensure equity" by getting industry donations, working with governments on doses and financing, and accelerating production.

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