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August 05, 2009

Novartis, Novavax and China's Sinovec Biotech Begin Human Field Testing Swine Flu Vaccines

Swiss drugmaker Novartis has begun injecting its swine flu vaccine into people in the company's first human tests, a spokesman said Wednesday. At the moment swine flu is rated only a "moderate" pandemic by WHO standards but it could worsen as temperatures cool, making conditions better for the virus. Swine flu deaths are at 1154 Regular flu still kills a lot more people.

UPDATE:
Novavax made swine flu vaccine at its new manufacturing facility in Rockville using technology that significantly reduces the time it takes to make a vaccine. Novavax says it created the vaccine candidate just 11 weeks after getting the gene sequence for the N1H1 strain from the U.S. Centers for Disease Control.

Novavax’s manufacturing technology creates virus-like particle (VLP) vaccines, identical to the virus targeted, but without the ability to replicate and not made using chicken eggs, a long process used in virtually all vaccine manufacturing today.




The vaccine is being tested in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States. The vaccine will likely be on the market before the trial finishes. Althoff said Swiss-based Novartis was conducting its clinical trials in a number of countries, including the United States, Britain and Germany, and was testing both single and booster, or repeat, doses of vaccines.

Novartis, in common with other manufacturers, will also compare vaccines with and without adjuvants -- ingredients that boost the immune system response.

AstraZeneca, whose MedImmune unit makes smaller amounts of a flu vaccine that is sprayed into the nose rather than injected, said it would start clinical trials in the United States around August 17. As well as racing against the clock, vaccine companies are also working flat out to maximize their production capacity.

Initially, all the manufacturers except MedImmune -- which uses a different process -- struggled with low yields when making swine flu vaccine, with most companies only getting about 30 percent of the usual yield of seasonal flu strains. But that is starting to improve.


Fierce Vaccines reports: China's Sinovac Biotech has also begun testing its vaccine. The clinical trial involves a total of 1,614 volunteers of all ages. The Beijing government has preordered 4 million doses that are expected to be delivered in September.

Novartis has a swine flu information center



GlaxoSmithKline announced that in the past two weeks it has received orders from 9 more governments, for a total of 96 million additional vaccine units. The drugmaker is now committed to meet 25 requests for 291 million H1N1 vaccines--and is still in talks with other governments.


Read more: at fiercevaccines.com

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