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Swine Flu Spreading; Drug Makers Begin Clinical Trials

by Lynn Shapiro, Writer | August 05, 2009
Public enemy number one
The H1N1 swine flu pandemic has claimed 1,154 lives since the outbreak was identified in April, the World Health Organization (WHO) said Wednesday. WHO also said that the number of confirmed cases was 162,380 worldwide as of July 31, 2009.

The Americas continued to have the highest number of confirmed cases, including 98,242 people who have become ill and 1,008 people who have died.

WHO also said 26,661 cases have been reported in the Western Pacific region and 26,089 in Europe, with the majority of cases being diagnosed in England. WHO has estimated that 2 billion people, or one in three of the world's population, will have been infected by the virus by the end of the pandemic.

Drug Makers Begin Clinical Trials

Meanwhile, Swiss vaccine-maker Novartis said it started testing its vaccine on August 5.

Approximately 6,000 people of all ages in the US, UK and Germany are being tested and the trial is expected to last for one year.

Novartis said the vaccine will probably hit the market before the trial is completed, under what's known as "fast-track approval," a process first instituted in the late 1980s, when AIDS activists insisted drugs get approved rapidly.

Half of Novartis' vaccine is being cultivated in chicken eggs, the conventional method of making flu vaccines. The other half of Novartis' medicine is based on a new method using cell-based technology. The trial will test the vaccine's safety and whether one or two shots are necessary. Officials believe that two shots will be needed.

Sanofi-Pasteur, which makes about 40 percent of the world's flu vaccines, says it will start testing its swine flu vaccine in a few days in the U.S. and Europe, according to a spokeswoman.

The vaccines being tested in Europe have an adjuvant, an ingredient used to boost the body's immune response. In the U.S., Novartis will be testing vaccines with and without adjuvants.

WHO recommends that countries use vaccines with adjuvants to increase the supply of swine flu vaccine. Flu vaccines in Europe contain adjuvants. However there are no approved flu vaccines with adjuvants in the US as yet.

The European Medicines Agency has previously said swine flu vaccines based on a pre-approved bird flu vaccine could be approved within five days, with very little testing done on human beings.

More than 35 countries have placed orders with Novartis for swine flu, or H1N1 vaccine, including France, the Netherlands, and Switzerland. The U.S. has ordered $979 million worth of bulk vaccine and Novartis' adjuvant.

GlaxoSmithKline PLC, which has orders for 291 million doses of vaccine from countries including Britain, has not yet started testing its vaccine in humans. The U.S. has also ordered $250 million worth of vaccine ingredients from Glaxo.