Progress against swine flu as Novartis begins human tests

August 5, 2009 – 9:18 am by Colette Pilkus

As swine flu spreads across 168 countries and territories, another company has begun testing a vaccine in humans. Novartis has begun the company’s first human tests in 6,000 people in a year-long trial in Britain, Germany, and the United States. Last month CSL Ltd., an Australian biopharmaceutical company, became the first to start testing a vaccine in humans in Australia.

About 10 days ago a person in Britain became the first to get the vaccine. Half of Novartis’ vaccines being tested are grown in chicken eggs, the traditional way of making flu vaccines. The other half use a new cell-based technology.

The trial will test the vaccine’s safety and whether one or two shots are necessary. The vaccines being tested in Europe use an adjuvant that boosts the body’s immune response. The company is not testing vaccines with adjuvants in the United States. Although the World Health Organization recommends using adjuvants in vaccines to extend the supply, there are no licensed flu vaccines with adjuvants in the United States. Company executives believe that the vaccine will be on the market before the trial ends.

Once preliminary data from the trial has been collected, Novartis will submit the information to FDA and EMEA, which have a fast-track process for approving a vaccine for swine flu to make it available before the fall flu surge. According to a study from researchers at Mt. Sinai Medical School, the flu virus is more stable and able to stay airborne longer when the air is cold and dry – such as during the fall and winter months. By fall, the government hopes to have 120 million doses of vaccine ready.

More than 35 countries have placed orders with Novartis for the swine flu vaccine, including France, the Netherlands, and Switzerland. The United States has ordered $979 million worth of bulk vaccine and the company’s adjuvant. Novartis expects to begin shipping the vaccine in the last quarter of 2009, continuing deliveries into 2010.

According to WHO, 1,154 victims have died from swine flu since April, with more than 300 new deaths in the United States. Two billion people are expected to catch the disease by the time the pandemic ends. This number is just as estimate as no one knows how many people have caught the new strain and many cases are so mild, they may go unnoticed.

H1N1 is pounding the southern hemisphere, where it is now winter. Argentina has recorded more than 160 deaths from H1N1, second most after the United States.

Tags: CSL Ltd., Novartis, swine flu, vaccines, WHO