Novartis starts yearlong swine flu vaccine testing

LONDON – Swiss drugmaker Novartis has begun injecting its swine flu vaccine into people in the company’s first human tests, a spokesman said Wednesday.

The vaccine is being tested in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States, Novartis spokesman Eric Althoff told the Associated Press, adding that the vaccine will likely be on the market before the trial finishes.

A person in Britain became the first to get the swine flu vaccine about 10 days ago, he said.

Since swine flu was declared to be a pandemic, or global outbreak, by the World Health Organization in June, pharmaceuticals have been racing to get their vaccines ready.

Last month, Australian drugmaker CSL became the first vaccine maker to start testing its vaccine in humans in Australia.

“We initiated clinical trials about 10 days ago,” Althoff said.

Half of Novartis’ vaccines being tested are grown in chicken eggs, the traditional way of making flu vaccines, while 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.

“Our assumption is that two doses will be required,” Althoff said.

Once Novartis has preliminary data from the trial, it will submit that to drug regulators, including the European Medicines Agency. European and U.S. regulators have a fast-track process for approving swine flu vaccine, to ensure it is available before the flu season starts in the fall, when swine flu is expected to surge.

More than 35 countries have placed orders with Novartis for swine flu, or H1N1 vaccine, including France, the Netherlands and Switzerland.

The United States 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 United States has also ordered $250 million worth of vaccine ingredients from Glaxo.

Since swine flu emerged in April, it has killed at least 1,154 people worldwide and is estimated to have infected millions, according to WHO.