(AP) Swiss drugmaker Novartis has started to test its Type A H1N1 influenza vaccine for people, a spokesman said Wednesday.
The vaccine is being tested in a year-long 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 is completed. A person in Britain became the first to get the Type A H1N1 vaccine about 10 days ago, he said.
Since Type A H1N1 was declared to be a pandemic, or global outbreak, by the World Health Organization in June, pharmaceutical companies have been racing to get their human vaccines ready. Last month, Australian drugmaker CSL became the first vaccine maker to start testing its vaccine in humans in Australia.
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.
The vaccines being tested in Europe use an adjuvant, an ingredient used to boost the body's immune response. In the U.S., however, Novartis is only testing vaccines without adjuvants, Althoff said.
WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of Type A H1N1 influenza vaccine for people. However there are no licensed flu vaccines with adjuvants in the United States.
Once Novartis AG 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 any Type A H1N1 vaccine, to ensure it is available before the human flu season starts in the fall, when the new H1N1 virus is expected to surge.
The European Medicines Agency has previously said H1N1 flu vaccines based on a pre-approved bird flu vaccine could be licensed within five days, even without extensive testing in humans.
Last month, WHO reported that the H1N1 flu viruses being used to make the vaccine were not growing enough of a key ingredient, and said they were only producing half as much "yield" as regular flu viruses. The agency asked its laboratory network to produce a new set of viruses for vaccine makers to use.
Althoff confirmed that Novartis is only getting about 30 percent to 50 percent of the usual yield it gets from flu viruses to make vaccines. Novartis made its vaccines with WHO's original set of flu viruses, and hasn't yet started working with the new viruses. The low virus yield could mean delays in when countries get their vaccine orders filled.
More than 35 countries have placed orders with Novartis for the Type A H1N1 human vaccine, including France, the Netherlands, and Switzerland. The U.S. has ordered $979 million worth of bulk vaccine and Novartis' adjuvant. Althoff said the company expected to start shipping vaccine in the last quarter of 2009 and will continue the deliveries next year.
Source: The Associated Press.