Novartis begins human trials in push for swine flu vaccine
Source: Agencies |
August 6, 2009, Thursday
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SWISS drugmaker Novartis has begun injecting its swine flu vaccine into people in the company's first human tests, a spokesman said yesterday.
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 said, 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 guess 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 US, however, Novartis is only testing vaccines without adjuvants, Althoff said.
WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of swine flu vaccine. 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 US 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.
Last month, WHO reported that the swine 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 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.
In India, meanwhile, hundreds of anxious people crowded a hospital waiting to be tested for swine flu yesterday.
Panic spread in the western city of Pune and fights broke out at the city's top hospital after authorities reported the country's first swine flu fatality two days ago.
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 said, 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 guess 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 US, however, Novartis is only testing vaccines without adjuvants, Althoff said.
WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of swine flu vaccine. 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 US 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.
Last month, WHO reported that the swine 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 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.
In India, meanwhile, hundreds of anxious people crowded a hospital waiting to be tested for swine flu yesterday.
Panic spread in the western city of Pune and fights broke out at the city's top hospital after authorities reported the country's first swine flu fatality two days ago.
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