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Novartis Hopeful of H1N1 Flu Vaccine by Autumn
Novartis expects a vaccine for the H1N1 virus, declared responsible on Thursday for the 21st century's first flu pandemic, to be available by the autumn after producing the first batch ahead of schedule.
The Swiss drugmaker said on Friday it would start clinical trials on the vaccine next month, a day after the World Health Organisation declared a pandemic and called on governments to prepare for a long-term battle against the virus.
Novartis, Sanofi-Aventis, GlaxoSmithKline and Solvay all obtained the influenza A (H1N1) seed virus in recent weeks, aiming to have a vaccine ready ahead of the flu season in the northern hemisphere.
Novartis said in a statement first results with the H1N1 wild type strain showed it was quicker to make the vaccine through cell-based than through egg-based production.
"Novartis has successfully completed the production of the first batch of influenza A (H1N1) vaccine, weeks ahead of expectations," it said.
A spokesman for the firm said he was unsure if any other company had completed the first cycle of the production process, and said Novartis should have the vaccine ready in September or October.
It hoped to be able to produce millions of doses per week.
Wayne Pisano, head of vaccines at Sanofi-Aventis, the world's largest flu vaccine supplier, said on Thursday his company would "produce the largest number of doses of vaccine in the shortest time frame," though it would be another four months before the first supply of bulk concentrate was ready.
Shares of Novartis closed 4.4 percent higher at 45 Swiss francs.
The H1N1 strain has spread widely, with 28,774 infections confirmed in 74 countries to date, including 144 deaths, according to the WHO's latest tally.
Although the strain seems mild at present, health officials are worried it might return in a more virulent form in the northern hemisphere winter.
Cell-Based Technology
While commercial production of vaccines usually depends on how easily a virus strain grows in chicken eggs, Novartis said its cell-based technology means it can produce a vaccine without having to adapt the virus strain to grow in eggs.
"This advance has cut weeks off the time required to begin vaccine production," Novartis said, adding that its cell-based facility in Germany should be able to produce millions of doses each week.
H1N1 vaccines must be tested first on ferrets and then on humans in clinical trials before regulatory approval is granted.
WHO Director-General Margaret Chan said on Thursday different regulatory authorities needed to work together to speed registration of a safe H1N1 flu vaccine.
Novartis said more than 30 governments have made requests to supply them with vaccine ingredients, which are a combination of pre-existing pandemic vaccine supply agreements and new requests for vaccines across all production platforms including egg-based manufacturing.
The question of how the vaccine would be dispensed was still open, the Novartis spokesman said.
"This will depend on government programs and what health authorities, the WHO and others say on how they want to make it available," he said.
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