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Race against time to produce flu vaccine

By Ding Qingfen (China Daily)
Updated: 2009-09-10 08:38

The 10 Chinese vaccine producers appointed by the government to develop the H1N1 Influenza vaccines are racing against time to finish clinical trials and start mass-producing the drug before the start of the flu season in October.

Beijing Sinovac Biotech, China's leading vaccine manufacturer and one of the 10 producers, received a license for producing vaccines from the State Food and Drug Administration (SFDA) on Sept 3 after the vaccine it developed was approved by a panel of experts.

The vaccine, called Panflu 1, is the first to receive official approval for production worldwide. It means China is likely to be the first nation that could mass-produce a vaccine against the flu.

On July 28, Sinovac Biotech, a joint venture between SinoBioway Group and Sinovac Biotech Ltd, a listed company on the New York Stock Exchange, announced the preliminary clinical trial showed the vaccine was "safe and effective". It was the first in the world to complete preliminary clinical trials.

The preliminary result came from injecting 1,614 volunteers in China.

Currently, there are six Chinese vaccine producers among the 10 that have finished clinical trials and applied for production certificates from the Chinese government. Henan-based Hualan Biological Engineering is expected to be the second company to receive production approval.

Industrial sources said most of the 10 vaccine producers would finish clinical trials around October.

Panflu 1 can safely be given to people aged from three to 60 years old in a single 15 microgram dose, according to the evaluation report.

Sinovac Biotech has the capacity to produce 5 million doses of vaccine before Oct 1, and 20 million to 30 million doses per year, said its president, Yin Weidong.

By the end of this year, China will produce H1N1 vaccines for 65 million people, covering 5 percent of the national population.

Suggested groups for vaccination are healthcare workers, who are more likely to be exposed to the virus, pregnant women, people aged above six months with chronic medical conditions such as respiratory and cardiovascular diseases, healthy adults aged 15-49 and children.

Given the population size, Chinese vaccine manufacturers will face a huge challenge meeting the potential needs with limited production capacity, said Keiji Fukuda, assistant director-general of the World Health Organization.

Xinhua reported that the Mexican government would buy 10 million doses of H1N1 flu vaccine from China, bringing its stockpile to 30 million doses, nearly 30 percent of its population.

An online survey by the news portal Sohu.com found that 68.4 percent of the 2,269 respondents said they wanted to be vaccinated.

(China Daily 09/10/2009 page31)