Flu vaccine production in pipeline

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China is set to be the first country to mass-produce a vaccine against the A/H1N1 flu pandemic, which scientists warn might erupt this fall and winter.

After passing a panel of experts certification organized by the State Food and Drug Administration (SFDA) yesterday, the vaccine is expected to be approved by the government this week.

The vaccine was developed by Beijing-based Sinovac.

The A/H1N1 influenza vaccine would be appropriate for anyone aged 3 to 60, said vaccine expert Zhao Kai, who is with SFDA's Drug Evaluation Center.

Only one shot is needed for inoculation.

"It's up to the international standard for safety and immunogenicity factors," Zhao said yesterday at the experts certification meeting.

Vice-Health Minister Yin Li yesterday emphasized the importance of vaccination.

"Local health departments should organize vulnerable groups for inoculation when A/H1N1 flu vaccination regulations are issued," he said.

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.

However, questions remain over such issues as when people will get the shot, how long the protection can last and what its price will be.

The vaccine will go into the national strategic stockpile instead of the marketplace and the Ministry of Health will devise a national inoculation plan, said Yang Jinrui, with the ministry's press office.

"Safety is always the top priority, thus it cannot be compromised by urgency," said Liang Wannian, vice director of the ministry's emergency office.

Health authorities will closely watch its safety after large-scale inoculation. No major adverse reactions were detected in clinical trials, said Li Guoqing, who heads the SFDA's Drug Evaluation Center.

The government will be responsible for any serious side effects from the vaccine, he said.

Vivian Tan, press officer with the World Health Organization Beijing office, said yesterday that the office had no details on the Sinovac clinical trials or the government's approval process, but gave recommendations on the immunization protocol.

Suggested target groups 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.

"Each country should adapt rules based on their own situations," she added.

Health Minister Chen Zhu said previously that China would prepare enough A/H1N1 vaccines for five percent of the population by year's end.

Keiji Fukuda, assistant director-general of the World Health Organization, said given the population size, vaccine manufacturers in China face a huge challenge in expanding the production capacity to meet potential needs.

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

Yang, of the Ministry of Health, refused to confirm the Mexico deal, but he said there are countries wanting to buy the vaccine from China, and they had contacted the ministry.

Nearly 75 percent of those polled in the Sohu.com survey said they opposed selling vaccine to other countries, saying it should first protect the Chinese.

"If used in the right areas and for specific groups, the amount of vaccine would work well to block the virus spreading among the people," said Zeng Guang, a senior epidemiologist at the Chinese Centers for Disease Control and Prevention.

The Ministry of Health yesterday called on the public to fight against A/H1N1 flu as risks are rising amid recent cases of group infection.

Mao Qun'an, the ministry spokesman, said universities, schools and nurseries should formulate plans to guard against A/H1N1 flu outbreaks following the start of the fall semester.

The Chinese mainland had reported 3,757 A/H1N1 flu cases by yesterday, 86.5 percent of whom had recovered, the ministry said.

Hong Kong's North District Hospital announced yesterday that a male patient who had been infected with A/H1N1 virus died in the hospital on the same day.

The 65-year-old patient, who returned from the Chinese mainland on Aug 24, attended the accident and emergency department of the hospital on the same day due to shortness of breath, fever and cough. He was admitted to the isolation ward. The patient had a history of asthma, pneumonia and heart disease, according to a statement from the hospital.

Hong Kong had confirmed 229 new cases of Influenza A/H1N1 in the 24 hours leading up to 2:30 pm yesterday, bringing the number of confirmed cases to 11,807, the special administrative region's health authorities said.

Globally, the disease has killed nearly 2,000 people and infected more than 180,000.

(China Daily September 2, 2009)

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