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Concern raised on A/H1N1 flu vaccine
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China's Health Ministry has designated Shanghai, Beijing and Guangdong Province as the first places to use the newly produced domestic A/H1N1 flu vaccine, but some epidemic disease experts are concerned about its safety.

Zhong Nanshan, an academician who is respected for his work in China's fight against the outbreak of severe acute respiratory syndrome in 2003, warned that more time may be needed to "prove the reliability of the vaccine."

"The vaccine should be put into mass use only after it has been proved safe through tests in many pilot places," Zhong said. "Though vaccine inoculation is the basic way for the country to prevent H1N1 flu, it needs time to see whether it has side effects on the human body."

On Monday, China's State Food and Drug Administration issued the first order for mass inoculations with domestic A/H1N1 flu vaccine, the first country in the world to do so. It announced that the safety and effectiveness of the vaccines had been proved in clinical tests.

But the clinical trial period for the vaccine was less than three months, in sharp contrast with the prevailing practices among the international medical community, which spends several years on safety tests.

A Shanghai-made A/H1N1 flu vaccine passed final evaluation by the State Food and Drug Administration yesterday and is expected to receive a license for mass production next Monday.

The news came as Shanghai health officials said local cases of A/H1N1 flu and seasonal flu are increasing.

A formulation created by the Shanghai Institute of Biological Products was the third domestically made A/H1N1 flu vaccine to receive production authorization from national authorities, following Sinovac Biotech Ltd in Beijing and Hualan Biological Engineering Inc in Henan Province.

Seven other domestic companies are still in the process of developing the drug. China hopes to be able to turn out 65 million doses of the medicine by the end of the year.

No market sales

Shao Jun, an official from the Shanghai institute, said the vaccine will be earmarked for the national market, as purchases and vaccination plans are being ultimately decided by the Ministry of Health.

"Our products will be bought by the government, rather than being sold on the market," he said.

The Shanghai Health Bureau has drafted a preliminary vaccination plan and submitted it to city government and the health ministry for approval. It calls for 60 to 70 percent of vulnerable groups to be vaccinated after the shots are available. The target population includes students between age 6 and 19, the elderly, health care workers and public service staff.

Beijing has already started to offer free swine flu shots to students in primary and middle schools and people over 60 years old.

China, meanwhile, has stepped up calls for government bodies and the public to continue fighting the A/H1N1 flu outbreak with free vaccinations, allowing flexible work hours and other measures.

Government bodies and large companies are required to make plans to deal with possible outbreaks, the State Council said in a notice yesterday.

The Cabinet notice said that railway, aviation, transportation and tourism departments should draft plans to handle epidemic emergencies.

As of Wednesday, the Chinese mainland had reported 6,457 cases of A/H1N1 flu. About 64 percent of the patients recovered, and no deaths were reported.

Since Shanghai's first case of the H1N1 virus was reported on May 25, 574 local residents contracted the disease, and the vast majority had recovered as of noon Monday. The only serious case involved a man who was still hospitalized in critical condition last night.

Officials said the incidence rate of A/H1N1 flu in the city is similar to the national level. Among the 866 samples that tested positive for flu virus "recently," 28 percent contained the A/H1N1 flu virus, indicating a rising trend.

(Shanghai Daily September 11, 2009)

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