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Local swine flu vaccine sent for state approval
By Cai Wenjun |
August 29, 2009, Saturday
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Print Edition
Print Edition
SHANGHAI-MADE swine flu vaccine is expected to go into mass production soon, following final approval from national authorities, the vaccine's makers said yesterday.
Samples from the first batch of 40,000 doses were sent yesterday by the Shanghai Institute of Biological Products to the National Institute for the Control of Pharmaceutical and Biological Products in Beijing.
If the vaccine passes this last hurdle, which should happen within a month, the institute will receive a production license from the State Food and Drug Administration, the Shanghai institute said yesterday.
But there are still questions to be answered before members of the public can begin rolling up their sleeves for shots.
"The price, who should receive the vaccine and how it will be administered are still being discussed by the Ministry of Health and other national departments," said Lou Jueren, the Shanghai institute's chief researcher.
"The ministry has planned to purchase batches of 13 million doses and 65 million doses from drug companies making the vaccines. But the government purchase may grow."
The Shanghai institute, the city's only licensed flu vaccine producer, is one of 11 companies in China authorized to develop and manufacture swine flu vaccine.
It obtained H1N1 flu strains recognized by the World Health Organization from the National Institute for Biological Standards and Control in Britain on June 18 and began carrying out research and production.
Using typical flu production technology, the vaccine is grown from the virus in fertilized chick eggs. The production period for each batch is one and a half months, officials said.
After passing checks by Shanghai Food and Drug Administration, the institute carried out a clinical test on 1,980 volunteers on July 25 in Hunan Province under the approval of the state FDA and the China Center for Disease Control and Prevention.
The trial found that the vaccine was both safe and effective for humans and the immunity effect was more than 90 percent. The results were approved by the China CDC on Wednesday.
"Under current production capability, we can produce eight to 10 million doses by this year's end," said Yang Zhongdong, the institute director.
The peak season for flu is usually between November and March in Shanghai. As of Wednesday, the Ministry of Health had reported 3,211 swine flu cases in the mainland since the outbreak began, and over 2,949 had recovered. There have been no fatalities. Shanghai has reported around 280 cases.
Samples from the first batch of 40,000 doses were sent yesterday by the Shanghai Institute of Biological Products to the National Institute for the Control of Pharmaceutical and Biological Products in Beijing.
If the vaccine passes this last hurdle, which should happen within a month, the institute will receive a production license from the State Food and Drug Administration, the Shanghai institute said yesterday.
But there are still questions to be answered before members of the public can begin rolling up their sleeves for shots.
"The price, who should receive the vaccine and how it will be administered are still being discussed by the Ministry of Health and other national departments," said Lou Jueren, the Shanghai institute's chief researcher.
"The ministry has planned to purchase batches of 13 million doses and 65 million doses from drug companies making the vaccines. But the government purchase may grow."
The Shanghai institute, the city's only licensed flu vaccine producer, is one of 11 companies in China authorized to develop and manufacture swine flu vaccine.
It obtained H1N1 flu strains recognized by the World Health Organization from the National Institute for Biological Standards and Control in Britain on June 18 and began carrying out research and production.
Using typical flu production technology, the vaccine is grown from the virus in fertilized chick eggs. The production period for each batch is one and a half months, officials said.
After passing checks by Shanghai Food and Drug Administration, the institute carried out a clinical test on 1,980 volunteers on July 25 in Hunan Province under the approval of the state FDA and the China Center for Disease Control and Prevention.
The trial found that the vaccine was both safe and effective for humans and the immunity effect was more than 90 percent. The results were approved by the China CDC on Wednesday.
"Under current production capability, we can produce eight to 10 million doses by this year's end," said Yang Zhongdong, the institute director.
The peak season for flu is usually between November and March in Shanghai. As of Wednesday, the Ministry of Health had reported 3,211 swine flu cases in the mainland since the outbreak began, and over 2,949 had recovered. There have been no fatalities. Shanghai has reported around 280 cases.
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