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China begins tests of first A/H1N1 flu vaccines
Source: Xinhua |
June 22, 2009, Monday
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Online Edition
Online Edition
LABORATORY tests began on China's first developed A/H1N1 flu vaccine today.
The vaccines are expected to hit the market in September after 14 days of safety tests in labs and two-month clinical tests from July, said Fan Bei, deputy general manager of Hualan Biological Engineering Inc., based in Henan Province.
The company had produced a first batch of 90,000 doses, but it would be able to make 600,000 doses a day once it was approved, Fan said.
"As the vaccines still need to go through several tests, we did not produce at full capacity."
A clinical test plan submitted by the firm was approved by the State Food and Drug Administration (SFDA), but she would not release the details of the plan.
The company received the seed virus from a World Health Organization (WHO) lab on June 3.
China has 11 drug firms that are qualified to produce flu vaccines. Another drug company, Sinovac Biotech Co. Ltd., announced that it had started development of A/H1N1 flu vaccines on June 15.
China has reported 414 cases of A/H1N1 flu. Epidemiologists have warned of a "very high" risk of outbreak in densely populated communities.
The Ministry of Health issued a document last Wednesday saying that, in case of a rampant spread of the virus in local communities, it would switch to monitor the "group activities" of each community instead of closely tracking and quarantining individual patients.
It also suggested that group activities of communities could besuspended or canceled, which means schools could be closed.
The vaccines are expected to hit the market in September after 14 days of safety tests in labs and two-month clinical tests from July, said Fan Bei, deputy general manager of Hualan Biological Engineering Inc., based in Henan Province.
The company had produced a first batch of 90,000 doses, but it would be able to make 600,000 doses a day once it was approved, Fan said.
"As the vaccines still need to go through several tests, we did not produce at full capacity."
A clinical test plan submitted by the firm was approved by the State Food and Drug Administration (SFDA), but she would not release the details of the plan.
The company received the seed virus from a World Health Organization (WHO) lab on June 3.
China has 11 drug firms that are qualified to produce flu vaccines. Another drug company, Sinovac Biotech Co. Ltd., announced that it had started development of A/H1N1 flu vaccines on June 15.
China has reported 414 cases of A/H1N1 flu. Epidemiologists have warned of a "very high" risk of outbreak in densely populated communities.
The Ministry of Health issued a document last Wednesday saying that, in case of a rampant spread of the virus in local communities, it would switch to monitor the "group activities" of each community instead of closely tracking and quarantining individual patients.
It also suggested that group activities of communities could besuspended or canceled, which means schools could be closed.
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