China announced here Monday thatits human-use bird flu vaccine had proved "safe" and "effective"during the second phase of clinical tests.
The vaccine was jointly developed by the Beijing-based vaccineproducer Sinovac Biotech, the first in the world to develop SARSvaccine, and the Chinese Center for Disease Control andPrevention. The program was also under support of the Ministry ofScience and Technology and the Ministry of Health.
Zhang Jiansan, vice-general manager of the Sinovac Biotech,said the second phase of clinical tests was carried out from thisSeptember to November after applying for human clinical trials forthe vaccine with the Chinese State Food and Drug Administration. Atotal of 402 people aged from 18 to 60 years took the test.
Test results showed that the major index of the vaccinereached international standards and performed well in the humanbody. None of the test takers were found to have a seriousnegative reaction, which proved that the vaccine was safe.
Zhang said test takers of different ages were given differentdosage of vaccine, and the result was also positive. "It means thevaccine could give multiple choices of treatment for flu infectedpeople."
"We have been able to control the dosage and immunityprocedure of the vaccine during the second phase of clinical tests,which also provided for us scientific and effective methods tocombat highly infective influenza," Zhang said.
Observers said China had completed its technologicalpreparation to combat influenza with the success of human-use birdflu vaccine research and clinical tests.
"China is also capable of producing human-use bird flu vaccinein appropriate quantity," Zhang stressed.
The first human infection case of bird flu was reported inChina's Hong Kong in 1997 and immediately became a world epidemicdisease. Up to now, the world has seen 304 human infection casesof bird flu, among which 209 died.
The World Health Organization estimated that a maximum of 2.3million people in developed countries may go into hospital and280,000 may die once the influenza outbreak comes. The situationin developing countries may be even worse.
Founded in 2001, Sinovac, known in China as Beijing KexingBioproducts Limited Company, focuses on manufacturing andmarketing human-use vaccines and related products for infectiousdiseases such as Hepatitis A and Hepatitis B, influenza and SARS.
The company was designated to cooperate with the state diseasecontrol and prevention center to carry out the research anddevelopment for human-use bird flu vaccine, to be used forpreventing the disease among humans, since the epidemic amongbirds was first uncovered in March 2004.
Source: Xinhua
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