As China reported its third case of human bird flu yesterday, the only
company in the nation approved to test a vaccine for humans said that clinical
trials on volunteers would start in days.
The Ministry of Health said a 35-year-old woman farmer surnamed Xu of East
China's Anhui Province developed fever and pneumonia-like symptoms on November
11 after contact with sick and dead poultry. She died on Tuesday.
Tests on the woman, a resident of Xiuning County, were positive for the
deadly H5N1 strain of the virus, said China's Centre for Disease Control and
Prevention.
The ministry has reported the new confirmed case to the World Health
Organization (WHO), according to the WHO Beijing Office.
Meanwhile, a new bird flu outbreak was reported in Miquan of Xinjiang Uygur
Autonomous Region, the Ministry of Agriculture said last night.
More than 2,000 chickens were killed by the deadly H5N1 virus on November 15.
So far 84,000 poultry have been culled to curb the spread of the disease.
As fears of person-to-person transmission grow with each new case of human or
poultry infection, Beijing-based Sinovac Biotech Ltd said it would be the first
company in Asia to begin human testing after it won fast-track State approval
for the trials on Tuesday.
The State Food and Drug Administration, the country's drug watchdog, has
approved the first phase of trials, company spokesperson Lu Zhenyou told China
Daily.
It might take at least a year before the "pandemic influenza vaccine"
finishes its two-phase clinical trials, Lu said.
Sinovac and a group of experts were putting the final touches on the clinical
trial plan involving 100 healthy volunteers between the ages of 18 and 60, Lu
said.
Pre-clinical trials have proved the vaccine is safe and effective, experts at
the drug regulator said.
When approved, the vaccine will first be used on high-risk groups such as
veterinary and laboratory workers and poultry farmers in afflicted regions, Lu
said.
Usually, the first phase of clinical testing takes nine months but in the
case of the bird flu vaccine, initial results could be available as soon as
three months later, Lu said.
In the second phase, tests will be conducted on many more people, she said,
without giving any specifics.
When approved, the vaccine will be made available at a price even cheaper
than normal flu jabs, Lu said.
The vaccine was jointly developed by Sinovac and the Chinese Centre for
Disease Control and Prevention over 21 months, targeting the H5N1 virus strain.
Even if the virus strain mutates, experts could substitute the core virus in
the vaccine with the latest strain, according to Lu.
"The vaccine we have now is specifically against the H5N1 strain of the bird
flu virus. But we are also capable of producing vaccines against other types of
influenza if the virus changes into other forms," Yin Weidong, managing director
of Sinovac, told China Daily last week.
Sinovac also developed a SARS (severe acute respiratory syndrome) vaccine -
the world's first - which has passed the first phase of human testing.