The vaccine for the A/H1N1 flu virus produced by Chinese pharmaceutical company Sinovac Monday passed with flying colors an experts' evaluation organized by the State Food and Drug Administration (SFDA), and is hopeful to obtain a production license this week.
Sinovac's A/H1N1 flu vaccine could safely be given to people aged from three to 60 years old in a single shot, 15 microgram dose, and was approved by the unanimous vote of 43 experts.
The clinical trials on the vaccine show immunogenicity factors reach international standards, and its adverse reactions were similar to those of split vaccines for seasonal flu, a medical conference on Monday was told.
The report will be the primary mover for the SFDA to issue a production license. It will be submitted to the SFDA Tuesday, after which a final decision will be made within three days, said Li Guoqing, the director of SFDA's Center for Drug Evaluation
Five other pharmaceutical companies have also submitted applications for registration of A/H1N1 flu vaccines. Evaluation of a vaccine developed by the Hualan Biological Engineering Inc. would be released Tuesday, Li said.
"It is the first time that we have invited so many experts from 11 different medical specializations to evaluate a drug. It was an urgent and crucial task," Li said.
Zhao Kai, the leader of the experts team and a member of the Chinese Academy of Engineering said if approved, the vaccine in mass production would be reserved by the State instead of going on general sale.
"The government will decide whether and how to distribute the vaccine, based on the flu's development," Zhao said.
The vaccine will be altered if the virus mutates.
Shu Yuelong, another member of the experts team, an official from the Chinese Center for Disease Control and Prevention (CDC), said a flu pandemic in the northern hemisphere was almost "inevitable" during the coming Autumn and Winter.
"Many countries are racing to develop a vaccine, and the World Health Organization hopes that every country is willing to share results of its clinical trials," Shu said.
Yin Weidong, president of Sinovac -- also known as Beijing Kexing Bioproducts -- said he was expecting a production license so the vaccine could help prevent and control the spread of A/H1N1 flu "not only in China, but worldwide".
The conference also invited 15 representatives of the public and 20 journalists who had signed up on SFDA's official website, to express concerns and raise questions about the vaccine.
Zhang Kai, a professor at Beijing-based Renmin University of China said he had kept a close eye on the progress of the flu vaccine after being terrified during 2003's SARS period.
"I care about its effectiveness, adverse actions and whether it's suitable for kids, pregnant women and the elderly," said Zhang, who has an 11-year-old son.
Li said the SFDA was ready to make drug evaluation open to the public, especially evaluation of innovative medicines and those in which the public had a major interest.
As of 3 p.m. Monday, China had reported 3,757 cases of A/H1N1 flu on the mainland, of whom 3,249 had recovered, with no confirmed deaths, said the Health Ministry.
Earlier this month, Health Minister Chen Zhu said China would be able to produce enough A/H1N1 flu vaccine for 65 million people by the end of the year.
(Xinhua News Agency September 1, 2009)
