More than 320,000 doses of rabies vaccine found to contain a banned ingredient have been recovered in China after regulators ordered a recall, an official said Wednesday.
The vaccines contain nucleic acid.
Among 360,200 doses of the flawed vaccines for human use, 323,200 had been recovered by Monday afternoon by the manufacturer, Dalian Jingang-Andi Bio-products Co. Ltd. in northeast China's Liaoning Province, said Yan Jiangying, spokeswoman for the State Food and Drug Administration (SFDA).
She said she believed the rest of the vaccines, where not used, had been held for recall.
There has been no report of vaccine-related illness so far.
The SFDA asked the province's drug administration department to make sure all products were recovered, Yan said at a press conference.
The agency ordered the company to recall all rabies vaccine it produced in 2008, totaling 3.389 million does, soon after the department received a report from the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) in early January.
The institute found in a test that 360,200 doses of the company's vaccines contained nucleic acid, which was not supposed to be added until its safety had been proven.
Nucleic acid acts as an adjuvant, or a substance used to enhance the effectiveness of anti-viral drugs. However, China hasn't yet approved it for use in rabies vaccine, said Dong Guanmu, a researcher at the NICPBP.
Dong said although animal tests showed the acid did enhance the effectiveness of the vaccine, it had to undergo clinical trials before it could be used on humans.
The company said on its website that it now supplies 20 percent of the rabies vaccine in China's market. The company could not be reached immediately for further information on the recall because the telephone number it published online was no longer in use.
(Xinhua News Agency February 12, 2009)