More than 30,000 doses of a rabies vaccine carrying an illegal additive still have not been recalled, and most of them might have been given to humans, according a media report yesterday.
The vaccine, manufactured by a pharmaceutical plant in northeast China's Liaoning Province, was discovered to contain an acid to increase the apparent content of the drug's active ingredient, according to the Southern Weekend newspaper.
Patients who receive it are at risk of not being protected from the disease and could experience an adverse reaction to the additive.
The State Food and Drug Administration said on its Website on February 6 that the Jingang Andi Biological Product Co Ltd in Liaoning's Dalian City had added illegal material to its rabies vaccine. The administration said it had begun an investigation and demanded a recall.
The company reportedly added the acid to the vaccine to save on antigen, the agent that forms antibodies to the disease.
License revoked
The company had its license, good manufacturing practice certificate and government permit revoked on March 10. Employees responsible for the tainted vaccine were banned from drug production and management for 10 years. Three suspects, including the general manager and a purchasing agent, were detained.
According to the State Adverse Drug Reactions Monitoring Center, more than 1,700 cases of adverse reactions from rabies vaccine were reported from January 1, 2004, to February 6 this year, among which 97 cases were linked to vaccines produced by Jingang Andi. Three of the victims were reported to be critically ill.
Eleven batches of frozen dry vaccines, or 360,200 doses, were involved, and about 33,400 have yet to be recalled, according to the Dalian FDA. They were sold from last February to last June. Some of the products had 51 percent less antigen than required.
(Shanghai Daily March )