China Bio-Immunity Corporation (CHHB.OB) has begun a voluntary recall of its rabies vaccines, which are produced under the JGAD label. In a routine test, the SFDA found the “possibility of a flaw” in one of its vaccines. At this point, no adverse reactions have been reported to the SFDA.
The SFDA has asked the Liaoning Provincial Food and Drug Administration to increase its monitoring of the company’s operating subsidiary, Dalian Jingang-Andi Bio-Products Co., Ltd. (JGAD). The production lines of the company have been shut down until an investigation of the problem is completed.
Although the company also produces a mumps vaccine, more than 90% of its revenues come from its rabies vaccine, so the recall is a significant setback for the company.
JGAD completed its reverse merger with China Bio-Immunity in August of 2008. JGAD‘s rabies vaccine is grown in vero cells, which are isolated from monkey kidney cells. They provide a continuous cell lineage that can be replicated through many cycles of division without losing their ability to divide. Sales of JGAD’s rabies vaccine took off in 2007 when the SFDA tightened its quality control standards on rabies vaccines, forcing many competing products off the market.
Disclosure: none.
