DALIAN, China, March 5 /PRNewswire-FirstCall/ -- China Bio-Immunity Corporation (OTC Bulletin Board: CHHB) (China Bio-Immunity" or "the Company"), a China-based company that develops, produces, manufactures and markets proprietary vaccine-based prophylactics and therapeutics exclusively within China through it wholly-owned subsidiary, Dalian Jingang-Andi Bio-products Co. Ltd (Dalian JGAD), today announced an update regarding the nationwide recall of its rabies vaccines.
The National Institute for the Control of Pharmaceutical and Biological Products has reported that the Company's flawed rabies vaccines contained nucleic acid, which as a prescription drug has been legally produced by more than twenty manufacturers in China and widely used in the Chinese market. However, it has not yet been approved as an ingredient to be added in human rabies vaccine in China. Although tests on animals demonstrated that the nucleic acid did enhance the effectiveness of the human rabies vaccine, it had to undergo clinical trials before it could be used as an adjuvant in human rabies vaccines. Dalian JGAD was found falling afoul of such regulatory rules. Among 360,200 doses of the flawed rabies vaccines in China, a total of 323,200 have been recovered by the manufacturer, Dalian JGAD. The rest of the rabies vaccines were not used and had been held for recall. To date, there has been no report of vaccine related illness received by Chinese National Center for Adverse Drug Reaction Monitoring.
Furthermore, the China State Food and Drug Administration ("SFDA") has confiscated all the flawed products and profits from the sales of the flawed rabies vaccines. The SFDA will also assess a punitive fine of 145 Million Chinese Yuan. Dalian JGAD has been suspended from production and sales of vaccines since the recall. The production permit of Dalian JGAD was also revoked. Additionally, the key officers involved have been forbidden from engaging in any
|SOURCE China Bio-Immunity Corporation|
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