Vaccine company doctored records

An investigation of Chinese vaccine maker Changchun Changsheng Life Sciences Limited found evidence that the company had illegally produced rabies vaccines for human use.

The State Council’s investigation team seized 1138 pages of documents as evidence, and recovered actual and forged production records via seized computers. Criminal suspects discarded and intended to destroy 60 computer hard drives. But the Police have recovered them, according to the investigation team.

The company was found to have violated the approved production process to reduce costs and improve the success rate of rabies vaccine production.

Violations included blending different batches of vaccine fluid for product packaging, using expired fluid to produce some batches of products, falsifying dates of production, and conducting certain product testing before the entire production process was completed.

To cover up such violations, the company “systematically” fabricated production and inspection records and issued invoices with false dates to meet inspection requirements.

The company was ordered to immediately stop production after drug regulatory authorities found illegal production behavior during an unannounced inspection from July 6 to July 8.

Soon after the inspection, the company replaced internal surveillance video storage cards and some computer hard drives to cover up and destroy potentially incriminating evidence.

On July 15, the State Drug Administration conducted an on-site investigation of the company. The public security organs have initiated investigations into the case.

As of July 25, the Police have detained 16 suspected criminals, including the chairperson of the company, and have frozen relevant corporate and personal accounts. Further investigation is in progress.

According to data from the Chinese Centre for Disease Control and Prevention, the incidence of adverse reactions caused by the rabies vaccine produced by Changchun Changsheng Life Sciences Limited was about 2 per 100,000 cases, and no serious adverse reactions were observed.

In 2017, there were 516 rabies cases in China. The incidence rate has been gradually decreasing in recent years.