Inspections find no concerns with vaccine production

No quality and safety issues were found in vaccines that are currently under production in China, the State Drug Administration said after a thorough inspection.

After Changchun Changsheng Bio-tech Co in Jilin province was found to have fabricated production records for freeze-dried rabies vaccines for human use and was linked to a substandard DTaP vaccine for infants in July, the administration sent out teams to the other 45 Chinese vaccine manufactures to conduct inspections on vaccine production from July 23 to Aug 9, according to a statement released by the administration on Friday evening.

Besides the seven manufacturers that have suspended production for more than three years, the other 38 manufacturers that are currently producing vaccines have relatively comprehensive quality control systems as required. Also, all the vaccines produced are up to standard, the statement said.

The inspection teams have attached greater importance in identifying the authenticity of production, laboratory records and paperwork required before market release. The teams have also inspected production equipment, material used as well as quality and laboratory control systems of each manufacturer. Key vaccine manufacturers have undergone stricter inspections, the administration said.

The administration vows to further improve quality control systems. It will step up efforts in risk control measures during vaccine production, especially for those with more complicated manufacturing and quality control procedures such as rabies, DTaP and polio vaccines. It will also enforce random and follow-up inspections so activities that are against the law can be handled in a timely manner, it added.

The latest scandal has caused widespread concerns over vaccine safety. On July 23, President Xi Jinping demanded an immediate and thorough investigation into the scandal and the severe punishment of those responsible, while improving the country's vaccine management system to safeguard people's safety.

Xi said that the illegal production of vaccines by Changchun Changsheng Bio-tech Co is vile and shocking. He urged related departments and local governments to pay attention to the incident and immediately carry out thorough investigations and ensure those responsible face the full force of law.

The investigation team sent by the State Council found that the producer of the substandard vaccines was improperly profiting in violation of the law, disregarding national standards for medicine and the regulations for quality control, and falsifying testing records for vaccine production.

On July 29, Jilin police asked the local prosecutor to approve the arrest of 18 people from the company, including its chairwoman, under suspicion of producing and distributing drugs of inferior quality.

The local government and supervision departments were also found to have neglected their duties, with some officials failing to properly conduct oversight of vaccine production, the State Council said.

More than 40 government officials, including seven at the provincial level, have been held accountable for the scandal. Jin Yuhui, vice-governor of Jilin, and five senior officials were removed or required to resign from their posts.