Amid a public outcry over vaccine safety and efficacy, Chinese officials and law enforcement are pressing fast ahead with their investigations, and their initial findings point to systematic data fabrication and doctored surveillance tapes at one of the largest vaccine makers in China.
Local police are now asking prosecutors to approve the arrest of 18 people for producing and selling faulty drugs. These people, Changchun Changsheng Life Sciences’ chairwoman Gao Junfang included, were found linked to alleged illegal actives during Changsheng’s rabies vaccines production, Changchun city police said in a Sunday statement.
The move by police came right after the revelation of similar findings made by a central government investigation team dispatched by Premier Li Keqiang.
Investigators found that the company breached the approved manufacturing process in order to lower costs and improve the success rate of rabies vaccine production, according to state-owned Xinhua news agency.
Changsheng mixed different batches of raw active antigenic substances in their final products, the team reported. In some cases, the company used expired materials and forged the production date. It was also found to have moved the mandatory mouse challenge test, used to determine rabies vaccine potency in final products, upstream to the raw material phase.
To cover it up, the company “systematically fabricated production and testing records,” as well as mice purchase invoices, the inspection team found. After a surprise inspection by the drug regulator uncovered misconduct, the company doctored surveillance tapes and computer data. Local police have retrieved 60 computer hard drives that the company meant to destroy.
After China’s State Drug Regulator revealed data fabrication issues at Changsheng and revoked its rabies vaccine GMP license about two weeks ago, the scandal has erupted into a public uproar over vaccine safety and efficacy. While no reports of serious adverse events have emerged related to the rabies vaccines, public confidence in domestically made vaccines has been shaken.
Shenzhen-listed Changsheng is China’s second-largest rabies vaccine maker, having delivered 3.69 million courses of rabies vaccines, and is also the country’s second-largest chickenpox vaccine provider by 2017 numbers, according to its annual report. In November 2017, 252,600 doses of the company’s acellular diphtheria/pertussis/tetanus (DTaP) vaccines meant for children were also found to be ineffective. Gao’s family ranked 371st on Forbes’ 2016 China Rich List, with $1 billion in wealth.
Carried out under direct orders from President Xi Jinping and Premier Li Keqiang, the Chinese government’s latest actions represent a series of synchronized moves aimed at containing public anger and restoring trust in its food and drug industry. The drug regulator has started a sweeping campaign to inspect all vaccine makers for misconduct. China Securities Regulatory Commission on Friday revised its delisting rule, adding actions that threaten public health as a new condition for enforced delisting.