The Chinese government has imposed a fine of more than $1.3 billion on a Changchun Changsheng Biotechnology Co. Ltd. of Jilin Sheng, China for manufacturing faulty rabies vaccines.1 The company was found to have falsified production and inspection data for 113,000 of its Vero cell-based human rabies vaccines.2
According to the AFP news service, food and drug regulators in China found Changchun Changsheng responsible for “wrongly mixing stock solutions, modifying centrifuges, and ‘destroying hard drives and evidence to conceal illegal actions'”.3 4
The fine against the pharmaceutical company, which is a subsidiary of Changsheng Biotech Co. Ltd., is the most stringent ever imposed on a vaccine maker.1
Jilin Province Food and Drug Administration (JFDA) revoked Changchun Changsheng’s license and confiscated $273 million in profits earned from selling illegally manufactured drugs.4 The government has also banned the company’s chairwoman Gao Junfang and fourteen other executives from working in China’s vaccine industry.1
The record fine and license revocation sends a strong message to Chinese vaccine makers that future safety violations will not be tolerated suggested Wang Yuedan Wang, professor of immunology at Peking University.1 Prof Wang said:
The government is imposing this heavy punishment to build effective order. From now on, no one will dare to touch this high-voltage wire.1
This rabies vaccine scandal comes amidst outrage of another vaccine scandal in China earlier this year. The China Food and Drug Administration (CFDA) found that Wuhan Institute of Biological Products Co. Ltd. of Wuhan, China had distributed 500,000 “substandard” doses of the diphtheria, pertussis and tetanus (DPT) vaccine.4 5
In a recent TIME article, Eli Meixler noted that the latest vaccine scandal in China has “reignited long-held fears over fake medicine and distrust in China’s scandal-plagued health and food authorities.” Meixler specifically referenced 2008 when “six children died and 300,000 became unwell after drinking contaminated milk powder formula” and, in 2016, when”$90 million worth of improperly stored vaccines were found to have been sold around the country.”4
1 Wee SL. China Imposes Record Fine on Vaccine Maker Over Safety Scandal. The New York Times Oct. 17, 2018.
2 Cáceres M. Vaccine Scandal in China Crosses “Moral Bottom Line”. The Vaccine Reaction July 25, 2018.
3 AFP. China fines pharma firm $1.3 billion in vaccine scandal. MSN Oct. 16, 2018.
4 Meixler E. Outrage in China Over Latest Vaccine Scandal. TIME July 23, 2018.
5 Cáceres M. Defective DTaP Vaccines in China Due to “Uneven Ratio of Liquid”. The Vaccine Reaction Aug. 3, 2018.