China’s drug regulator just pulled a manufacturing permit for the country’s second-largest maker of rabies vaccines over data falsification, marking the latest episode in China’s drug safety scandal.
During an inspection, China’s State Drug Administration found Changchun Changsheng Life Sciences forged production records for its Vero cell-based rabies vaccines. The agency immediately moved to revoke the company’s GMP license tied to the vaccine—just three months after its issuance—and dispatched a team to investigate the incident on site, according to a Sunday statement (Chinese).
In its announcement filed to Shenzhen Stock Exchange, the Changchun, China-based company said it has started recalling all unexpired rabies vaccines, even though the batches under question weren’t released to the market, and it hasn’t received any adverse event report related to the quality of the vaccines through years of monitoring.
The company claims to be China’s second-largest rabies vaccine supplier, having delivered 3.55 million courses of the five-dose-per-course freeze-dried vaccine in 2017, making up about a quarter of the market, according to the firm’s annual report.
Changsheng’s recent scandal comes eight months after a batch, or 252,600 doses, of its diphtheria/tetanus/pertussis (DTP) combo shot was found below the potency requirement. It also comes shortly after the company became one of the first two companies to get Chinese approvals for quadrivalent flu vaccines.
Besides rabies, DTP and flu vaccines, Changsheng also sells vaccines against chickenpox, hepatitis A and group ACYW meningococcal. A small proportion of its business comes from abroad, including India, Cambodia, Egypt and Belarus, among others. It’s not yet clear whether it sells its rabies vaccines outside of China.
China has taken a hardball policy to safeguard vaccine safety after a high-profile scandal in 2016. At that time, a ring led by a mother and daughter team in Shangdong province was found to have illegally sold millions of dollars’ worth of vaccines across the country without following proper storage and distribution requirements. Vaccines made by some of the country’s top makers were involved, over 100 people have since been handed criminal sentences, over 300 government officials were removed or punished, and most importantly, it hurt the public’s confidence in Chinese-made vaccines.
After that, China banned middlemen in vaccine distribution, asking provincial CDCs to buy vaccines directly from manufacturers, and established a better vaccines tracing system.