The China State Council has been investigating the defective rabies vaccine manufactured by Jilin-based Changsheng Biotechnology — one of China’s largest vaccine makers — after the China Food and Drug Administration ordered the company to halt production on July 15, 2018.
The Council confirmed that some of the vaccine had been sold abroad and that a drug recall had been issued, according to Xinhua News Agency. Authorities say they are also punishing the company for producing a substandard vaccine for diphtheria, pertussis, and tetanus (DPT), which began as early as 2017.
Outrage continues on Chinese social media as officials try to contain revelations that children had been given defective vaccines after parents were told they must follow a vaccination schedule.
“I just want to express a mother’s anxiety… the vaccine case is like pouring poison into the well,” one mother wrote on social media, Weibo. “I am truly terrified.”
It is unclear how many children have been affected by Changsheng vaccines. Nearly 250,000 doses of the DPT vaccine in question had been sold to Shandong Province alone, reported Chinese state media.
Investigators have found that Changsheng Biotech had been blending expired materials in their manufacturing processes and fabricating manufacturing dates, lot numbers, and inspection records since April 2014. The initial tip-off came from the company’s own employees. It is still unclear when and to which countries the faulty vaccines were sold.
Changsheng Biotech had been vigorously expanding its international market, with established relations in nearly 20 countries, including Southeast Asia, the Middle East, Africa, Central and South America, India, Russia, and Egypt, according to recent reports by Southern Metropolis Daily.
On July 18, 2018, the Jilin Food and Drug Administration Bureau imposed penalties on Changsheng Biotech, including a fine of just over US$500,000.
The rabies vaccine produced by Changsheng Biotech in 2017 accounted for a quarter of China’s vaccine supply. According to the company’s annual report, their freeze-dried human rabies vaccine (Vero cells) was issued in a batch of 3.55-million copies, ranking second in China.