The company behind the rabies vaccine, Changchun Changsheng Biotechnology, has faced criticism after the China Food and Drug Administration (CFDA) revealed that the company had violated good manufacturing practice (GMP). In particular, noting that the company had falsified data regarding the production of freeze-dried human rabies vaccine.
The CFDA stated that all of the rabies batches affected had not been shipped or listed for sale.
However, in addition to the rabies vaccines, the country’s regulator found that the company had sold ‘substandard’ ADPT (adsorbed diphtheria-pertussis-tetanus) vaccines.
Chinese premier Li Keqiang released a statement on the government’s website suggesting that the vaccine-maker had “crossed a moral line”.
Both vaccines were used in children, which has caused a particularly strong public backlash. China has the second highest number of reported rabies cases in the world, according to the World Health Organisation (WHO), making vaccination particularly important to the country.
After Keqiang released a statement demanding a “clear explanation” and that “the whole industrial chain covering vaccine production and sales must be examined thoroughly to discover the truth as soon as possible”, share prices of numerous drugmakers in China were hit.
The share price of Changsheng has steadily fallen by the daily limit of 10% from the day the investigation was announced – it now sits at ¥11.75 ($1.72). Alongside Changsheng, Shenzhen Kangtai Biological is also down to ¥52.16 from ¥71.02 before the scandal broke and Walvax Biotechnology similarly suffering a drop from ¥21.67 to ¥18.92.
The scandal comes at an inopportune time for the broader life science industry in China, which has been experiencing strong growth.
As more Western companies look to invest into the country and domestic companies look to expand, any news highlighting potential safety issues across the industry will cause concern. The CFDA moved to reassure the public that no one receiving the vaccines had so far been reported as harmed.