WHO Offers Support in Chinese Vaccine Scandal
The World Health Organization (WHO) offered its support for recent regulatory actions to apprehend a Chinese manufacturer’s human rabies vaccines, China’s National Drug Administration (NDA) said Wednesday.During an unannounced inspection at the manufacturing site of Changchun Changsheng Life Sciences Ltd., a vaccine manufacturer in China's northeastern Jilin province, the NDA discovered data integrity in the production of the batches of rabies vaccine.
This is not the first time that an inspection resulted in citations to the facility. An “unqualified” Baibai vaccine batch was still in production at the facility during an October 2017 inspection, NDA reported earlier this week.
WHO’s support follows the detainment of 15 company executives by Chinese police, according to media outlets.
Government officials in China have already apprehended all the affected batches of the manufacturer’s freeze-dried human rabies vaccine and suspended production, WHO added.
Regulators have also called on the Jilin Provincial Food and Drug Administration to retract the company’s GMP certificate, at least until certain manufacturing requirements are met, such as conducting risk-hazard assessments.
WHO applauded these regulatory actions and said it is prepared to also show its support to the Chinese National Health Authority. “This incident is undoubtedly regrettable,” WHO said. But it “also shows that the system supervision and on-site inspection of the regulatory authorities can effectively protect people's health.”