A top vaccine manufacturer involved in a probe regarding its production of rabies vaccines for human use is under investigation for its substandard absorbed diphtheria-pertussis-tetanus (ADPT) vaccine for infants, according to thepaper.cn.
As reported by the Shanghai-based online media organization, Changchun Changsheng Bio-tech Co., in Northeast China’s Jilin Province, received a punishment notice by Jilin Provincial Food and Drug Administration, which fined it and confiscated 3.44 million yuan (US$508,000) due to its substandard ADPT vaccine.
Thepaper.cn said the Jilin Provincial Drug Administration announced Friday that a total of 253,338 ADPT vaccines produced by Changchun Changsheng Bio-tech Co. couldn’t meet the standard of immunity result and were recalled last year.
Most of those vaccines had been sold to Shandong Province. But the provincial administration didn’t reveal details of related problems and the recall.
On July 15, China Food and Drug Administration (CFDA) issued an announcement asking the company to terminate the production of its Vero-cell rabies vaccines, China Global Televison Network reported.
The announcement came after authorities carried out a snap inspection and found the company was forging production data and violating the country’s drug production quality management protocols.
CFDA has asked the Jilin Provincial Food and Drug Administration, to revoke Changchun Changsheng’s Good Manufacturing Practice (GMP) certificate, an international recognized license for drug production.
CFDA stated that the batch of rabies vaccines involved in the inspection had not been put on the market and had been “effectively controlled.” Inspectors from both state and provincial food and drug administrations have been stationing at the company for further investigation.
CFDA said last week that during an inspection by the administration, Changsheng was found to have serious irregularities, including fudging production records for freeze-dried rabies vaccines for human use.
The centers for disease control and prevention in Beijing and Guangdong Province both announced that neither of the two regions have vaccines involved in the two cases.
The two cases have aroused massive public concern about vaccine safety in the past few days.
Several State media organizations are calling for severe punishment and stricter supervision over vaccines. People’s Daily released a commentary yesterday, saying that drug makers should stick to the moral principle and prioritize life rather than profits.
In a news report released yesterday, the Procuratorate Daily calls for stronger supervision on vaccine production from the related departments and suggests imposing tougher penalties on violators as a warning to prevent similar cases from occurring again.
According to a statement released by the CFDA, no products involved in the inspection are on sale, and all the vaccines involved have been removed.