SDA to carry out surprise checks on vaccine makers

The State Drug Administration will conduct unannounced inspections on all companies that produce vaccines.

Investigation starts on new vaccine scandal

The State Drug Administration has launched an investigation of Changchun Chang­sheng Bio-tech Co, which was found to have fabricated production records for freeze-dried rabies vaccines for human use.

The cases of those suspected of violating laws will be transferred to public security departments, the authority said on Sunday.

Premier Li Keqiang said in an instruction that the vaccine case has crossed a moral line, and the nation deserves a clear explanation, the State Council said on its website on Sunday.

The State Council should immediately send a group to investigate to uncover the truth as soon as possible, and any wrongdoing will be severely punished regardless of who is involved, Li said.

Xu Jinghe, deputy head of the drug administration, said the company was found to have fabricated production and inspection records.

Such activities are in violation of the country’s drug management law and related regulations on drug production, Xu said.

In a notification on July 15, the drug administration ordered the company to stop producing the human rabies vaccine. It said no products involved in the inspection were currently being sold and all the vaccine involved had been removed.

The administration has also revoked the company’s certificate that is needed for production and sales of the vaccine.

The administration confirmed that the company’s other vaccines now available on the market have been tested and no quality problems were found. The administration also launched further tests on the vaccine samples kept by the company.

Its remarks came amid public concerns about vaccine safety in China over the weekend, after it was also revealed that Changsheng Bio-tech was linked to a substandard adsorbed diphtheria-pertussis-tetanus, or ADPT, vaccine for infants. 

On Friday, the Jilin Provincial Drug Administration announced a penalty regarding Changchun Changsheng Bio-tech Co’s substandard ADPT vaccine.

The company was fined 2.58 million yuan ($282,000), and 859,000 yuan in assets from sales of the vaccine were confiscated.

The case was under investigation last year.

Changsheng Bio-tech Co, parent company of Changchun Changsheng Bio-tech Co, revealed in November that 252,600 doses of the substandard ADPT vaccine that couldn't meet the standard of immunity results were all sold to Shandong province and had been recalled. 

“The substandard ADPT vaccine won’t post safety threats to people’s health, but will reduce the expected immune effects,” Dingxiang­yuan, a professional medical website, said in an online reply to public concerns about the vaccine’s safety. 

The state drug administration confirmed on Sunday that it was discovered in October that one batch of Changsheng’s ADPT vaccine was substandard, and its production of ADPT has been suspended since then.

A plan for reinoculation of those affected was worked out in February.

Several state media called for severe punishment and stricter supervision of vac­cines. People’s Daily released a commentary on Sunday saying that drugmakers should stick to moral principles and make life their priority rather than profits. 

In a news report released on Sunday, the Procuratorate Daily, a publication of the Supreme People's Procuratorate, called for stronger supervision of vaccine production and tougher penalties for violators. 

The Shenzhen Stock Exchange announced that it sent letters to Changsheng Bio-tech Co on Sunday, calling for early disclosure of the two cases to the public. 

“We will maintain strict supervision over the listed company’s information disclosure responsibility according to the law and guarantee legal rights of investors,” it said in the online announcement. 

The Shenzhen Stock Exchange posted a reply from Changsheng Bio-tech Co later in the afternoon on its website. It says, “We feel very remorseful and guilty about what has happened, and we apologize to all those vaccinated and investors.”

The company added that it will learn a lesson.