Official probe into vaccines scandal
Print Edition
CHINA has established a cross-departmental working group to investigate the trade in improperly handled vaccines, following a scandal that raised concerns nationwide.
A large quantity of improperly stored or expired vaccines are believed to have been sold in more than 20 provincial-level regions since 2011.
Twenty-nine pharmaceutical companies are said to have been involved in selling them and 16 vaccination institutions are suspected of buying them, authorities say.
More than 130 people have been questioned and 69 criminal cases have been filed nationwide.
The State Council said the scandal had exposed weaknesses in the vaccine distribution system.
The working group established by the State Council is led by Bi Jingquan, head of the China Food and Drug Administration.
Senior officials from the National Health and Family Planning Commission, the Ministry of Public Security, Ministry of Supervision and the CFDA are deputy heads.
Officials from the publicity department of the Party’s Central Committee, the Cyberspace Administration of China and the Supreme People’s Procuratorate are also members of the group.
The State Council said the group will also have a committee of experts but gave no further details about who would be members of it.
The State Council has also formed a supervision team to oversee and guide the investigation, and said it would publish results timely.
Meanwhile, medical experts have stressed the safety of Chinese vaccines and urged the public to continue to receive immunizations.
“The vaccines on the market are stable and controllable in terms of their safety and effectiveness,” said Wang Junzhi, a member of the Expert Committee on Biological Standardization of the World Health Organization.
“China has set up a national management system that is up to WHO standards to ensure the safety of its vaccines,” he said.
Initially, Chinese regulators only conducted examinations of finished vaccines. However, the quality control system has gradually evolved to cover the entire process from vaccine design and production to the finished product, Wang said.
Regulators have also conducted sample inspections of vaccines circulating in the market, Wang added.
In addition to allowing only authorized bodies to provide raw materials and produce and distribute vaccines, China has also introduced a batch release system to ensure vaccine safety, said Yang Xiaoming, chief scientist of the vaccine project under the 863 program, a national government-funded high-tech development initiative.
Under the system, which has covered all vaccine products since 2006, regulators conduct compulsory inspection and approval of each batch of vaccines before they leave factories. Items that fail inspection or approval will not be allowed to be sold or imported.
“The batch release system gears the vaccines to international standards,” Yang said.
A sign of endorsement of the quality and management system of Chinese vaccines, China is now lining up vaccines for WHO prequalification, Wang said.
At present, the Henan-based Hualan Biological Bacterin Co Ltd and the Chengdu subsidiary of China National Biotec Group have been approved by the WHO for their seasonal flu vaccine and Japanese encephalitis vaccine respectively, making them eligible for purchase by the United Nations.
Wang called for the public to have faith in Chinese vaccines and encouraged them to continue inoculations despite the scandal. “It’s more effective and cheaper to prevent a disease than to treat it,” Wang said.
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