China's health and drug authorities are warning local officials they must provide better safeguards for the production, circulation and inoculation of vaccines.
"Governments at all levels must learn from the vaccination incident in Anhui province's Sixian County and rigorously carry out regulations on inoculation management to prevent such accidents from happening again," the Ministry of Health and State Food and Drug Administration said in a joint circular.
In June 2005, about 2,500 primary and secondary school students in 19 schools in Dazhuang Town, in Sixian County, east China's Anhui Province, suffered a heart-related reaction after they were vaccinated with hepatitis A vaccines. Some 311 students took ill and one died.
An investigation by the Ministry of Health and Food and Drug Administration found that the vaccines were manufactured by Pukang Biotech Co. in Zhejiang Province. The company illegally sold the vaccines to Zhang Peng, a private dealer, who was not authorized to make such a transaction. The township hospital then purchased the vaccines from Zhang and organized the vaccination of the school children without approval from the local government.
The central government circular called for stronger supervision by health departments and a nationwide crack down on the illegal production, distribution and application of stale dated vaccines. Violators will be severely punished according to law.
The biotech company and the township hospital involved in the incident were fined and related health officials in Sixian County were punished. The private dealer, Zhang Peng and the chief of the Dazhuang Township Hospital, Zhou Shiming, along with health care workers Hou Huafeng and Zhou Shikai were all held accountable.
The Chinese State Council, or the central government, on March 24, 2005 issued the regulation on vaccine circulation and inoculation management, which took effect on June 1, 2005. The regulation clearly stated that disease prevention and control institutions must check the qualification permit of vaccine producers before purchasing.
The circular said organized inoculations must comply with the regulation and coordinated work of health worker training, promotion, material allocation and emergency response planning must be accomplished to prevent mass vaccination accidents.
"Institutions and individuals must not organize mass vaccination without approval. Disease control and prevention departments must not purchase vaccines from companies without authorization," it said.
It also said food and drug bureaus must step up supervision over the circulation of vaccination and strictly check the injectors.
The circular called for activities to promote the knowledge of vaccination and state policies regarding vaccination. Meanwhile, the general public should be informed of the possible reactions after vaccination so as to ease the anxiety and worries.
(Xinhua News Agency March 16, 2006)