The national drug testing authority said Wednesday that the hepatitis A vaccines implicated in the death of one child and hospitalization of hundreds of others in Anhui Province last month were actually both genuine and safe.
The confirmation from the China Institute for the Control of Drugs and Biological Products means that the cause of the events following the immunization of 2,500 students from 19 schools in 17 villages on June 16 and 17 remains unconfirmed.
The injections were organized by the epidemic prevention station of Dazhuang Town in Sixian County without the required official approval.
They used 1,000 vaccines purchased from the county epidemic prevention center and 3,000 from a private dealer, Zhang Peng, who was detained by police on July 4 for selling medicines without a license.
Three local health workers were arrested last month for allegedly overcharging students for the injections in a scheme that reportedly also profited local schools and doctors.
All the shots were manufactured by Zhejiang-based Pukang Biotech Co. Ltd., and a ban that had been placed on their vaccines was lifted by the State Food and Drug Administration after their products were cleared.
One six-year-old girl, Li Wei, died on June 23 and 304 other children complained of nausea and breathing difficulties shortly after the vaccinations.
A July 5 China Daily report quoted the local health department as saying Li's funeral had gone ahead without an autopsy, though an article in the same paper the next day said a postmortem examination had found she had suffered from "respiratory failure and serious infection."
The Ministry of Health said health departments should follow proper procedures when organizing inoculations.
According to Xinhua News Agency, the ministry had assumed the accident was caused by an allergic reaction to the vaccines.
Mao Jiangsen, president of Pukang Biotechnology, told Shanghai Morning Post at the end of June that the hospitalizations were probably caused by food poisoning.
At a press conference in Suzhou on June 29, Health Minister Gao Qiang said they could have been the result of "mass hysteria" after Li's death.
According to the WHO's website, hepatitis A vaccines in current use are "well tolerated and no serious adverse events have been statistically linked to their use."
(Xinhua News Agency July 15, 2005)
