7 Apr 2010 11:01

MoH confirms adverse vaccine reaction cases in Shanxi

By Karl Zhong

Shanghai. April 7. INTERFAX-CHINA - The Ministry of Health (MoH) confirmed three cases of adverse drug reactions (ADR) in its probe of problematic vaccines in Shanxi Province on April 6 and announced the same day that investigations into the vaccine distributor are now under way.

Beijing-based China Economic Times reported on March 17 that between 2006 and 2008, four children died and at least 74 children were sickened after receiving vaccinations against diseases including rabies, hepatitis B and Japanese encephalitis. Illnesses included convulsion, cerebral atrophy, epilepsy and Henoch-Schonlein purpura.

In response, on March 17 the Shanxi Health Department told state-run Xinhua news agency that the report was untrue as routine inspections organized by the government had shown no problems with the quality of vaccines in the province.

According to the announcement, experts have examined 15 of the children who were sickened after receiving vaccinations and concluded that three children suffered ADRs, including Henoch-Schonlein purpura, acute flaccid paralysis and swelling and pain at the immunization point. In the remaining 12 cases, illnesses were not caused by the vaccinations.

When asked if the other cases of illnesses cited in the China Economic Times report were caused by the vaccinations in a press briefing on April 6, MoH spokesman Deng Haihua chose not to answer the question directly and instead emphasized that the latest investigations outcome shows three cases.

According to the announcement, the MoH team analyzed vaccination data in Shanxi since 2006 and found that the incidence of sickness following vaccination was not higher than the national average. In addition, the team said that reports of vaccine-related ADR cases were not unusually high between 2006 and 2008.

The MoH started setting up a national monitoring system in 2005 to record vaccine-related ADRs and it has been increasing monitoring since that time.

"The monitoring system had records of adverse reactions suffered by six children out of the 15 children examined," said Yu Jingjin, vice director of the MoH's division for disease control and prevention, at the press briefing.

The company responsible for marketing and distributing the suspect vaccines, Beijing Huawei Shidai Pharmaceutical and Biotech Co. Ltd., has also been found to have affixed non-approved labels on the vaccine packaging, the announcement said.