2010-04-03 09:55

Two companies produced low quality rabies serums in 2008

SHANGHAI - China will step up the monitoring of a faulty rabies vaccine that has been recalled but may still be on the market, officials from the country's State Food and Drug Administration (SFDA) said on Friday.

Although the vaccine was recalled and production shut down late last year, China's lax regulatory environment means doses of the vaccine may still be on the shelves, officials said.

Administration officials also said they are watching for any reactions in people who took the vaccine last year.

The rabies vaccine problems are the latest in a series of quality concerns in China in recent years, including tainted infant formula and other milk products that sickened children.

More than 200,000 units of the rabies vaccine manufactured by Jiangsu Ealong Biotech Co and Hebei Bioforwell Co were recalled because they did not meet national quality standards, the administration said on its website.

Officials made the move following a four-month investigation after its first announcement last December that seven batches, or a total of 215,800 units of rabies vaccine produced by Jiangsu Ealong Biotech Company and Hebei Bioforwell Company from July to October 2008 had quality problems.

The administration said the Jiangsu Ealong Biotech Company had resorted to deception when producing the rabies vaccines.

The company escaped supervision by related departments, causing the unqualified vaccine products to come into the market. Some of the company's personnel are suspected of committing criminal offenses, and local police are investigating.

Meanwhile, an illegal operation was found in the Hebei Bioforwell Company, and its vaccines products also failed to meet the national standard. But no criminal activity was found in the company.

Administration officials said they will further investigate the defective vaccines with local authorities and police departments.

Media has reported that those defective vaccines had already been sent to 364 disease prevention and control centers in 27 provinces and cities across the country. According to reports, all of them were used up by July of 2009.

Officials estimate that more than 1 million people nationwide may have been affected by the vaccines, which was not mentioned in the statement of the administration.

Administration officials said they have received no reports so far on adverse reactions from the rabies vaccine shots. The monitoring of any adverse reactions is still going on.

The health departments have dispatched a "sufficient quantity" of safe rabies vaccines to local departments, and free re-vaccination work will be carried out soon.

The Guangzhou-based 21st Century Business Herald reported on Friday that frequent personnel changes in the SFDA in recent months was allegedly connected to the defective rabies vaccines produced by two Chinese drug makers.

The newspaper said the SFDA is restructuring its personnel duties and at least 16 personnel appointment and dismissal cases have been handled since last November when Jin Shaohong, the former director of the Center for Drug Evaluation of the SFDA, was dismissed.

Most of them are high-level officials working for departments such as food safety inspection, drug safety inspection and drug evaluation.

The newspaper quoted an insider as saying that Wei Liang, an official from the drug registry department of SFDA, has already been detained for allegedly accepting bribes of "1 million yuan at the most".

China Daily