Findings of vaccine probe revealed
Changchun Changsheng Bio-tech Co, the vaccine producer in Jilin province involved in a drug safety scandal, had been seriously in violation of laws and regulations in producing rabies vaccines since April 2014, a central government investigation team said.
Violations included adulteration involving expired vaccines, and faking production dates and batch codes, the team said on Monday, Xinhua News Agency reported.
Recalls of affected rabies vaccines are underway, including those sold overseas, according to the team.
The company was found falsifying production and inspection records while producing rabies vaccines during a State Drug Administration inspection on July 15.
The discovery shocked the nation, given the almost 100 percent mortality rate of untreated rabies. A State Council investigation team, headed by Bi Jingquan, deputy chief of the State Administration for Market Regulation, arrived in the company’s home city of Changchun on July 23.
The company has been ordered to suspend production. Fifteen people, including company Chairwoman Gao Junfang, have been detained for criminal investigation. All involved in the case, including responsible regulatory officials, must be severely punished by law, the team said.
The investigators have organized a team comprising experts in fields like virology, vaccines and epidemiology to evaluate the safety and quality risks of the rabies vaccines involved that have been sold.
The experts suggested that those who have received the vaccine in question but who have not completed the whole vaccination procedure can continue to receive qualified rabies vaccines produced by other companies.
People who have completed the whole procedure with the products involved may not need additional vaccination, experts said, but those with concerns were advised to contact their local Center for Disease Control and Prevention for additional information.
Zheng Dongyi, a vaccine specialist at First Hospital of Tsinghua University, said customarily a person gets five doses of rabies vaccine within 28 days to acquire sufficient protection. While products made by different companies can be used during the treatment, it is preferable to use the same products, Zheng said.
Tao Lina, a Shanghai-based vaccine expert, said those who have received substandard rabies vaccine need not panic. Rabies symptoms usually appear within three months, so a person who was bitten and received the vaccine more than three months ago is very unlikely to be infected.