Chinese Premier Li Keqiang has called for an immediate investigation into a scandal over faulty vaccines that he said had crossed a moral line, and urged severe punishment for the companies and people implicated. The scandal erupted a week ago, after major vaccine maker Changsheng Biotechnology Co was found to have violated standards in making rabies vaccine for humans. There did not appear to be reports, however, of people harmed by the vaccine or having contracted rabies after receiving it.
The case has sparked anger on social media and dealt a blow to China’s drug regulator, which has been struggling to clean up the world’s second-biggest drug industry and promote domestically made vaccines. In a statement posted on the government’s website late on Sunday, Li said the public deserved a clear explanation. “We will resolutely crack down on illegal and criminal acts that endanger the safety of peoples’ lives, resolutely punish lawbreakers according to the law, and resolutely and severely criticise dereliction of duty in supervision,” he was quoted as saying. The Food and Drug Administration said in a statement on Sunday evening that its investigation had found that Changsheng fabricates production records and product inspection records, and arbitrarily changes process parameters and equipment, “serious violations” of the law.
In a stock exchange statement on Sunday, the company said its suspension of rabies vaccine production would have a significant impact on its finances and that some regional disease control agencies had suspended some of its other vaccines. Changsheng’s shares fell the maximum limit of 10 percent on Friday, to stand at 14.5 yuan ($2.14). They have lost 40 percent of their value since July 13.
An editorial on Monday in the China Daily warned that the case could become a public health crisis if it is not handled “in a reasonable and transparent manner”. “The government needs to act as soon as possible to let the public know it is resolved to address the issue and will punish any wrongdoers without mercy,” it said. “Those who dare to challenge the bottom line and make substandard or even fake vaccines need to receive the heaviest penalties according to the law.”
Late on Sunday, the state news agency Xinhua ran an editorial calling for strict punishment for any violations, big or small, in the vaccine industry and for regulators to close loopholes and tighten oversight of the industry. The China Securities News also weighed in, saying that listed companies – like Changsheng Biotechnology – have a duty to the public and to conduct business with integrity. “Cases like Changsheng Biotechnology, where laws and regulations are ignored and internal controls exist only in name bring a painful price,” it said.
State media have said the listed company made a public apology and recalled all their rabies vaccine available on the market.
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