President Xi Jinping has ordered an investigation — and promised serious punishment — after a drug company was found to have faked production records for a rabies vaccine and sold more than 250,000 doses of a vaccine for infants that didn’t meet medical standards.
Regulators said the large drugmaker, Changchun Changsheng Life Sciences Limited, had arbitrarily changed the way it makes freeze-dried human rabies vaccines, as well as falsifying records and inspection reports. The government says it has ordered the company to halt production of the vaccine.
Problems with the rabies vaccine were found on July 5, after a tip prompted regulators from the China Food and Drug Administration and a local agency to hold a spot inspection, state-run Xinhua reports. The drugmaker’s chairwoman and four high-ranking managers are now under criminal investigation.
Public outrage has grown steadily, with the news echoing a large recall from late last year, when Changsheng recalled 252,600 doses of the infant DPT vaccine (for diphtheria, pertussis, and tetanus). Despite not meeting standards, the medicine was sold to the Shandong Center for Disease Control and Prevention.
Describing the public’s reaction, the South China Morning Post reports:
“Fury and fear filled China’s social media over the weekend as parents questioned how such a scandal could have been allowed to happen.
“On WeChat, the country’s most popular messaging service, the Chinese word for vaccine appeared in 321 million articles and searches, 80 times the number of times it appeared on Friday.”
The DPT recall also included another company, the Wuhan Institute of Biological Products — a subsidiary of the state-owned China National Pharmaceutical Group — which produced even more of the bad doses. As China Daily reported last November, the Wuhan firm sent more than 400,000 DPT doses to city and provincial governments that were then recalled.
As for the potential effects of the bad DPT vaccine, the state-run China News Service quotes a medical website as saying that while the vaccine shouldn’t pose a safety threat in itself, it “will reduce the expected immune effects.”
A plan to inoculate the infants again was made in February, CNS says.
The scandals have sparked a social media uproar and threatened confidence in China’s health regulators, coming two years after nationwide fraud was unearthed in the country’s vaccine market. In 2016, investigators busted a crime ring for illegally reselling millions of vaccines without following proper storage and refrigeration protocols — leaving many parents worried that their kids might be either sickened or left unprotected from future illness.
And as NPR’s Anthony Kuhn reports from Beijing, “Many consumers are angry because they believe that the government coddles drug firms and regulators, while punishing whistleblowers who bring the scandals to light.”
Other Chinese pharmaceutical companies are now facing intense scrutiny and potential spot inspections, especially after some of them have run into their own high-profile problems.
Earlier this month, the U.S. Food and Drug Administration issued a safety alert for some blood pressure and heart medications, if their active ingredient valsartan was produced by China’s Zhejiang Huahai Pharmaceuticals. The reason: The products were tainted by a potentially cancer-causing impurity.
The FDA said the problem was linked to a change in the manufacturing process in China — and that the impurity might have gone undetected for “as long as four years.”
The current vaccine case “crossed a moral line,” Chinese Premier Li Keqiang said over the weekend. He added, “Any wrongdoing will be severely punished regardless of who is involved.”
The scandals have cast an ugly blight on China’s public vaccination system, which has previously been credited with cutting the number of polio, hepatitis B and tetanus cases.
Shares of several Chinese vaccine companies dropped by 10 percent on Monday, The Wall Street Journal reports.
The setbacks come months after China’s central government announced it was shifting the structure of its drug regulation agency — the latest in a string of changes since the agency was created in 1998, according to the industry publication Pharmaceutical Technology.