China vaccine scandal: investigations begin into faulty rabies and DTaP shots

Milestones :: Perspectives

China: “Vaccine Scandal”
Editor’s Note:
See additional coverage in various publications in Media Watch below.
China vaccine scandal: investigations begin into faulty rabies and DTaP shots
BMJ 2018; 362 doi: (Published 25 July 2018)
Flynn Murphy
Trust in China’s authorities to guarantee the safety of medicines has been shaken after the nation’s second largest producer of rabies vaccines was found to have faked records.

Changsheng Biotechnology, based in the northeastern Jilin province, was ordered to cease producing a Vero cell based rabies vaccine on 15 July after China’s State Food and Drug Administration found that it had forged production and inspection data, the regulator said.1 Investigators reportedly acted on a tip-off from an ex-employee.

Changsheng issued an apology and announced a recall as shares in the company tumbled. It was not clear whether the batches had been released to market or how the substandard vaccine might affect people, but no injuries had been reported so far.

But days later Jilin’s provincial drug watchdog reported that the same company had last year sold over 250,000 faulty doses of a combined childhood shot for diphtheria, typhoid, and pertussis (DTaP), which it had uncovered in November. A local blogger apparently sent the story viral in a now deleted post that sparked confusion and anger among parents.

Local reports showed that police in Jilin swooped on the company on 23 July, arresting five executives including its chair, Gao Junfang, 64, who is also the company’s largest single shareholder. Gao and her family appeared on the Forbes 2016 rich list with combined assets of US$1bn (£0.76bn; €0.85bn).

China’s premier, Li Keqiang, said on 22 July that the incident had “crossed a moral line,” and he ordered an investigation. He was later joined by the president and Communist Party leader Xi Jinping, who called the scandal “vile in nature and shocking” and also ordered an investigation. Both urged severe punishment of those responsible.

At least four investigations are now under way, involving multiple regulators, police, securities inspectors, and the party’s feared anti-graft unit. Some people welcomed the strength of the response, in a nation where local reporting on such scandals has often been censored and whistleblowers jailed.

Others noted that it has been a decade since melamine laced powdered milk killed six babies and caused 54 000 others to be admitted for kidney damage, in a product safety case that still ripples today.2

In 2016 over 200 people were arrested over a different scandal involving expired and improperly refrigerated vaccines, which saw “middlemen” banned and provincial health bodies instructed to buy vaccines directly from manufacturers.

The Changsheng scandal is expected to trigger a renewed run on health services in Hong Kong, where parents were already travelling to secure vaccines for their children. One Hong Kong based biotech insider told The BMJ that his colleagues from the mainland were already “bringing their kids across the border for vaccinations.”

He said, “If you are in [neighbouring] Shenzhen you can bring your kids to Hong Kong, but I have no idea what parents in the interior of China are going to do. With the cold chain it’s much harder to get around than just importing tins of foreign powdered milk.”

The People’s Republic of China has the second highest number of reported rabies cases in the world, say data from the World Health Organization.3 But deaths from the disease more than halved from 2013 (1128 deaths) to 2017 (502) [WHO China, email communication]. Last year China reported no cases of diphtheria, 10 791 cases of typhoid (three fatal), and 10 390 cases of pertussis (none fatal), showed figures from China’s National Health Commission.4

[01] The person in charge of the State Food and Drug Administration introduced the Changchun Longevity Vaccine Case: ordered to suspend production, file an investigation, and organize flight inspections for all vaccine manufacturers. Xinhua News Agency 22 July 2018. [Translatable to English]
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[02] Parry J. China’s tainted milk scandal spreads around world. BMJ2008;337:a1890. doi:10.1136/bmj.a1890 pmid:18829644
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[03] World Health Organization  Rabies.
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[04] National Health and Family Planning Commission. Overview of the national legal infectious disease epidemic in 2017. 26 Feb 2018. [Translatable to English]
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