I wrote an article in 2016 titled “Should We Be Concerned About Vaccines Made in China?” in response to a growing scandal in China involving the sale of thousands vaccines that had been improperly stored and expired and sold illegally on the black market.1 As it turned out, it wasn’t thousands of faulty vaccines, but rather millions, including vaccines for encephalitis, hepatitis B, influenza, meningococcal meningitis, mumps, polio and rabies.2 3
That scandal continued throughout 2016 and resulted in the arrests of more than 300 people and the investigation of more than 170 government officials. It was followed in 2017 by a recall in China of more than 650,000 “substandard” DPT (diphtheria, pertussis, tetanus) vaccines produced by Chinese vaccine manufacturers Changchun Changsheng BioTech and Wuhan Institute of Biological Products.4 5 6
Now, there is another vaccine scandal that has broken in China involving the sale of at least 250,000 doses of “faulty” DPT vaccines produced by Changchun Changsheng Biotechnology of Jilin Sheng, China7 8 and the falsification of production and inspection data for 113,000 of its Vero cell-based human rabies vaccines.9 10 11
Reuters recently reported:
According to the China Food and Drug Administration, Changsheng fabricated production records as well as product inspection records, and arbitrarily changed process parameters and equipment…12
A statement released on July 22, 2018 by China’s Premier Li Keqiang characterized his country’s latest vaccine scandal as a violation of a “moral bottom line.”11 President Xi Jinping followed up those comments by saying that his administration has launched an investigation into the case “so as to scratch the bone and get rid of the poison.”13
It is unclear how many Chinese-made vaccines are circulating in the United States or how safe they are, so it is difficult to say whether Americans should be concerned about them. However, vaccines are pharmaceutical products, and we know that Chinese pharmaceuticals—notably the ingredients that go into those drugs—are being sold in the U.S. in large quantities. It has been reported that China has more than 500 companies registered to sell pharmaceutical ingredients in the U.S.14
The U.S. Food and Drug Administration (FDA) estimated a few years ago that 80 percent of the ingredients in pharmaceuticals produced by U.S. companies originated in China and India.1 15 That figure may well be higher today.
Moral bottom line? Poison?
2 Buckley C. China’s Vaccine Scandal Threatens Public Faith in Immunizations? The New York Times Apr. 18, 2016.
3 Qiu J, Hu H, Zhou S, Liu Q. Vaccine scandal and crisis in public confidence in China. The Lancet 387(10036); 2382 June 11, 2016.
4 Xinhua China sentences man for illegal vaccine trade. Xinhuanet Feb. 20, 2018.
5 TVR Staff. DPT Vaccines Recalled in China. The Vaccine Reaction Nov. 30, 2017.
6 Yiwen C. China’s FDA Says 650,000 Vaccines Failed National Standards. Sixth Tone Nov. 6, 2017.
7 Hernández JC. In China, Vaccine Scandal Infuriates Parents and Tests Government. The New York Times July 23, 2018.
8 Bloomberg New and Associated Press. Bio-tech execs taken away by Chinese police after 250,000 doses of defective vaccine sold. National Post July 24, 2018.
9 Lo K. Changsheng Bio-tech, the vaccine maker behind China’s latest public health scare. South China Morning Post July 24, 2018.
10 Liu A. Chinese rabies vaccine maker ordered to stop production over forged data. Fierce Pharma July 17, 2018.
11 Meixler E. Outrage in China Over Latest Vaccine Safety Scandal. TIME July 23, 2018.
12 Jourdan A, Ruwitch J. China police probe vaccine maker after scandal sparks fury. Reuters July 22, 2018.
13 Strong treatment needed to remedy vaccine system: China Daily editorial. China Daily July 23, 2018.
14 Palmer E. China drug exports to U.S. rise but companies struggle with quality. Fierce Pharma Aug. 30, 2016.
15 Marsteller D. As drug making goes global, oversight found lacking. USA Today Oct. 21, 2012.