Defective DTaP Vaccines in China Due to “Uneven Ratio of Liquid”?

Defective DTaP Vaccines in China Due to “Uneven Ratio of Liquid”?

China’s top drug regulator, the China Food and Drug Administration (CFDA), announced on July 31, 2018 that a temporary equipment malfunction was to blame for the production of 400,520 faulty DTaP (diphtheria, tetanus, acellular pertussis) vaccines by Chinese pharmaceutical company Wuhan Institute of Biological Products Co. Ltd. of Wuhan (Hubei province), China.1

According to the China News Service (CNS):

Based on an inspection of the production site and the company’s analysis, it can be concluded that the primary cause of the substandard vaccines was a temporary malfunction of equipment that resulted in an uneven ratio of liquid in doses to be packaged, the State Drug Administration said in a statement…1

It is unclear what an “uneven ratio of liquid” in the vaccines means or, for that matter, what specific liquid is referenced. In addition to diphtheria and tetanus toxoids and acellular pertussis antigens, ingredients found in DTaP vaccines licensed in the United States include aluminum hydroxide and aluminum phosphate, bovine serum albumin, filamentous hemagglutinin, fimbriae types 2 and 3, formaldehyde, glutaraldehyde, neomycin, pertactin, 2-phenoxyethanol, poliovirus, polymyxin B sulfate, polysorbate 80 (Tween 80), sodium chloride, sucrose, and yeast protein.2

CNS noted that health authorities had “found no signs of major health risks” due to the “substandard” vaccines.1 However, it is unclear what that means. Have the vaccines caused any side effects? Is there any way to know for sure that side effects will not develop over time? More to the point, have Chinese health authorities followed up with the hundreds of thousands of children who received the vaccines and interviewed their parents?

In a recent interview on China Global Television Network (CGTN), pediatrician Joel Selanikio, MD of Georgetown University Hospital was asked about the risks to the children who received the faulty DTaP vaccines. Dr. Selanikio commented:

We don’t know what was administered. We don’t have any concrete information, at least not at this point, exactly what was the problem with the vaccine. We only know that it wasn’t a valid vaccine.4

In 2013, 17 children, ages five years and under, died in China after receiving a hepatitis B vaccine manufactured by Shenzhen Kangtai Biological Products Co., Ltd. Eight of the children died within hours after getting the vaccine, and in some cases within minutes.5 6 7

In 2010, the China Economic Times reported that defective vaccines had killed four children and sickened 74 other children who had received the encephalitis, hepatitis B and rabies vaccines during 2006-2008 in China’s Shanxi province. The four deceased children died between 2007 and 2008. An article in The New York Times described the 74 children as having developed “severe health problems.”8 9


1 Yan L. Malfunction led to problem vaccines. China News Service Aug. 1, 2018.
2 China Daily/Asia News Network. Equipment malfunction led to ineffective vaccines for children by Wuhan firm: China drug regulator. The Straits Times Aug. 1, 2018.
3 Centers for Disease Control and Prevention. About Diphtheria, Tetanus, and Pertussis Vaccines.
4 China Global Television Network.  Dr. Joel Selanikio discusses China’s vaccine scandal. July 25, 2018 (published).
5 Cáceres M. Should We Be Concerned About Vaccines Made in China?
 The Vaccine Reaction Apr. 3, 2016.
6 China’s child deaths not linked to hepatitis vaccine: health authoritiesAustralian Broadcasting Corporation Jan. 3, 2014.
7 Mercola J. 17 Children Die After Receiving Hepatitis B Vaccine. Jan. 7, 2014.
8 Shanxi discloses investigation result on problematic vaccine report.
 China Central Television Mar. 19, 2010
9 Bradsher K. Report Says China Sold Bad Vaccines to Hospitals. The New York Times Mar. 18, 2010.

5 Responses to "Defective DTaP Vaccines in China Due to “Uneven Ratio of Liquid”?"

  1. JCLincoln   August 5, 2018 at 3:18 pm

    I’ve lost a taste for all the world’s BS. I don’t ingest it anymore.

  2. JCLincoln   August 5, 2018 at 3:19 pm

    It leaves a bad taste in my mouth.

  3. sheldon101   August 6, 2018 at 10:03 pm

    My understanding is that in the US and Canada and other countries, approved vaccines must still be approved lot by lot. That is, you can’t simply manufacture a vaccine and distribute it. Each lot of the vaccine must pass specified tests before it can distributed. This is a result of the Cutter debacle.

    If I’m correct, the problem in China could not occur in most countries and any Chines made vaccines exported to most countries would have to meet the same lot by lot requirements.

  4. Jennifer   August 6, 2018 at 11:10 pm

    Are these vaccines being exported?
    Do we, in the US, even know where our vaccines are being manufactured?

  5. Nelda Plenskofski   September 14, 2018 at 2:57 pm

    Deference to author, some fantastic selective information.


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