Wuhan Institute of Biological Products Rabies Vaccine Recall due to Endotoxin Contamination

That was in 2010.

Delving into history of Endotoxin Disasters in Jabs we find interesting connections.

In 2010 the State Food and Drug Administration (SFDA) of China announced a “voluntary” Recall of Rabies jab due to Endotoxin contamination.¹

Unfortunately the recall was rather late as the “Batch number 200905007-3, involved 10,902 doses, of which 8,376 had been used”.

A review from China discusses the reduction of allowed Endotoxin following the recall to a quarter of the previous limit set in 2005, but does not mention what level was present in the recalled batch.²

A 2012 paper by He and coworkers³ mentions a limit of 50 EU/ml in Rabies jab in that year.

Production of Rabies jab⁴ involves Vero cells that are easily contaminated with E. coli.

Another Rabies Jab Recall in 2018

The full reasons apparently not given, numerous jabs in China were recalled, including Rabies and Diphtheria, Pertussis, and Tetanus (DPT) in 2018.⁵⁶

Perhaps my Chinese reading friends can find more details of these stories for us?

1. Shan Juan. 27 May 2010. Substandard human rabies vaccine recalled. http://www.chinadaily.com.cn/china/2010-05/27/content_9897165.htm

2. Cui-ping Yin, Hang Zhou, Hui Wu, Xiao-yan Tao, Simon Rayner, Shu-mei Wang, Qing Tang, Guo-dong Liang. 2012. Analysis on Factors Related to Rabies Epidemic in China from 2007-2011. https://www.virosin.org/article/doi/10.1007/s12250-012-3244-y

3. Yihui He*, Zi’an Mao, Yueqing Chen, Liming Jiang, Yongxue Li, Haiying Huang. 2012. Detection of Bacterial Endotoxin in Rabies Vaccine by the Gel-clot Assay with Tachypleus Amoebocyte Lysate. https://www.researchgate.net/publication/299357341_Detection_of_Bacterial_Endotoxin_in_Rabies_Vaccine_by_the_Gel-clot_Assay_with_Tachypleus_Amoebocyte_Lysate

4. Pengcheng Yu, Ying Huang, Yibin Zhang, Qing Tang, and Guodong Liang. 2012. Production and evaluation of a chromatographically purified Vero cell rabies vaccine (PVRV) in China using microcarrier technology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579903/

5. Robert Carlson. 22 July 2018. Chinese Rabies Vaccine Recall Expands With DPT and Heart Medicine Alert from FDA. https://www.precisionvaccinations.com/changsheng-biotechnology-zhejiang-huaihai-pharmaceutical-and-wuhan-institute-biological-products

6. Michael Walsh and Ning Pan. 23 Jul 2018. https://www.abc.net.au/news/2018-07-23/chinese-vaccine-scandal-sparks-outrage/10025352