Vaccine recall in China
July 30, 2018
* Cette information est seulement disponible en anglais.
To our community health care providers:
We are writing to inform you of recent vaccine recalls in China that may impact your patients.
Two batches of DTaP vaccine were recalled by the China Food and Drug Administration (CFDA) on October 29, 2017 after failing potency testing. This issue is one of vaccine potency, not vaccine safety. The affected lot numbers and location of distribution in China include:
- 252,600 doses of DTaP batch 201605014-01 produced by Changchun Biotechnology Co. and distributed in Shandong province
- 400,520 doses of DTaP batch 201607050-2 produced by Wuhan Institute of Biological Products and distributed to Chongqing and Hebei provinces
Affected lots were released in China between March 2017 and May 2017 and were available for use from March to October 2017. Recent information suggests that the Chinese Center for Disease Control and Prevention has identified and notified all children who received substandard DTaP vaccines and is in the process of revaccinating those identified.
These vaccines have not been distributed in Canada.
However, it is unclear if children who are in Ontario but received vaccination with an affected product while in China will be identified/notified.
At this time please consider children who received vaccines in China with recalled DTaP lot numbers, or in the absence of a lot number, DTaP vaccines administered from March to October 2017 in Hebei, Shandong and Chongqing provinces, to be invalid. These children should be revaccinated after consideration of the child’s current age and the number of previous doses of DTaP received according to Ontario’s Catch-Up Immunization Schedule (http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf) and the Canadian Immunization Guide. It is likely that the only cohort of children impacted would be those between approximately 3 months and 24 months of age at the time they were immunized in China, given the vaccine schedule used there and allowing for late administration.
Changchun Biotechnology Co. was found to have falsified production records of rabies vaccines in an unannounced inspection by the CFDA. A recall was issued on July 15, 2018, however, there is limited information on the specifics of vaccines associated with this July 2018 recall at this time. The company’s licence has been revoked with orders to stop production, issue recalls of the rabies vaccines, and suspend the issuance of all products. The Public Health Agency of Canada is reaching out to the Chinese public health officials through the International Health Regulations Focal Point to request the additional information.
At this time, if someone is suspected to have received recalled rabies vaccine while in China, these individuals should be assessed for revaccination based on the Canadian Immunization Guide.
Should you have any questions, please contact Public Health Sudbury & Districts’ immunization program at 705.522.9200, ext. 301.
Ariella Zbar, MD, CCFP, MPH, MBA, FRCPC
Associate Medical Officer of Health
This item was last modified on July 30, 2018