The BC Centre for Disease Control has obtained information about two batches of vaccines that failed testing and were recalled from use in October 2017.
The BC Centre for Disease Control has obtained information about two lots (batches) of vaccines that failed testing and were recalled from use in October 2017. These two lots may not offer complete protection. The vaccines were used in China from March to October 2017 for childhood vaccination and children who received the vaccines may need additional vaccine doses.
The recalled vaccines are for DTP (diphtheria, tetanus and pertussis (whooping cough)):
- Lot # 201605014-01 produced by Changchun Changsheng Biotechnology Co., Ltd.
- Purchased by: Shandong Provincial Center for Disease Control and Prevention
- Lot # 201607050-2 produced by Wuhan Biological Products Research Institute Co., Ltd.
Purchased by:
- Chongqing (City) Disease Prevention and Control Centers
- Hebei Provincial Center for Disease Control and Prevention.
There are no safety concerns related to these vaccines. China has not reported more cases of diphtheria, tetanus or whooping cough in relation to the use of these vaccines.
These lots were released between March and May 2017 and could have been administered until October 2017, at which time they were recalled from use. The exact dates of release of each lot are not known to BCCDC.
In China, these vaccines are routinely given to children at three, four, five and 18 months of age. Children who were residing in any of the three geographic areas at the time these vaccines were in use and who received one of more doses of these vaccines may need to receive additional vaccine doses for full protection.
China CDC has reported that children who received these substandard DTP vaccines have been identified through its national electronic Children Immunization Information Management System (CIIMS) and are being revaccinated. Furthermore, Chinese public health authorities have advised that parents or guardians of children can check the vaccination record of DTP on the child vaccination certificate and compare with the vaccine manufacturer and lot number information (listed above) to determine whether the recalled DTP vaccine was used. Parents can also consult the inoculation unit in China where the child was immunized to find out whether their child received a dose of the recalled vaccine lot. Parents in China can also call the 12320 health hotline for consultation.
Advice for B.C. parents
If your child resided in Chongqing, Shandong or Hebei in the period from March to October 2017, were under 2 years old during that time, and were vaccinated during that time, please check your child’s immunization record. If you do not have their record, you may be able to obtain it from Chinese public health authorities as outlined in the paragraph above.
If your child’s record indicates that they received DTP vaccine with an affected lot number (see above), or if a lot number is not recorded but DTP vaccine was given any time from March to October 2017, please contact your local health unit or immunization service provider to arrange for additional vaccination.
Doses of affected lots may not have provided full protection, and your child may be offered additional doses of diphtheria, tetanus and pertussis-containing vaccine, depending on their vaccination history in Canada and their current age.
There are no safety concerns related to these vaccines. China has not reported more cases of diphtheria, tetanus or whooping cough in relation to the use of these vaccines.
Advice to immunization service providers
Consider any doses that meet the criteria outlined above to be ‘invalid’ doses, and proceed with immunizing the child based on their historical receipt of valid doses, in keeping with the schedule for their current age. An interrupted series does not need to be repeated, and the series can be completed regardless of the interval between doses.
B.C. immunization schedules for children at various ages are here.
If you have any questions, please contact your local health unit. To find a public health unit anywhere in the province, see the site finder on ImmunizeBC.ca