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Faulty vaccines in China

Advice regarding re-vaccination after faulty Chinese vaccines updated 14th August 2018.

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 i.e. the vaccines are not expected to have caused any harm but may have not induced a protective immune response.

None of these vaccines were distributed within New Zealand.

Please consider DTaP vaccines administered to children from March to October 2017 in Hebei, Shandong and Chongqing provinces to be invalid. The Ministry of Health and IMAC advises these children should be offered re-vaccination, if requested, as per catch up recommendations. Serology testing is not required to determine a child’s immune status prior to offering re-vaccination. Should parents wish to have an additional dose of the vaccine, there are no significant safety concerns associated with receiving an additional dose, although children may have an increased local reaction such as redness or swelling at the vaccination site.

To work out if an additional dose is required please consider the child’s current age and the number of previous doses of DTaP received as per Appendix 2 of the Immunisation Handbook.

It is likely that the only age groups of children impacted would be those between approximately 3 months and 24 months of age at the time they were immunised in China, given the vaccine schedule used there and allowing for late administration.

Should a child need re-vaccination, the vaccines to be used would be those included on the NZ Immunisation Schedule i.e. DTaP-IPV-HepB/Hib (Infanrix Hexa ®) or DTaP-IPV (Infanrix-IPV).

If the child’s overseas vaccinations were entered onto the NIR, and these doses need to be repeated, they should be noted as ‘invalid’. Invalidating doses will require a phone call or fax to your NIR administrator. The new doses are entered as per usual onto the PMS, and messaged through to the NIR.

As there is a large amount of vaccine given within China, the batches of concern are an extremely small portion of all vaccines delivered and we expect the number of children in NZ requiring revaccination to be limited.

Adapted by IMAC from Public Health Sudbury and Districts Advisory Alert (Canada) in conjunction with NZ Ministry of Health Immunisation team.

Earlier information

There have been news reports last week about significant issues with production of some vaccines in China. One manufacturer in South East China falsified records on the testing of a rabies vaccine. Consequently a batch of DTaP vaccine released in March-October 2017 from the same company was withdrawn for failing testing as well.

We appreciate that this causes concern for many New Zealand based families who had their children vaccinated in China. Whilst there is no clear information from China specifically about the nature of the vaccine issues, there are no reports of injury. We would therefore reassure parents that if their child was vaccinated with the faulty vaccine that there appears to be no cause for concern that they may suffer any ill effects from that.

The concern is more about whether the vaccine has been effective, and therefore whether they need to have their vaccination repeated.  There is no clear advice yet from China on this. Clearly, it is very difficult to assess if any individual child received the faulty vaccine. The number of doses affected (around 250,000) would appear to be limited to distribution in the south east of China, and within the last six months. Therefore, the likelihood of receiving the vaccine for any migrant child in NZ, considering the very large population size of vaccinated children in China is very small.

News updates:

The Wuhan Institute of Biological Products, which was reported to have produced a batch of 400,520 doses of substandard diphtheria, tetanus and whooping cough vaccines (DTaP) for infants, has passed an inspection and resumed production, according to the State Drug Administration.

Last year, the company, based in Wuhan, Hubei province, was linked to substandard DTaP vaccines along with Changchun Changsheng Bio-tech Co in Jilin province.

The 252,600 doses of vaccine produced by Changchun Changsheng Bio-tech Co were all sold in Shandong province, with 215,184 children being vaccinated, according to the Center for Disease Control and Prevention in Shandong.

from China today: http://www.chinadaily.com.cn/a/201807/27/WS5b5a60c0a31031a351e9071f.html

The information below has been posted by a public health unit in Canada and provides information on distribution and batch numbers. 


Last updated: Apr 2019