The World Health Organization warmly welcomes proposed changes to China’s vaccines system announced by the State Council, and by NHFPC / CFDA, triggered by the recently-exposed activities of an illegal vaccine re-selling ring operating from Shandong province.
“The Shandong event clearly revealed shortcomings in the distribution of Category 2 vaccines – those vaccines bought and sold on the private market,” said Dr Bernhard Schwartländer, WHO Representative in China.
“Vaccines are one of the most powerful tools we have in public health. The danger of the Shandong incident was not only the potential risk to children’s health posed by inappropriately handled vaccines, but the risk that parents would lose confidence in the Chinese vaccine system – and stop getting their children vaccinated as a result,” said Dr Schwartländer.
“The comprehensive set of proposals announced by the Chinese authorities, not only sets the path to ensure illegal activities such as those exposed in Shandong cannot happen elsewhere, but will make the system stronger overall – including by making more life-saving high quality vaccines available to all children in China,” Dr Schwartländer said.
In particular, WHO welcomes the proposed changes to:
- Tighten distribution of category 2 or private market vaccines, including by using the Expanded Program on Immunization’s (EPI) high-quality vaccine distribution system, and by placing a much stronger onus on vaccine manufacturers to ensure appropriate distribution arrangements into the EPI system;
- Establish an enhanced vaccine tracing system – which, once implemented, will enable every dose of vaccine bought and sold in China to be traced at every step, from manufacturer, to warehouse, to distributor, to clinic, to the child;
- Remove incentives – and potential conflict of interest – for local clinics to make up revenue shortfalls from selling category 2 vaccines, including through additional funding to vaccination clinics; and
- Establish an evidence-based mechanism for moving category 2 vaccines into the routine EPI system – building on an already highly accomplished program, and in so doing ensuring that more life-saving vaccines are provided free-of-charge to all children.
“Manufacturing of vaccines in China is already at world class standards: WHO has twice in the last 6 years conducted in-depth, independent assessments of China’s regulation of vaccine manufacturing, finding both times that China’s regulatory system meets or exceeds WHO standards. Implemented well, the proposed changes to China’s system will ensure that distribution, at each step of the process, of all vaccines in China – public and private – is also world class,” Dr Schwartländer said.
“The challenge from here will be in implementation: the proposed changes are powerful and wide-reaching, and some will be complex to put into practice. A diligent, rigorous, and transparent approach to implementation will be critical – to ensure effectiveness, and to fully restore public confidence in China’s vaccine system,” said Dr Schwartländer.
“The Chinese Government is responding to a very unfortunate event by putting forward a strong package of changes that not only fix the specific problems exposed in Shandong, but strengthening the system overall - setting the path to implement a world class vaccine system. WHO stands ready to support the Government in implementing these important reforms to the system,” Dr Schwartländer concluded.
About the World Health Organization (WHO)
WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.
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Ms WU Linlin
WHO China Office
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