Rabies Vaccine Incident in China: WHO Statement

The World Health Organization (WHO) fully supports the actions of the National Drug Administration (NDA) of China aimed at retaining problematic lots of rabies vaccine and ensuring that it is safe to use. they are not put on the market

Upon an unannounced inspection at the Changchun Changshun Life Sciences Ltd. manufacturing site, a vaccine manufacturer in Jilin Province in northeast China, the NDA has discovered data integrity issues.The authorities have detained all the vaccines involved, to prevent that they reach the patients, and have suspended production in the company WHO is awaiting the results of further investigations and stands ready to support the national health authorities. [1] 9659004] "Regulatory oversight of vaccines is of paramount importance. This is the government's main method for ensuring that vaccines produced and used in China are safe, of good quality and effective, "said Gauden Galea, WHO Representative for China. "This incident shows that when regulatory oversight is working well, potential risks can be avoided."

Good manufacturing and regulatory practices are designed to prevent problems in the quality badurance process for vaccines. problems are discovered, the regulator must act.WHO welcomes the rapid and transparent measures taken by China NDA to suspend production and investigate these incidents.

WHO evaluated national regulatory authorities in 2010 and 2014 and found that they met the criteria of WHO as a functional regulator of vaccines.A clear commitment to continuous improvement.The WHO is Congratulates that China's NDA continues to work with the WHO's Regulatory Systems Strengthening Program, as it has done for almost 20 years. Although the current incident is clearly unfortunate, the detection of this event by an unannounced inspection shows that the control and counterweight system of the regulatory authority is effective.

The WHO reiterates that quality vaccines are essential for disease prevention. urges countries to continue using this cost-effective public health intervention. The Expanded Program on Immunization in China has yielded results. It has allowed China to escape polio and dramatically reduce vaccine-preventable diseases such as measles, mumps, rubella and hepatitis A and B in children. To this end, WHO also helps vaccine manufacturers in China to ensure that they comply with international standards and meet WHO expectations for prequalification.