Opening remarks by Dr Bernhard Schwartländer, WHO Representative in China, at the China FDA meeting about Kunming Biologicals Institute’s Sabin IPV

Beijing, China
17 December 2013

Honourable Mr LI Maozhong, Mr DING Jianhua, Mr Lei Zhenglong, Mr XU Jiaqi,
Distinguished polio vaccine experts,
Ladies and gentlemen,

Good morning.

It is great to be here today with friends and the best experts in the world to solve the remaining technical issues to make Sabin IPV vaccine a reality in China.

The eradication of polio is a top priority of WHO. Although the science and program of polio eradication is enormously challenging, great progress has been made.

The world is now entering the final stages of polio eradication with implementation of the Polio Endgame Strategic Plan, which was approved by the World Health Assembly this May.

Vaccines are essential lifeblood of immunization programs, and the polio eradication effort is no different.

Safe, effective, and safely manufactured vaccines, expertly applied to populations, have reduced the number of countries that have not gotten rid of polio from 125 countries to only three.

The Kunming Institute has been developing and testing its novel Sabin strain IPV for over a decade, and has submitted its dossier for licensure of the vaccine earlier this year. Once approved and licensed, this will be the first domestically produced IPV in China and the second IPV to be licensed in the world.

This would represent a major game changer for the implementation of the Polio Endgame Strategic Plan in China. In addition, should the vaccine be WHO prequalified, China could play a more important role in global polio eradication.

The Polio Endgame Strategic Plan calls for the insertion of at least one dose of IPV into routine immunization schedules of countries like China that use only OPV in their routine programs. At least one dose of IPV will provide an immunity benefit and a safety benefit to children in China.

WHO is working together with the national experts and collecting the best informed evidence to finalize the most appropriate vaccine schedule that would meet China’s needs. Once decided, both political and financial commitments will be needed to show that China is leading global efforts on polio eradication.

Today’s important meeting brings together national and international polio vaccine experts to discuss remaining technical questions about the evidence supporting licensure of this new Sabin IPV.

The WHO China country office is pleased to support and participate in this critically important meeting about a vaccine that has the potential to be used by China’s EPI system, the largest and one of the most effective EPI systems in the world, to maintain a high wall of immunity against poliovirus during the implementation of the Polio Endgame Strategic Plan.

Thank you.