According to the agreement, Sinovac has committed to commercializing the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV vaccine.
In addition, Sinovac has committed to having the capacity to supply, or making arrangements for the supply of, sIPV to the public sector of other countries in sufficient quantities to make a meaningful contribution to meeting global demand (e.g. at least 20 million doses annually).
In developing countries around the globe including China, oral polio vaccine (OPV) is widely utilized to eradicate polio. OPV is a live attenuated formulation, which contains a weakened form of poliovirus. Although OPV is considered safe and effective, in extremely rare instances, the live attenuated vaccine virus in OPV can cause paralysis, resulting in cases of vaccine-associated paralytic polio (VAPP) or circulating vaccine-derived poliovirus (cVDPVs).
Therefore, to eliminate the risk of such cases, OPV will be phased out from routine immunization programs around the world. To enable countries to maintain immunity levels, inactivated polio vaccines (IPV) will be introduced. Sabin IPV is both safer to manufacturer and more affordable as compared to the currently available Salk IPV.
The global demand for IPV is increasing as the Global Polio Eradication Initiative has called for IPV to be introduced into 126 countries currently using OPV only by the end of 2015. According to Eradication and Endgame Strategic Plan developed under the Global Polio Eradication Initiative, from 2014 to 2018, the use of OPV in routine immunization will be gradually ceased.
The WHO called for Expressions of Interest (EOI) in 2010, 2011 and 2012 from private or public sector vaccine manufactures interested incollaborating with the WHO and Intravacc to develop and supply sIPV under the Global Polio Eradication Initiative. Sinovac submitted its EOI in 2012 and was selected as a technology transfer recipient after the qualification review and site inspection by the WHO and Intravacc.
National Health and Family Planning Commission of China is developing a vaccination strategy to add at least one dose of IPV into its national Expanded Program of Immunization (EPI). At present, no IPV is produced by manufacturers in China. Imported IPV became available in September 2009, but the supply is limited and the vaccine has to be paid for out-of-pocket by the recipient.
Sinovac chairman, president and CEO Weidong Yin noted that the company is honored to partner with WHO and Intravacc to develop and commercialize sIPV for future distribution both domestically and internationally.
"As part of selection process, we demonstrated our fully integrated vaccine capabilities, inclusive of conducting clinical trials, obtaining regulatory approval and operating GMP certified manufacturing facilities, and exemplified our commercialization expertise based on our broad vaccine portfolio.
"Polio represents significant unmet medical need in China and other developing countries. By moving forward with the clinical development of sIPV with the objective of producing this vaccine in China, Sinovac is helping keep China polio-free and achieve a lasting polio-free world, free of all polio paralytic cases," Yin added.