Sinovac Biotech Ltd.’s 5-dose Sabin Strain Inactivated Polio Vaccine Approved for Global Polio Eradication Efforts

April 15, 2024  Source: drugdu 136

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On April 9, 2024, Beijing Sinovac Biotech Ltd., a subsidiary of Sinovac Holdings Biotechnology Ltd. (Sinovac Biotech), obtained the approval for registration of the 5-dose Sabin Strain Inactivated Polio Vaccine (Vero Cells) (hereinafter referred to as the 5-dose sIPV) developed by Sinovac Biotech Ltd. from the National Drug Administration (NDA) for the prevention of polio caused by the poliovirus types I, II and III. (hereinafter referred to as "sIPV") received the approval of drug registration from the State Drug Administration (NMPA) for the prevention of poliomyelitis caused by poliovirus types I, II and III (commonly known as "polio"), and is suitable for the immunization of children aged 2 months and above. Compared with the single-dose sIPV vaccine, the 5-dose sIPV vaccine can significantly reduce the global immunization cost, and has been listed as an urgently needed variety in the WHO Polio Eradication Action Plan, and the launch of Sinovac Biotech Ltd.'s 5-dose sIPV vaccine is expected to change the status quo of insufficient supply of vaccines globally, and better help the global eradication of polio in the "last mile". "SINOVAC sIPV

Polio is a highly infectious disease that affects infants and children under the age of five. Since the World Health Assembly launched the Global Polio Eradication Initiative (GPEI) in 1988, the incidence of polio has been reduced by more than 99% globally, and the number of countries with polio epidemics has been reduced from 125 to 2 (as of October 2023). This has allowed more than 10 million people who might otherwise be paralyzed to now walk normally.

However, insufficient vaccine supplies have made global polio eradication a huge challenge. In response, the WHO commissioned Intravacc of the Netherlands to develop an attenuated inactivated vaccine, and transferred the technology to qualified manufacturers around the world. sinovac Biotech Ltd. was one of the six global manufacturers to receive the technology transfer qualification, and began the development of the sIPV vaccine in 2012. on July 12, 2021, Sinovac Biotech Ltd. received a drug registration approval for the single dose of the sIPV vaccine from the State Drug Administration (SDA). Drug Registration Approval issued by the State Drug Administration (SDA), and on June 2, 2022, it passed WHO Pre-Qualification (PQ).

On April 8, 2024, the IHR Committee on Polio Emergencies issued a statement in which the Committee unanimously concluded that the risk of international transmission of the poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended that the provisional recommendation be extended for another three months. At the same time WHO called on countries at risk of international transmission of wild poliovirus (WPV1) and circulating vaccine-derived poliovirus (cVDPV) to take all necessary measures to support polio eradication, which should be implemented urgently by countries that have not yet included an inactivated polio vaccine in their schedules, and to further intensify their efforts to increase routine immunization coverage, as increased routine immunization coverage is An important component of the polio eradication strategy, especially as the world moves closer to polio eradication.

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