Benzinga | Jul 19, 2021 07:08AM EDT

SINOVAC Receives Approval on Sabin Strain Based Inactivated Polio Vaccine To Support Global Polio Endgame Strategy

SINOVAC Biotech Ltd. (NASDAQ:SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced it received a drug registration approval from the National Medical Product Administration of China ("NMPA") for its Sabin strain based inactivated polio vaccine (Vero cells) ("sIPV") on July 12, 2021. The vaccine is expected to be available on the market by the end of 2021. SINOVAC also submitted an application for prequalification (PQ) to the World Health Organization ("WHO") in early 2020 and the WHO conducted its on-site inspection in February 2021.

SINOVAC's sIPV is approved for use on infants and children aged 2 months and above to prevent poliomyelitis due to infection of types I, II and III polioviruses. The primary immunization requires 3 doses at least one month apart, beginning at 2 months of age. A booster shot will be given at 18 month of age. According to the results of phase III clinical trial, no serious or rare adverse events were observed in relation to vaccinations, which indicates the good safety profile of SINOVAC's sIPV vaccine. Inactivated polio vaccine (IPV) contains no live virus and, thus, carries no risk of emergence from vaccine-derived poliovirus (VDPV) or vaccine-associated paralytic polio (VAPP).

As the COVID-19 pandemic impact persists, countries where the wild polio strain still exist have been experiencing an increase in prevalence of polio casese. In addition, some other countries also reported more vaccine-derived poliovirus (VDPV) and vaccine-associated paralytic polio (VAPP) cases as a result of the virus circulating in the environment and human body, especially as the number of VAPP cases has reached a peak in the past 10 years.

The WHO called for Expressions of Interest (EOI) in 2010, 2011 and 2012 from vaccine manufacturers in the private or public sectors to collaborate with the WHO and Intravacc (Institute for Translational Vaccinology) from The Netherlands 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. In 2014, SINOVAC entered into a license agreement with Intravacc to develop and commercialize the Sabin strain based Inactivated Polio Vaccine (sIPV) for distribution to China and other countries. According to the agreement, SINOVAC committed to commercializing the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval, commercializing the sIPV vaccine and seeking pre-qualification by WHO. In addition, SINOVAC committed to having the capacity to supply, or make arrangements for the supply of, sIPV to the public sector in other countries, as well as international organizations in sufficient quantities to ensure a meaningful contribution to the global endgame of polio eradication.