07.20.21
Intravacc, a provider of translational research and development of vaccines for infectious diseases and therapeutics, said the Chinese National Medical Products Administration (NMPA) formally known as the Chinese FDA, granted Sinovac Biotech market authorization for its Sabin-IPV (sIPV) inactivated polio vaccine, developed by Intravacc and out-licensed to Sinovac. This multivalent polio vaccine was developed by Intravacc for the purpose of providing low and middle-income countries with the opportunity to produce their own safe polio vaccine in the context of the global polio eradication initiative.
The approval of Sinovac's Eupolio vaccine (sIPV) by the NMPA in China is a major milestone in the ongoing efforts towards global polio eradication and to reduce the vaccine-associated paralytic polio (VAPP) caused by oral polio vaccines (OPV), which are based on live attenuated polio viruses. It will also help to close the gap between demand and supply of safe and effective Inactivated Polio Vaccines (IPV) for millions of infants in need of immunization against poliovirus. As a result of the current SarsCov-2 pandemic, the vaccination campaigns to eradicate polio were either put on hold or delayed worldwide. The pandemic may also further delay polio eradication due to indirect effects on vaccine supplies and financial resources.
Sinovac's Eupolio vaccine contains all three Sabin virulent polio strains. One of the main advantages of using attenuated Sabin poliovirus strains in the production of IPV is that it results in a lower biosafety risk compared to wild-type polioviruses used to manufacture conventional IPVs. These IPV vaccines pose a potential biosafety hazard in case they escape from the manufacturing facility.
Sinovac expects to deliver the first Eupolio vaccines for the immunization of infants in 2021. Sinovac is the second manufacturer, following Korean LG Chem, to bring Intravacc's sIPV vaccine to the market. Intravacc will receive milestones and low single digit royalties for its considerable role in the development of this vaccine.
The vaccine technology developed by Intravacc and transferred to Sinovac to manufacture Eupolio was also used for the development of "CoronaVac" Sinovac's inactivated Covid-19 vaccine validated by the WHO for emergence use and over 430 million doses have already been administrated globally. In May 2021 the EMA started with the rolling review of Sinovac's Covid-19 vaccine. A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. In that case EMA's human medicines committee (CHMP) reviews data as they become available from ongoing studies.
"This is a great example project in which Intravacc's innovation and knowledge have been the foundation of the development of an affordable vaccine that contributes to the reduction of infectious disease burden on a global level. We have recently launched a similar program for our Avacc 10 Covid-19 nasal spray vaccine, intending to make this vaccine available to the world,” said Jan Groen, CEO, Intravacc.
The approval of Sinovac's Eupolio vaccine (sIPV) by the NMPA in China is a major milestone in the ongoing efforts towards global polio eradication and to reduce the vaccine-associated paralytic polio (VAPP) caused by oral polio vaccines (OPV), which are based on live attenuated polio viruses. It will also help to close the gap between demand and supply of safe and effective Inactivated Polio Vaccines (IPV) for millions of infants in need of immunization against poliovirus. As a result of the current SarsCov-2 pandemic, the vaccination campaigns to eradicate polio were either put on hold or delayed worldwide. The pandemic may also further delay polio eradication due to indirect effects on vaccine supplies and financial resources.
Sinovac's Eupolio vaccine contains all three Sabin virulent polio strains. One of the main advantages of using attenuated Sabin poliovirus strains in the production of IPV is that it results in a lower biosafety risk compared to wild-type polioviruses used to manufacture conventional IPVs. These IPV vaccines pose a potential biosafety hazard in case they escape from the manufacturing facility.
Sinovac expects to deliver the first Eupolio vaccines for the immunization of infants in 2021. Sinovac is the second manufacturer, following Korean LG Chem, to bring Intravacc's sIPV vaccine to the market. Intravacc will receive milestones and low single digit royalties for its considerable role in the development of this vaccine.
The vaccine technology developed by Intravacc and transferred to Sinovac to manufacture Eupolio was also used for the development of "CoronaVac" Sinovac's inactivated Covid-19 vaccine validated by the WHO for emergence use and over 430 million doses have already been administrated globally. In May 2021 the EMA started with the rolling review of Sinovac's Covid-19 vaccine. A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. In that case EMA's human medicines committee (CHMP) reviews data as they become available from ongoing studies.
"This is a great example project in which Intravacc's innovation and knowledge have been the foundation of the development of an affordable vaccine that contributes to the reduction of infectious disease burden on a global level. We have recently launched a similar program for our Avacc 10 Covid-19 nasal spray vaccine, intending to make this vaccine available to the world,” said Jan Groen, CEO, Intravacc.
