Communiqué de presse
Intravacc’s Sabin Inactivated Polio vaccine (sIPV), out-licensed to LG Chem, receives WHO prequalification
- sIPV development is part of Intravacc’s contribution to the eradication of polio
- LG Chem is the first to receive WHO prequalification for the sIPV vaccine
- LG Chem signed an $80 million contract with UNICEF to supply polio vaccine starting early 2021
Bilthoven, the Netherlands, 21 January 2021 – Intravacc, a world leader in translational research and development of vaccines, today announces the WHO prequalification for the Sabin-IPV (sIPV) vaccine Eupolio™, developed by Intravacc and out-licensed to South Korean LG Chem in 2014. The vaccine was developed by Intravacc for technology transfer to manufacturers in low- and middle-income countries in the context of the global polio eradication initiative.
Eupolio™ received the prequalification status from the World Health Organization (WHO) by the end of December. LG Chem signed a contract with UNICEF to supply $80 millions worth of polio vaccine Eupolio™ from 2021 to 2022. The company will supply the vaccine to 70 countries in the Middle East, Africa and Southeast Asia starting in January 2021. Intravacc will receive milestones and low single digit royalties for its considerable role in the development of this vaccine.
In a phase III study completed in 2019 with Eupolio™ high neutralizing antibody titres were obtained against both wild-type and Sabin polioviruses, which will also protect against circulating vaccine-derived polioviruses (cVDPV) that make up the majority of polio cases in recent years. WHO prequalification of Eupolio™ is a major milestone in ongoing efforts towards global polio eradication, as it will help close the gap between demand and supply of safe and effective Inactivated Polio Vaccine (IPV) for millions of infants in need of immunization against poliovirus.
To reduce the use of the virulent vaccine derived polioviruses, a switch to inactivated polio vaccines (IPV) was desired. Because of the limited supply and relatively high-cost price world-wide of IPV, Intravacc in collaboration with the WHO, initiated the development of a cost-effective manufacturing process for an inactivated poliovirus vaccine using attenuated (Sabin) poliovirus strains (sIPV) to be transferred to local manufacturers. LG Chem is the first manufacturer to bring the sIPV vaccine to the market.
Dr. Jan Groen, Intravacc’s CEO, said:
“This is a great example project in which Intravacc’s innovation and knowledge has been the basis of the development of an affordable vaccine that contribute to the reduction of infectious disease burden at a global level. We are confident that this joint effort with several of our license partners will significantly contribute to the polio eradication program.”
Poliomyelitis is an infectious disease caused by the poliovirus and is transmitted through the oral fecal route. There are 3 serotypes of the virus that cause poliomyelitis in humans. While most infections are asymptomatic, in few cases the virus moves from the gut to the central nervous system and cause flaccid paralysis. Currently there is no treatment for polio, however vaccination has proved to be successful. Since the start of poliovirus vaccination in the 1950s, cases world-wide dropped tremendously and now there are only a few hundred cases per year. Most of these cases are vaccine derived after vaccination with oral poliovirus vaccines, where the attenuated poliovirus becomes virulent again due to mutations in the virus. This happens in under vaccinated areas and takes a long time to develop. The use of the inactivated vaccine developed by Intravacc alleviates this problem.
Eupolio™ is the first Sabin-IPV to obtain WHO prequalification. The main advantage of using attenuated Sabin poliovirus strains in the production of IPV is that there is a lower biosafety risk compared to wild-type polioviruses used to manufacture conventional IPVs, which has the potential to pose a biosafety hazard in case they escape from the manufacturing facility. Eupolio contains all three virulent polio strains.
About Intravacc’s Vero cell platform
Intravacc’s viral vaccine production process is based on a cGMP-grade, regulatory approved, Vero cell line. This proprietary platform is being used for routine large-scale commercial vaccine manufacturing by Intravacc’s customers world-wide. In addition, virus seed lots and clinical batches have regularly been produced and validated on the Vero cells, for example Poliovirus, Enterovirus (EV71), and Respiratory Syncytial Virus (RSV).
Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization of innovative vaccines against infectious diseases. As an established independent CDMO with over 100 years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology related to polio vaccines, measles vaccines, DPT vaccines, Hib vaccines and influenza vaccines around the world. Around 40% of childhood disease vaccines are based on Intravacc’s proprietary technology. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies for partners around the world, including universities, public health organizations (WHO, Bill & Melinda Gates Foundation), biotech and pharmaceutical companies. For more information, please visit www.intravacc.nl.