Intravacc’s Sabin Inactivated Polio vaccine (sIPV), outlicensed to LG Chem, receives WHO prequalification
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 million 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.