- 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,
Jan. 21, 2021 /PRNewswire/ --
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
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.
About Eupolio
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).
About Intravacc
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.
Contact info
Intravacc
Dr. Jan Groen, CEO
P: +31 30 7920 454
Mirjam Hartman, Media
relations
P: +31 6 115 969 94
E: press.office@intravacc.nl
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
P: +31 6 538 16427
E: lmelens@lifespring.nll