We are running two parallel development projects. The paediatric presentation is tailor-made for children below five years of age in Low- and Middle-Income Countries and is developed as an “all-in-one” solution that will be administered with a spoon, syringe or a glass. The other vaccine presentation contains two components – a carbonate buffer and a vaccine component – that are mixed into water to prepare the final oral vaccine suspension. This formulation targets adult and paediatric travellers, military personnel as well as adults and children above five years of age in endemic areas.

In total, Scandinavian Biopharma has conducted five clinical trials in the US, Bangladesh and Sweden, that all generated very promising results. The vaccine candidate ETVAX® has the potential to be the first vaccine for protection against diarrhoea caused by ETEC.

The importance of an ETEC vaccine

An ETEC vaccine would have a significant impact on global health.

Positive results from our on-going and finished studies are accelerating the development of our tailor-made vaccine presentation for infants in low-to middle income countries where ETVAX® potentially could save hundreds of thousands of lives per year and prevent immense physical suffering and malnutrition due to repeated bouts of illness. The recurring episodes of diarrhoea are known to have a detrimental effect on poverty in ETEC-endemic countries.

ETVAX® will also prevent long-term gastrointestinal syndromes due to diarrhoeal infections following travel, saving millions of well-deserved holiday trips and reducing the disease burden of military and health workers deployed in ETEC-endemic areas.

New vaccines are critical to combat antimicrobial resistance, believed to be one of the biggest global health threats in the future.

Vaccine composition

ETVAX® is a multivalent oral vaccine that contains 4 different inactivated strains expressing the most prevalent ETEC colonization factors (CFs), i.e. CFA/I, CS3, CS5 and CS6 plus the hybrid protein LCTBA and a mucosal adjuvant, i.e. a double mutant of LT (dmLT).

The vaccine composition offers two potential lines of defense. It prevents adhesion and colonization of ETEC bacteria in the intestine and it induces antibodies that neutralize the heat-labile toxin (LT) produced by the bacteria.

We are on the right path

ETVAX® has demonstrated an excellent safety profile and exceeded expectations for immunogenicity in the completed and on-going studies.

Another proof that we are on the right path and that our vaccine is of very high standard is that we are supported by PATH, an important product development partner of Bill and Melinda Gates Foundation, and the EU Research and Innovation programme, Horizon2020.

In June 2018 during WHO’s 5th Product Development for Vaccines Advisory Committee meeting, ETVAX® was rated by independent scientists as the most advanced ETEC vaccine candidate in the world.