The World Health Organization concludes that ETEC remains a priority pathogen and is encouraged by our preliminary phase 2B results from Benin
The Product Development for Vaccines Advisory Committee (PDVAC) is an independent standing WHO committee of experts with the mission is to accelerate product development of vaccines and technologies that are urgently needed and ensure they are appropriately targeted for use in low and middle income contexts.
The committee is identifying priority pathogens where there is evident public health need for a vaccine. ETEC was discussed at PDVAC already in 2015 and was in 2016 identified as a priority pathogen. In June 2020, a virtual PDVAC meeting was held to determine if ETEC should remain a priority pathogen.
Scandinavian Biopharma was invited to present its ETEC vaccine candidate ETVAX® including the preliminary results from our phase 2b study in Finnish travellers to Benin. The Committee’s conclusion was that “The data from the ETVAX phase 2b study are encouraging, albeit preliminary”.
The meetings conclusion and recommendation were that ETEC should remain a priority pathogen for WHO since ETEC is one of the leading bacterial causes of diarrhoea, especially among children in low resource settings, as well as travellers and military personnel from high-income countries. For children in LMIC infections can result in substantial mortality and long-lasting morbidity impact due to malnutrition, stunting, and cognitive impairment.
PDVAC will continue to advocate for and support the development of an ETEC vaccine and our vaccine candidate ETVAX® was described as the most advanced ETEC candidate with encouraging phase 2b study data.
Scandinavian Biopharma is developing, together with researchers at the University of Gothenburg and the international non-profit organization PATH, a new oral ETEC vaccine for use in both travellers and infants and young children in LMICs who continue to be at high risk for infection and severe illness from this bacterial enteric pathogen. The programs are mainly funded by the European Union’s (EU) Research and Innovation Framework Program, Horizon 2020 through the EDCTP organization, DFID, and SME Instruments supporting innovative SMEs in the health care biotechnology sector.
ETVAX® is the only ETEC vaccine candidate in late-stage development. The strong immunogenicity and safety data, as well as the early field efficacy seen in Benin clearly distinguish ETVAX® from other vaccine candidates that are under development against ETEC-induced diarrhoea. Successful development of this vaccine will address an unmet medical need of children in LMICs as well as in travellers. Currently, there is no ETEC vaccine available on the market for use in either children or travellers.
About Scandinavian Biopharma
We are a research-based specialty biopharma company determined to give people worldwide a longer and better life. We are developing the first vaccine for protection against diarrhoea caused by ETEC in both travellers and endemic populations. We distribute a wide range of specialty biopharma products with focus on vaccines and immunoglobulins.