The Phase 1 trial is expected to enroll 60 volunteers in the United States with no history of malaria to assess the vaccine candidate at three-dose levels.
Known as BNT165b1, it is the first vaccine candidate from BioNTech's malaria project, which will also establish vaccine production in Africa.
The effort is one of several focused on addressing the mosquito-borne disease that kills over 600,000 each year, most of them children in Africa. The complicated structure and lifecycle of the malaria parasite has long stymied efforts to develop vaccines.
After decades of work, the only approved malaria vaccine, Mosquirix, made by British drugmaker GSK, was this year endorsed by the World Health Organization (WHO), but a lack of funding and commercial potential has thwarted GSK's capacity to produce as many doses as needed.
Another keenly-watched effort is a malaria vaccine from Oxford University. Mid-stage trial data was published in September.
No direct comparisons have been made, but some scientists suggest the Oxford shot is a step forward from Mosquirix and provides longer immunity.
BioNTech's malaria vaccine effort is based on its mRNA technology, which was employed during the pandemic to quickly develop COVID-19 vaccines, by prompting the human body to make a protein that is part of the pathogen, triggering an immune response.
