BioNTech initiates clinical trial of mRNA-based malaria vaccine candidate

BioNTech has initiated a first-in-human Phase 1 clinical trial of its BNT165b1 malaria vaccine candidate using mRNA technology, the German company announced on Friday.

The Phase 1 trial is expected to enroll 60 volunteers in the United States with no history of malaria to evaluate the vaccine candidate at three dose levels, BioNTech said in a statement.

BNT165b1 is the first vaccine candidate from BioNTech’s malaria project, which aims to develop a highly effective mRNA vaccine as well as establish vaccine production in Africa.

The company said it will initially evaluate different antigens of the parasite that causes malaria over the coming months to help select the multi-antigen vaccine candidate with which to proceed to later-stage trials.

Scientists around the world have been working for decades to develop a vaccine to prevent malaria, which infects millions of people every year and leads to hundreds of thousands of deaths – most of them babies and young children in the poorest parts of Africa.

The world’s first and only licensed malaria vaccine, Mosquirix, was developed by GSK over many years of clinical trial across several African countries, but is only around 30 per cent effective. In addition, a lack of funding and commercial potential have thwarted GSK’s capacity to produce as many doses of its shot as needed.

MRNA vaccines, which came into the spotlight amid drug makers’ race to develop a vaccine against the coronavirus, prompt the human body to make a protein that is part of the pathogen, triggering an immune response.