US FDA places BioNTech's malaria vaccine study on clinical hold

The US Food and Drug Administration has placed a clinical hold on BioNTech's early-to-mid stage trial of an experimental malaria vaccine, the drugmaker said in a filing, sending its US-listed shares down 1.5 per cent after the bell on Tuesday.

The trial was to evaluate the safety and efficacy of the RNA-based vaccine called BNT165e for prevention of malaria caused by the P. falciparum parasite in healthy adults who have never had malaria before.

The P. falciparum parasite is one of two malaria causing parasite species that pose the greatest threat to humans.

Malaria is a life-threatening disease caused by parasites transmitted to people through the bites of infected female Anopheles mosquitoes.

BioNTech said it is taking actions to address the FDA's requests and will work with the regulator to assess the next steps.