BioNTech malaria vaccine study placed on clinical hold by USFDA
BioNTech's early-to-mid stage trial of an experimental malaria vaccine has been put on a clinical hold by the U.S. Food and Drug Administration (USFDA), the drugmaker said in a filing.
The trial was designed to assess the safety and efficacy of BNT165e, an RNA-based vaccine for prevention of malaria caused by the Plasmodium falciparum parasite in healthy adults with no prior history of malaria infection.
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 spread to humans by some types of mosquitoes. It is mostly found in tropical countries. It is preventable and curable.
The infection is caused by a parasite and does not spread from person to person.
Symptoms can be mild or life-threatening. Mild symptoms are fever, chills and headache. Severe symptoms include fatigue, confusion, seizures, and difficulty breathing.
Infants, children under 5 years, pregnant women and girls, travellers and people with HIV or AIDS are at higher risk of severe infection.
Malaria can be prevented by avoiding mosquito bites and with medicines.
Medical Dialogues team had earlier reported that BioNTech SE and Biotheus have announced the signing of a definitive agreement for the acquisition of Biotheus, a clinical-stage biotechnology company.
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