BioNTech’s Malaria Vaccine Trial Temporarily Suspended by FDA

The U.S. Food and Drug Administration (FDA) has placed a hold on BioNTech’s phase 1/2a clinical trial, temporarily suspending the company’s progress in developing an RNA-based vaccine aimed at malaria prevention.
The FDA’s hold applies to BioNTech’s investigational new drug (IND) application, as well as the associated clinical study evaluating BNT165e, a multi-antigen malaria vaccine candidate. This information was disclosed in a Securities and Exchange Commission (SEC) filing dated March 4. The Germany-based biotechnology firm has stated that it is cooperating with the FDA and is in the process of determining the appropriate next steps to address the agency’s concerns.

Prior to the regulatory action, BioNTech had already chosen to voluntarily pause the study. The company has not provided further details beyond the SEC filing, which it considers its official statement on the matter.
The suspended trial was designed to investigate the potential of BNT165e in preventing Plasmodium falciparum malaria, the deadliest strain of the malaria-causing parasite. The study targeted healthy, malaria-naïve adults as its participant group. According to ClinicalTrials.gov, the two-phase trial planned to enroll 177 individuals, with preliminary findings initially expected to be available in September of this year.
As BioNTech works to resolve the situation, the broader efforts to combat malaria with novel vaccine technologies remain an area of interest within the global scientific and public health communities. The RNA-based approach being explored by BioNTech represents an alternative to more traditional vaccine platforms, which have seen varying degrees of success in addressing malaria worldwide.
While the specifics of the FDA’s hold remain undisclosed, clinical trial pauses can occur for various reasons, including safety concerns, regulatory considerations, or data-related issues. The company has indicated its commitment to working with the FDA to determine how best to proceed with its research and development efforts in this area.

The outcome of BioNTech’s discussions with the FDA will likely determine the future trajectory of its malaria vaccine program and could potentially influence broader RNA vaccine applications for infectious disease prevention.