FDA Places Hold on BioNTech's RNA-Based Malaria Vaccine Trial

The U.S. Food and Drug Administration (FDA) has placed a hold on BioNTech's phase 1/2a clinical trial for its RNA-based malaria vaccine candidate, BNT165e. This development, disclosed in a Securities and Exchange Commission (SEC) filing on March 4, 2025, marks a significant setback in the company's efforts to develop a novel preventative treatment for P. falciparum malaria.

Clinical Trial Details and FDA Hold

BioNTech's investigational new drug application and the associated clinical trial for BNT165e have been paused as a result of the FDA hold. The study, which was designed to evaluate the vaccine's efficacy in healthy malaria-naïve adults, had planned to enroll 177 participants with a primary readout initially scheduled for September 2025.

Prior to the FDA's intervention, BioNTech had proactively suspended the study, according to the company's statement in the SEC filing. The German biotechnology firm has stated that it is complying with the hold and is actively working with the FDA to determine the next steps for the trial.

Implications for RNA-Based Vaccine Development

This setback for BioNTech's malaria vaccine candidate comes at a time of increased interest in RNA-based vaccine technologies, particularly following the success of mRNA vaccines in combating the COVID-19 pandemic. The BNT165e vaccine represents an innovative approach to malaria prevention, utilizing a multi-antigen strategy to target the P. falciparum parasite.

The hold on this trial may have broader implications for the field of RNA-based vaccines, potentially impacting the development timeline for similar technologies aimed at addressing other infectious diseases. As the pharmaceutical industry closely watches the progress of such novel vaccine platforms, the resolution of this FDA hold will be crucial in determining the path forward for BNT165e and related vaccine candidates.