FDA Pauses BioNTech’s Malaria Vaccine Trial Amid Regulatory Scrutiny
The FDA has placed a clinical hold on BioNTech's Phase I/IIa trial of BNT165e, an investigational RNA-based malaria vaccine14.
BioNTech has complied with the hold and proactively paused the study14.
The company is working to address the FDA's requests and determine next steps for the trial14.
The trial was testing the safety, tolerability, immunogenicity and efficacy of BNT165e in healthy malaria-naive adults6.
It was expected to enroll around 177 participants and conclude in September 202568.
The hold comes amid broader challenges in the vaccine space, including postponed CDC and FDA advisory committee meetings1.
BioNTech's stock fell around 3% following news of the clinical hold47.
This setback impacts BioNTech's efforts to expand its mRNA technology beyond COVID-19 vaccines4.
The company is still progressing other mRNA vaccine candidates for diseases like tuberculosis and HIV9.
Sources:
1. https://www.biospace.com/fda/fda-pauses-study-of-biontechs-malaria-shot-as-problems-for-vaccine-space-mount
4. https://www.investing.com/news/stock-market-news/biontech-stock-falls-after-fda-clinical-hold-on-malaria-vaccine-trial-93CH-3907253
6. https://clinicaltrials.biontech.com/trials/BNT165-02
7. https://www.tipranks.com/news/company-announcements/fda-places-hold-on-biontechs-malaria-vaccine-trial
8. https://in.benzinga.com/general/biotech/25/03/44148407/fda-places-clinical-hold-on-biontechs-early-phase-trial-for-rna-based-malaria-vaccine
9. https://investors.biontech.de/news-releases/news-release-details/biontech-achieves-milestone-mrna-based-vaccine-manufacturing-0