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# FDA Clinical Hold on BioNTech Malaria Vaccine
- URL: https://www.fdaweb.com/fda-clinical-hold-on-biontech-malaria-vaccine/
- Published: 2025-03-05T12:00:00.000Z
- Updated: 2026-09-14T14:54:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158770

FDA has placed a clinical hold on BioNTech’s Phase 1/2a dose escalation clinical trial (NCT06069544) evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for preventing *P. falciparum* malaria in healthy malaria-naive adults. The company says the trial is being paused while it takes actions to address the agency’s requests and concerns.

The company describes the multi-antigen malaria vaccine as a “combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles. The BNT165c RNA encodes the full *Plasmodium falciparum* circumsporozoite protein. The BNT165d1 and BNT165d2 RNAs both encode conserved, immunogenic segments of liver stage-expressed proteins.”