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On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on BioNTech SE’s (NASDAQ:BNTX) Investigational New Drug application (IND) and the related Phase 1/2a trial evaluating the safety, tolerability, immunogenicity, and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.
The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2).
