Moderna says norovirus vaccine trial on FDA clinical hold

Moderna (MRNA) said that the two-season Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against norovirus is fully enrolled in the Northern Hemisphere and the company is preparing second season enrollment in the Southern Hemisphere. The trial is currently on FDA clinical hold following a single adverse event report of a case of Guillain-Barre syndrome, which is currently under investigation. The company does not expect an impact on the study’s efficacy readout timeline as enrollment in the Northern Hemisphere has already been completed. The timing of the Phase 3 readout will be dependent on case accruals.