EMA’s updated guideline to include broader coverage on Human Challenge Trials

The European Medicines Agency (EMA) published an updated Guideline on clinical evaluation of vaccines (EMEA/ CHMP/VWP/164653/05 Rev. 1). This guideline was updated following EMA` s experience in the past decade with new vaccines applications, including the approval of the COVID-19 vaccines.

These applications have raised several issues for vaccine clinical development programmes that were not addressed in the previous guideline. EMA also encountered requests for scientific advice on vaccine clinical development programmes that have pointed to the need to provide updated or additional guidance on some issues. For example, on considerations for conducting vaccine efficacy trials,
identification of immune correlates of protection, vaccines intended to be used in heterologous prime-boost regimens and vaccines to be administered to pregnant women to protect their infants during the first months of life.

hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.

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