Pe­ter Marks on Covid-19 vac­cine ef­fi­ca­cy, EUAs and chal­lenge tri­als

A week af­ter the FDA is­sued guid­ance on vac­cines to pre­vent Covid-19, Pe­ter Marks, di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, shed light on the rea­son­ing be­hind the agency’s 50% ef­fi­ca­cy thresh­old and where the agency stands on chal­lenge tri­als and emer­gency use au­tho­riza­tions.

Ef­fi­ca­cy and ap­proval

In its guid­ance, FDA said it ex­pect­ed spon­sors to demon­strate a vac­cine is at least 50% ef­fec­tive in a place­bo-con­trolled tri­al, with an ad­just­ed low­er bound of >30%.

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