Mid­dle-of-the-night NIH state­ment rais­es con­cerns on As­traZeneca's US vac­cine tri­al read­out

The NIH took the very un­usu­al step to re­lease a state­ment at mid­night, rais­ing fresh ques­tions about da­ta from As­traZeneca’s US-based Covid-19 vac­cine tri­al.

The state­ment says that late Mon­day, the Da­ta and Safe­ty Mon­i­tor­ing Board (DSMB) over­see­ing the tri­al no­ti­fied the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID), the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA), and As­traZeneca “that it was con­cerned by in­for­ma­tion re­leased by As­traZeneca on ini­tial da­ta from its COVID-19 vac­cine clin­i­cal tri­al. The DSMB ex­pressed con­cern that As­traZeneca may have in­clud­ed out­dat­ed in­for­ma­tion from that tri­al, which may have pro­vid­ed an in­com­plete view of the ef­fi­ca­cy da­ta.”

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