EX­CLU­SIVE: As­traZeneca makes tough un­blind­ing call, grap­pling with a vac­cine roll­out that threat­ens to im­pair their em­bat­tled PhI­II

As the FDA pre­pared to OK the first Covid-19 vac­cine last week, As­traZeneca sent in­struc­tions to its US in­ves­ti­ga­tors for what to do when some of their vol­un­teers will sud­den­ly be left to choose be­tween stay­ing in the British phar­ma’s study or re­ceiv­ing an FDA-au­tho­rized vac­cine.

The doc­u­ment, whose con­tents were de­scribed to End­points News by two in­ves­ti­ga­tors and whose ex­is­tence was con­firmed by an­oth­er, says that in­ves­ti­ga­tors are al­lowed to in­di­vid­u­al­ly un­blind par­tic­i­pants who be­come el­i­gi­ble for the Pfiz­er or Mod­er­na vac­cine and tell them which arm of the As­traZeneca study they were in. The par­tic­i­pant can then de­cide whether to re­ceive the au­tho­rized vac­cine. Whichev­er they choose, they will be al­lowed to re­main in the study for long-term fol­lowup.

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