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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