FDA Asks Advisers To Mull How Vaccine EUAs Will Affect Trial Blinding

By Beth Wang / October 21, 2020 at 7:01 PM
FDA on Thursday (Oct. 22) will ask its vaccines advisors to consider whether COVID-19 vaccine sponsors should keep their phase 3 trials blinded even after an emergency use authorization is granted, coming as two of the leading vaccine developers, Pfizer and Johnson & Johnson, warn that if granted an EUA they might ethically need to unblind their studies to allow participants to access EUA vaccines or to cross over to the vaccine arm of a trial. J&J, however, is also...


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