BIO Calls For Journal Publication Of COVID-19 Trial Data, Independent FDA
In an open letter to the biopharmaceutical industry, BIO lays out principles for conducting COVID-19 clinical trials and disclosing and using the data. Senator Durbin asks eight vaccine makers backed by Operation Warp Speed how they will withstand political pressure to speed up the approval process.
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The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.
Bourla reassures on scientific integrity amid fears of a politically motivated Emergency Use Authorization.
COVID Vaccine Distribution Plan From National Academies Leaves Room For Adjustments Based On Trial Results
Draft allocation framework expects health care workers would take up much of the initial vaccine supply and suggests the elderly and people with two comorbid conditions receive vaccination next. NAM suggests states get a population-based allotment, leaving local officials to make many of the tough decisions under the framework, which could be adjusted based on clinical trial data.