Black health matters: Distribute COVID-19 vaccine equitably - 0 views
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Moderna’s RNA vaccine candidate is joining the ranks of Pfizer/BioN Tech’s already-announced RNA vaccine candidate with preliminary Phase 3 clinical trials results showing excellent efficacy. Pfizer’s preliminary results now show 95% efficacy and Moderna’s show 94% efficacy. The FDA's bar of 50% efficacy could potentially be cleared with Olympian results if the final reviews by the FDA judges are in agreement with the preliminary results.
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Following the FDA rules, COVID-19 vaccine candidates must have been observed in volunteer trial participants for at least 2 months and will be continued to be observed in Phase 4 for at least 2 years after the vaccine is made available.
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Emergency Use Authorization (EUA) was added to FDA authority by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, which authorizes the FDA to facilitate availability of an unapproved product during a state of emergency such as this public health COVID-19 pandemic.
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