Monthly Archives: September 2020

Key parameters in the Phase 3 Moderna COVID-19 vaccine protocol: Symptomatic infections, interim analyses and an oversight group 

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By Daniel R. Lucey M.D., MPH, FIDSA Moderna and Pfizer-BioNTech on Sept. 17 publicly posted their ongoing Phase 3 efficacy vaccine trials. Initially today for the Moderna trial, some of the key points are emphasized below on how the primary endpoint for vaccine efficacy is defined, and when the two interim analyses are planned. After […]

COVID-19: New EUA guidance in time for Oct. 22 FDA vaccine meeting?

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By Daniel R. Lucey M.D., MPH, FIDSA On Sept. 11 the U.S. Food and Drug Administration Commissioner Dr. Hahn tweeted a link to a five-page FDA document, “The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health” in which he states: “The FDA also intends to issue additional guidance shortly to provide sponsors […]

Trick or treat? A fact check on a COVID-19 Vaccine before Halloween

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By Daniel R. Lucey M.D., MPH, FIDSA On August 26, U.S. Food & Drug Administration Commissioner Dr. Stephen Hahn tweeted that the FDA Vaccine Advisory Committee will be convened Oct. 22 to review COVID-19 vaccines. On August 30 Dr. Hahn was reported in the Financial Times stating he would consider issuing an EUA — an […]

WHO website lists nine Phase 3 vaccine candidate protocols around the world

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By Daniel R. Lucey M.D., MPH, FIDSA The World Health Organization updated its website Sept. 9 on COVID-19 vaccine candidates with a line listing of 180 different candidates including 35 in clinical trials and 145 still in pre-clinical stage. Of the 35 vaccine candidates in clinical trials (Phase 1, 2 and/or 3), WHO has listed […]