Category Archives: Dr. Lucey Vaccine Posts

Pfizer/BioNTech COVID-19 vaccine efficacy: Six key questions

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By Daniel R. Lucey M.D., MPH, FIDSA The Pfizer/BioNTech announcement today on findings from their first interim analysis of its Phase 3 COVID-19 vaccine candidate study showing 90% efficacy among 94 cases included the following excerpts, with key data pending: “Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned […]

Will the Oct. 22 FDA COVID-19 vaccine EUA meeting discuss the statistical basis for requiring at least five severe cases in placebo group of Phase 3 vaccine studies? 

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By Daniel R. Lucey M.D., MPH, FIDSA In reference to potential enhanced respiratory disease associated with COVID-19 vaccine candidates, the U.S. Food and Drug Administration briefing document for the Oct. 22 public advisory committee meeting on COVID-19 Vaccine Emergency Use Authorization states (on p. 11 of Appendix II): “Sufficient cases of severe COVID-19 among study […]

FDA posts advice on EUA for COVID-19 vaccines with Oct. 22 meeting materials: Monitoring for eosinophilic vaccine-induced enhanced respiratory disease

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By Daniel R. Lucey M.D., MPH, FIDSA As promised by the U.S. Food and Drug Administration, the materials for the first public Vaccine Advisory Committee on Emergency Use Authorization (EUA) issues for COVID-19 vaccines Oct. 22 — Thursday — have been posted online as of today. The agenda, Advisory Committee roster, and a one-page statement […]

Paused: Eli Lilly monoclonal antibody study and J&J COVID-19 vaccine trials

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By Daniel R. Lucey M.D., MPH, FIDSA In the past 24 hours both the Johnson & Johnson Phase 3 single-dose vaccine study, and the Eli Lilly monoclonal antibody study (studies?) have been paused, and their Data-Safety Monitoring Board (DSMB) convened to evaluate safety concern(s). Johnson and Johnson (J&J)  issued a statement saying: “We have temporarily […]

National Academies leaders speak out on COVID science, trust, vaccines as controversies and toll accumulate

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By Daniel R. Lucey M.D., MPH, FIDSA On Sept. 24 President of the U.S. National Academy of Sciences Martha McNutt and President of National Academy of Medicine Victor Dzau, issued the public statement “NAS and NAM Presidents Alarmed by Political Interference in Science Amid Pandemic.”   They emphasize the essential importance of “science-based decision-making” during the […]

Four steps to build trust in COVID-19 vaccines

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By Daniel R. Lucey M.D., MPH, FIDSA COVID-19 vaccine availability will be accelerated by receiving U.S. Food and Drug Administration emergency use authorization as opposed to the longer approval and licensure process. No unlicensed new vaccine candidate has ever received an EUA. For this reason and others, too many Americans may not trust the safety […]

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 […]