Category Archives: Covid-19/2019-nCoV Dr. Lucey Q&A

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 […]

COVID-19: With high tide waves across America, a request to the National Academy of Medicine on masks

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By Daniel R. Lucey M.D., MPH, FIDSA Today the Washington Post reported the United States had recorded the highest number of new cases (104,004) in one day, the highest number of hospitalizations in 18 states and 1,114 more deaths. In my opinion, the National Academy of Medicine should convene this month to provide a public […]

COVID-19: When will FDA convene an independent advisory committee for monoclonal antibody EUAs?  

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By Daniel R. Lucey M.D., MPH, FIDSA Rapidly evolving events regarding studies of monoclonal antibodies reemphasize the call first made here Oct. 19  that the U.S. Food and Drug Administration convene an outside expert advisory committee ASAP to advise on requests for Emergency Use Authorization for monoclonal antibodies against SARS-CoV-2. On Oct. 7 Lilly announced […]

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 […]

COVID-19: When will FDA convene a public meeting of its Antimicrobial Drugs Advisory Committee for monoclonal antibody EUA requests?

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By Daniel R. Lucey M.D., MPH, FIDSA On Oct. 7, the U.S. Food and Drug Administration received requests for Emergency Use Authorization for monoclonal antibodies from two companies (Regeneron and Eli Lilly), but has not yet announced any public meetings of its Antimicrobial Drugs Advisory Committee to advise on either general issues or specific requests […]

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 […]

Regeneron REGN-COV2 monoclonal antibody reported better in (non-hospitalized) patients who lack their own antibodies to SARS-CoV-2

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By Daniel R. Lucey M.D., MPH, FIDSA In assessing any potential benefit on symptom duration or viral load reduction, let alone “cure,” it is important to know whether non-hospitalized patients are already making their own antibodies against SARS-CoV-2 at the time they receive the Regeneron ”REGN-COV2 cocktail” of two monoclonal antibodies against the spike protein […]

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 […]

COVID 2020 Echo from 1633 Galileo’s ”Eppur si muove”

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(“And yet it moves”) Watch this space . . . Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious […]