Author Archives: IDSA Contributor

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 […]

National Latinx AIDS Awareness Day: An overlooked crisis leads to missed opportunities

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Dr. Vincent Guilamo-Ramos is the vice-chair of the board of directors of the Latino Commission on AIDS, and director and founder of the Center for Latino Adolescent and Family Health and the co-chair of the Ending the HIV Epidemic working group for the HIV Medicine Association, which produces this blog. Today, on National Latinx AIDS […]

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 […]

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 […]