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 […]

CDC data on COVID-19 incidence among children highlight outcomes and disparate impacts

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MMWR released today underscores need for monitoring, prevention and responses to disease impacts of school-aged children, school staff and their families Between March 1 and Sept. 19 laboratory tests confirmed COVID-19 in 277,285 school-aged children across the United States. With information on symptoms missing or unknown for 37% of those children, 58% of the children […]

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 […]

Science, not politics, must lead to COVID vaccine approvals

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Political pressure to speed the introduction of COVID vaccines threatens scientifically proven systems to protect public safety and research integrity The following is a guest post from Uché Blackstock, MD, Founder & CEO, Advancing Health Equity, and Mitchell Warren, Executive Director, AVAC COVID-19 has devastated communities and health systems around the world – but it […]

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 […]