Monthly Archives: October 2020

IDWeek 2020: Dr. Frieden, WHO’s Dr. Ryan wrap up “Chasing the Sun” with a look at COVID-19 as a long term public health threat

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Get to know this new coronavirus well. “”We’re not halfway through it,” Dr. Thomas Frieden, former director of the U.S. Centers of Disease Control and Prevention said, in the concluding session of “Chasing the Sun,” a 24-hour global view of the pandemic that opened IDWeek 2020’s virtual gathering of infectious diseases specialists worldwide. Calling the […]

The 51st Union Conference on Lung Health: Four-month regimen cures TB as well as standard six-month treatment course

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A shorter four-month drug regimen to treat tuberculosis is as safe and effective as the standard six-month regimen in curing drug-susceptible TB, researchers presented at the 51st Union World Conference on Lung Health being held virtually this week. The shorter regimen – the first successful short treatment regimen for TB identified in more than 40 […]

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 […]

IDWeek 2020: Dr. Fauci opens “Chasing the Sun” with a view of COVID-19 in the U.S.

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“His advice is honest and rooted in sound science,” former President George W. Bush “He’s the guy I’ve gone to since 1993 . . . and still do,” National Institutes of Health Director Dr. Francis Collins “Thank you for what you do and who you are,” World Health Organization Director-General Tedros Adhanom Ghebreyesus The former President […]

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 […]

Training advances benefits of HIV data

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The following is a guest post by Serge Bisore, MPH and Hypax Mbanye, MA, of Data.FI Using data to improve performance is challenging when the quality of the data is uneven. As we move towards epidemic control, national AIDS control programs and ministries of health need complete, timely, and accurate information on HIV indicators so […]