Monthly Archives: October 2020

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 […]