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 […]

Trick or treat? A fact check on a COVID-19 Vaccine before Halloween

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By Daniel R. Lucey M.D., MPH, FIDSA On August 26, U.S. Food & Drug Administration Commissioner Dr. Stephen Hahn tweeted that the FDA Vaccine Advisory Committee will be convened Oct. 22 to review COVID-19 vaccines. On August 30 Dr. Hahn was reported in the Financial Times stating he would consider issuing an EUA — an […]

WHO website lists nine Phase 3 vaccine candidate protocols around the world

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By Daniel R. Lucey M.D., MPH, FIDSA The World Health Organization updated its website Sept. 9 on COVID-19 vaccine candidates with a line listing of 180 different candidates including 35 in clinical trials and 145 still in pre-clinical stage. Of the 35 vaccine candidates in clinical trials (Phase 1, 2 and/or 3), WHO has listed […]

Dr. Fauci Speaks: Takeaways from a discussion on COVID-19

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National Institutes of Allergy and Infectious Diseases Director Dr. Anthony Fauci talked with Dr. Carlos del Rio for an Infectious Diseases Society of America podcast, released today, on challenges of, and answers to, the COVID-19 pandemic. The two physician scientists, both IDSA members, discussed the outlook for a safe and effective vaccine, testing strategies needed, […]

Phase 3 vaccine trials in the U.S. July 27-Aug. 20/21: A timeline

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By Daniel R. Lucey M.D., MPH, FIDSA Phase 3 COVID-19 vaccine trials in the United States began July 27 with both the Moderna vaccine and the Pfizer/BioNTech vaccine. Given that both vaccine studies are (separately) enrolling 30,000 volunteers (half receive placebo), and given that both require two doses separated by either 28 days (Moderna) or […]

COVID vaccine candidates:  WHO lists 30 in clinical evaluation, six in phase 3 

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By Daniel R. Lucey M.D., MPH, FIDSA Today the World Health Organization updated its DRAFT landscape of COVID-19 candidate vaccines. In a nine-page table format, WHO lists 30 candidate vaccines in clinical evaluation, and 139 candidate vaccines in preclinical evaluation. For all 169 candidate vaccines, information is provided for the name of the developer and […]

As we face a new pandemic, the Ryan White Program has shown us the path ahead

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Thirty years ago this week Congress passed the Ryan White Comprehensive AIDS Resources Emergency Act, named for the young man who stood up to stigma and discrimination before losing his life to the virus in 1990. The legislation, launching a program that addresses obstacles to consistent and effective HIV care confronting communities hardest hit by […]

Three decades after passage of the Ryan White Care Act, an HIV physician looks at gains and the challenges ahead

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Thirty years ago today Congress passed the Ryan White Comprehensive AIDS Resources Emergency Act, named for the young man who stood up to stigma and discrimination against people with HIV before losing his life to the virus in 1990. The legislation, launching a program addressing obstacles to consistent and effective HIV care confronting communities hardest […]

COVID-19: Eight key factual statements from Wuhan Institute of Virology’s Dr. Zhengli Shi

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By Daniel R. Lucey M.D., MPH, FIDSA In response to a series of questions asked by Science magazine’s Jon Cohen, the Wuhan Institute of Virology’s internationally-renowned bat coronavirus researcher and collaborator (with scientists in the United States, Singapore, and elsewhere), Dr. Zhengli Shi provided key facts about her work. Among questions she addressed were ones […]