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Key parameters in the Phase 3 Moderna COVID-19 vaccine protocol: Symptomatic infections, interim analyses and an oversight group 

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 […]

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Recent Posts

COVID-19: New EUA guidance in time for Oct. 22 FDA vaccine meeting?

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 […]

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

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 […]

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

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 […]

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Live Blog Archive

CODEL Video

Click above for a video on our Congressional study tour to Africa, and click here to read more.

HIV

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

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 […]

Tuberculosis

Cost of pandemic includes setbacks to South Africa tuberculosis testing, diagnoses

In the six weeks before South Africa responded its first diagnoses of COVID-19 with the start of physical distancing measures, more than 47,000 people on average […]

Research & Development

CDC urges physicians, parents to be on lookout for AFM, a polio-like illness seen predominately in children

With 2018 data showing highest incidence acute flaccid myelitis since monitoring began, officials say awareness, recognition of rare life threatening condition will be crucial to early […]

Policy

As environmental destruction accelerates the spread of emerging infections, we need to talk

By Karen Carvajal, M.D. Over the course of human history we have come a long way in our fight against the threat of infectious diseases and, […]