Category Archives: Dr. Lucey Vaccine Posts

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 […]

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 […]

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 […]

COVID-19: HHS explains “Operation Warp Speed”

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By Daniel R. Lucey M.D., MPH, FIDSA On Friday, The U.S. Department of Health and Human Services posted a succinct 4-page document titled “Explaining Operation Warp Speed.” The summary begins by answering three questions: What is the goal [of OWS]? How will the goal will be accomplished? Who is working on OWS? It moves to […]

COVID-19: FDA Emergency Use Authorization for a vaccine in the fall of 2020 means the time for public dialogue is August      

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By Daniel R. Lucey M.D., MPH, FIDSA The only past U.S. Food and Drug Administration Emergency Use Authorization for any vaccine was in January 2005 for the licensed (since 1970) anthrax vaccine to be used in military personnel “for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed […]

COVID-19: China approves vaccine for use by military only without phase III study

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By Daniel R. Lucey M.D., MPH, FIDSA Today China approved a Covid-19 vaccine, for use only by its military. Importantly, however, this approval occurred despite the vaccine not having undergone a phase III efficacy study. As reported by Josephine Ma in the South China Morning Post, this vaccine was developed by the company CanSino Biologics […]

COVID-19: Does the multisystem inflammatory syndrome in children have  implications for vaccines?  

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On Saturday, the World Health Organization released a scientific brief on the multisystem inflammatory syndrome seen in  children and adolescents with COVID-19. Today in Science Speaks two guest posts respond to findings around the syndrome. The following is a guest post Daniel R. Lucey M.D., MPH and Kristen R. Kent, MPhil. Since April 26 England, […]