Category Archives: Dr. Lucey Vaccine Posts

P.1 variant in Manaus, Brazil linked with COVID resurgence now despite reportedly crossing “theoretical herd immunity threshold” in October

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When will new vaccines include the P.1. variant? By Daniel R. Lucey MD, MPH, FIDSA The resurging epidemic in the northern Brazil city of Manaus, Amazonas state, is another of the many cautionary lessons in humility this pandemic has shown the world over the past 13+ months.  On Jan. 26 the Pan American Health Organization […]

South Africa COVID vaccine results cause Novavax to begin work immediately on ”a booster and/or combination bivalent vaccine”

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By Daniel R. Lucey MD, MPH, FIDSA Today the U.S.-based Novavax announced the results in a press release that its COVID-19 vaccine had 49.4% vaccine efficacy (95% Confidence Interval: 6.1 – 72.8) in its overall trial population in a Phase 2b trial in South Africa. Novavax stated that “approximately 90% of COVID-19 cases attributed to […]

Bivalent COVID vaccines: When will studies begin in order to stay ahead of the multiple known (and unknown) variants?

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By Daniel R. Lucey MD, MPH, FIDSA The New York Times reported Monday (Jan. 25) that: “As a precaution, Moderna has begun developing a new form of its vaccine that could be used as a booster shot against the variant in South Africa . . . Moderna said it also planned to begin testing whether […]

Mapping one dose and two dose COVID vaccine efficacy for virus variants: Data to inform policy decisions

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By Daniel R. Lucey MD, MPH, FIDSA The last month saw three timelines overlap: global recognition of SARS-CoV-2 “variants”, worsening of the pandemic, and COVID-19 vaccine authorizations in many nations. As a result, policy decisions have been made regarding use of two doses of vaccine at varying intervals, and discussion of using only one dose […]

Pfizer/BioNTech COVID-19 vaccine efficacy: Six key questions

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By Daniel R. Lucey M.D., MPH, FIDSA The Pfizer/BioNTech announcement today on findings from their first interim analysis of its Phase 3 COVID-19 vaccine candidate study showing 90% efficacy among 94 cases included the following excerpts, with key data pending: “Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned […]

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 […]

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 […]

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 […]

National Academies leaders speak out on COVID science, trust, vaccines as controversies and toll accumulate

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By Daniel R. Lucey M.D., MPH, FIDSA On Sept. 24 President of the U.S. National Academy of Sciences Martha McNutt and President of National Academy of Medicine Victor Dzau, issued the public statement “NAS and NAM Presidents Alarmed by Political Interference in Science Amid Pandemic.”   They emphasize the essential importance of “science-based decision-making” during the […]

Four steps to build trust in COVID-19 vaccines

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By Daniel R. Lucey M.D., MPH, FIDSA COVID-19 vaccine availability will be accelerated by receiving U.S. Food and Drug Administration emergency use authorization as opposed to the longer approval and licensure process. No unlicensed new vaccine candidate has ever received an EUA. For this reason and others, too many Americans may not trust the safety […]