Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization. Author(s): Patel MK, Bergeri I, Bresee JS, Cowling BJ, Crowcroft NS, Fahmy K, Hirve S, Kang G, Katz MA, Lanata CF, L'Azou Jackson M, Joshi S, Lipsitch M, Mwenda JM, Nogareda F, Orenstein WA, Ortiz JR, Pebody R, Schrag SJ, Smith PG, Srikantiah P, Subissi L, Valenciano M, Vaughn DW, Verani JR, Wilder-Smith A, Feikin DR|Journal: Vaccine|PMID: 34119350| June 2021 Phase 3 randomized-controlled trials have provided promising results of COVID-19 vaccine efficacy, ranging from 50 to 95% against symptomatic disease…
Reply to Hasford and to Spinola et al. Author(s): Eyal N, Lipsitch M, Smith PG|Journal: J Infect Dis|PMID: 32845306| August 2020 We proposed human challenge trials (HCTs) as a possible alternative or complement to conventional phase 3 trials for expedited severe…
Response to Cioffi. Author(s): Eyal N, Lipsitch M, Smith PG|Journal: J Infect Dis|PMID: 32348499| June 2020 Dr Cioffi rails against our comparison of human challenge studies to organ donation, but the risk of donor death from…
Response to Dawson et al. Author(s): Eyal N, Lipsitch M, Smith PG|Journal: J Infect Dis|PMID: 32495823| June 2020 Dawson et al raise three concerns about human challenge trials to assess the efficacy of SARS-CoV-2 vaccines. First, that current…
Human challenge studies to accelerate coronavirus vaccine licensure. Author(s): Eyal N, Lipsitch M, Smith PG|Journal: J Infect Dis|PMID: 32232474| May 2020 Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing…
Choices in vaccine trial design in epidemics of emerging infections. Author(s): Kahn R, Rid A, Smith PG, Eyal N, Lipsitch M|Journal: PLoS Med|PMID: 30086139| August 2018 In a Policy Forum, Marc Lipsitch and colleagues discuss trial design issues in infectious disease outbreaks.