Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities

R Dal-Ré, LG Bekker, C Gluud, S Holm… - The Lancet Infectious …, 2021 - thelancet.com
Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2
and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates …

The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials

JA Singh, REG Upshur - The Lancet Infectious Diseases, 2021 - thelancet.com
An efficacious COVID-19 vaccine is currently the world's leading research priority. Several
nations have indicated that if there is a compelling case for use of a vaccine before it is …

COVID-19 vaccine trials: The use of active controls and non-inferiority studies

TR Fleming, PR Krause, M Nason, IM Longini… - Clinical …, 2021 - journals.sagepub.com
Background: Recently emerging results from a few placebo-controlled randomized trials of
COVID-19 vaccines revealed estimates of 62%–95% relative reductions in risk of …

Are some COVID-19 vaccines better than others? Interpreting and comparing estimates of efficacy in vaccine trials

RR Rapaka, EA Hammershaimb… - Clinical Infectious …, 2022 - academic.oup.com
Abstract Coronavirus disease 2019 (COVID-19) vaccine trials provide valuable insight into
the safety and efficacy of vaccines, with individually randomized, placebo-controlled trials …

What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2

SH Hodgson, K Mansatta, G Mallett, V Harris… - The lancet infectious …, 2021 - thelancet.com
The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),
has caused more than 1 million deaths in the first 6 months of the pandemic and huge …

Vaccines for COVID-19: learning from ten phase II trials to inform clinical and public health vaccination programmes

SS Bhopal, B Olabi, R Bhopal - Public health, 2021 - Elsevier
Public health professionals and clinicians, in many countries, are immersed in the ongoing
and upcoming vaccination programmes for COVID-19. Published information from vaccine …

Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization

MK Patel, I Bergeri, JS Bresee, BJ Cowling… - Vaccine, 2021 - Elsevier
Phase 3 randomized-controlled trials have provided promising results of COVID-19 vaccine
efficacy, ranging from 50 to 95% against symptomatic disease as the primary endpoints …

Looking beyond COVID-19 vaccine phase 3 trials

JH Kim, F Marks, JD Clemens - Nature medicine, 2021 - nature.com
After the recent announcement of COVID-19 vaccine efficacy in clinical trials by several
manufacturers for protection against severe disease, a comprehensive post-efficacy strategy …

COVID-19 vaccine trials should seek worthwhile efficacy

P Krause, TR Fleming, I Longini, AM Henao-Restrepo… - The Lancet, 2020 - thelancet.com
Three issues are crucial in planning COVID19 vaccine trials:(1) whether to demand not only
proof of some vaccine efficacy but also proof of worthwhile efficacy;(2) whether the initial …

COVID-19 vaccine trials in Africa

M Makoni - The Lancet Respiratory Medicine, 2020 - thelancet.com
On Aug 17, 2020, screening began for participants to enrol in the midstage study of an
experimental COVID-19 vaccine by Novavax, a US drug developer of next-generation …