[HTML][HTML] 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 …

[HTML][HTML] 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 …

Clinical development and approval of COVID-19 vaccines

U Kalinke, DH Barouch, R Rizzi… - Expert Review of …, 2022 - Taylor & Francis
ABSTRACT Introduction The coronavirus 19 (COVID-19) pandemic triggered a
simultaneous global demand for preventative vaccines, which quickly became a high priority …

[HTML][HTML] Emergency use authorization of Covid vaccines—safety and efficacy follow-up considerations

PR Krause, MF Gruber - New England Journal of Medicine, 2020 - Mass Medical Soc
Emergency Use Authorization of Covid Vaccines A median 2-month follow-up after
completion of an investigational Covid-19 vaccine regimen is necessary to provide safety …

[HTML][HTML] 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 …

[HTML][HTML] Evaluation of the safety profile of COVID-19 vaccines: a rapid review

Q Wu, MZ Dudley, X Chen, X Bai, K Dong, T Zhuang… - BMC medicine, 2021 - Springer
Background The rapid process of research and development and lack of follow-up time post-
vaccination aroused great public concern about the safety profile of COVID-19 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 …

[HTML][HTML] 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 …

[HTML][HTML] Challenges in the rollout of COVID-19 vaccines worldwide

TK Burki - The Lancet Respiratory Medicine, 2021 - thelancet.com
On Feb 24, 2021, 600 000 doses of the Oxford–AstraZeneca COVID-19 vaccine arrived in
Ghana. 2 days later, 500 000 doses of the same vaccine landed in the Ivory Coast. The west …

[PDF][PDF] Evaluation of COVID-19 vaccine effectiveness: interim guidance, 17 March 2021

World Health Organization - 2021 - apps.who.int
Since its emergence in December 2019, SARS-CoV-2, the virus that causes coronavirus
disease 2019 (COVID-19), has taken a tremendous toll globally; by 28 February 2021, there …