Operation Warp Speed: implications for global vaccine security

JH Kim, P Hotez, C Batista, O Ergonul… - The Lancet Global …, 2021 - thelancet.com
Several global efforts are underway to develop COVID-19 vaccines, and interim analyses
from phase 3 clinical testing have been announced by nine organisations: Pfizer, the …

[HTML][HTML] Developing safe and effective Covid vaccines—Operation Warp Speed's strategy and approach

M Slaoui, M Hepburn - New England Journal of Medicine, 2020 - Mass Medical Soc
Operation Warp Speed's Strategy and Approach The public–private initiative Operation
Warp Speed aims to deliver tens of millions of doses of an FDA-approved SARS-CoV-2 …

[HTML][HTML] Addressing vaccine inequity—Covid-19 vaccines as a global public good

DJ Hunter, SS Abdool Karim, LR Baden… - … England Journal of …, 2022 - Mass Medical Soc
Covid-19 Vaccines—A Global Public Good The editors of the Journal note that although the
rapid development of Covid-19 vaccines would appear to be a landmark success in global …

[HTML][HTML] Evaluating and deploying COVID-19 vaccines—The importance of transparency, scientific integrity, and public trust

JL Schwartz - New England Journal of Medicine, 2020 - Mass Medical Soc
Evaluating and Deploying Covid-19 Vaccines New entities and investments have aided the
pursuit of Covid-19 vaccines. Moving forward, relying on time-tested mechanisms for …

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 …

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 …

Planning for COVID-19 vaccines safety surveillance

S Kochhar, DA Salmon - Vaccine, 2020 - Elsevier
COVID-19 vaccines are the most important tool to stem the pandemic. They are being
developed with unprecedented global collaboration and accelerated timelines to achieve …

Global COVID-19 vaccine inequity

T Burki - The Lancet Infectious Diseases, 2021 - thelancet.com
On May 27, 2021, the WHO Strategic Advisory Group of Experts on Immunization (SAGE)
convened to discuss COVID-19 vaccines. 15 vaccines are currently in use (the Oxford …

An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19: Analysis reviews the Food and Drug Administration's critical …

AS Kesselheim, JJ Darrow, M Kulldorff, BL Brown… - Health …, 2021 - healthaffairs.org
The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh
the risks for their intended use. In this article we review the standard FDA approach to …

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 …