Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization
AuthorPatel, Minal K
Bresee, Joseph S
Cowling, Benjamin J
Crowcroft, Natasha S
Katz, Mark A
Lanata, Claudio F
L'Azou Jackson, Maïna
Mwenda, Jason M
Orenstein, Walter A
Ortiz, Justin R
Schrag, Stephanie J
Smith, Peter G
Vaughn, David W
Verani, Jennifer R
Feikin, Daniel R
MetadataShow full item record
AbstractPhase 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, resulting in emergency use authorization/listing for several vaccines. However, given the short duration of follow-up during the clinical trials, strict eligibility criteria, emerging variants of concern, and the changing epidemiology of the pandemic, many questions still remain unanswered regarding vaccine performance. Post-introduction vaccine effectiveness evaluations can help us to understand the vaccine's effect on reducing infection and disease when used in real-world conditions. They can also address important questions that were either not studied or were incompletely studied in the trials and that will inform evolving vaccine policy, including assessment of the duration of effectiveness; effectiveness in key subpopulations, such as the very old or immunocompromised; against severe disease and death due to COVID-19; against emerging SARS-CoV-2 variants of concern; and with different vaccination schedules, such as number of doses and varying dosing intervals. WHO convened an expert panel to develop interim best practice guidance for COVID-19 vaccine effectiveness evaluations. We present a summary of the interim guidance, including discussion of different study designs, priority outcomes to evaluate, potential biases, existing surveillance platforms that can be used, and recommendations for reporting results.
Rights/TermsCopyright © 2021.
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/16056
- A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial.
- Authors: Brakenhoff TB, Franks B, Goodale BM, van de Wijgert J, Montes S, Veen D, Fredslund EK, Rispens T, Risch L, Dowling AV, Folarin AA, Bruijning P, Dobson R, Heikamp T, Klaver P, Cronin M, Grobbee DE, COVID-RED Consortium.
- Issue date: 2021 Jun 22
- Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial.
- Authors: Palacios R, Patiño EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C
- Issue date: 2020 Oct 15
- COVID-19 vaccine trials: The potential for "hybrid" analyses.
- Authors: Fleming TR, Nason M, Krause PR, Longini IM, Henao-Restrepo AM
- Issue date: 2021 Aug
- COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna Vaccines.
- Authors: Meo SA, Bukhari IA, Akram J, Meo AS, Klonoff DC
- Issue date: 2021 Feb