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

TitleEvaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization
Authors
KeywordsCOVID-19
Vaccination
Vaccine effectiveness
Issue Date2021
PublisherElsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccine
Citation
Vaccine, 2021, v. 39 n. 30, p. 4013-4024 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/300990
ISSN
2023 Impact Factor: 4.5
2023 SCImago Journal Rankings: 1.342
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorPatel, MK-
dc.contributor.authorBergeri, I-
dc.contributor.authorBresee, JS-
dc.contributor.authorCowling, BJ-
dc.contributor.authorCrowcroft, NS-
dc.contributor.authorFahmy, K-
dc.contributor.authorHirve, S-
dc.contributor.authorKang, G-
dc.contributor.authorKatz, MA-
dc.contributor.authorLanata, CF-
dc.contributor.authorL'Azou Jackson, M-
dc.contributor.authorJoshi, S-
dc.contributor.authorLipsitch, M-
dc.contributor.authorMwenda, JM-
dc.contributor.authorNogareda, F-
dc.contributor.authorOrenstein, WA-
dc.contributor.authorOrtiz, JR-
dc.contributor.authorPebody, R-
dc.contributor.authorSchrag, SJ-
dc.contributor.authorSmith, PG-
dc.contributor.authorSrikantiah, P-
dc.contributor.authorSubissi, L-
dc.contributor.authorValenciano, M-
dc.contributor.authorVaughn, DW-
dc.contributor.authorVerani, JR-
dc.contributor.authorWilder-Smith, A-
dc.contributor.authorFeikin, DR-
dc.date.accessioned2021-07-06T03:13:01Z-
dc.date.available2021-07-06T03:13:01Z-
dc.date.issued2021-
dc.identifier.citationVaccine, 2021, v. 39 n. 30, p. 4013-4024-
dc.identifier.issn0264-410X-
dc.identifier.urihttp://hdl.handle.net/10722/300990-
dc.description.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.-
dc.languageeng-
dc.publisherElsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccine-
dc.relation.ispartofVaccine-
dc.subjectCOVID-19-
dc.subjectVaccination-
dc.subjectVaccine effectiveness-
dc.titleEvaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization-
dc.typeArticle-
dc.identifier.emailCowling, BJ: bcowling@hku.hk-
dc.identifier.authorityCowling, BJ=rp01326-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1016/j.vaccine.2021.05.099-
dc.identifier.pmid34119350-
dc.identifier.pmcidPMC8166525-
dc.identifier.scopuseid_2-s2.0-85107573013-
dc.identifier.hkuros323242-
dc.identifier.volume39-
dc.identifier.issue30-
dc.identifier.spage4013-
dc.identifier.epage4024-
dc.identifier.isiWOS:000672535200001-
dc.publisher.placeUnited Kingdom-

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