Title
Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization
Date Issued
05 July 2021
Access level
open access
Resource Type
conference paper
Author(s)
Patel M.K.
Bergeri I.
Bresee J.S.
Cowling B.J.
Crowcroft N.S.
Fahmy K.
Hirve S.
Kang G.
Katz M.A.
L'Azou Jackson M.
Joshi S.
Lipsitch M.
Mwenda J.M.
Nogareda F.
Orenstein W.A.
Ortiz J.R.
Pebody R.
Schrag S.J.
Smith P.G.
Srikantiah P.
Subissi L.
Valenciano M.
Vaughn D.W.
Verani J.R.
Wilder-Smith A.
Feikin D.R.
Publisher(s)
Elsevier Ltd
Abstract
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, 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.
Start page
4013
End page
4024
Volume
39
Issue
30
Language
English
OCDE Knowledge area
Epidemiología
Bioquímica, Biología molecular
Salud pública, Salud ambiental
Subjects
Scopus EID
2-s2.0-85107573013
PubMed ID
Source
Vaccine
ISSN of the container
0264410X
Sponsor(s)
The following authors have disclosures to make. Gagandeep Kang is vice chair of CEPI, is on the board of directors of Ignite Life Science Foundation, and her institution receives funding in her capacity as independent director of the MSD Wellcome Trust Hilleman Laboratories Private Limited. Claudio F. Lanata’s institution has received research funding for COVID-19 vaccine studies from CureVac AG. Maïna L’Azou Jackson was an employee of Sanofi Pasteur until January 2020. Marc Lipsitch receives financial support from Bristol Myers Squibb and Sanofi Pasteur related to general COVID-19 work for presentations. He participates on the data safety monitoring board or advisory boards of Covaxx, Pfizer, Janssen, Astra-Zenca, One Day Sooner (all unpaid). He is a former unpaid board member of One Day Sooner. He also receives general support from the Morris Singer Foundation and the National Cancer Institute/National Institutes of Health USA. Walter A. Orenstein is a member of the Scientific Advisory Board for Moderna. Justin R. Ortiz receives honoraria and travel support for participation on scientific advisory board for Immunization for All Ages (Pfizer); honoraria and travel support for participation on scientific advisory board for Real World Evidence (Seqirus); his institution receives research funding for COVID-19 vaccine studies from NIH and Pfizer. Peter Smith is a member of the Data Safety Monitoring Board for Imperial College’s trial of SARS-CoV-2 vaccine, for Curevac’s trial of SARS-CoV-2 vaccine, and for Imperial College and Oxford University’s human challenge trials with SARS-CoV-2.
We would like to acknowledge Qian An for her assistance in providing input into the statistical section of the guidance document, Tamara Pilishvili for providing into various sections of the guidance document, and Michael Jackson, Kim Mulholland and Marc-Alain Widdowson for their critical review of the guidance document. The following authors have disclosures to make. Gagandeep Kang is vice chair of CEPI, is on the board of directors of Ignite Life Science Foundation, and her institution receives funding in her capacity as independent director of the MSD Wellcome Trust Hilleman Laboratories Private Limited. Claudio F. Lanata's institution has received research funding for COVID-19 vaccine studies from CureVac AG. Maïna L'Azou Jackson was an employee of Sanofi Pasteur until January 2020. Marc Lipsitch receives financial support from Bristol Myers Squibb and Sanofi Pasteur related to general COVID-19 work for presentations. He participates on the data safety monitoring board or advisory boards of Covaxx, Pfizer, Janssen, Astra-Zenca, One Day Sooner (all unpaid). He is a former unpaid board member of One Day Sooner. He also receives general support from the Morris Singer Foundation and the National Cancer Institute/National Institutes of Health USA. Walter A. Orenstein is a member of the Scientific Advisory Board for Moderna. Justin R. Ortiz receives honoraria and travel support for participation on scientific advisory board for Immunization for All Ages (Pfizer); honoraria and travel support for participation on scientific advisory board for Real World Evidence (Seqirus); his institution receives research funding for COVID-19 vaccine studies from NIH and Pfizer. Peter Smith is a member of the Data Safety Monitoring Board for Imperial College's trial of SARS-CoV-2 vaccine, for Curevac's trial of SARS-CoV-2 vaccine, and for Imperial College and Oxford University's human challenge trials with SARS-CoV-2. The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC) nor the World Health Organization. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This work was supported by German Federal Ministry of Health (BMG) COVID-19 Research and development funding to WHO and by the National Cancer Institute of the National Institutes of Health under Award Number U01CA261277. MKP and DF conceived and wrote the draft of the global guidance document and this manuscript. All authors contributed to the development of the content of the guidance document, and critically revised the guidance document and this manuscript. All authors have given approval to submit this document for publication.
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The following authors have disclosures to make. Gagandeep Kang is vice chair of CEPI, is on the board of directors of Ignite Life Science Foundation, and her institution receives funding in her capacity as independent director of the MSD Wellcome Trust Hilleman Laboratories Private Limited. Claudio F. Lanata’s institution has received research funding for COVID-19 vaccine studies from CureVac AG. Maïna L’Azou Jackson was an employee of Sanofi Pasteur until January 2020. Marc Lipsitch receives financial support from Bristol Myers Squibb and Sanofi Pasteur related to general COVID-19 work for presentations. He participates on the data safety monitoring board or advisory boards of Covaxx, Pfizer, Janssen, Astra-Zenca, One Day Sooner (all unpaid). He is a former unpaid board member of One Day Sooner. He also receives general support from the Morris Singer Foundation and the National Cancer Institute/National Institutes of Health USA. Walter A. Orenstein is a member of the Scientific Advisory Board for Moderna. Justin R. Ortiz receives honoraria and travel support for participation on scientific advisory board for Immunization for All Ages (Pfizer); honoraria and travel support for participation on scientific advisory board for Real World Evidence (Seqirus); his institution receives research funding for COVID-19 vaccine studies from NIH and Pfizer. Peter Smith is a member of the Data Safety Monitoring Board for Imperial College’s trial of SARS-CoV-2 vaccine, for Curevac’s trial of SARS-CoV-2 vaccine, and for Imperial College and Oxford University’s human challenge trials with SARS-CoV-2. Note that as we do not discuss any specific brand of vaccine, we do not feel any of these disclosures are a conflict of interest, but in the interest of transparency we have detailed relationships with pharmaceutical and other organizations.
This work was supported by German Federal Ministry of Health (BMG) COVID-19 Research and development funding to WHO and by the National Cancer Institute of the National Institutes of Health under Award Number U01CA261277.
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