Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization |
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| Institution: | 1. World Health Organization, 20 Avenue Appia, Geneva 1211, Switzerland;2. U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA, USA;3. School of Public Health, The University of Hong Kong, Pokfulam, Hong Kong, China;4. World Health Organization Regional Office for the Eastern Mediterranean, Monazamet El Seha El Alamia Str, Extension of Abdel Razak El Sanhouri Street, P.O. Box 7608, Nasr City, Cairo 11371, Egypt;5. Christian Medical College, Ida Scudder Road, Vellore, Tamil Nadu 632004, India;6. World Health Organization Regional Office of Europe, UN City, Marmorvej 51, Copenhagen DK-2100, Denmark;7. Instituto de Investigación Nutricional, Av. la Molina 1885, La Molina 15024, Peru;8. The Coalition for Epidemic Preparedness Innovations (CEPI), Gibbs building, 215 Euston Rd, Bloomsbury, London NW1 2BE, United Kingdom;9. World Health Organization Regional Office for South-East Asia, World Health House, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110 002, India;10. Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA, USA;11. World Health Organization Regional Office for Africa, Cité du Djoué, P.O. Box 06, Brazzaville, Republic of Congo;12. Consultant to the Pan American Health Organization, 525 23rd Street NW, Washington, DC 20037, USA;13. Emory Vaccine Center, 954 Gatewood Road, Atlanta, GA 30329, USA;14. Center for Vaccine Development & Global Health, University of Maryland School of Medicine, 685 W. Baltimore St., Room #480, Baltimore, MD 21201, USA;15. MRC International Epidemiology & Statistics Group, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom;p. Bill & Melinda Gates Foundation, 500 5th Ave N., Seattle, WA 98109, USA;q. Epiconcept, 25 rue de Titon, Paris 75011, France |
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| 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. |
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| Keywords: | COVID-19 Vaccination Vaccine effectiveness |
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