Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials

Keywords: COVID-19, Clinical trials, candidate vaccines, Solicited and Unsolicited Systemic Adverse Events, Immunogenicity

Abstract

Background:  To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines.

Methods: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020.

Results: We have included fourteen non-randomized and randomized controlled phase I-III trials. Implementation of a universal vaccination program with proven safety and efficacy through robust clinical evaluation is the long-term goal for preventing COVID-19. The immunization program must be cost-effective for mass production and accessibility. Despite pioneering techniques for the fast-track development of the vaccine in the current global emergency, mass production and availability of an effective COVID-19 vaccine could take some more time.

Conclusion: Our findings suggest a revisiting of the reported solicited and unsolicited systemic adverse events for COVID-19 candidate vaccines. Hence, it is alarming to judiciously expose thousands of participants to COVID-19 candidate vaccines at Phase-3 trials that have adverse events and insufficient evidence on safety and effectiveness that necessitates further justification.

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Author Biographies

Brijesh Sathian, Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar

Scientist, Geriatric and long term care Department, Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar

Mohammad Asim, Trauma and vascular surgery, Hamad General Hospital, Doha, Qatar

Trauma and vascular surgery, Hamad General Hospital, Doha, Qatar

Indrajit Banerjee, Sir Seewoosagur Ramgoolam Medical College: Belle Rive, Vacoas-Phoenix, Mauritius

Associate Professor, Department of Pharmacology, Sir Seewoosagur Ramgoolam Medical College: Belle Rive, Vacoas-Phoenix, Mauritius

Bedanta Roy, Faculty of Medicine, QIUP, Malaysia

Senior Lecturer, Department of Physiology, Faculty of Medicine, QIUP, Malaysia

Ana Beatriz Pizarro, Pontificia Universidad Javeriana, Bogotá, Colombia

Pontificia Universidad Javeriana, Bogotá, Colombia

Maraeh Angela Mancha, Hamad General Hospital, Doha, Qatar

Hamad General Hospital, Doha, Qatar

Edwin R. van Teijlingen, Bournemouth University, Bournemouth, England, United Kingdom

Professor, Bournemouth University, Bournemouth, England, United Kingdom

Hamed Kord Varkaneh, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Ahammed Abdulla Mekkodathil, Trauma Surgery, Hamad General Hospital, Doha, Qatar

Trauma Surgery, Hamad General Hospital, Doha, Qatar

Supram Hosuru Subramanya, Manipal College of Medical Sciences, Pokhara, Nepal

Manipal College of Medical Sciences, Pokhara, Nepal

Israel Júnior Borges do Nascimento, University Hospital and School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

University Hospital and School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

Neema Antony, Confederation of Epidemiological Associations, India.

Confederation of Epidemiological Associations, India.

Ritesh G Menezes, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

Padam Simkhada, University of Huddersfield, United Kingdom

Associate Dean International and Professor of Global Health (School of Human and Health Sciences), University of Huddersfield, United Kingdom

Hanadi Al Hamad, Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar

Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar

Published
2021-03-31
How to Cite
Sathian, B., Asim, M., Banerjee, I., Roy, B., Pizarro, A., Mancha, M., Teijlingen, E., Varkaneh, H., Mekkodathil, A., Subramanya, S., Nascimento, I., Antony, N., Menezes, R., Simkhada, P., & Al Hamad, H. (2021). Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials. Nepal Journal of Epidemiology, 11(1), 959-982. https://doi.org/10.3126/nje.v11i1.36163
Section
Original Articles