959 Nepal Journal of Epidemiology Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials Brijesh Sathian 1 , Mohammad Asim 2 , Indrajit Banerjee 3 , Bedanta Roy 4 , Ana Beatriz Pizarro 5 , Maraeh Angela Mancha 2 , Edwin R. van Teijlingen 6 , Hamed Kord-Varkaneh 7 , Ahammed A Mekkodathil 2 , Supram Hosuru Subramanya 8 , Israel Júnior Borges do Nascimento 9 , Neema Antony 10 , Ritesh G Menezes 11 , Padam Simkhada 12 , Hanadi Al Hamad 1 Copyright © 2021 CEA& INEA. Published online by NepJOL-INASP. www.nepjol.info/index.php/NJE Correspondence: Dr Mohammad Asim, Trauma Surgery, Hamad General Hospital, Doha, Qatar. Email: asim.jmi@gmail.com Received 7 Jan 2021/Revised 25 Jan 2021/Accepted 25 Jan 2021 Citation: Sathian B, Asim M, Banerjee I, Roy B, Pizarro AB, Mancha MA, van Teijlingen ER, Pizarro AB, Kord- Varkaneh H, Mekkodathil AA, Subramanya SH, Borges do Nascimento IJ, Antony N, Menezes RG, Simkhada P, Al Hamad H. Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials. Nepal J Epidemiol. 2021;11(1); 959-982. DOI: 10.3126/nje.v11i1.36163 This work is licensed under a Creative Commons Attribution 4.0 International License. Research Article Open Access 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. Keywords: COVID-19, candidate vaccines, Immunogenicity, Solicited and Unsolicited Systemic Adverse Events eISSN 2091-0800