1. Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials
- Author
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Ahammed Mekkodathil, Israel Júnior Borges do Nascimento, Padam Simkhada, Ritesh G. Menezes, Edwin van Teijlingen, Indrajit Banerjee, Bedanta Roy, Brijesh Sathian, Ana Beatriz Pizarro, Hanadi Al Hamad, Maraeh Angela Mancha, Mohammad Asim, Neema Antony, Hamed Kord-Varkaneh, and Supram Hosuru Subramanya
- Subjects
medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Epidemiology ,business.industry ,MEDLINE ,COVID-19 ,Solicited and Unsolicited Systemic Adverse Events ,030204 cardiovascular system & hematology ,Immunogenicity ,Vaccination ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Meta-analysis ,medicine ,Immunization program ,030212 general & internal medicine ,candidate vaccines ,Intensive care medicine ,Adverse effect ,business ,Clinical evaluation ,Research Article - Abstract
Introduction: 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. Conclusions: Our findings invited a revisit to the reported solicited and unsolicited SAE 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.
- Published
- 2021
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