3.8 Article

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

期刊

NEPAL JOURNAL OF EPIDEMIOLOGY
卷 11, 期 1, 页码 959-982

出版社

INT NEPAL EPIDEMIOLOGICAL ASSOC
DOI: 10.3126/nje.v11i1.36163

关键词

COVID-19; candidate vaccines; Immunogenicity; Solicited and Unsolicited Systemic Adverse Events

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The study evaluates the safety and immunogenicity of COVID-19 vaccine candidates and the implementation of mass immunization. Despite advanced techniques for rapid vaccine development in emergency situations, production and availability of an effective vaccine may still take some time.
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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