TY - JOUR
T1 - Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine
T2 - A systematic review and meta-analysis of vaccine clinical trials
AU - Sathian, Brijesh
AU - Asim, Mohammad
AU - Banerjee, Indrajit
AU - Roy, Bedanta
AU - Pizarro, Ana Beatriz
AU - Mancha, Maraeh Angela
AU - van Teijlingen, Edwin R
AU - Kord-Varkaneh, Hamed
AU - Mekkodathil, Ahammed A
AU - Subramanya, Supram Hosuru
AU - Borges do Nascimento, Israel Júnior
AU - Antony, Neema
AU - Menezes, Ritesh G
AU - Simkhada, Padam
AU - Al Hamad, Hanadi
N1 - © 2021 CEA& INEA.
PY - 2021/3/31
Y1 - 2021/3/31
N2 - 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.
AB - 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.
KW - COVID-19
KW - Candidate vaccines
KW - Immunogenicity
KW - Solicited and Unsolicited Systemic Adverse Events
U2 - 10.3126/nje.v11i1.36163
DO - 10.3126/nje.v11i1.36163
M3 - Review article
C2 - 33868742
VL - 11
SP - 959
EP - 982
JO - Nepal Journal of Epidemiology
JF - Nepal Journal of Epidemiology
SN - 2091-0800
IS - 1
ER -