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

Sathian, Brijesh; Asim, Mohammad; Banerjee, Indrajit; Roy, Bedanta; Pizarro, Ana Beatriz; Mancha, Maraeh Angela; van Teijlingen, Edwin R.; Kord-Varkaneh, Hamed; Mekkodathil, Ahammed A; Subramanya, Supram Hosuru; Borges do Nascimento, Israel Júnior; Antony, Neema; Menezes, Ritesh G; Simkhada, Padam; Al Hamad, Hanadi

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.