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

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.

Drugs repurposing for COVID-19: phase III clinical trial evaluation

World Health Organization (WHO) has announced coronavirus disease 2019 (COVID-19) as a global pandemic which is the largest public health crisis in this century. The spread of COVID-19 is still not well-controlled even become global health threat. As new disease, the specific drugs for COVID-19 have not been available, yet. Face of this condition, repurposing existing drugs become the best options in order to meet the urgently need of the effective drugs. In this article, the clinical trial results of some drugs for the treatment of COVID-19 included hydroxychloroquine, chloroquine, lopinavir/ritonavir, remdesivir, oseltamivir, favipiravir, and corticosteroids were reviewed. Hydroxychloroquine, choloquine and lopinavir/ritonavir were shown to be ineffective. Therefore, they were excluded from the list of drugs for the tratment of COVID-19 by WHO and the National Agency of Drug and Food Control of Republic of Indonesia (NCDE NA-DFC RI). Furthermore, NA-DFC RI has issued an emergency use authorization (EUA) for the use of remdesivir and favipiravir for the treatment of COVID-19.