ABSTRACT
In the early SARS-CoV-2 (COVID-19) pandemic, four major vaccines were approved despite limited efficacy and safety data through short regulatory review periods. Thus, it is necessary to assess the benefit-risk (BR) profiles of the COVID-19 vaccines. We conducted a quantitative BR assessment for four COVID-19 vaccines (mRNA-based: mRNA-1273 and BNT162b2; viral vector-based: Ad26.COV.2 and ChAdOx1-S) using multi-criteria decision analysis. Three benefit criteria and two risk criteria were considered: preventing COVID-19 infection for (1) adults aged ≥18 years; (2) seniors aged 60 years or older; and (3) severe COVID-19, adverse events (AEs), and serious AEs. Data were retrieved from clinical trials, observational studies, and county-specific AE monitoring reports. Based on the collected data, vaccines were scored for each criterion. 22 professionals weighted each criterion. The overall BR score was calculated using scores and weights. mRNA-1273 was the most preferred vaccine in pre-authorization and BNT162b2 in post-authorization. We found that the mRNA vaccine had a good balance between the benefits and risks. Using this BR assessment, the benefit-risk profile of COVID-19 vaccines can be updated with cumulated data. It will contribute to building evidence for decision making by policy makers and health professionals.
ABSTRACT
Background: The severity of the coronavirus disease 2019 (COVID-19) pandemic has discouraged organ donation. However, the prevalence of COVID-19 in Korea was much lower in comparison to Western countries. With this, the authors decided to determine the real-world impact of COVID-19 on organ donation and transplantation in Korea. Methods: The number of kidney transplantations (KTs) and liver transplantations (LTs) performed in 2020 were compared with those in 2019 using the Korean Network for Organ Sharing database and Asan Medical Center (AMC) database. Results: The annual number of deceased donors (DDs) was 450 in 2019 compared to 478 in 2020. Monthly DD number was 37.5±5.9 in 2019 and 39.8±4.4 in 2020 (P=0.284). Annual number of DD kidney transplant (DDKT) was 794 in 2019 and 848 in 2020, and monthly number was 66.1±10.4 in 2019 and 70.7±9.8 in 2020 (P=0.285). The annual number of DDLT was 391 in 2019 and 395 in 2020, and the monthly number was 32.6±5.7, 2019 and 32.9±4.7 in 2020 (P=0.877). The annual number of living donor (LD) KT was 2,293 in 2019 and 1,432 in 2020, and the monthly number was 191.1±19.5 in 2019 and 119.3±11.7 in 2020 (P<0.001). Annual number of living donor LDLT was 1,577 in 2019 and 1,146 in 2020, and monthly number was 131.4±18.1 in 2019 and 95.5±8.0 in 2020 (P<0.001). In the AMC, not all types of KT and LT changed significantly. Conclusions: The results of this study indicate that the number of DD organ transplantations remained stable in Korea in 2020, but the number of LD organ transplantations was significantly reduced. However, the number of organ transplantations did not change in the AMC.