Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform

Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.

Polybrominated Diphenyl Ethers Orally Administration to Mice Were Tansferred to Offspring during Gestation and Lactation with Disruptions on the Immune System

BACKGROUND: The present study was undertaken to examine the immunological effects of pentabrominated diphenyl ether (penta-BDE) and decabrominated diphenyl ether (deca-BDE) on the immune system of the dams and the developmental immune system of the offsprings. METHODS: In this study, mated female C57BL/6J mice were orally administered penta-BDE, deca-BDE or corn oil for 5 weeks, from gestational day 6 to lactational day 21. RESULTS: The body weight of PND21 exposed to penta-BDE was significantly decreased relative to control mice, but that of post-natal day 63 (PND63) were recovered. Orally dosed dams with penta-BDE had significantly smaller absolute and relative spleen masses than control mice. Absolute and relative spleen and thymus masses of PND21 exposed to penta-BDE were significantly decreased over control. The exposure of dams and PND21 with penta-BDE reduced the number of splenocytes and thymocytes. As results of hematologic analysis, percentage WBC and percentage neutrophils increased in dams with deca-BDE. Splenic T cell proliferation in dams and PND21 exposed to penta-BDE was increased, and there were no significant difference in splenic B cell proliferation in all treatment groups. As results of flow cytometric analysis of splenocyte, percentage total T cell, Th cell and Tc cell in PND21 exposed to penta-BDE was slightly increased, and percentage macrophage in dams and PND21 exposed to deca-BDE was decreased. The ELISA results of antibody production show no significant difference in all treatment groups relative to controls. CONCLUSION: These results imply that PBDEs given to the dam were transferred to the offspring during gestation and lactation, and PBDEs transferred from the dam affect immune system of offspring.

Clinical Efficacy for 1% Zinc Pyrithione Shampoo for the Treatment of Dandruff / 대한피부과학회지

BACKGROUND: Dandruff is a common complaint, and is suffered by up to 50% of the population at some time. Malassezia yeasts, which comprise part of the normal skin flora, might be a critical factor in this disease, as they have been found in higher proportions in patients with seborrheic dermatitis or dandruff, its milder form. OBJECTIVE: The aim of this study was to evaluate the clinical efficacy of 4 weeks of treatment with 1% zinc pyrithione (ZP) shampoo. METHODS: A randomized, double-blind, 4-week treatment period was preceded by a 1-week run-in period. A total of 30 patients were enrolled in this study. Assessments included the patient's subjective score (PSS) and the investigator's assessment score (IAS), images of the affected scalp area, the severity of sebum production, and the erythema and moisturizing effect of the shampoo. RESULTS: 1% ZP shampoo significantly reduced the extent and severity of scaling, as measured by folliscope imaging on visit 2 (p=0.0391) and visit 3 (p=0.0381), as well as pruritus related to the disease as measured by the grading systems, PSS (p=0.0352) and IAS (p=0.0142). Additionally, the results of this study show that a treatment regimen with 1% ZP shampoo significantly reduced scalp sebum production as measured by a sebumeter. Erythema measured by the chromameter was not as meaningful. The corneometric values were slightly increased in the group treated with 1% ZP shampoo but not in the group treated with ZP-free shampoo. Side effects of the ZP shampoo were quite mild and tolerable, and were observed only in a small group of patients. CONCLUSION: 1% ZP shampoo appears to be both effective and well-tolerated when used for the treatment of dandruff.