• Journal of Plant Biotechnology
• /
• v.45 no.3
• /
• pp.171-182
• /
• 2018

Papaya (Carica papaya L.) is one of the crops widely planted in tropical and subtropical areas. The papaya fruit has low calories and are plentiful in vitamins A and C and in minerals. A major problem in papaya production is a plant disease caused by the papaya ringspot virus (PRSV). The first PRSV-resistant GM papaya expressing a PRSV coat protein gene was developed by USA scientists in 1992. The first commercial GM papaya cultivars derived from the event was approved by the US government in 1997. Development of transgenic papayas has been focused on vaccine production and limited agricultural traits, including insect and pathogen resistance, long shelf life, and aluminum and herbicide tolerance. Approximately 17 countries, including the USA and China, produced transgenic papayas and/or commercialized them, which provoked studies on biosafety assessment and development of GM-detection technologies. For the biosafety assessment of potential effects on human health, effects of long-term feeding to model animals have been studied in terms of toxicity and allergenicity. Studies on environmental safety assessment include influence on soil-microbial biodiversity and transfer to soil bacteria of GM selection markers. Many countries, such as Korea, the European Union, and Japan, that have strict regulations for GM crops have serious concerns about unintended introduction of GM cultivars and food commodities using unauthorized GM crops. Transgene- and/or GM event-specific molecular markers and technologies for genomics-based detection of unauthorized GM papaya have been developed and have resulted in the robust detection of GM papayas.

• The Korean Society of Law and Medicine
• /
• v.21 no.1
• /
• pp.223-259
• /
• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Pediatric Infection and Vaccine
• /
• v.22 no.2
• /
• pp.55-62
• /
• 2015

Purpose: Varicella Zoster Immune Globulin (VZIG) is available in Korea for post-exposure prophylaxis of the Varicella-zoster virus (VZV) in high-risk patients. In July 2013, the United States Centers for Disease Control and Prevention (US CDC) recommended extending the time for administration of VariZIG$^{(R)}$ from within 96 hours up to 10 days after VZV exposure. This study was performed to analyze the effectiveness of VZIG prophylaxis between the two groups of patients who received VZIG within 96 hours and more than 96 hours of exposure to varicella. Methods: A retrospective chart review was performed in pediatric patients who received VZIG at Samsung Medical Center, Seoul, Korea from January 2001 to December 2012. Results: A total of 91 patients were identified. Fifty-seven patients were male (62.6%) and the median age was 5.91 years. Thirty-nine patients (42.9%) were exposed to VZV in the hospital. Underlying diseases were solid tumors (41.8%), hematologic malignancies (40.7%), and others (17.5%). Forty-five patients (49.5%) were hematopoietic cell transplant recipients. Seventy-four patients (81.3%) received VZIG within 96 hours after VZV exposure. There was no significant difference in the development of chickenpox between the two groups (2.7% vs. 5.9%, P=0.4664). In 22 seronegative patients, we also observed no significant difference between the groups in terms of the development of chickenpox (6.6% vs. 0%, P=0.667). Conclusions: This study showed that the effectiveness of VZIG for the prevention of chickenpox was comparable between patients who received VZIG within 96 hours and those who received VZIG more than 96 hours after exposure to VZV.

• Journal of fish pathology
• /
• v.24 no.2
• /
• pp.153-160
• /
• 2011

The specific antibody response of olive flounder, Paralichthys olivaceus to change in rearing-environmental conditions post immunization with antigen (bovine serum albumin, BSA) and different routes of antigen administration were investigated by enzyme-linked immunosorbent assay (ELISA). To test the effect of routes of antigen administration, flounder were injected intraperioneally or intramuscularlly with 1 mg of BSA. In addition, to test the effect of change in environmental condition post immunization, flounder were injected intraperioneally with 1 mg of antigen, and then were exposed to acute thermal change (the water temperature (WT) was decreased from $21^{\circ}C$ to $15^{\circ}C$ within 30 min and maintained at $15^{\circ}C$ for 3 h), handling (fish were caught and subsequently held out of water for 1 min) or heavy oil (76 g/200 L for 2 days). Consequently, there was no significant difference between intraperioneal (IP) and intramuscular (IM) injections except at 10 days post-immunization. With these results, it suggests that both 1M and IP injections may be used as route of vaccination. Furthermore, no significant difference was observed in the antibody response among the groups exposed to heavy oil, handling, sudden drop of WT and positive control except at 10 days post-immunization. From these results, it was confirmed that specific antibody response was not affected by the above mentioned rearing-environmental conditions, suggesting that vaccination can be employed at changing rearing-environmental conditions.

• Pediatric Infection and Vaccine
• /
• v.14 no.1
• /
• pp.75-82
• /
• 2007

Purpose : Human metapneumovirus (hMPV) is a newly identified paramyxovirus that causes a variety of clinical syndromes in children, including upper and lower respiratory tract illnesses. hMPV is considered an ubiquitous virus causing respiratory tract diseases among children especially during late winter and spring seasons. We report clinical features of human metapneumovirus infection in Korean children. Methods : hMPV infection was diagnosed by reverse transcriptase-polymerase chain reaction (RT-PCR) in respiratory specimens obtained from patients with acute respiratory tract infections from October, 2004 to May, 2005. Medical records of all hMPV-positive patients were reviewed, retrospectively. Results : A total of 15 hMPV were identified from 443 nasopharyngeal aspirations by RT-PCR (3.4%). The range of age of the patients with hMPV infection was from 1 month to 62 months (median age, 31.5 months), with similar numbers of females (8/15) and males (7/15). Among hMPV-positive children, 53.3% (8/15) were aged less than 24 months. Fever, cough, rhinorrhea, vomiting, diarrhea, tachypnea, and chest wall retractions were common findings. Most common clinical diagnosis was pneumonia (60%). Two of the 15 hMPV-positive patients were also positive for adenovirus. Fever persisted from 0 to 10 days (mean 4.9 days). The duration of hospitalization ranged from 4 to 7 days (mean 5.6 days). Conclusion : hMPV accounted for a small but significant proportion of respiratory tract infection in infants and children. Future development and application of diagnostic tools will determine the burden of disease caused by this newly discovered pathogen.

• Pediatric Infection and Vaccine
• /
• v.13 no.1
• /
• pp.63-70
• /
• 2006

Purpose : We hypothesized that mannose binding lectin gene(MBL2), a key molecule of innate immunity, may contirbute to the development and the outcome of respiratory syncytial virus(RSV) disease in early childhood. This study was performed to investigate the genetic basis of polymorphisms and haplotypes of MBL2 for RSV disease severity in Korean children. Methods : Cases with severe RSV diseases are 99 children with severe RSV lower respiratory tract infections, who were admitted to the Seoul National University Children's Hospital through 1993~2000. The control subjects consisted of 224 anonymous healthy Korean blood donors. The frequency of promoter variant(-221, X/Y) and structural variant(codon 54) were compared between the case patient group and the control subject group. Results : The mean age of patients was 11.8 months; 49% were <6 months, 39% were 6-24 months and 12% were >24 months. In the cohort of cases of severe RSV diseases, the genotypic frequencies of structural variant in codon 54 were 61% for AA, 34% for AB, and 5% for BB. Those of the promoter X/Y variant were 85% for YY and 15% for XY. There were no significant differences in overall distribution of both structural and promoter variants between the cases and the control subjects. We did not observe statistical difference in the haplotypic frequencies of MBL2. Conclusion : Common variants of MBL2 gene most likely do not contribute to the risk for severe RSV diseases in Korean children. Further genetic association studies should be conducted in a larger propsectively recruited cohort of children with RSV infection.

• Pediatric Infection and Vaccine
• /
• v.23 no.1
• /
• pp.54-61
• /
• 2016

Purpose: Bacille Calmette-$Gu{\acute{e}}rin$ (BCG) lymphadenitis is a relatively frequent local adverse reactions after BCG vaccination. Its incidence rate is usually <1%. However, this rate may be different according to BCG strain, vaccination method or skill, etc. In the Republic of Korea, two BCG strains are used: intradermal Danish-1331 or percutaneous Tokyo-172. We surveyed the incidence rates of BCG lymphadenitis. Methods: This survey was performed in total 25 centers (5 general hospitals, 20 private pediatric clinics). Immunized type of BCG strain in study subjects was verified by directly observing the scar. The occurrence of BCG lymphadenitis was asked to their parent. In cases of BCG lymphadenitis, location, diameter size, progression of suppuration, and treatment method were investigated, as well. Results: The total number of study subjects was 3,342. Among these, the subjects suitable for enrollment criteria (total 3,222; Tokyo strain 2,501, Danish strain 721) were analyzed. BCG lymphadenitis regardless of its size developed in each five of subjects per strains, therefore, its incidence rate was 0.20% in Tokyo and 0.69% in Danish strain, respectively (P=0.086). However, when applying the WHO criteria - the development of lymph node swelling with diameter 1.5 cm or more, the incidence rate of BCG lymphadenitis was 0.16% (4 cases) in Tokyo and 0.42% (3 cases) in Danish strain, respectively. Conclusions: The incidence rate of lymphadenitis in two BCG types, percutaneous Tokyo and intradermal Danish strain BCG, is 0.20% and 0.69%, respectively. Both rates are acceptable.

• Pediatric Infection and Vaccine
• /
• v.23 no.1
• /
• pp.31-39
• /
• 2016

Purpose: The aim of this study was to investigate the prognostic factors for Pneumocystis jirovecii pneumonia (PCP) and to evaluate the influence of PCP prophylaxis in pediatric patients. Methods: From January 2002 to April 2015, patients aged <18 years with a diagnosis of confirmed PCP at our institute were reviewed retrospectively. Clinical characteristics and outcomes were compared according to the groups with or without PCP prophylaxis. Risk factors associated with PCP-related death were analyzed by logistic regression analysis. Results: During study period, a total of 24 patients were diagnosed with PCP by immunofluorescence assay and/or PCR. The median age of the patients was 5 years (range, 3 months-18 years) and 23 (96%) had immunocompromised conditions including hematologic disorders with or without hematopoietic stem cell transplantation (n=15), solid organ transplantation (n=4), and primary immune deficiency (n=4). Most common presenting symptoms were tachypnea and cough (92%, each). At the time of diagnosis, 79% (19/24) and 25% (6/24) suffered from respiratory failure and multi-organ dysfunction syndrome (MODS), respectively. Mechanical ventilation was required in 8 (33%) patients and 5 (21%) patients died of PCP. Multivariate analysis showed that MODS at initial presentation was an indicator of poor prognosis (OR, 17.1 [95% CI 1.13-257.67]; P=0.04). Compared to the patients without PCP prophylaxis, the frequency of MODS at diagnosis, need for mechanical ventilation and length of hospital days were significantly less common in the children who received PCP prophylaxis. Conclusions: MODS at presentation was a significant predictor for poor outcome and PCP prophylaxis could alleviate the clinical courses of pediatric PCP. Prospective study will be mandatory to determine the risk factors for development and deterioration of PCP in children.

• Journal of Plant Biotechnology
• /
• v.37 no.3
• /
• pp.313-318
• /
• 2010

To develop edible vaccines for swine, the embryogenic calli (type II) derived from HiII genotype were inoculated with A. tumefaciens strain C58C1 containing the binary vector pMYV611, 613, 616, and V621, 622 and 623 respectively. Six of those vectors carry nptII gene which confers resistance to paromomycin and apxIIA gene producing ApxII toxin which is generated in various serum types of A. pleuropneumoniae as a target gene. The 4,120 callus clones for pMYV611, 5,959 callus clones for pMYV613, 7,581 callus clones for pMYV616, 52,329 callus clones for V621, 48,948 callus clones for V622, and 56,188 callus clones for V623 were inoculated. The frequency of positive response clone was confirmed into range of 2.3% - 4.4% for each vectors by NPTII ELISA kit assay, and the selected callus clones of them were finally 3 callus clones from pMYV611 (0.07%), 4 callus clones from pMYV613 (0.07%), 2 callus clones from pMYV616 (0.03%), 51 callus clones from V621 (0.1%), 72 callus clones from V622 (0.15%), and 102 callus clones from V623 (0.18%) respectively. From the selected callus clones of each binary vector, the integration of the apxIIA gene into maize genome was detected from 2 plants of pMYV613 and 2 plants of V623 by Southern blot analysis.

• Journal of Hospice and Palliative Care
• /
• v.4 no.2
• /
• pp.122-129
• /
• 2001

Purpose : After Acquired Immunodeficiency Syndrome (AIDS) is known to be a fatal disease, efforts and studies are made to determine the cause, treatment method and method of preventing infection. However, no treatment method is present and vaccine development has not been made. Therefore, the most effective treatment method is prevention, and almost 100% prevention is possible when correct preventive measures are taken. We suggest effective prevention education by comparing knowledge and attitude of those unmarried men who had sexual encounters with prostitutes (high risk group) and those with no sexual encounters with prostitutes (low risk group). Methods : From January 1, 2000 to June 30, 2000, a survey was done in 516 unmarried soldiers and college students. With the collected data, chi-square test was used to compare and analyze the demographic characteristic, knowledge on AIDS, and attitude on AIDS between the high risk group and low risk group. One-way ANOVA test was used to compare and analyze the scores on knowledge between these two groups. Results : Among 516 unmarried men, 256 men (49.6%) fell into the high risk group and 260 men (50.4%) into the low risk group. Both groups showed that they heard of AIDS during their middle school years. The main route of obtaining knowledge on AIDS was through TV programs with 124 men(48.4%) in the high risk group and 167 men (64.2%) in the low risk group (P=0.002). Among 20 items, the average score on knowledge was $13.9{\pm}1.9$ in the high risk group and $14.1{\pm}1.8$ in the low risk group with no statistical difference between these two groups (P=0.191). Two items showed statistical significance in the low risk group compared with the high risk group; these were the item of AIDS being transmitted through transfusion (P=0.014) and through mosquitoes (P=0.009). As for attitude, statistical significance was present in the item stating that AIDS patients should be isolated in the high risk group compared with the low risk group (P=0.029). Conclusions : The present study showed that both the high risk group and low risk group obtained knowledge on AIDS through TV. No statistical difference was present between the two groups other than the high risk group showed statistically high results in two items on knowledge and one item on attitude. Thus, these results showed that exposure to AIDS can be lowered with better knowledge and the attitude of those with a low risk of infection was more positive.