A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea.

BACKGROUND: Incidence of whooping cough is increasing in Korea. Since 2011, occurrence among adolescents and adults has risen putting vulnerable neonates at risk. National immunization guidelines now include Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination during pregnancy and as a cocooning strategy (i.e., vaccinating adults and adolescents in contact with neonates). This study assessed post-marketing Tdap (Boostrix®, GSK, Belgium) vaccine safety in subjects ≥ 10 years. METHODS: This open, non-comparative multi-center study was conducted over six years at 10 hospitals in Korea. Subjects received Tdap in normal clinical practice according to local prescribing information. All adverse events (AEs) were recorded, classified as expected or unexpected, and severity and relationship to Tdap were assessed. RESULTS: The analysis included 672 Korean subjects (mean age, 44 years; range, 11-81), 451 were women and 211 were pregnant. Ninety subjects experienced 124 AEs (incidence 13.39%) of which six were serious AEs (SAEs) assessed as not related to vaccination, and 51 were non-SAEs related to vaccination (mostly administration site reactions). Overall 65/124 AEs were unexpected; the most common were 14 constipation, 5 dyspepsia, 4 common cold and 4 premature labor cases. One case of common cold was assessed as possibly related to vaccination. Pregnancy outcome was 'live infant, no apparent congenital anomaly' in 195 subjects (92.42%) or 'lost to follow-up' in 16 subjects. CONCLUSION: Tdap administration to Korean subjects ≥ 10 years, including pregnant women, for the prevention of diphtheria, tetanus and pertussis was shown to have a well-tolerated safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01929291.

Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea.

PURPOSE: To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea. METHODS: A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542). RESULTS: Injection-site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4-11.6]); the local pain was transient and lasted 4-7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7-1.4]) and 16 subjects (0.7% [95%CI: 0.3-0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1-0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period. CONCLUSIONS: This is the first post-marketing surveillance study in Korea that provides 6-year safety data for HPV-16/18 AS04-adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10-25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

Computed tomography for the preoperative diagnosis of pelvic actinomycosis.

AIMS: The aim of this study was to review the clinical manifestations of pelvic actinomycosis in order to aid clinicians in its diagnosis and treatment. METHODS: We retrospectively reviewed the histopathology and clinical records of all cases confirmed by surgery as pelvic actinomycosis from 1996 to 2006. RESULTS: A total of 16 cases of pelvic actinomycosis were selected and evaluated. The median age was 51 years (range, 36-66 years). All patients experienced childbirth, and had risk factors including use of an intrauterine device (93.8%) or pessary (6.2%), and/or a history of dilatation and curettage (68.8%), or previous abdominal surgery (31.3%). Nine patients (56.3%) were correctly diagnosed before surgery with computed tomography. Other common preoperative diagnoses were intra-abdominal malignancy (18.8%) and tubo-ovarian abscess (25%). The most common initial laboratory abnormalities were anemia (68.8%) and leukocytosis (62.5%). In six patients (37.5%), the preoperative values of carbohydrate antigen-125 were elevated. All patients were cured by surgery and no recurrence or mortality was noted. CONCLUSIONS: The correct initial diagnosis of pelvic actinomycosis is important for decreasing treatment-related morbidity. Imaging studies, especially computed tomography, might have assisted the diagnoses of actinomycosis.

Operating a National Hotline in Korea During the COVID-19 Pandemic.

The importance of effective communication cannot be overestimated during a pandemic. The Korea Disease Control and Prevention Agency national 1339 hotline has been in operation since the Middle East respiratory syndrome coronavirus outbreak in 2016. The hotline is open 24 hours a day, 7 days a week, 365 days a year, and provides accurate, reliable information based upon the Korea Disease Control and Prevention Agency guidelines in response to queries. During the coronavirus disease 2019 (COVID-19) pandemic, the 1339 hotline received callers' questions about symptoms and the implications of their actions regarding the epidemic. Through the 1339 hotline, callers received the up-to-date information that enabled them to protect themselves as well as others from COVID-19. This public service may have influenced on reduced risk of virus transmission in Korea.

COVID-19 in Nursing Facilities: Experience in Republic of Korea.

OBJECTIVES: Coronavirus disease 2019 (COVID-19) outbreaks in nursing facilities can easily lead to a high rate of infection and fatality. A surge in newly infected cases in the first quarter of 2020 in Gyeongsan-si, in the Republic of Korea, was followed by several outbreaks in nursing facilities in the same area. The aim of this study is to report on the epidemiological investigation and the management to reduce the infection rate in nursing facilities for older adults. METHODS: The municipal government and the Korea Centers for Disease Control and Prevention performed an epidemiological investigation into 5 nursing facilities that reported a high number of COVID-19 infection cases from February to May 2020. COVID-19 infected cases in the facilities were investigated to identify the infection routes, and the fatality rate of the 5 facilities. RESULTS: The 5 facilities had a combined fatality rate of 12.2% (9 deceased among the 74 infected cases). The median age of the deceased was 87 years old (range: 82-91). The infection was first identified on February 27th, 2020, peaked on March 6th, and was last detected on March 24th, 2020. CONCLUSION: Difficulties specific to such facilities included the delay in the recognition of symptoms and limitation in distancing. Tailored strategies such as daily monitoring of symptoms and proactive COVID-19 screening of quarantined residents, contributed to a decline in the infections in the facilities.

Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children.

Infanrix-IPV (GSK, Belgium) is a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combination vaccine (DTaP-IPV) licensed in many countries including Korea. In accordance with Korean regulations, we conducted a post-marketing surveillance (PMS) to evaluate the safety of DTaP-IPV administered to Korean children in routine immunization schedules. Children aged <7 years receiving at least one dose of DTaP-IPV either as part of a primary (3-dose) vaccination series or as a subsequent booster were enrolled. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose during the 30-day post-vaccination follow-up period. Among a total of 639 children, 289 subjects (45.2%) experienced AEs, mostly (79.2%) assessed as being unlikely to be related to the vaccination. ADRs were reported in 13.0% of subjects. Fever was the most commonly reported expected AE (11.9% of subjects) and also the most commonly reported expected ADR (8.5% of subjects). No obvious association between AE incidence and vaccine dose sequence was apparent. An unexpected AE was seen in 32.9% of children, and unexpected ADRs were far less common (1.9%). Thirty-four SAEs were recorded in 26 subjects (4.1%), in two of whom a causal association with the vaccine could not be excluded, although both resolved quickly. Data from this PMS indicate that DTaP-IPV has an acceptable safety profile when given to Korean children in accordance with local prescribing recommendations in routine childhood immunization. ClinicalTrials.gov identifier: NCT01568060.

Post-cerclage ultrasonographic cervical length can predict preterm delivery in elective cervical cerclage patients.

OBJECTIVE: To evaluate the usefulness of transvaginal ultrasound measurements of cervical length before and after elective prophylactic cervical cerclage in predicting preterm delivery before 32 weeks of gestation. METHODS: Women who underwent an elective cerclage operation at 14 to 19 weeks of gestation and who delivered between January 2004 and December 2009 were enrolled in this study (n=52). Ultrasonography was performed to measure cervical length before and after cerclage. The primary outcome was defined as preterm delivery before 32 weeks of gestation. A receiver operating characteristic curve was used to determine the most discriminating cut-off values of ultrasonographic cervical parameters predictive of preterm delivery before 32 weeks of gestation. RESULTS: Among the 52 patients studied, ten delivered before 32 weeks of gestation. Among the ultrasonographic cervical parameters compared, only the cervical length after cerclage was significantly different (shorter) in patients who delivered before 32 weeks of gestation (P=0.037) compared to that of those who delivered after 32 weeks of gestation in univariate and multivariate analyses (odds ratio, 0.402; 95% confidence interval, 0.174 to 0.925; P=0.021). The receiver operating characteristic curve showed that a cervical length of 25 mm or less after cerclage was predictive of preterm delivery before 32 weeks of gestation (area under curve, 0.71; 95% confidence interval, 0.56 to 0.87; P=0.029) with a sensitivity of 91.0% and a specificity of 30.0%. CONCLUSION: Patients with a cervical length less than 25 mm after elective cerclage may be at higher risk of preterm delivery before 32 weeks of gestation.