1.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
2.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
3.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
4.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
5.Genotypic analysis of zoonotic Enterocytozoon bieneusi in wild deer in Korea
Gyeonguk NOH ; Haeseung LEE ; Seung-Hun LEE ; Min-Goo SEO ; Kyoo-Tae KIM ; Junho LEE ; Kaifa NAZIM ; Sang Joon PARK ; Man Hee RHEE ; Dongmi KWAK
Parasites, Hosts and Diseases 2024;62(4):484-489
Enterocytozoon bieneusi is an important microsporidian protozoa that causes intestinal disorders in humans. We collected 191 fecal samples from roadkill deer carcasses, among which 13 (6.8%) showed positive reaction for E. bieneusi by polymerase chain reaction assay. Phylogenetic analysis revealed 6 distinct genotypes, 1 of which was novel. All genotypes belonged to Group 1, which has low host specificity, indicating possible transmission through sylvatic cycle. E. bieneusi infection was predominant in female deer (p<0.05).
6.Genotypic analysis of zoonotic Enterocytozoon bieneusi in wild deer in Korea
Gyeonguk NOH ; Haeseung LEE ; Seung-Hun LEE ; Min-Goo SEO ; Kyoo-Tae KIM ; Junho LEE ; Kaifa NAZIM ; Sang Joon PARK ; Man Hee RHEE ; Dongmi KWAK
Parasites, Hosts and Diseases 2024;62(4):484-489
Enterocytozoon bieneusi is an important microsporidian protozoa that causes intestinal disorders in humans. We collected 191 fecal samples from roadkill deer carcasses, among which 13 (6.8%) showed positive reaction for E. bieneusi by polymerase chain reaction assay. Phylogenetic analysis revealed 6 distinct genotypes, 1 of which was novel. All genotypes belonged to Group 1, which has low host specificity, indicating possible transmission through sylvatic cycle. E. bieneusi infection was predominant in female deer (p<0.05).
7.Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea
Eliel NHAM ; Jin Gu YOON ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Won Suk CHOI ; Hakjun HYUN ; Hye SEONG ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Hee Jin CHEONG
Journal of Korean Medical Science 2024;39(5):e45-
Background:
In Korea, there are no surveillance programs for vaccines that are not included in the national immunization program (NIP), and vaccine safety monitoring in the adult population is inadequate. This study aimed to establish a safety monitoring system for nonNIP vaccines in adults.
Methods:
Frequently administered non-NIP vaccines were selected. Individuals were included if they received at least one of the selected vaccines at a participating institution and provided informed consent. Solicited and unsolicited adverse events were monitored using questionnaires sent through text messages on days 1, 3, 7, 28, and 90 post-vaccination.Selected adverse events of special interest (AESIs) were monitored monthly by retrospective review of electronic medical records. Causality was assessed according to the Korea Disease Control and Prevention Agency guidelines.
Results:
Four vaccines (tetanus-diphtheria-pertussis [Tdap], pneumococcal conjugate 13-valent [PCV13], live zoster vaccine [ZVL], and recombinant zoster vaccine [RZV]) were selected, and their safety profiles were monitored at four tertiary hospitals and 10 primary care clinics. The response rates of the questionnaires on post-vaccination days 1, 7, 28, and 90 were 99.2%, 93.6%, 81.0%, and 48.7%, respectively. Of 555 AESI identified over 10 months, 10 cases received one of the selected non-NIP vaccines within 90 days of the event.
Conclusion
We are establishing the first safety monitoring system for selected non-NIP vaccines in Korea since September 2022 and report its progress as of July 2023. However, continuous government support is essential for its maintenance and improvement.
8.Genotypic analysis of zoonotic Enterocytozoon bieneusi in wild deer in Korea
Gyeonguk NOH ; Haeseung LEE ; Seung-Hun LEE ; Min-Goo SEO ; Kyoo-Tae KIM ; Junho LEE ; Kaifa NAZIM ; Sang Joon PARK ; Man Hee RHEE ; Dongmi KWAK
Parasites, Hosts and Diseases 2024;62(4):484-489
Enterocytozoon bieneusi is an important microsporidian protozoa that causes intestinal disorders in humans. We collected 191 fecal samples from roadkill deer carcasses, among which 13 (6.8%) showed positive reaction for E. bieneusi by polymerase chain reaction assay. Phylogenetic analysis revealed 6 distinct genotypes, 1 of which was novel. All genotypes belonged to Group 1, which has low host specificity, indicating possible transmission through sylvatic cycle. E. bieneusi infection was predominant in female deer (p<0.05).
9.Genotypic analysis of zoonotic Enterocytozoon bieneusi in wild deer in Korea
Gyeonguk NOH ; Haeseung LEE ; Seung-Hun LEE ; Min-Goo SEO ; Kyoo-Tae KIM ; Junho LEE ; Kaifa NAZIM ; Sang Joon PARK ; Man Hee RHEE ; Dongmi KWAK
Parasites, Hosts and Diseases 2024;62(4):484-489
Enterocytozoon bieneusi is an important microsporidian protozoa that causes intestinal disorders in humans. We collected 191 fecal samples from roadkill deer carcasses, among which 13 (6.8%) showed positive reaction for E. bieneusi by polymerase chain reaction assay. Phylogenetic analysis revealed 6 distinct genotypes, 1 of which was novel. All genotypes belonged to Group 1, which has low host specificity, indicating possible transmission through sylvatic cycle. E. bieneusi infection was predominant in female deer (p<0.05).
10.Genotypic analysis of zoonotic Enterocytozoon bieneusi in wild deer in Korea
Gyeonguk NOH ; Haeseung LEE ; Seung-Hun LEE ; Min-Goo SEO ; Kyoo-Tae KIM ; Junho LEE ; Kaifa NAZIM ; Sang Joon PARK ; Man Hee RHEE ; Dongmi KWAK
Parasites, Hosts and Diseases 2024;62(4):484-489
Enterocytozoon bieneusi is an important microsporidian protozoa that causes intestinal disorders in humans. We collected 191 fecal samples from roadkill deer carcasses, among which 13 (6.8%) showed positive reaction for E. bieneusi by polymerase chain reaction assay. Phylogenetic analysis revealed 6 distinct genotypes, 1 of which was novel. All genotypes belonged to Group 1, which has low host specificity, indicating possible transmission through sylvatic cycle. E. bieneusi infection was predominant in female deer (p<0.05).

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