Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea

被引：0

作者：

Nham, Eliel ^{[1
,2
]}

Yoon, Jin Gu ^{[1
,2
]}

Choi, Min Joo ^{[3
]}

Bin Seo, Yu ^{[4
]}

Lee, Jacob ^{[4
]}

Choi, Won Suk ^{[1
,2
]}

Hyun, Hakjun ^{[1
,2
]}

Seong, Hye ^{[1
,2
]}

Noh, Ji Yun ^{[1
,2
]}

Song, Joon Young ^{[1
,2
]}

Kim, Woo Joo ^{[1
,2
]}

Cheong, Hee Jin ^{[1
,2
,5
,6
]}

机构：

[1] Korea Univ, Coll Med, Dept Internal Med, Div Infect Dis, Seoul, South Korea

[2] Vaccine Innovat Ctr KU Med VIC K, Seoul, South Korea

[3] Catholic Kwandong Univ, Int St Marys Hosp, Coll Med, Dept Internal Med, Incheon, South Korea

[4] Hallym Univ, Kangnam Sacred Heart Hosp, Dept Internal Med, Div Infect Dis,Coll Med, Seoul, South Korea

[5] Korea Univ, Korea Univ Guro Hosp, Dept Internal Med, Div Infect Dis,Coll Med, 148 Gurodong Ro, Seoul 08308, South Korea

[6] Ajou Univ, Sch Med, Dept Internal Med, Div Infect Dis, Suwon, South Korea

来源：

JOURNAL OF KOREAN MEDICAL SCIENCE | 2024年 / 39卷 / 05期

关键词：

Vaccines; Safety; Monitoring; Surveillance; Non-NIP; HERPES-ZOSTER VACCINE; DIPHTHERIA; TETANUS; SURVEILLANCE; LICENSURE;

D O I：

10.3346/jkms.2024.39.e45

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：7