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Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea.
Nham, Eliel; Yoon, Jin Gu; Choi, Min Joo; Seo, Yu Bin; Lee, Jacob; Choi, Won Suk; Hyun, Hakjun; Seong, Hye; Noh, Ji Yun; Song, Joon Young; Kim, Woo Joo; Cheong, Hee Jin.
Afiliación
  • Nham E; Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
  • Yoon JG; Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea.
  • Choi MJ; Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
  • Seo YB; Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea.
  • Lee J; Department of Internal Medicine, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, Korea.
  • Choi WS; Division of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
  • Hyun H; Division of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
  • Seong H; Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
  • Noh JY; Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea.
  • Song JY; Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
  • Kim WJ; Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea.
  • Cheong HJ; Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
J Korean Med Sci ; 39(5): e45, 2024 Feb 05.
Article en En | MEDLINE | ID: mdl-38317446
ABSTRACT

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 non-NIP 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tétanos / Vacuna contra el Herpes Zóster Tipo de estudio: Guideline / Qualitative_research Límite: Adult / Humans País/Región como asunto: Asia Idioma: En Revista: J Korean Med Sci Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article Pais de publicación: Corea del Sur
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tétanos / Vacuna contra el Herpes Zóster Tipo de estudio: Guideline / Qualitative_research Límite: Adult / Humans País/Región como asunto: Asia Idioma: En Revista: J Korean Med Sci Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article Pais de publicación: Corea del Sur