Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea
© 2024 The Korean Academy of Medical Sciences..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:39 |
|---|---|
| Enthalten in: |
Journal of Korean medical science - 39(2024), 5 vom: 05. Feb., Seite e45 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Nham, Eliel [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Herpes Zoster Vaccine |
|---|
| Anmerkungen: |
Date Completed 07.02.2024 Date Revised 10.02.2024 published: Electronic Citation Status MEDLINE |
|---|
| doi: |
10.3346/jkms.2024.39.e45 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM368067033 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM368067033 | ||
| 003 | DE-627 | ||
| 005 | 20240210233232.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240206s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3346/jkms.2024.39.e45 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1287.xml |
| 035 | |a (DE-627)NLM368067033 | ||
| 035 | |a (NLM)38317446 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Nham, Eliel |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 07.02.2024 | ||
| 500 | |a Date Revised 10.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024 The Korean Academy of Medical Sciences. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Monitoring | |
| 650 | 4 | |a Non-NIP | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a Surveillance | |
| 650 | 4 | |a Vaccines | |
| 650 | 7 | |a Herpes Zoster Vaccine |2 NLM | |
| 650 | 7 | |a Pneumococcal Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Synthetic |2 NLM | |
| 700 | 1 | |a Yoon, Jin Gu |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Min Joo |e verfasserin |4 aut | |
| 700 | 1 | |a Seo, Yu Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Won Suk |e verfasserin |4 aut | |
| 700 | 1 | |a Hyun, Hakjun |e verfasserin |4 aut | |
| 700 | 1 | |a Seong, Hye |e verfasserin |4 aut | |
| 700 | 1 | |a Noh, Ji Yun |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Joon Young |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Woo Joo |e verfasserin |4 aut | |
| 700 | 1 | |a Cheong, Hee Jin |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of Korean medical science |d 1995 |g 39(2024), 5 vom: 05. Feb., Seite e45 |w (DE-627)NLM012649317 |x 1598-6357 |7 nnns |
| 773 | 1 | 8 | |g volume:39 |g year:2024 |g number:5 |g day:05 |g month:02 |g pages:e45 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3346/jkms.2024.39.e45 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 39 |j 2024 |e 5 |b 05 |c 02 |h e45 | ||