Evidence map›Paper›PMID 38317446›Full record

ArticleJournal of Korean medical science2024

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 and 2 more

Abstract read
In one paragraph

Article in Journal of Korean medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Eliel NhamDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-7509-4863
Jin Gu YoonDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-3283-1880
Min Joo ChoiDepartment of Internal Medicine, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, Korea.ORCID https://orcid.org/0000-0002-2739-0948
Yu Bin SeoDivision of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-5183-1996
Jacob LeeDivision of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7041-065X
Won Suk ChoiDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-5874-4764
Hakjun HyunDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-1193-8948
Hye SeongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-5633-7214
Ji Yun NohDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-8541-5704
Joon Young SongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-0148-7194
Woo Joo KimDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-4546-3880
Hee Jin CheongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-2532-1463

Funding

Ministry of Food and Drug Safety 22183MFDS435
6 · The paper itself

Abstract

backgroundIn 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.

methodsFrequently 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.

resultsFour 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.

conclusionWe 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.

Indexed as

Herpes Zoster VaccineTetanusAdultHumansImmunization ProgramsPneumococcal VaccinesRepublic of KoreaVaccinationVaccines, SyntheticHerpes Zoster VaccinePneumococcal VaccinesVaccines, SyntheticMonitoringNon-NIPSafetySurveillanceVaccines

Identifiers

PMID38317446
PMCPMC10843970

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.