J Korean Med Sci.  2024 Dec;39(46):e333. 10.3346/jkms.2024.39.e333.

Letter to the Editor: Clarification of Evidence and Consensus on Strengthening Pharmacovigilance for Vaccine Safety

Affiliations
  • 1Medical Affairs, SK bioscience Co. Ltd., Seongnam, Korea


Reference

1. Lee J. Varicella vaccine safety: absence of evidence is not evidence of absence. J Korean Med Sci. 2024; 39(35):e245. PMID: 39252685.
2. Kang HM, Kang KR, Kim YJ, Kang JH, Lee SY. A booster administration of the OKA/SK strain causes fatal disseminated varicella in an immunocompetent child. J Med Virol. 2023; 95(9):e29108. PMID: 37715715.
3. Korea Disease Control and Prevention Agency, Ministry of Health and Welfare. Announcement of joint public-private investigation results on the safety of varicella vaccine. Updated 2024. Accessed September 19, 2024. https://www.kdca.go.kr/board/board.es?mid=a20501010000&bid=0015&list_no=725423&cg_code=&act=view&nPage=1&newsField= .
4. Park SB, Lee SJ, Kim HY. A booster administration of the OKA/SK strain causes fatal disseminated varicella in an immunocompetent child. J Med Virol. 2024; 96(7):e29786. PMID: 39011792.
5. Ansari R, Rosen LB, Lisco A, Gilden D, Holland SM, Zerbe CS, et al. Primary and acquired immunodeficiencies associated with severe varicella-zoster virus infections. Clin Infect Dis. 2021; 73(9):e2705–e2712. PMID: 32856043.
6. Leung J, Siegel S, Jones JF, Schulte C, Blog D, Schmid DS, et al. Fatal varicella due to the vaccine-strain varicella-zoster virus. Hum Vaccin Immunother. 2014; 10(1):146–149. PMID: 23982221.
7. Woodward M, Marko A, Galea S, Eagel B, Straus W. Varicella virus vaccine live: a 22-year review of postmarketing safety data. Open Forum Infect Dis. 2019; 6(8):ofz295. PMID: 31392326.
8. Moro PL, Leung J, Marquez P, Kim Y, Wei S, Su JR, et al. Safety surveillance of varicella vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. J Infect Dis. 2022; 226(Suppl 4):S431–S440. PMID: 36265846.
9. Chaves SS, Haber P, Walton K, Wise RP, Izurieta HS, Schmid DS, et al. Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005. J Infect Dis. 2008; 197(Suppl 2):S170–S177. PMID: 18419393.
10. Choi UY, Kim KH, Cho HK, Kim DH, Ma SH, Choi YY, et al. Immunogenicity and safety of a newly developed live attenuated varicella vaccine in healthy children: a multi-national, randomized, double-blinded, active-controlled, phase 3 study. Vaccines (Basel). 2023; 11(9):1416. PMID: 37766093.
11. Ministry of Food and Drug Safety. Drug Safety. Accessed September 19, 2024. https://nedrug.mfds.go.kr/index .
12. Lee J. Concerns on a new varicella vaccine introduced in Korea. J Med Virol. 2024; 96(11):e70069. PMID: 39545346.
13. Council for International Organizations of Medical Science. Current challenges in pharmacovigilance: pragmatic approaches – report of CIOMS Working Group V. Council for International Organizations of Medical Science;2001.
14. Medical Dictionary for Regulatory Activities. MedDRA® term selection: points to consider. Updated 2024. Accessed October 29, 2024. https://admin.new.meddra.org/sites/default/files/guidance/file/001006_termselptc_r4_24_mar2024.pdf .
15. Korea Expert Committee on Immunization Practices. The meeting minutes of the 3rd meeting, 2024. Updated 2024. Accessed October 30, 2024. https://nip.kdca.go.kr/irhp/infm/goVcntInfo.do?menuLv=1&menuCd=1414 .
16. Moon JY, Seo J, Lee J, Park D. Assessment of attenuation of varicella-zoster virus vaccines based on genomic comparison. J Med Virol. 2023; 95(3):e28590. PMID: 36807919.
17. News1. Controversy over a fatal case in 6-year-old child receiving varicella vaccine…the Korea Disease Control and Prevention Agency said “a causal association is unlikely”. Updated 2024. Accessed October 30, 2024. https://www.news1.kr/bio/general/5444789 .
18. Council for International Organizations of Medical Sciences. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. Council for International Organizations of Medical Sciences;2010.
20. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module V – risk management systems (Rev. 2). Updated 2024. Accessed October 30, 2024. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf .
21. SK bioscience. The summary of the risk management plan. Updated 2024. Accessed October 30, 2024. https://nedrug.mfds.go.kr/pbp/CCBBB01/getRmpInfo?itemSeq=201802323 .
22. European Commission. A guideline on summary of product characteristics (SmPC). Updated 2009. Accessed October 30, 2024. https://health.ec.europa.eu/document/download/6a043dea-7d0f-4252-947b-cef58f53d37e_en .
23. Council for International Organizations of Medical Sciences. Guidelines for preparing core clinical-safety information on drugs, second edition, report of CIOMS working groups III and V. Council for International Organizations of Medical Sciences;1999.
Full Text Links
  • JKMS
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2025 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr