Study of Adverse Events following BCG Immunization in Vaccinated Infants in 4 Hospitals, Thailand, 2007 - 2012
Keywords:
BCG vaccine, lymphadenitis, passive surveillance system, vaccine safety monitoringAbstract
Bacillus Calmette–Guérin (BCG) vaccination is an important strategy to prevent Mycobacterium tuberculosis infection in infants and young children worldwide with high efficacy and safety, however, it may cause some adverse events after vaccination. In May 2012, Bureau of Epidemiology was notified an increasing number of BCG lymphadenitis cases had been treated in a hospital in Bangkok since 2010. The Bureau of Epidemiology conducted a study of BCG lymphadenitis in vaccinated infants in 4 hospitals by reviewing outpatient and in-patient charts according to ICD-10-TM during 2007 - 2012. Data analysis on adverse events after BCG vaccination in passive surveillance system was also performed to gain relevant data which would be proposed to authorities in responding to BCG vaccination safety and surveillance. The study and analysis showed the number of BCG lymphadenitis in 4 hospitals was 20 times higher than the number of those reported in passive surveillance system. The occurrence rate of BCG lymphadenitis in a reviewed hospital was higher than the expected rate. Passive surveillance system could not detect abnormality in BCG vaccination. Therefore, passive surveillance system should be strengthen, authorities in vaccine administration and vaccine safety monitoring should review or study for finding causes or factors which impact to adverse events after BCG vaccination especially in BCG lymphadenitis to determine the effective measure and strongly resolve the problem.
References
World Health Organization. Tuberculosis [internet]. 2013 [cited 2013 December 15]. Available from: http://www.who.int/mediacentre/factsheets/fs104/en/
Center for Disease Control. Tuberculosis (TB) [internet]. 2013 [cited 2013 December 15]. Available from: http://www.cdc.gov/tb/
สำนักวัณโรค กรมควบคุมโรค. แนวทางการดำเนินงานควบคุมวัณโรคแห่งชาติ ปี พ.ศ. 2556. พิมพ์ครั้งที่ 2. กรุงเทพมหานคร: สำนักงานกิจการโรงพิมพ์องค์การสงเคราะห์ทหารผ่านศึกในพระบรมราชูปถัมภ์; 2556. หน้า 16-7.
World Health Organization. Tuberculosis [internet]. 2013 [cited 2013 December 15]. Available from: http://www.who.int/immunization/diseases/tuberculosis/en/
พิรังกูร เกิดพานิช. วัคซีนป้องกันวัณโรค. ใน: โอฬาร พรหมาลิขิต, อัจฉรา ตั้งสถาพรพงษ์ และอุษา ทิสยากร, บรรณาธิการ. วัคซีน. พิมพ์ครั้งที่ 1. กรุงเทพมหานคร: บริษัท นพชัยการพิมพ์ จำกัด; 2554. หน้า 295-316.
สถานเสาวภา สภากาชาด. วัคซีนบีซีจี [อินเทอร์เน็ต]. [สืบค้นวันที่ 17 พฤศจิกายน 2556]. เข้าถึงได้จาก http://www.saovabha.com/th/product_vaccine.asp?nTopic=1
Jamison D, Breman J, Measham A, Alleyne G, Claeson M, Evans D, et al. The World Bank Group. Disease Control Priorities in Developing Countries, Second Edition. 2006.
World Health Organization. Information Sheet Observed Rate of Adverse Reactions Bacille Calmette-Guerin (BCG) vaccine [internet]. 2013 [cite 2013 December 15]. Available from: http://www.who.int/vaccine_safety/initiative/tools/BCG_Vaccine_rates_information_sheet.pdf?ua=1
สำนักโรคติดต่อทั่วไป กรมควบคุมโรค. ตำราวัคชีนและการสร้าง เสริมภูมิคุ้มกันโรค ปี 2556. พิมพ์ครั้งที่ 1. กรุงเทพฯ: โรงพิมพ์ มหาวิทยาลัยราชภัฏสวนสุนันทา; 2556. หน้า 14-6.
Lotte A, Wasz-Hockert, Poisson N, et al. Second IUATLD study on complications induced by intradermal BCG - vaccination. Bulletin of the International Union against Tuberculosis and Lung Diseases 1988;63:47–59.
Milstien JB, Gibson JJ. Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety. Bulletin of the World Health Organization 1990;68:93–108.
World Health Organization. Supplementary Information on Vaccine Safety: Part 2: Background Rates of Adverse Events Following Immunization. Geneva: 2000.
World Health Organization. Immunization safety surveillance: Guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. Manila: Regional Office for the Western Pacific; 1999. p 9-11.
Lotte A, Wasz-Hockert O, Poisson N, Dumitrescu N, Verron M, Couvet E. BCG Complications: estimates of risks among vaccinated subjects and statistical analysis of their main characteristics. Advance Tuberculosis Research 1984;21:107-93.
Ahmad F, Abu Zeid, Muna M Dahabreh. Bacille Calmette-Guerin Lymphadenitis: A single Center Experience. Journal of the Royal Medical Services 2010;4:64-7.
Mostafa B, Jamshid A. Post BCG Lymphadenitis in Vaccinated Infants in Yazd, Iran. Iran Journal Pediatric 2008;18:351-6.
De Souza GR, Sant’Anna CC, Lapa e Silva, Mano DB, Bethiem NM. Intradermal BCG Vaccination complication analysis of 51 cases. Tubercle 1983; 64(1):23-7.
Goraya JS, Virdi VS, Bacilli calmette - Guerin lymphadenitis. Postgraduate Medical Journal London 2002;78:327-9.
Caglayan S, Yegin O, Kayran K, et al. Is medical therapy effective for regional lymphadenitis following BCG vaccination? American Journal Disease in Children 1987;141:1213–4
The Advisory Council for the Elimination of Tuberculosis and the Advisory Committee on Immunization Practices. The role of BCG vaccine in the prevention and control of tuberculosis in the United State. MMWR Recommendation Report 1996; 45:1-18.
Teo SS, Smeulders N, Shingadia D. BCG Vaccine associated Suppurative Lymphadenitis. Vaccine 2005; 23:2676-9.
National Center for Biotechnology Information. Adverse events following BCG vaccination [Internet]. 2013 [cited 2013 December 20]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15686221
Kemp EB, Belshe RB, Hoft DF. Immune response stimulated by percutaneous and intradermal Bacilli Calmette - Guerin. Journal of Infectious Disease 1996;174:113-9.
Dommergues MA, Rocque F de La, Guy C, Lecuyer A, Jacquet A, Guerin N, et al. Local and regional adverse reaction to BCG-SSI vaccination: A 12 months cohort follow up study. Vaccine 2009; 27:6967-73.
ฉันทพัทธ์ พฤกษะวัน. การศึกษาเชิงพรรณนาการเกิดอาการ ภายหลังการได้วัคซีน BCG ในผู้ป่วยที่มารับการรักษาใน โรงพยาบาลแห่งหนึ่ง ปี พ.ศ. 2555. (เอกสารอัดสําเนา)
World Health Organization. Surveillance of adverse events following immunization: Field Guide for managers of immunization programmes. Geneva; 1997.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2014 Weekly Epidemiological Surveillance Report
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Responsibility and Copyright
1. Author Responsibility and Editorial Disagreement
The content and data in all articles published in WESR are the direct opinions and responsibility of the article authors, and the Journal's Editorial Board is not necessarily in agreement with, or jointly responsible for, them.
2. Copyright and Referencing
All articles, data, content, figures, etc., published in WESR are considered the copyright of the academic journal. If any individual or entity wishes to disseminate all or any part of the published material, appropriate citation of the article is required.
