Side Effect Profile of Meningococcal B Vaccine in Children

Öz

Objective: Invasive meningococcal infections have a clinical picture with a rapid onset and can lead to serious sequelae and death even in individuals who are treated early. The most common causes of related epidemics are serogroups A, B, C, W, Y, and X, and two different vaccines have been developed against serogroups A, C, W, and Y and serogroup B. The serogroup B-containing MenB-4C vaccine (Bexsero®) was licensed in Turkey in 2018 and is still being administered. In this study, the side effects of this vaccine in infants and children followed up in a tertiary pediatric clinic were questioned. Materials and Methods: In our study, the local and systemic side effects of the MenB-4C vaccine doses, which were administered between March 1, 2019, and March 1, 2022, at the Child Health Follow-up Outpatient Clinic of Gazi University Faculty of Medicine, were evaluated retrospectively. All infants and children aged 0-18 years who were vaccinated at this clinic on the specified dates (n = 102) were recruited, and a questionnaire was completed by calling their parents by telephone and questioning the side effects of the vaccine. Results: It was determined that a total of 224 doses of the MenB-4C vaccine were administered to 102 children over the three-year study period, Of these vaccines, 21.6% were administered during the year before the pandemic and 78.4% during the two years after the pandemic. According to the total number of doses, the rate of local and systemic side effects was 30.8% (n= 69). It was found that among the 69 doses with side effects, 42 (60.8%) were systemic (fever), and 27 (39.1%) were local (stiffness, redness, and pain at the injection site). Side effects were observed in 41.3% of the patients after the first dose of the vaccine, 23.3% after the second dose, and 25.9% after the third dose. Conclusion: In our study, no serious post-vaccine reactions, such as anaphylaxis and encephalopathy, were observed following vaccination with MenB-4C, and the most common side effects of this vaccine were fever and local pain, which were only transient and self-limiting, lasting only two to three days at most. Since the MenB-4C vaccine, which has been included in the vaccination schedule of most countries, is a strong tool to help prevent meningococcal infections, every parent presenting to a health institution should be informed by the physician about the necessity of this vaccine, and if possible, conjugated meningococcal vaccines containing not only serogroups A, C, W, and Y but also serogroup B should be added to the national vaccine scheme.

Anahtar Kelimeler

• Childhood
• vaccination
• meningococcal type B conjugate vaccine

Çocuklarda Meningokok B Aşısının Yan Etki Profili

Öz

AMAÇ: İnvazif meningokok enfeksiyonları hızlı başlangıçlı bir klinik tabloya sahiptir ve erken tedavi edilen kişilerde dahi ciddi sekellere ve ölüme yol açabilmektedir. İlgili salgınların en yaygın nedenleri serogrup A, B, C, W, Y ve X olup, serogrup A, C, W ve Y ile serogrup B'ye karşı iki farklı aşı geliştirilmiştir. Serogrup B içeren MenB-4C aşısı (Bexsero®) Türkiye'de 2018 yılında ruhsatlandırılmış olup halen uygulanmaktadır. Bu çalışmada üçüncü basamak pediatri kliniğinde takip edilen bebek ve çocuklarda bu aşının yan etkileri sorgulandı. GEREÇ VE YÖNTEM: Çalışmamızda Gazi Üniversitesi Tıp Fakültesi Çocuk Sağlığı Takip Polikliniği'nde 1 Mart 2019 ile 1 Mart 2022 tarihleri arasında uygulanan MenB-4C aşı dozlarının lokal ve sistemik yan etkileri geriye dönük olarak araştırıldı. Belirlenen tarihlerde (n=102) bu klinikte aşı olan 0-18 yaş arası tüm bebek ve çocuklar çalışmaya dahil edildi ve ebeveynleri telefonla aranarak aşının yan etkileri sorgulanarak anket dolduruldu. BULGULAR: Üç yıllık çalışma süresi boyunca 102 çocuğa toplam 224 doz MenB-4C aşısı uygulandığı belirlendi. Bu aşıların %21,6'sının pandemiden önceki yıl, %78,4'ünün ise pandemi sonrası iki yıl içinde uygulandığı belirlendi. salgın. Toplam doz sayısına göre lokal ve sistemik yan etki oranı %30,8 (n= 69) idi. Yan etki görülen 69 dozun 42'sinin (%60,8) sistemik (ateş), 27'sinin (%39,1) ise lokal (enjeksiyon yerinde sertlik, kızarıklık, ağrı) olduğu belirlendi. Aşının ilk dozundan sonra hastaların yüzde 41,3'ünde, ikinci dozundan sonra yüzde 23,3'ünde, üçüncü dozundan sonra ise yüzde 25,9'unda yan etki görüldü. TARTIŞMA: Çalışmamızda MenB-4C aşılaması sonrasında aşı sonrası anafilaksi, ensefalopati gibi ciddi bir reaksiyon gözlenmemiştir ve bu aşının en sık görülen yan etkileri geçici ve kendini sınırlayan, en fazla iki ila üç gün süren ateş ve lokal ağrı olmuştur. Çoğu ülkenin aşılama takviminde yer alan MenB-4C aşısı meningokok enfeksiyonlarını önlemeye yardımcı güçlü bir araç olduğundan, sağlık kuruluşuna başvuran her ebeveynin hekim tarafından bu aşının gerekliliği konusunda bilgilendirilmesi ve mümkünse sadece A, C, W ve Y serogruplarını değil serogrup B'yi de içeren konjuge meningokok aşıları ulusal aşı şemasına eklenmelidir.

Anahtar Kelimeler

• ÇOCUKLUK ÇAĞI
• AŞILAMA
• MENİNGOKOK B AŞISI

Kaynakça

1. 1. Ladhani SN, Campbell H, Parikh SR, Saliba V, Borrow R, Ramsay M. The introduction of the meningococcal B (MenB) vaccine (Bexsero®) into the national infant immunisation programme--New challenges for public health. J Infect. 2015;71(6):611-614. (611-14)
2. 2. Edmond K, Clark A, Korczak VS, Sanderson C, Griffiths UK, Rudan I. Global and regional risk of disabling sequelae from bacterial meningitis: a systematic review and meta-analysis. Lancet Infect Dis. 2010;10(5):317-28.
3. 3. Jafri RZ, Ali A, Messonnier NE, et al. Global epidemiology of invasive meningococcal disease. Popul Health Metr. 2013;11(1):17.
4. 4. Centers for Disease Control and Prevention. Meningococcal home. Meningococcal disease in other countries. (Accessed August 30, 2022, available at https://www.cdc.gov/meningococcal/global.html)
5. 5. Ceyhan M, Yildirim I, Balmer P, et al. A prospective study of etiology of childhood acute bacterial meningitis, Turkey. Emerg Infect Dis. 2008;14(7):1089-96.
6. 6. Meningitis caused by Neisseria Meningitidis, Hemophilus Influenzae Type B and Streptococcus Pneumoniae during 2005-2012 in Turkey. A multicenter prospective surveillance study [published correction appears in Hum Vaccin Immunother. 2021 Jul 3;17(7):2351]. Hum Vaccin Immunother. 2014;10(9):2706-12.
7. 7. Marshall HS, Koehler AP, Wang B, et al. Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia. Vaccine. 2020;38(37):5914-22.
8. 8. Manolya, K. and A. SOMER. Meningokok Aşıları. Çocuk Dergisi 19 (2): 51-9.

9. 9. Vesikari T, Esposito S, Prymula R, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials [published correction appears in Lancet. 2013 Mar 9;381(9869):804]. Lancet. 2013;381(9869):825-35.
10. 10. Santolaya ME, O'Ryan ML, Valenzuela MT, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study [published correction appears in Lancet. 2015 May 2;385(9979):1728]. Lancet. 2012;379(9816):617-24.
11. 11. U Özdemir, T Çelik, et al. Pediatristlerin meningokok enfeksiyonları ve aşıları ile ilgili bilgi düzeyleri ve tutumları. J Pediatr Inf 12 (2018): 58-64.
12. 12. Toneatto D, Pizza M, Masignani V, Rappuoli R. Emerging experience with meningococcal serogroup B protein vaccines. Expert Rev Vaccines. 2017;16(5):433-51.
13. 13. De Serres C, Gariépy M-C, Billard M-N, Rouleau I. Initial dose of amulticomponent serogroup B meningococcal vaccine in the Saguenay-Lac-Saint-Jean region, Québec, Canada: an interim safety surveillance report. 2014. https://www.inspq.qc.ca/pdf/publications/1902_SerogroupB_Meningococcal_Vaccine.pdf (accessed Dec 24, 2022).
14. 14. Varricchio F, Iskander J, Destefano F, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2004;23(4):287-294.
15. 15. McMahon AW, Iskander J, Haber P, et al. Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003. Pediatrics. 2005;115(2):453-60.
16. 16. Gossger N, Snape MD, Yu LM, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573-82.
17. 17. Parikh SR, Andrews NJ, Beebeejaun K, et al. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study. Lancet. 2016;388(10061):2775-82.
18. 18. Flacco ME, Manzoli L, Rosso A, et al. Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis [published correction appears in Lancet Infect Dis. 2018 Mar 22;]. Lancet Infect Dis. 2018;18(4):461-72.
19. 19. Bryan P, Seabroke S, Wong J, et al. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. Lancet Child Adolesc Health. 2018;2(6):395-403.
20. 20. Hall GC, Douglas I, Heath PT, et al. Postlicensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero) vaccination within the routine UK immunisation program. Vaccine. 2021;39(24):3296-330.
21. 21. N. Prymula R, Esposito S, Zuccotti GV, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I): effects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB. Hum Vaccin Immunother. 2014; 10:1993–2004.
22. 22. Insititut National de Sante Publique du Quebec. Rapport final de surveillance de la Securite de la vaccination des jeunes de 20 ANS et Moins Contre Le Meningococque de Serogroupe B Au Saguenay-Lac-Saint-Jean, 2016.
23. 23. E Dubé, D Gagnon, M Ouakki, et al. Meningococcal B vaccine acceptability: Results of a longitudinal study in Quebec (Canada). Vaccine Reports, 2016, 6: 29-35.
24. 24. Jackson C, Yarwood J, Saliba V, Bedford H. UK parents' attitudes towards meningococcal group B (MenB) vaccination: a qualitative analysis. BMJ Open. 2017;7(4):e012851.