Postmarketing surveillance of adverse events following meningococcal B vaccination: data from Apulia Region, 2014–19

References

• Gianchecchi E, Torelli A, Piccini G, Piccirella S, Montomoli E. Neisseria meningitidis infection: who, when and where? Expert Rev Anti Infect Ther. 2015;13(10):1249–63. PMID: 26190347. doi:10.1586/14787210.2015.1070096.
   PubMed Web of Science ®Google Scholar
• Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet. 2007;369(9580):2196–210. PMID: 17604802. doi:10.1016/S0140-6736(07)61016-2.
   PubMed Web of Science ®Google Scholar
• Gianchecchi E, Piccini G, Torelli A, Rappuoli R, Montomoli E. An unwanted guest: neisseria meningitidis – carriage, risk for invasive disease and the impact of vaccination with insight on Italy incidence. Expert Rev Anti Infect Ther. 2017;15(7):689–701. PMID: 28524748. doi:10.1080/14787210.2017.1333422.
   PubMed Web of Science ®Google Scholar
• Bosis S, Mayer A, Esposito S. Meningococcal disease in childhood: epidemiology, clinical features and prevention. J Prev Med Hyg. 2015;56(3):E121–4. PMID: 26788732.
   PubMedGoogle Scholar
• Caugant DA, Maiden MCJ. Meningococcal carriage and disease–population biology and evolution. Vaccine. 2009;27(Suppl 2):B64–70. PMID: 19464092. doi:10.1016/j.vaccine.2009.04.061.
   PubMed Web of Science ®Google Scholar
• Dwilow R, Fanella S. Invasive meningococcal disease in the 21st century-an update for the clinician. Curr Neurol Neurosci Rep. 2015;15(3):2. PMID: 25637287. doi:10.1007/s11910-015-0524-6.
   PubMed Web of Science ®Google Scholar
• Bories S, Slaterus KW, Faucon R, Audiffren P, Vandederdove M. Peut-on individualiser deux nouveaux groupes serologiques de Neisseria meningitidis? Med Trop. 1966;26:603–16.
   Google Scholar
• Evans JR, Artenstein MS, Hunter DH. Prevalence of meningococcal serogroups and description of three new groups. Am J Epidemiol. 1968;87:643–46. PMID: 4968345. doi:10.1093/oxfordjournals.aje.a120854.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Meningococcal meningitidis - Key Facts. February 2018. [Accessed 2021 January 23]. https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis .
   Google Scholar
• Borrow R, Alarcón P, Carlos J, Caugant DA, Christensen H, Debbag R, De Wals P, Echániz-Aviles G, Findlow J, Head C, et al. The global meningococcal initiative: global epidemiology, the impact of vaccines on meningococcal disease and the importance of herd protection. Expert Rev Vaccines. 2017;16(4):313–28. PMID: 27820969. doi:10.1080/14760584.2017.1258308.
   PubMed Web of Science ®Google Scholar
• Halperin SA, Bettinger JA, Greenwood B, Harrison LH, Jelfs J, Ladhani SN, McIntyre P, Ramsay ME, Sáfadi MA. The changing and dynamic epidemiology of meningococcal disease. Vaccine. 2012;30(Suppl 2):B26–36. PMID: 22178525. doi:10.1016/j.vaccine.2011.12.032.
   PubMed Web of Science ®Google Scholar
• Lewis R, Nathan N, Diarra L, Belanger F, Paquet C. Timely detection of meningococcal meningitis epidemics in Africa. The Lancet. 2001;358(9278):287–93. PMID: 11498215. doi:10.1016/S0140-6736(01)05484-8.
   PubMed Web of Science ®Google Scholar
• Balmer P, Burman C, Serra L, York L. Impact of meningococcal vaccination on carriage and disease transmission: a review of the literature. Human Vaccines & Immunotherapeutics. 2018;14(5):1118–30. PMID: 29565712. doi:10.1080/21645515.2018.1454570.
   PubMed Web of Science ®Google Scholar
• ECDC. Surveillance Report - Invasive meningococcal disease - Annual epidemiological report for 2017. [accessed 2021 Jan 27]. https://ecdc.europa.eu/sites/portal/files/documents/AER_for_2017-invasive-meningococcal-disease.pdf .
   Google Scholar
• Grodet C, Dequin PF, Watt S, Lanotte P, de Gialluly C, Taha MK, Alonso JM, Quentin R, Goudeau A, Mereghetti L. Outbreak in France of Neisseria meningitidis B:15: P1.12belonging to sequence type 1403. Clin Microbiol Infect. 2004;10(9):845–48. PMID: 15355418. doi:10.1111/j.1469-0691.2004.00935.x.
   PubMed Web of Science ®Google Scholar
• Caron F, du Châtelet I, Leroy J, Ruckly C, Blanchard M, Bohic N, Massy N, Morer I, Floret D, Delbos V, et al. From tailor-made to ready-to-wear meningococcal B vaccines: longitudinal study of a clonal meningococcal B outbreak. Lancet Infect Dis. 2011;11(6):455–63. PMID: 21489881. doi:10.1016/S1473-3099(11)70027-5.
   PubMed Web of Science ®Google Scholar
• Folaranmi T, Rubin L, Martin SW, Patel M, MacNeil JR. Use of serogroup B meningococcal vaccines in persons aged ≥10 years at increased risk for serogroup B meningococcal disease: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(22):608–12. PMID: 26068564.
   PubMed Web of Science ®Google Scholar
• Atkinson B, Gandhi A, Balmer P. History of meningococcal outbreaks in the United States: implications for vaccination and disease prevention. Pharmacotherapy. 2016;36(8):880–92. PMID: 27332671. doi:10.1002/phar.1790.
   PubMed Web of Science ®Google Scholar
• Granoff DM. Review of meningococcal group B vaccines. Clin Infect Dis. 2010;50((s2)Suppl 2):S54–65. PMID: 20144017. doi:10.1086/648966.
   PubMed Web of Science ®Google Scholar
• Harrison LH. Vaccines for prevention of group B meningococcal disease: not your father’s vaccines. Vaccine. 2015;33(Suppl.4):D32–8. doi:10.1016/j.vaccine.2015.05.101.
   PubMed Web of Science ®Google Scholar
• European Medicine Agency (EMA). Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed]). [accessed 2021 Jan 26]. https://www.ema.europa.eu/en/documents/overview/bexsero-epar-summary-public_en.pdf .
   Google Scholar
• ECDC. Expert opinion on the introduction of the meningococcal B (4CMenB) vaccine in the EU/EEA. December 2017. [accessed 2021 Jan 31]. https://www.ecdc.europa.eu/sites/portal/files/documents/Introduction-of-4CMenB-vaccine.pdf .
   Google Scholar
• Martin NG, Snape MD. A multicomponent serogroup B meningococcal vaccine is licensed for use in Europe: what do we know, and what are we yet to learn? Expert Rev Vaccines. 2013;12(8):837–58. PMID: 23984957. doi:10.1586/14760584.2013.814862.
   PubMed Web of Science ®Google Scholar
• Serruto D, Bottomley MJ, Ram S, Giuliani MM, Rappuoli R. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: immunological, functional and structural characterization of the antigens. Vaccine. 2012;30(Suppl 2):B87–97. PMID: 22607904. doi:10.1016/j.vaccine.2012.01.033.
   PubMed Web of Science ®Google Scholar
• Block S, Shepard J, Garfield H, Xie F, Han L, Dull P, Smolenov I. Immunogenicity and safety of a 3- and 4-dose vaccination series of a meningococcal ACWY conjugate vaccine in infants: results of a phase 3b, randomized, open-label trial. Pediatr Infect Dis J. 2016 Feb;35(2):e48–59. PMID: 26479973. doi:10.1097/INF.0000000000000965.
   PubMed Web of Science ®Google Scholar
• Santolaya M, O’Ryan M, Valenzuela M, Prado V, Vergara R, Muñoz A, Toneatto D, Graña G, Wang H, Dull P. Persistence of antibodies in adolescents 18−24 months after immunization with one, two, or three doses of 4CMenB meningococcal serogroup B vaccine. Human Vaccines & Immunotherapeutics. 2013;9(11):2304–10. doi:10.4161/hv.25505.
   PubMed Web of Science ®Google Scholar
• Santolaya M, O’Ryan M, Valenzuela M, Prado V, Vergara R, Muñoz A, Toneatto D, Graña G, Wang H, Clemens R, 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. The Lancet. 2012;379(9816):617–24. PMID: 22260988. doi:10.1016/S0140-6736(11)61713-3.
   PubMed Web of Science ®Google Scholar
• Lee H, Choe Y, Hong Y, Kim K, Park S, Kim Y, Oh C, Lee H, Song H, Bock H, et al. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea—A randomised trial. Vaccine. 2016;34(9):1180–86. PMID: 26826544. doi:10.1016/j.vaccine.2016.01.033.
   PubMed Web of Science ®Google Scholar
• Di Pasquale A, Bonanni P, Garçon N, Stanberry L, El-Hodhod M, Tavares Da Silva F. Vaccine safety evaluation: practical aspects in assessing benefits and risks. Vaccine. 2016;34:6672–80. PMID: 27836435. doi:10.1016/j.vaccine.2016.10.039.
   PubMed Web of Science ®Google Scholar
• Zafack J, Bureau A, Skowronski D, de Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019;9(5):e026953. PMID: 31110098. doi:10.1136/bmjopen-2018-026953.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. 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. Lancet. 2013 Mar 9;381(9869):825–35. PMID: 23324563. doi:10.1016/S0140-6736(12)61961-8.
   PubMed Web of Science ®Google Scholar
• Flacco ME, Manzoli L, Rosso A, Marzuillo C, Bergamini M, Stefanati A, Cultrera R, Villari P, Ricciardi W, Ioannidis JPA, et al. Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis. Lancet Infect Dis. 2018 Apr;18(4):461–72. PMID: 29371070. doi:10.1016/S1473-3099(18)30048-3.
   PubMed Web of Science ®Google Scholar
• AIFA. Rapporto sulla Sorveglianza post-marketing dei Vaccini in Italia Anno 2019. [accessed 2021 Feb 4]. https://www.aifa.gov.it/documents/20142/241052/Rapporto_Vaccini_2019.pdf .
   Google Scholar
• Di Pietro A, Visalli G, Antonuccio GM, Facciolà A. Today’s vaccination policies in Italy: the national plan for vaccine prevention 2017-2019 and the Law 119/2017 on the mandatory vaccinations. Ann Ig. 2019;31(2 Supple 1):54–64. PMID: 30994164. doi:10.7416/ai.2019.2277.
   PubMed Web of Science ®Google Scholar
• Regione Puglia. Bollettino ufficiale della Regione Puglia n. 74 del 11/06/2014 – DGR 958 del 20/ 05/2014.Modifica Calendario Regionale per la vita 2012 - DGR 241/2013. Approvazione nuovo Calendario Vaccinale per la vita 2014. [accessed 2021 Feb 3]. http://www.regione.puglia.it/documents/10192/4808761/DELIBERAZIONE+DELLA+GIUNTA+REGIONALE+20+maggio+2014%2C%20n.+958+%28id+4808942%29/268b2b1a-7a73-4653-a758-a10a6706a410;jsessionid=861CA1EEE44809BE84188569E51A8684 .
   Google Scholar
• AIFA – gruppo di Lavoro sull’analisi dei segnali dei vaccini. Guida alla valutazione delle reazioni avverse osservabili dopo vaccinazione. 2016. [accessed 2021 Jan 28]. http://www.aifa.gov.it/sites/default/files/Guida_valutazione_reazioni_avverse_osservabili_dopo_vaccinazione_2.pdf .
   Google Scholar
• European Medical Agency. Important medical event terms list version (MedDRA) – version 24.0. [accessed 2021 Mar 25]. https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview .
   Google Scholar
• WHO. Causality Assessment of an adverse event following immunization (AEFI). User manual for the revised WHO classification. [accessed 2021 Feb 26]. http://apps.who.int/iris/bitstream/handle/10665/259959/9789241513654-eng.pdf?sequence=1 .
   Google Scholar
• Stefanizzi P, Calabrese G, Infantino V, Del Matto G, Tafuri S, Quarto M. Systematic use of causality assessment in AEFI surveillance: a 2013-2016 pilot study in Puglia. EBMJ. 2017;12(33):154–58. doi:10.3269/1970-5492.2017.12.33.
   Google Scholar
• Varallo F, Guimarães S, Abjaude S, Mastroianni P. Causes for the underreporting of adverse drug events by health professionals: a systematic review. Rev Escola Enfermagem USP. 2014;48(4):739–47. PMID: 25338257. doi:10.1590/S0080-623420140000400023.
   PubMed Web of Science ®Google Scholar
• Mentzer D, Oberle D, Keller-Stanislawski B. Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016. Eurosurveillance. 2018;23(17). PMID: 29717697. doi:10.2807/1560-7917.ES.2018.23.17.17-00468.
   Web of Science ®Google Scholar
• Puliyel J, Naik P. Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique. F1000 Research. 2018;7:243. PMID: 30026925. doi:10.12688/f1000research.
   PubMedGoogle Scholar
• Murdoch H, Wallace L, Bishop J, Robertson C, Claire Cameron J. Risk of hospitalisation with fever following MenB vaccination: self-controlled case series analysis. Arch Dis Child. 2017;102(10):894–98. PMID: 28931535. doi:10.1136/archdischild-2017-313079.
   PubMed Web of Science ®Google Scholar
• Government of South Australia. Managing possible fever after meningococcal B vaccine (Bexsero) administration. [accessed 2021 Feb 17]. https://www.sahealth.sa.gov.au/wps/wcm/connect/d4c91180-7abb-470c-ab5b-954e47c90d20/3.+Managing+possible+fever+after+Bexsero+vaccine+%28A5+pad%29+%28WEB+READY%29.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-d4c91180-7abb-470c-ab5b-954e47c90d20-nwLvY6M .
   Google Scholar
• Public Health England. Publications gateway number: GW-1249. Protocol for the supply or administration of paracetamol oral suspension 120mg/5mL to infants under 12 months of age receiving primary doses of MenB vaccination. [accessed 2021 Mar 2]. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/881402/20200427PHEParacetamolProtocol__1_.pdf .
   Google Scholar
• Vigo A, Costagliola G, Ferrero E, Noce S. Hypotonic-hyporesponsive episodes after administration of hexavalent DTP-based combination vaccine: a description of 12 cases. Hum Vaccin Immunother. 2017;13(6):1375–78. PMID: 28301267. doi:10.1080/21645515.2017.1287642.
   PubMed Web of Science ®Google Scholar