1,114
Views
2
CrossRef citations to date
0
Altmetric
Review

Real-world evidence of quadrivalent meningococcal conjugate vaccine safety in the United States: a systematic review

, , &
Pages 1432-1441 | Received 30 Jun 2020, Accepted 21 Sep 2020, Published online: 17 Dec 2020

References

  • Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13 ed. Washington, D.C.: Public Health Foundation; 2015.
  • Halperin SA, Bettinger JA, Greenwood B, Harrison LH, Jelfs J, Ladhani SN, McIntyre P, Ramsay ME, Sáfadi MAP. The changing and dynamic epidemiology of meningococcal disease. Vaccine. 2012;30(Suppl 2):B26–36. doi:10.1016/j.vaccine.2011.12.032.
  • MacNeil JR, Blain AE, Wang X, Cohn AC. Current Epidemiology and Trends in Meningococcal Disease—United States, 1996–2015. Clin Infec Dis. 2018;66(8):1276–81. doi:10.1093/cid/cix993.
  • Kaplan SL, Schutze GE, Leake JA, Barson WJ, Halasa NB, Byington CL, Tan TQ, Hoffman JA, Wald ER, et al. Multicenter surveillance of invasive meningococcal infections in children. Pediatrics. 2006;118(4):e979–984. doi:10.1542/peds.2006-0281.
  • Madelaine T, Cour M, Bohé J, Floccard, Duperret S, Hernu R, Argaud L. Invasive meningococcal disease-induced myocarditis in critically ill adult patients: initial presentation and long-term outcome. Intensive Care Med. 2017;43(2):279–81. doi:10.1007/s00134-016-4623-x.
  • Kirsch EA, Barton RP, Kitchen L, Giroir BP. Pathophysiology, treatment and outcome of meningococcemia: a review and recent experience. Pediatr Infect Dis J. 1996;15(11):967–79. quiz 979. doi:10.1097/00006454-199611000-00009.
  • Edwards MS, Baker CJ. Complications and sequelae of meningococcalinfections in children. J Pediatr. 1981;99(4):540–45. doi:10.1016/S0022-3476(81)80250-8.
  • Cohn AC, MacNeil JR, Clark TA, Ortega-Sanchez IR, Briere EZ, Meissner CH, Baker CJ, Messonnier NE. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommend Rep. 2013;62(RR–2):1–28.
  • Sanofi Pasteur Inc. Menactra package insert: highlights of prescribing information; 2018. [accessed date 2020 Jun 25]. https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert—Menactra.pdf
  • GlaxoSmithKline Biologicals SA. MENVEO package insert: highlights of prescribing information; 2017. [accessed date 2020 Jun 25]. https://www.fda.gov/media/78514/download
  • Sanofi Pasteur Inc. MenQuadfi, Meningococcal (Groups A, C, Y, W) conjugate vaccine; 2020. [accessed date 2020 Jun 29]. https://www.fda.gov/media/137306/download.
  • MacNeil JR, Rubin L, McNamara L, Briere EC, Clark TA, Cohn AC. Use of MenACWY-CRM vaccine in children aged 2 through 23 months at increased risk for meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2013. MMWR Morb Mortal Wkly Rep. 2014;63:527–30.
  • Keshavan P, Pellegrini M, Vadivelu-Pechai K, Nissen M. An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine. Expert Rev Vaccines. 2018;17(10):865–80. doi:10.1080/14760584.2018.1521280.
  • Myers TR, McNeil MM. Current safety issues with quadrivalent meningococcal conjugate vaccines. Hum Vaccin Immunother. 2018;14(5):1175–78. doi:10.1080/21645515.2017.1366393.
  • U.S. Food & Drug Administration. Framework for FDA’s real-world evidence program; 2018. [accessed date 2020 Jun 04]. https://www.fda.gov/media/120060/download.
  • Zheteyeva Y, Moro PL, Yue X, Broder K. Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the vaccine adverse event reporting system. Am J Obstet Gynecol. 2013;208(6):478.e471-476. doi:10.1016/j.ajog.2013.02.027.
  • Becerra-Culqui TA, Sy LS, Ackerson BK, Chen LH, Fischetti CA, Solano Z, Schmidt JE, Malvisi L, Curina C, Pellegrini M, et al. Safety of MenACWY-CRM vaccine exposure during pregnancy. Vaccine. 2020;38(12):2683–90. doi:10.1016/j.vaccine.2020.02.008.
  • Myers TR, McNeil MM, Ng CS, Li R, Lewis PW, Cano MV. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015. Vaccine. 2017;35(14):1758–63. doi:10.1016/j.vaccine.2017.02.030.
  • Hansen J, Zhang L, Klein NP, Robertson CA, luo MD, Greenberg DP, Bassily E, Baxter R. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017;35(49):6879–84. doi:10.1016/j.vaccine.2017.09.032.
  • Becerra-Culqui TA, Sy LS, Ackerson BK, Slezak JM, Luo Y, Fischetti CA, Ohadike YU, Curina C, Pellegrini M, Solano Z, et al. Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old. Vaccine. 2020;38(2):228–34.
  • Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018;36(16):2133–38. doi:10.1016/j.vaccine.2018.02.107.
  • Tartof SY, Sy LS, Ackerson BK, Hechter RC, Haag M, Slezak JM, Fischetti CA, Takhar HS, et al. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2–10 Years. Pediatr Infect Dis J. 2017;36(11):1087–92. doi:10.1097/INF.0000000000001696.
  • Centers for Disease Control and Prevention. Update: guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, June 2005-September 2006. MMWR Morb Mortal Wkly Rep. 2006;55(41):1120–24.
  • Yih WK, Weintraub E, Kulldorff M. No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studies. Pharmacoepidemiol Drug Saf. 2012;21(12):1359–60. doi:10.1002/pds.3353.
  • Velentgas P, Amato AA, Bohn RL, Arnold Chan K, Cochrane T, Funch, Dashevsky I, Duddy AL, Gladowski P, Greenberg SA, et al. Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol Drug Saf. 2012;21(12):1350–58. doi:10.1002/pds.3321.
  • Baxter R, Lewis N, Bakshi N, Vellozzi C, Klein NP. Recurrent Guillain-Barre syndrome following vaccination. Clin Infec Dis. 2012;54(6):800–04. doi:10.1093/cid/cir960.
  • Tseng H-F, Sy LS, Ackerson BK, Hechter RC, Tartof SY, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, et al. Safety of quadrivalent meningococcal conjugate vaccine in 11- to 21-Year-Olds. Pediatrics. 2017;139(1):e20162084. doi:10.1542/peds.2016-2084.
  • Centers for Disease Control and Prevention. Syncope after vaccination–United States, January 2005-July 2007. MMWR Morb Mortal Wkly Rep. 2008;57(17):457–60.
  • Narwaney KJ, Breslin K, Ross CA, Shoup JA, Wain KF, Weintraub ES, McNeil MM, Hambidge SJ. Vaccine adverse events in a safety net healthcare system and a managed care organization. Vaccine. 2017;35(9):1335–40. doi:10.1016/j.vaccine.2017.01.017.
  • Rowhani-Rahbar A, Klein NP, Lewis N, Fireman B, Ray P, Rasgon B, Black S, Klein JO, Baxter R. Immunization and Bell’s Palsy in children: a case-centered analysis. Am J Epidemiol. 2012;175(9):878–85. doi:10.1093/aje/kws011.
  • Jackson LA, Yu O, Nelson J, Belongia EA, Hambidge SJ, Baxter R, Naleway A, Nordin J, Baggs J, Iskander J, et al. Risk of medically attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: a Vaccine Safety Datalink study. Vaccine. 2009;27(36):4912–16. doi:10.1016/j.vaccine.2009.06.038.
  • Gyurkocza B, Rezvani A, Storb RF. Allogeneic hematopoietic cell transplantation: the state of the art. Expert Rev Hematol. 2010;3(3):285–99. doi:10.1586/ehm.10.21.
  • Li R, Weintraub E, McNeil MM, Kulldorff M, Lewis EM, Nelson, Xu S, Qian L, Klein NP, Destefano F, et al. Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method. Pharmacoepidemiol Drug Saf. 2018;27(4):391–97. doi:10.1002/pds.4397.
  • Cheng MP, Pandit A, Antin JH, Walsh SR, Huynh D, Ghobrial IM, Baden LR, Marty FM, Issa NC. Safety and immunogenicity of conjugate quadrivalent meningococcal vaccination after hematopoietic cell transplantation. Blood Advances. 2018;2(11):1272–76. doi:10.1182/bloodadvances.2018018911.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.