PMID- 32747215 OWN - NLM STAT- MEDLINE DCOM- 20210427 LR - 20220916 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 38 IP - 40 DP - 2020 Sep 11 TI - Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra(R)) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. PG - 6291-6298 LID - S0264-410X(20)30957-9 [pii] LID - 10.1016/j.vaccine.2020.07.039 [doi] AB - BACKGROUND: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barre syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM(197) conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: VAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. We searched the VAERS database for U.S. reports of AEs after administration of MenACWY-D from January 2005 through June 2016. We conducted clinical reviews of serious reports after MenACWY-D administered alone, reports of MenACWY-D use during pregnancy, and reports of selected pre-specified outcomes. We screened for disproportionate reporting of AEs after MenACWY-D using empirical Bayesian data mining. RESULTS: VAERS received 13,075 U.S. reports after receipt of MenACWY-D; most (86%) described vaccination in adolescents, were classified as non-serious (94%), and described AEs consistent with pre-licensure studies. We did not find any evidence that reported deaths were related to vaccination. In serious reports, GBS and meningococcal infection were the most commonly reported medical conditions. Many reports of MenACWY-D use during pregnancy described inadvertent vaccination; most (61%) did not report any AE. CONCLUSIONS: Findings from our comprehensive review of reports to VAERS following MenACWY-D are consistent with data from pre-licensure studies and provide further reassurance on the safety of MenACWY-D. CI - Published by Elsevier Ltd. FAU - Myers, Tanya R AU - Myers TR AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. Electronic address: vje9@cdc.gov. FAU - McNeil, Michael M AU - McNeil MM AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. FAU - Ng, Carmen S AU - Ng CS AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. FAU - Li, Rongxia AU - Li R AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. FAU - Marquez, Paige L AU - Marquez PL AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. FAU - Moro, Pedro L AU - Moro PL AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. FAU - Omer, Saad B AU - Omer SB AD - Yale Institute for Global Health, 1 Church Street, New Haven, CT 06517, USA. FAU - Cano, Maria V AU - Cano MV AD - Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA. LA - eng GR - U01 AI047996/AI/NIAID NIH HHS/United States GR - UL1 TR001863/TR/NCATS NIH HHS/United States GR - T32 AI074492/AI/NIAID NIH HHS/United States GR - CC999999/ImCDC/Intramural CDC HHS/United States GR - UM1 AI148574/AI/NIAID NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Review DEP - 20200731 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Diphtheria Toxoid) RN - 0 (Meningococcal Vaccines) RN - 0 (Vaccines, Conjugate) SB - IM MH - Adolescent MH - Adverse Drug Reaction Reporting Systems MH - Bayes Theorem MH - Diphtheria Toxoid/adverse effects MH - Female MH - Humans MH - *Meningococcal Vaccines/adverse effects MH - Pregnancy MH - United States/epidemiology MH - Vaccines, Conjugate/adverse effects PMC - PMC7495357 MID - NIHMS1618811 OTO - NOTNLM OT - Adolescent OT - Meningococcal vaccine OT - Surveillance OT - Vaccine safety COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2020/08/05 06:00 MHDA- 2021/04/28 06:00 PMCR- 2021/09/11 CRDT- 2020/08/05 06:00 PHST- 2020/05/25 00:00 [received] PHST- 2020/07/16 00:00 [revised] PHST- 2020/07/18 00:00 [accepted] PHST- 2020/08/05 06:00 [pubmed] PHST- 2021/04/28 06:00 [medline] PHST- 2020/08/05 06:00 [entrez] PHST- 2021/09/11 00:00 [pmc-release] AID - S0264-410X(20)30957-9 [pii] AID - 10.1016/j.vaccine.2020.07.039 [doi] PST - ppublish SO - Vaccine. 2020 Sep 11;38(40):6291-6298. doi: 10.1016/j.vaccine.2020.07.039. Epub 2020 Jul 31.