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Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016.
Vaccine. 2020 09 11; 38(40):6291-6298.V

Abstract

BACKGROUND

Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM197 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.

Authors+Show Affiliations

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.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.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.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.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.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.Yale Institute for Global Health, 1 Church Street, New Haven, CT 06517, USA.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.

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Review

Language

eng

PubMed ID

32747215

Citation

Myers, Tanya R., et al. "Adverse Events Following Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (Menactra®) Reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016." Vaccine, vol. 38, no. 40, 2020, pp. 6291-6298.
Myers TR, McNeil MM, Ng CS, et al. Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. Vaccine. 2020;38(40):6291-6298.
Myers, T. R., McNeil, M. M., Ng, C. S., Li, R., Marquez, P. L., Moro, P. L., Omer, S. B., & Cano, M. V. (2020). Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. Vaccine, 38(40), 6291-6298. https://doi.org/10.1016/j.vaccine.2020.07.039
Myers TR, et al. Adverse Events Following Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (Menactra®) Reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. Vaccine. 2020 09 11;38(40):6291-6298. PubMed PMID: 32747215.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. AU - Myers,Tanya R, AU - McNeil,Michael M, AU - Ng,Carmen S, AU - Li,Rongxia, AU - Marquez,Paige L, AU - Moro,Pedro L, AU - Omer,Saad B, AU - Cano,Maria V, Y1 - 2020/07/31/ PY - 2020/05/25/received PY - 2020/07/16/revised PY - 2020/07/18/accepted PY - 2020/8/5/pubmed PY - 2021/4/28/medline PY - 2020/8/5/entrez KW - Adolescent KW - Meningococcal vaccine KW - Surveillance KW - Vaccine safety SP - 6291 EP - 6298 JF - Vaccine JO - Vaccine VL - 38 IS - 40 N2 - BACKGROUND: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM197 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/32747215/Adverse_events_following_quadrivalent_meningococcal_diphtheria_toxoid_conjugate_vaccine__Menactra®__reported_to_the_Vaccine_Adverse_Event_Reporting_System__VAERS__2005_2016_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(20)30957-9 DB - PRIME DP - Unbound Medicine ER -