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Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018.
Vaccine. 2022 01 21; 40(2):247-254.V

Abstract

BACKGROUND

Bexsero® (GlaxoSmithKline) is a four-component Neisseria meningitidis serogroup B vaccine (MenB-4C). It was licensed in the United States in 2015 for use among individuals ages 10-25 years. We aimed to assess the post-licensure safety profile of MenB-4C by examining reports received in the Vaccine Adverse Event Reporting System (VAERS).

METHODS

VAERS is a national passive surveillance system for adverse events (AEs) following immunization that uses the Medical Dictionary for Regulatory Activities to code reported AEs and the Code of Federal Regulations to classify reports by seriousness. In this case series, we analyzed U.S. reports involving MenB-4C received between January 23, 2015 through December 31, 2018. We used Empirical Bayesian data mining to identify MenB-4C/AE combinations reported at least twice as often as expected.

RESULTS

VAERS received 1,867 reports following MenB-4C administration, representing 332 reports per million doses distributed. Most reports were for females (59%), with a median age of 17 years (interquartile range: 16-18 years); 40% of reports described simultaneous administration of other vaccines. The majority of reports were classified as non-serious (96%). The most commonly reported AEs were injection site pain (22%), pyrexia (16%), and headache (16%). Data mining identified disproportionate reporting for "injected limb mobility decreased" secondary to injection site reactions, including extensive swelling of the vaccinated limb and injection site pain.

CONCLUSIONS

Analysis of passive surveillance data from over 5.6 million doses of MenB-4C distributed in the United States did not reveal new safety concerns. The large majority of reports were classified as non-serious and the reported AEs were generally consistent with the safety experience described in clinical studies and the product's package insert. While our results are reassuring, continued post-marketing surveillance is warranted.

Authors+Show Affiliations

Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, United States. Electronic address: silvia.perezvilar@fda.hhs.gov.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, United States. Electronic address: graca.dores@fda.hhs.gov.Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: fqv9@cdc.gov.Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: csng14@hku.hk.Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: canmz007@aol.com.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, United States. Electronic address: anuja.rastogi@fda.hhs.gov.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, United States. Electronic address: lucia.lee@fda.hhs.gov.Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: ezu2@cdc.gov.Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: jduffy@cdc.gov.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34887130

Citation

Perez-Vilar, Silvia, et al. "Safety Surveillance of Meningococcal Group B Vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018." Vaccine, vol. 40, no. 2, 2022, pp. 247-254.
Perez-Vilar S, Dores GM, Marquez PL, et al. Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. Vaccine. 2022;40(2):247-254.
Perez-Vilar, S., Dores, G. M., Marquez, P. L., Ng, C. S., Cano, M. V., Rastogi, A., Lee, L., Su, J. R., & Duffy, J. (2022). Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. Vaccine, 40(2), 247-254. https://doi.org/10.1016/j.vaccine.2021.11.071
Perez-Vilar S, et al. Safety Surveillance of Meningococcal Group B Vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. Vaccine. 2022 01 21;40(2):247-254. PubMed PMID: 34887130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. AU - Perez-Vilar,Silvia, AU - Dores,Graça M, AU - Marquez,Paige L, AU - Ng,Carmen S, AU - Cano,Maria V, AU - Rastogi,Anuja, AU - Lee,Lucia, AU - Su,John R, AU - Duffy,Jonathan, Y1 - 2021/12/07/ PY - 2021/09/22/received PY - 2021/11/20/revised PY - 2021/11/23/accepted PY - 2023/01/21/pmc-release PY - 2021/12/11/pubmed PY - 2022/1/27/medline PY - 2021/12/10/entrez KW - 4CMenB vaccine KW - Meningococcal vaccines KW - Neisseria meningitidis serogroup B KW - Pharmacovigilance KW - Vaccine Adverse Event Reporting System SP - 247 EP - 254 JF - Vaccine JO - Vaccine VL - 40 IS - 2 N2 - BACKGROUND: Bexsero® (GlaxoSmithKline) is a four-component Neisseria meningitidis serogroup B vaccine (MenB-4C). It was licensed in the United States in 2015 for use among individuals ages 10-25 years. We aimed to assess the post-licensure safety profile of MenB-4C by examining reports received in the Vaccine Adverse Event Reporting System (VAERS). METHODS: VAERS is a national passive surveillance system for adverse events (AEs) following immunization that uses the Medical Dictionary for Regulatory Activities to code reported AEs and the Code of Federal Regulations to classify reports by seriousness. In this case series, we analyzed U.S. reports involving MenB-4C received between January 23, 2015 through December 31, 2018. We used Empirical Bayesian data mining to identify MenB-4C/AE combinations reported at least twice as often as expected. RESULTS: VAERS received 1,867 reports following MenB-4C administration, representing 332 reports per million doses distributed. Most reports were for females (59%), with a median age of 17 years (interquartile range: 16-18 years); 40% of reports described simultaneous administration of other vaccines. The majority of reports were classified as non-serious (96%). The most commonly reported AEs were injection site pain (22%), pyrexia (16%), and headache (16%). Data mining identified disproportionate reporting for "injected limb mobility decreased" secondary to injection site reactions, including extensive swelling of the vaccinated limb and injection site pain. CONCLUSIONS: Analysis of passive surveillance data from over 5.6 million doses of MenB-4C distributed in the United States did not reveal new safety concerns. The large majority of reports were classified as non-serious and the reported AEs were generally consistent with the safety experience described in clinical studies and the product's package insert. While our results are reassuring, continued post-marketing surveillance is warranted. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/34887130/Safety_surveillance_of_meningococcal_group_B_vaccine__Bexsero®__Vaccine_Adverse_Event_Reporting_System_2015_2018_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(21)01545-0 DB - PRIME DP - Unbound Medicine ER -