Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018

Silvia Perez-Vilar¹, Graça M Dores², Paige L Marquez³, Carmen S Ng⁴, Maria V Cano⁵, Anuja Rastogi⁶, Lucia Lee⁷, John R Su⁸, Jonathan Duffy⁹

Affiliations

¹ 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.
² 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.
³ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: fqv9@cdc.gov.
⁴ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: csng14@hku.hk.
⁵ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: canmz007@aol.com.
⁶ 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.
⁷ 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.
⁸ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: ezu2@cdc.gov.
⁹ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: jduffy@cdc.gov.

PMID: 34887130
PMCID: PMC9009159
DOI: 10.1016/j.vaccine.2021.11.071

Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018

Silvia Perez-Vilar et al. Vaccine. 2022.

. 2022 Jan 21;40(2):247-254.

doi: 10.1016/j.vaccine.2021.11.071. Epub 2021 Dec 7.

Authors

Silvia Perez-Vilar¹, Graça M Dores², Paige L Marquez³, Carmen S Ng⁴, Maria V Cano⁵, Anuja Rastogi⁶, Lucia Lee⁷, John R Su⁸, Jonathan Duffy⁹

Affiliations

¹ 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.
² 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.
³ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: fqv9@cdc.gov.
⁴ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: csng14@hku.hk.
⁵ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: canmz007@aol.com.
⁶ 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.
⁷ 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.
⁸ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: ezu2@cdc.gov.
⁹ Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, United States. Electronic address: jduffy@cdc.gov.

PMID: 34887130
PMCID: PMC9009159
DOI: 10.1016/j.vaccine.2021.11.071

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.

Keywords: 4CMenB vaccine; Meningococcal vaccines; Neisseria meningitidis serogroup B; Pharmacovigilance; Vaccine Adverse Event Reporting System.

Published by Elsevier Ltd.

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Conflict of interest statement

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.

References

1. MacNeil JR, Blain AE, Wang X, Cohn AC. Current Epidemiology and Trends in Meningococcal Disease-United States, 1996–2015. Clin Infect Dis 2018;66:1276–81. - PubMed
1. U.S. Food and Drug Administration. Bexsero (meningococcal serogroup B vaccine), Approval Letter dated January 23, 2015. 2015.
1. Duffy J, Johnsen P, Ferris M, Miller M, Leighton K, McGilvray M, et al. Safety of a meningococcal group B vaccine used in response to two university outbreaks. J Am Coll Health. 2017;65(6):380–8. - PMC - PubMed
1. McNamara LA, Shumate AM, Johnsen P, MacNeil JR, Patel M, Bhavsar T, et al. First Use of a Serogroup B Meningococcal Vaccine in the US in Response to a University Outbreak. Pediatrics 2015;135(5):798–804. - PMC - PubMed
1. U.S. Food and Drug Administration. Bexsero (meningococcal serogroup B vaccine), Clinical review dated January 23, 2015. 2015.

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Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018

Affiliations

Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018

Authors

Affiliations

Abstract

Conflict of interest statement

References

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources