Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015–2018. Issue 2 (21st January 2022)

• Record Type: Journal Article
• Authors: Perez-Vilar, Silvia; Dores, Graça M.; Marquez, Paige L.; Ng, Carmen S.; Cano, Maria V.; Rastogi, Anuja; Lee, Lucia; Su, John R.; Duffy, Jonathan
• Is Part Of: Vaccine. Volume 40:Issue 2(2022)
• Page Start: 247
• Page End: 254
• Publication Date: 2022-01-21
• Subjects: 4CMenB vaccine -- Meningococcal vaccines -- Neisseria meningitidis serogroup B -- Pharmacovigilance -- Vaccine Adverse Event Reporting System; ADEM Acute disseminated encephalomyelitis -- AEs Adverse events -- ACIP Advisory Committee on Immunization Practices -- CDC Centers for Disease Control and Prevention -- EBGM Empirical Bayes Geometric Mean -- GBS Guillain-Barré syndrome -- ITP Immune thrombocytopenia -- IND Investigational new drug -- IQR Interquartile range -- ISR Injection site reaction -- MRI Magnetic resonance imaging -- MedDRA Medical Dictionary for Regulatory Activities -- MenACWY Meningococcal serogroups A, C, W, and Y -- MS Multiple sclerosis -- MenB-4C Four-component Neisseria meningitidis serogroup B vaccine -- MGPS Multi-Item Gamma Poisson Shrinker -- PTs Preferred Terms -- FDA U.S. Food and Drug Administration -- VAERS Vaccine Adverse Event Reporting System -- HPV Human papillomavirus; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2021.11.071
• Languages: English
• ISSNs: 0264-410X

Abstract

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.