Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014–2018. (27th October 2020)

• Record Type: Journal Article
• Authors: Duffy, Jonathan; Marquez, Paige; Dores, Graça M; Ng, Carmen; Su, John; Cano, Maria; Perez-Vilar, Silvia
• Is Part Of: Open forum infectious diseases. Volume 7:Number 12(2020)
• Publication Date: 2020-10-27
• Subjects: meningococcal vaccines -- neisseria meningitidis serogroup B -- pharmacovigilance; Communicable diseases -- Periodicals; Medical microbiology -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.1093/ofid/ofaa516
• Languages: English
• ISSNs: 2328-8957

Abstract

Abstract: Background: In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first meningococcal group B vaccine licensed in the United States. It is approved for use in individuals aged 10–25 years. Our objective was to evaluate the safety of MenB-FHbp postlicensure. Methods: The Vaccine Adverse Event Reporting System (VAERS) is a national passive vaccine safety surveillance system. We analyzed US VAERS reports for MenB-FHbp received from the date of licensure in October 2014 through December 2018. We described the characteristics of the persons and adverse events (AEs) reported and calculated reporting rates using the number of doses distributed. We used empirical Bayesian data mining to identify AEs reported at least twice as often as expected compared with all other vaccines. Results: VAERS received 2106 reports involving MenB-FHbp, representing 698 reports per million doses distributed. The median age of vaccinees was 17 years, and 55% were female. MenB-FHbp was given simultaneously with other vaccines in 37% of reports. Most reports (57%) described AEs that started on the day of or day after vaccination. The most common AEs reported were pyrexia (27%), headache (25%), and pain (16%). There were 44 serious reports (2% of all reports), among which 42 reported a hospitalization. Data mining identified disproportional reporting of headache, pyrexia, chills, and myalgia. Conclusions: The AEs most commonly or disproportionately reported following MenB-FHbp were consistent with those identified in clinical trials as described in the US package insert. We did not identify any new safety issues.