Jonathan Duffy1, Paige Marquez1, Graça M Dores2, Carmen Ng1, John Su1, Maria Cano1, Silvia Perez-Vilar2. 1. Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. 2. Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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. Published by Oxford University Press on behalf of Infectious Diseases Society of America 2020.
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. Published by Oxford University Press on behalf of Infectious Diseases Society of America 2020.
Authors: Neal A Halsey; Kathryn M Edwards; Cornelia L Dekker; Nicola P Klein; Roger Baxter; Philip Larussa; Colin Marchant; Barbara Slade; Claudia Vellozzi Journal: Vaccine Date: 2012-04-14 Impact factor: 3.641
Authors: Lars Ostergaard; Timo Vesikari; Judith Absalon; Johannes Beeslaar; Brian J Ward; Shelly Senders; Joseph J Eiden; Kathrin U Jansen; Annaliesa S Anderson; Laura J York; Thomas R Jones; Shannon L Harris; Robert O'Neill; David Radley; Roger Maansson; Jean-Louis Prégaldien; John Ginis; Nina B Staerke; John L Perez Journal: N Engl J Med Date: 2017-12-14 Impact factor: 91.245
Authors: Tanja Y Walker; Laurie D Elam-Evans; David Yankey; Lauri E Markowitz; Charnetta L Williams; Benjamin Fredua; James A Singleton; Shannon Stokley Journal: MMWR Morb Mortal Wkly Rep Date: 2019-08-23 Impact factor: 17.586
Authors: Silvia Perez-Vilar; Graça M Dores; Paige L Marquez; Carmen S Ng; Maria V Cano; Anuja Rastogi; Lucia Lee; John R Su; Jonathan Duffy Journal: Vaccine Date: 2021-12-07 Impact factor: 3.641
Authors: Pasquale Stefanizzi; Francesco Paolo Bianchi; Andrea Martinelli; Antonio Di Lorenzo; Paola De Petro; Giusi Graziano; Sabrina Lattanzio; Giusy Diella; Paolo Stella; Domenica Ancona; Silvio Tafuri Journal: Hum Vaccin Immunother Date: 2022-02-24 Impact factor: 3.452