Silvia Perez-Vilar1, Graça M Dores2, Paige L Marquez3, Carmen S Ng4, Maria V Cano5, Anuja Rastogi6, Lucia Lee7, John R Su8, Jonathan Duffy9. 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.
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. Published by Elsevier Ltd.
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. Published by Elsevier Ltd.
Authors: Frederick Varricchio; John Iskander; Frank Destefano; Robert Ball; Robert Pless; M Miles Braun; Robert T Chen Journal: Pediatr Infect Dis J Date: 2004-04 Impact factor: 2.129
Authors: James J Sejvar; Katrin S Kohl; Roman Bilynsky; Dean Blumberg; Therese Cvetkovich; Jochem Galama; Jane Gidudu; Lakshmi Katikaneni; Najwa Khuri-Bulos; James Oleske; Terhi Tapiainen; Max Wiznitzer Journal: Vaccine Date: 2007-05-11 Impact factor: 3.641
Authors: Lucy A McNamara; Alice M Shumate; Peter Johnsen; Jessica R MacNeil; Manisha Patel; Tina Bhavsar; Amanda C Cohn; Jill Dinitz-Sklar; Jonathan Duffy; Janet Finnie; Denise Garon; Robert Hary; Fang Hu; Hajime Kamiya; Hye-Joo Kim; John Kolligian; Janet Neglia; Judith Oakley; Jacqueline Wagner; Kathy Wagner; Xin Wang; Yon Yu; Barbara Montana; Christina Tan; Robin Izzo; Thomas A Clark Journal: Pediatrics Date: 2015-05 Impact factor: 7.124
Authors: Elisabeth M Hesse; Sarah Atanasoff; Beth F Hibbs; Oluwasegun J Adegoke; Carmen Ng; Paige Marquez; Mark Osborn; John R Su; Pedro L Moro; Tom Shimabukuro; Narayan Nair Journal: Vaccine Date: 2019-11-23 Impact factor: 4.169
Authors: Heidi M Soeters; Lucy A McNamara; Amy E Blain; Melissa Whaley; Jessica R MacNeil; Susan Hariri; Sarah A Mbaeyi Journal: Emerg Infect Dis Date: 2019-03 Impact factor: 6.883