“Compassionate Use” for Public Health
Authors: Kristen A. Feemster, Paul Offit
Journal: Annals of Internal Medicine (2013)

Ideas and Opinions18 March 2014“Compassionate Use” for Public HealthKristen A. Feemster, MD, MPH, MSHP and Paul Offit, MDKristen A. Feemster, MD, MPH, MSHPFrom the University of Pennsylvania and the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.Search for more papers by this author and Paul Offit, MDFrom the University of Pennsylvania and the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M13-2927 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Since 22 March 2013, 8 cases of confirmed Neisseria meningitidis serogroup B (MenB) meningitis have occurred among students and visitors at Princeton University. For a serogroup that is generally associated with about 150 sporadic cases of invasive disease per year, this is a massive outbreak. The most recent case was identified in mid-November. Although all affected students have survived, 1 may have permanent deafness. In response to the outbreak, the university and the Centers for Disease Control and Prevention have made an unusual move—to immunize students with a vaccine that is not licensed in the United States.Bexsero (Novartis, New ...References1. Granoff DM. Commentary: European Medicines Agency recommends approval of a broadly protective vaccine against serogroup B meningococcal disease. Pediatr Infect Dis J. 2013;32:372-3. [PMID: 23263177] CrossrefMedlineGoogle Scholar2. Food and Drug Administration, HHS. Expanded access to investigational drugs for treatment use. Final rule. Fed Regist. 2009;74:40900-45. [PMID: 19691173] MedlineGoogle Scholar3. Food and Drug Administration, HHS. Charging for investigational drugs under an investigational new drug application. Final rule. Fed Regist. 2009;74:40871-900. [PMID: 19691172] MedlineGoogle Scholar4. Serruto D, Bottomley MJ, Ram S, Giuliani MM, Rappuoli R. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: immunological, functional and structural characterization of the antigens. Vaccine. 2012;30 Suppl 2 B87-97. [PMID: 22607904] CrossrefMedlineGoogle Scholar5. Gorringe AR, Pajón R. Bexsero: a multicomponent vaccine for prevention of meningococcal disease. Hum Vaccin Immunother. 2012;8:174-83. [PMID: 22426368] CrossrefMedlineGoogle Scholar6. Kim E, Paulos S, Carlone G, Plikaytis B, Cohn A, Messonier N, et al. Meningococcal antigen typing system (MATS) based coverage prediction for the 4CMenB vaccine in United States. Presented at XVIIIth International Pathogenic Neisseria Conference, Würzburg, Germany, 9–14 September 2012. Google Scholar Author, Article, and Disclosure InformationAuthors: Kristen A. Feemster, MD, MPH, MSHP; Paul Offit, MDAffiliations: From the University of Pennsylvania and the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2927.Corresponding Author: Kristen A. Feemster, MD, MPH, MSHP, The Children's Hospital of Philadelphia, Division of Infectious Diseases, Room 1202 Abramson Building, 3615 Civic Center Boulevard, Philadelphia, PA 19104; e-mail, feemster@email.chop.edu.Current Author Addresses: Drs. Feemster and Offit: The Children's Hospital of Philadelphia, Division of Infectious Diseases, Room 1202 Abramson Building, 3615 Civic Center Boulevard, Philadelphia, PA 19104.Author Contributions: Conception and design: K. A. Feemster, P. Offit.Drafting of the article: K. A. Feemster, P. Offit.Critical revision of the article for important intellectual content: K. A. Feemster, P. Offit.Final approval of the article: K. A. Feemster, P. Offit.Collection and assembly of data: K. A. Feemster.This article was published online first at www.annals.org on 24 December 2013. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 18 March 2014Volume 160, Issue 6Page: 421-422KeywordsAntigensChildrenDrug distributionDrugsMeningitisNeisseria meningitidisOuter membrane proteinsPrevention, policy, and public healthSafetyVaccines ePublished: 18 March 2014 Issue Published: 18 March 2014 Copyright & PermissionsCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...