Kristen A. Feemster, MD, MPH, MSHP; Paul Offit, MD
This article was published online first at www.annals.org on 24 December 2013.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2927.
Requests for Single Reprints: 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, firstname.lastname@example.org.
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.
Feemster KA, Offit P. “Compassionate Use” for Public Health. Ann Intern Med. 2014;160:421-422. doi: 10.7326/M13-2927
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Published: Ann Intern Med. 2014;160(6):421-422.
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 York, New York), the only vaccine in production that protects against MenB, was approved for use in Europe and Australia in January 2013 (1). Its distribution in response to an outbreak marks the first time the “compassionate use” or “expanded access” mechanism for drug approval (2, 3) has been granted to distribute a nontherapeutic biological drug to a group of healthy persons. This unprecedented evolution of events at Princeton has resulted in a flurry of media coverage falling into 3 main categories: support for a cooperative response between public health institutions and the university, concern that students are being used as “guinea pigs” for an untested product, and questions of fairness when many other groups are at risk for disease from MenB.
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Infectious Disease, Healthcare Delivery and Policy, Vaccines/Immunization, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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