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Clinical Guidance for Smallpox Vaccine Use in a Postevent Vaccination Program

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Clinical Guidance for Smallpox Vaccine Use in a Postevent Vaccination Program Morbidity and Mortality Weekly Report Recommendations and Reports / Vol. 64 / No. 2 February 20, 2015 Clinical Guidance for Smallpox Vaccine Use in a Postevent Vaccination Program Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html. U.S. Department of Health and Human Services Centers for Disease Control and Prevention Recommendations and Reports CONTENTS Disclosure of Competing Interests Introduction ............................................................................................................2 The expert panelists who participated in the development of this guidance reported no potential competing interests to the Methods ....................................................................................................................2 steering committee with the following exceptions: J. Michael Background .............................................................................................................3 Lane, MD, disclosed that he has worked on data and safety monitoring boards for clinical trials sponsored by the NIH Control and Prevention .......................................................................................5 and by Bavarian Nordic and was supported by Acambis (the ACAM2000 ...............................................................................................................5 manufacturer of ACAM2000 before being purchased by Sanofi Aventis Pasteur Smallpox Vaccine ................................................................ 10 Pasteur) to review photos of the arms of vaccinees in their initial trial of the ACAM2000 vaccine to determine if a major Imvamune ............................................................................................................. 11 or equivocal cutaneous reaction had occurred; Sharon E. Frey, Recommended Uses of Smallpox Vaccine ................................................ 12 MD, disclosed that she has worked on several clinical trials for Guidance for Other Special Populations .................................................... 21 smallpox vaccines in the past that were funded by the current manufacturers of smallpox vaccines (i.e., Sanofi Pasteur and Knowledge Gaps and Future Research....................................................... 23 Bavarian Nordic) and by the NIH, received funding from Acknowledgments ............................................................................................. 23 the current smallpox vaccine manufacturers for past travel References ............................................................................................................. 23 expenses to present at conferences and a training session, and will organize one study site for a clinical trial investigating Imvamune funded by the NIH and Bavarian Nordic. Following the workshop and during the writing of the guidance, Dr. Frey disclosed that she accepted an offer by Bavarian Nordic before initiation of guidance development to serve as the chair of a committee evaluating the ability of smallpox vaccine to induce a major or equivocal cutaneous reaction in participants of a clinical study. This report includes recommendations for two investigational smallpox vaccines (i.e., Imvamune and Aventis Pasteur Smallpox Vaccine [APSV]) that are anticipated to be used under emergency use authorization or investigational new drug protocols in the event of a declared public health emergency involving smallpox. Front cover photo: Transmission electron micrograph depicting smallpox virus virions; magnification approximately 370,000x. (Photo/CDC) The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA 30329-4027. Suggested citation: [Author names; first three, then et al., if more than six.] [Title]. MMWR Recomm Rep 2015;64(No. RR-#):[inclusive page numbers]. Centers for Disease Control and Prevention Thomas R. Frieden, MD, MPH, Director Harold W. Jaffe, MD, MA, Associate Director for Science Joanne Cono, MD, ScM, Director, Office of Science Quality Chesley L. Richards, MD, MPH, Deputy Director for Public Health Scientific Services Michael F. Iademarco, MD, MPH, Director, Center for Surveillance, Epidemiology, and Laboratory Services MMWR Editorial and Production Staff (Serials) Sonja A. Rasmussen, MD, MS, Editor-in-Chief Martha F. Boyd, Lead Visual Information Specialist Charlotte K. Kent, PhD, MPH, Executive Editor Maureen A. Leahy, Julia C. Martinroe, Christine G. Casey, MD, Editor Stephen R. Spriggs, Terraye M. Starr Teresa F. Rutledge, Managing Editor Visual Information Specialists David C. Johnson, Lead Technical Writer-Editor Quang M. Doan, MBA, Phyllis H. King Jeffrey D. Sokolow, MA, Project Editor Information Technology Specialists MMWR Editorial Board William L. Roper, MD, MPH, Chapel Hill, NC, Chairman King K. Holmes, MD, PhD, Seattle, WA Matthew L. Boulton, MD, MPH, Ann Arbor, MI Timothy F. Jones, MD, Nashville, TN Virginia A. Caine, MD, Indianapolis, IN Rima F. Khabbaz, MD, Atlanta, GA Jonathan E. Fielding, MD, MPH, MBA, Los Angeles, CA Patricia Quinlisk, MD, MPH, Des Moines, IA David W. Fleming, MD, Seattle, WA Patrick L. Remington, MD, MPH, Madison, WI William E. Halperin, MD, DrPH, MPH, Newark, NJ William Schaffner, MD, Nashville, TN Recommendations and Reports Clinical Guidance for Smallpox Vaccine Use in a Postevent Vaccination Program Prepared by Brett W. Petersen, MD1 Inger K. Damon, MD, PhD1 Carol A. Pertowski, MD2 Dana Meaney-Delman, MD3 Julie T. Guarnizo4 Richard H. Beigi, MD5 Kathryn M. Edwards, MD6 Margaret C. Fisher, MD7 Sharon E. Frey, MD8 Ruth Lynfield, MD9 Rodney E. Willoughby, MD10 1Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, CDC 2Office of the Director, Office of Public Health Preparedness and Response, CDC 3Office of the Director, National Center for Emerging and Zoonotic Infectious Diseases, CDC 4Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases, CDC 5Magee-Womens Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 6Vanderbilt Vaccine Research Program, Vanderbilt University, Nashville, Tennessee 7The Unterberg Children’s Hospital at Monmouth Medical Center, Barnabas Health, Long Branch, New Jersey 8Center for Vaccine Development, Saint Louis University School of Medicine, Saint Louis, Missouri 9Minnesota Department of Health, St. Paul, Minnesota 10Children’s Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, Wisconsin Summary This report outlines recommendations for the clinical use of the three smallpox vaccines stored in the U.S. Strategic National Stockpile for persons who are exposed to smallpox virus or at high risk for smallpox infection during a postevent vaccination program following an intentional or accidental release of the virus. No absolute contraindications exist for smallpox vaccination in a postevent setting. However, several relative contraindications exist among persons with certain medical conditions. CDC recommendations for smallpox vaccine use were developed in consideration of the risk for smallpox infection, risk for an adverse event following vaccination, and benefit from vaccination. Smallpox vaccines are made from live vaccinia viruses that protect against smallpox disease. They do not contain variola virus, the causative agent of smallpox. The three smallpox vaccines stockpiled are ACAM2000, Aventis Pasteur Smallpox Vaccine (APSV), and Imvamune. Surveillance and containment activities including vaccination with replication-competent smallpox vaccine (i.e., vaccine viruses capable of replicating in mammalian cells such as ACAM2000 and APSV) will be the primary response strategy for achieving epidemic control. Persons exposed to smallpox virus are at high risk for developing and transmitting smallpox and should be vaccinated with a replication-competent smallpox vaccine unless severely immunodeficient. Because of a high likelihood of a poor immune response and an increased risk for adverse events, smallpox vaccination should be avoided in persons with severe immunodeficiency who are not expected to benefit from vaccine, including bone marrow transplant recipients within 4 months of transplantation, persons infected with HIV with CD4 cell counts <50 cells/mm3, and persons with severe combined immunodeficiency, complete DiGeorge syndrome, and other severely immunocompromised states requiring isolation. If antivirals are not immediately available, it is reasonable to consider the use of Imvamune in the setting of a smallpox virus exposure in persons with severe immunodeficiency. Persons without a known smallpox virus exposure might still be at high risk for developing smallpox infection depending on the magnitude of the outbreak and the effectiveness of the public health response. Such persons will be defined by public health authorities and should be screened for relative contraindications to smallpox vaccination. Relative contraindications include atopic dermatitis (eczema), HIV infection (CD4 cell counts of 50–199 cells/mm3), other immunocompromised states, and vaccine or vaccine-component allergies. Persons with relative contraindications should be vaccinated with Imvamune when available and authorized for use by the Food and Drug Administration. These Corresponding preparer: Brett W. Petersen, Division of
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