 |
|
Adverse Events Associated With Smallpox Vaccination in the United States, January-October 2003
Christine G. Casey, MD;
John K. Iskander, MD, MPH;
Martha H. Roper, MD, MPH;
Eric E. Mast, MD, MPH;
Xiao-Jun Wen, MD;
Thomas J. Török, MD, MPH;
Louisa E. Chapman, MD, MSPH;
David L. Swerdlow, MD;
Juliette Morgan, MD;
James D. Heffelfinger, MD, MPH;
Charles Vitek, MD, MPH;
Susan E. Reef, MD;
La Mar Hasbrouck, MD, MPH;
Inger Damon, MD, PhD;
Linda Neff, PhD;
Claudia Vellozzi, MD, MPH;
Mary McCauley, MTSC;
Raymond A. Strikas, MD;
Gina Mootrey, DO, MPH
JAMA. 2005;294:2734-2743.
Context On January 24, 2003, the US Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a bioterrorism event.
Objective To describe results from the comprehensive DHHS smallpox vaccine safety monitoring and response system.
Design, Setting, and Participants Descriptive study of adverse event reports from the DHHS smallpox vaccine safety monitoring and response system received between January 24 and October 31, 2003, through the Vaccine Adverse Event Reporting System (VAERS) and the Centers for Disease Control and Prevention. A total of 37 901 volunteers in 55 jurisdictions received at least 1 dose of smallpox vaccine.
Main Outcome Measures Number of vaccinations administered and description of adverse events and reporting rates.
Results A total of 38 885 smallpox vaccinations were administered, with a take rate of 92%. VAERS received 822 reports of adverse events following smallpox vaccination (overall reporting rate, 217 per 10 000 vaccinees). A total of 590 adverse events (72%) were reported within 14 days of vaccination. Nonserious adverse events (n = 722) included multiple signs and symptoms of mild and self-limited local reactions. One hundred adverse events (12%) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis and/or pericarditis and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized vaccinia and 1 case of postvaccinial encephalitis were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with vaccinia immune globulin were identified. Serious adverse events were more common among older revaccinees than younger first-time vaccinees.
Conclusions Rigorous smallpox vaccine safety screening, educational programs, and older vaccinees may have contributed to low rates of preventable life-threatening adverse reactions. Other rare, clinically significant, or unexpected cardiac adverse events were detected by timely review of VAERS data and intensive clinical case investigation.
Author Affiliations: Smallpox Vaccine Adverse Event Monitoring and Response Activity, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention (CDC), Atlanta, Ga (Drs Casey, Iskander, Roper, Mast, Wen, Török, Chapman, Swerdlow, Morgan, Heffelfinger, Vitek, Reef, Hasbrouck, Neff, Strikas, and Mootrey); Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Coordinating Center for Infectious Diseases (Dr Damon), Office of Preparedness and Emergency Response (Drs Neff and Vellozzi), and Office of the Associate Director for Science (Ms McCauley), National Immunization Program, CDC, Atlanta, Ga; and Logistics Health Inc, La Crosse, Wis (Dr Vellozzi). Drs Casey, Iskander, Roper, Mast, Wen, Török, Swerdlow, Morgan, Heffelfinger, Vitek, Hasbrouck, Neff, and Strikas are now affiliated with different divisions within the CDC.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Disparity between Levels of In Vitro Neutralization of Vaccinia Virus by Antibody to the A27 Protein and Protection of Mice against Intranasal Challenge
Fogg et al.
J. Virol. 2008;82:8022-8029.
ABSTRACT
| FULL TEXT
Differential Antigen Requirements for Protection against Systemic and Intranasal Vaccinia Virus Challenges in Mice
Kaufman et al.
J. Virol. 2008;82:6829-6837.
ABSTRACT
| FULL TEXT
Task Force II: Indirect and Secondary Cardiovascular Effects of Biological Terrorism Agents and Diseases
Ornato et al.
J Am Coll Cardiol 2007;49:1389-1397.
FULL TEXT
Task Force III: Prevention and Control of Cardiovascular Complications of Emerging Infectious Diseases and Potential Biological Terrorism Agents and Diseases
Cooper et al.
J Am Coll Cardiol 2007;49:1398-1406.
FULL TEXT
Task Force IV: Cardiovascular Effects of Emerging Infectious Diseases and Biological Terrorism Threats: Basic, Clinical, and Population Science Research and Training Needs
Madjid et al.
J Am Coll Cardiol 2007;49:1407-1412.
FULL TEXT
From the Cover: Smallpox transmission and control: Spatial dynamics in Great Britain
Riley and Ferguson
Proc. Natl. Acad. Sci. USA 2006;103:12637-12642.
ABSTRACT
| FULL TEXT
Smallpox vaccinations and adverse events.
Cohen et al.
JAMA 2006;295:1897-1898.
FULL TEXT
The smallpox vaccine: An update for oral health care professionals
Rinaggio and Glick
Journal of the American Dental Association 2006;137:452-460.
ABSTRACT
| FULL TEXT
Smallpox Vaccination Associated with Rare Serious Complications
JWatch Emergency Med. 2006;2006:13-13.
FULL TEXT
A Look Back at the Recent Smallpox Vaccination Program
JWatch General 2006;2006:1-1.
FULL TEXT
Neurologic Adverse Events Associated With Smallpox Vaccination in the United States, 2002-2004
Sejvar et al.
JAMA 2005;294:2744-2750.
ABSTRACT
| FULL TEXT
|
