Smallpox

In response to concern about smallpox possibly being used as a biological weapon, the President of the United States launched the National Smallpox Pre-Event Vaccination Program on December 13, 2002. The journal Clinical Infectious Diseases published a special supplement entitled “Posteradication Vaccination against Smallpox” on March 15, 2008. The 14 articles in this supplement describe the context in which the national smallpox vaccination program was implemented, and focus on the overall safety and effectiveness of the vaccine.

The following four articles explain the Immunization Safety Office's role in this initiative.

• A “Review of the Smallpox Vaccine Adverse Events Active Surveillance System” first-authored by ISO, explains how the Vaccine Adverse Event Reporting System (VAERS) helped monitor serious health problems among those vaccinated against smallpox as part of the National Smallpox Pre-Event Vaccination Program.
• “Ischemic Cardiac Events during the Department of Health and Human Services Smallpox Vaccination Program, 2003,” co-authored by ISO, notes that out of 37,901 smallpox vaccines, 10 had heart attacks ("ischemic cardiac events") within 28 days of vaccination. Seven of the 10 had three or more risk factors for a heart attack before vaccination. After people with three or more risk factors were excluded from receiving the smallpox vaccine, 6,638 people were vaccinated, and more had heart attacks.
• “Myocarditis, Pericarditis, and Dilated Cardiomyopathy after Smallpox Vaccination among Civilians in the United States, January-October 2003,” co-authored by ISO, explains the risk that people who are vaccinated against smallpox will have heart problems other than heart attacks. The article concludes that the risks are small, but that "future US smallpox vaccination programs should include education material, appropriate clinical follow-up, and adequate surveillance" to prepare for and respond to this risk.
• “A Process for Sentinel Case Review to Assess Causal Relationships between Smallpox Vaccination and Adverse Outcomes, 2003-2004,” co-authored by ISO, reports the results of an investigation into the mysterious death of a young, previously healthy Army reservist a month after being vaccinated against smallpox, typhoid, anthrax, hepatitis B, measles, mumps, and rubella. The scientists were asked to determine if this death was related to the smallpox vaccination, and if so, if this death indicated the existence of an unknown vaccine-associated syndrome. After an extensive review, the authors "identified no pattern that justified recognition of a new possibly smallpox vaccine-associated clinical syndrome," and noted the need for further study on adult responses to multiple vaccines.

Complete List of Articles

“Introduction: Vaccination against Smallpox in the Posteradication Era” by Louisa E. Chapman, Gina T. Mootrey, and Linda J. Neff. Clin Infect Dis 2008 Mar 15;46.

“US Civilian Smallpox Preparedness and Response Program, 2003” by Raymond A. Strikas, Linda J. Neff, Lisa Rotz, Joanne Cono, Donna Knutson, Joseph Henderson, and Walter A. Orenstein. Clin Infect Dis 2008 Mar 15;46.

“Economics of Cardiac Adverse Events after Smallpox Vaccination: Lessons from the 2003 US Vaccination Program” by Ismael R. Ortega-Sanchez, Mercedes M. Sniadack, and Gina T. Mootrey. Clin Infect Dis 2008 Mar 15;46.

“The Smallpox Vaccine Injury Compensation Program” by Paul T. Clark and Stan Levin.Clin Infect Dis 2008 Mar 15;46.

“Evaluating Public Health Responses to Reintroduced Smallpox via Dynamic, Socially Structured, and Spatially Distributed Metapopulation Models” by John W. Glasser, Stanley O. Foster, J. Donald Millar, and J. Michael Lane.Clin Infect Dis 2008 Mar 15;46.

“Performance of an Algorithm for Assessing Smallpox Risk among Patients with Rashes That May Be Confused with Smallpox” by Sonja S. Hutchins, Iddrisu Sulemana, Katherine L. Heilpern, William Schaffner, Gary Wax, E. Brooke Lerner, Barbara Watson, Robert Baltimore, Rachel A. Waltenburg, Dominik Aronsky, Susan Coffin, Gladys Ng, Allen S. Craig, Amy Behrman, James Meek, Eileen Sherman, Sandra S. Chavez, Rafael Harpaz, and Scott Schmid. Clin Infect Dis 2008 Mar 15;46.

“Public Health Surveillance for Suspected Smallpox in the United States, 2003 - 2005: Results of a National Survey” by Sonja S. Hutchins, Guthrie S. Birkhead, Kristin Kenyan, John Abellera, Jennifer Lemmings, and the Council of State and Territorial Epidemiologists Smallpox Working Group. Clin Infect Dis 2008 Mar 15;46.

“A Review of the Smallpox Vaccine Adverse Events Active Surveillance System” by Tracy N. Thomas, Susan Reef, Linda Neff, Mercedes M. Sniadack, and Gina T. Mootrey. Clin Infect Dis 2008 Mar 15;46.

“Pregnancy, Birth, and Infant Health Outcomes from the National Smallpox Vaccine in Pregnancy Registry, 2003 - 2006” by Margaret A. K. Ryan and Jane F. Seward, for the Smallpox Vaccine in Pregnancy Registry Team. Clin Infect Dis 2008 Mar 15;46.

“Dermatological Lesions near the Smallpox Vaccination Site after Scab Detachment” by Andrew Kroger, Claudia Vellozzi, Michael Deming, Christine G. Casey, Xiaojun Wen, and Scott A. Norton. Clin Infect Dis 2008 Mar 15;46.

“Ischemic Cardiac Events during the Department of Health and Human Services Smallpox Vaccination Program, 2003” by David L. Swerdlow, Martha H. Roper, Juliette Morgan, Richard A. Schieber, Laurence S. Sperling, Mercedes M. Sniadack, Linda Neff, Jacqueline W. Miller, Christine R. Curtis, Mona E. Marin, John Iskander, Pedro Moro, Paige Hightower, Nancy H. Levine, Mary McCauley, James Heffelfinger, Inger Damon, Thomas J. Török, Melinda Wharton, Eric E. Mast, Gina T. Mootrey, and the Smallpox Vaccine Cardiac Adverse Events Working Group. Clin Infect Dis 2008 Mar 15;46.

“Myocarditis, Pericarditis, and Dilated Cardiomyopathy after Smallpox Vaccination among Civilians in the United States, January - October 2003” by Juliette Morgan, Martha H. Roper, Laurence Sperling, Richard A. Schieber, James D. Heffelfinger, Christine G. Casey, Jacqueline W. Miller, Scott Santibanez, Barbara Herwaldt, Paige Hightower, Pedro L. Moro, Beth F. Hibbs, Nancy H. Levine, Louisa E. Chapman, John Iskander, J. Michael Lane, Melinda Wharton, Gina T. Mootrey, and David L. Swerdlow, for the Smallpox Vaccine Adverse Event Monitoring and Response Activity. Clin Infect Dis 2008 Mar 15;46.

“Follow-Up of Cardiovascular Adverse Events after Smallpox Vaccination among Civilians in the United States, 2003” by Mercedes M. Sniadack, Linda J. Neff, David L. Swerdlow, Richard A. Schieber, Mary M. McCauley, and Gina T. Mootrey. Clin Infect Dis 2008 Mar 15;46.

“Monitoring the Safety of a Smallpox Vaccination Program in the United States: Report of the Joint Smallpox Vaccine Safety Working Group of the Advisory Committee on Immunization Practices and the Armed Forces Epidemiological Board” by John Neff, John Modlin, Guthrie S. Birkhead, Gregory Poland, Rose Marie Robertson, Kent Sepkowitz, Clyde Yancy, Pierce Gardner, Gregory C. Gray, Toby Maurer, Jane Siegel, Fernando A. Guerra, Tim Berger, W. Dana Flanders, and Robert Shope. Clin Infect Dis 2008 Mar 15;46.

“A Process for Sentinel Case Review to Assess Causal Relationships between Smallpox Vaccination and Adverse Outcomes, 2003 - 2004” by Louisa E. Chapman, John K. Iskander, Robert T. Chen, John Neff, Guthrie S. Birkhead, Gregory Poland, Gregory C. Gray, Jane Siegel, Kent Sepkowitz, Rose Marie Robertson, Clyde Yancy, Fernando A. Guerra, Pierce Gardner, John F. Modlin, Toby Maurer, Tim Berger, W. Dana Flanders, and Robert Shope. Clin Infect Dis 2008 Mar 15;46.