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Press Release

March 28, 2003
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ACIP Summary Statement

The ACIP held an emergency meeting by conference call on Friday, March 28, 2003, to make recommendations to CDC regarding cases of cardiac adverse events that have been reported following smallpox vaccination. A list of participants appears at the bottom of this page.

The specific questions that the Committee was asked to address were:

1. While more information is gathered, are there levels and types of cardiac-related conditions that should be added to the list of reasons for pre-event smallpox vaccine medical deferral?
2. If so, what are the specific pragmatic and feasible methods to screen for these conditions in the vaccine clinic setting?
3. What additional specific operational, policy, or research/investigation advice can the Committee provide to move us forward?
4. Is special follow-up required for persons with cardiovascular risk factors who have been recently vaccinated.

Ten cases of myopericarditis have been reported among several hundred thousand members of the military, and two such cases (one of myocarditis and one of pericarditis) have been reported among civilian vaccinees. Additionally, CDC has received reports of 5 patients with cardiac ischemic events following smallpox vaccination, including 3 patients with myocardial infarctions and two patients with angina. Two of the persons with heart attacks, have died. These cases were reported this week in the MMWR.

Options considered by the Committee included:

1. Exclusion of persons with known underlying heart disease, with or without symptoms.
2. In addition to exclusion of persons with known underlying heart disease, exclude those with 3 or more major cardiac risk factors.
3. In addition to exclusion of persons with known underlying heart disease and three or more risk factors, exclude persons 50 years of age and older.

The Committee recommended that CDC exclude persons with known underlying heart disease and persons with 3 or more major cardiac risk factors (option 2). Draft screening questions were presented to the Committee and will be further reviewed with cardiologists and finalized early next week. The Committee approved CDC抯 proposed research and did not recommend that special medical follow-up was needed for persons with cardiovascular risk factors who had been vaccinated.

However, persons who have received the smallpox vaccine should see a health care provider right away if they develop shortness of breath, chest pain or other symptoms of cardiac disease. Persons who have been diagnosed by a physician as having heart disease and have questions, should contact their heart disease specialist or regular health care provider. All people with heart disease or risk factors should receive the routine care recommended for persons with these conditions.

The ACIP is an advisory committee of the Centers for Disease Control and Prevention.

Participants on March 28 ACIP Meeting

MODLIN, John F., M.D.
Professor of Pediatrics and Medicine
Dartmouth Medical School

SNIDER, Dixie E., Jr., M.D.
Associate Director for Science
Centers for Disease Control and Prevention
Atlanta, Georgia

BIRKHEAD, Guthrie S., M.D.
Director, Center for Community Health
New York State Department of Health

BONOW, Robert (Cardiologist)
American Heart Association

BROOKS, Dennis A., M.D., M.P.H.
Assistant Professor of Pediatrics
Johns Hopkins School of Medicine
Johnson Medical Center

BRAINWALD, Eugene (retired) (Cardiologist)
Harvard
AHA

FOSTER, Valentine (Cardiologist)
Past President AHA

GARDENER, Pierce, M.D.
Fellow of the American College of Physicians Diplomate, ABIM Assoc. Dean of Academic Affairs

GUERRA, Fernando A., M.D.,
Dir. of Health San Antonio Metropolitan Health District

HANSON, I. Celine, M.D.
Bureau Chief
Bureau of Communicable Disease Control
Texas Department of Health

MENSAH, George (Cardiologist)
CDC

LEVIN, Myron J., M.D.
Professor of Pediatrics & Medicine
Chief, Pediatric Infectious Diseases
University of Colorado School of Medicine

NEFF, John M.D. (SP Vac. Safety Working Gp.)
Dir. Center for Children with Special Needs
Div. of General Pediatrics Children's Hospital and Regional Medical Center
Univ. of Washington School of Medicine

NEWCASTLE, Katherine
State Health Dept. AE coordinator

OFFIT, Paul A., M.D.
Chief, Section of Infectious Diseases
The Children's Hospital of Philadelphia

RENNELS, Margaret B., M.D.
Professor, Department of Pediatrics
University of Maryland School of Medicine

SALAMONE, John E.
National Italian American Foundation

SIEGEL, Jane D., M.D. (SP Vaccine Safety Working group (SVSWG))
Professor of Pediatrics
Department of Pediatrics
University of Texas

SMITH, Natalie J., M.D., M.P.H.
Chief, Immunization Branch
Division, Communicable Disease Control
California Department of Health Services

TOMPKINS, Lucy S., M.D., Ph.D.
Professor, Department of Medicine and Microbiology and Immunology
Stanford University Medical Center

Other Who Spoke

GRABENSTEIN, John (DOD)
Deputy Dir. Of Clinical Operations
Smallpox Vaccine Immunization Program

For more information on smallpox, visit http://www.bt.cdc.gov/agent/smallpox/.

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