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CDC accepts ACIP recommendations regarding smallpox vaccination and cardiac events and distributes revised pre-vaccination education materials

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    Tuesday, April 01, 2003, 16:21 EST (4:21 PM EST)

    CDCHAN -00134-03-04-01 ADV-N

    The AC IP 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, including myocarditis and/or pericarditis, myocardial infarction, and angina.

    The available data suggest that smallpox vaccine can cause myocarditis and/or pericarditis. However, the number of cases of angina and myocardial infarction reported are compatible with the expected background rate. This means that observed angina and heart attack cases may have a coincidental rather than a causal relation to the vaccine. Nevertheless, as a precautionary measure, it is prudent to defer vaccination at this time of persons most at risk for heart attacks and angina, independent of vaccination.

    Therefore, the AC IP recommended that persons be excluded from the pre-event smallpox vaccination program who have been diagnosed as having a heart condition or ischemic cardiovascular condition, with or without symptoms (such as previous myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart conditions under the care of a doctor). The Committee also recommended that persons be excluded if they have three or more known major cardiac risk factors including hypertension, diabetes, hypercholesterolemia, and smoking. After consulting with experts in cardiology, CDC added to this the additional risk factor of having an immediate family member who has had onset of a heart condition before age 50. The Committee supported including the risk factors in pre-vaccination clinic education materials, so potential vaccinees could evaluate their risk status with their personal physician prior to presentation for vaccination if they had concerns; at the vaccination clinic, verbal screening for known risk factors was recommended.

    The Committee did not recommend special medical follow-up for persons with cardiovascular risk factors who had been vaccinated. Persons with risk factors or known atherosclerotic coronary artery disease should be cared for by their physicians in accordance with standard guidelines for treatment and control of these conditions.

    CDC has accepted the ACIP recommendations and has revised and distributed fact sheets and pre-vaccination clinic education and screening materials that reflect the new exclusion criteria. These revised forms, dated March 31 2003, replace previously distributed versions and should be used immediately in smallpox vaccination clinics. The materials are available at www.cdc.gov/smallpox.

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