Heart Issues Linked to Smallpox Vaccine
CDC Suspends Vaccination Program for People with Heart Disease
March 26, 2003 -- People with known heart disease will no longer be eligible for the smallpox vaccine after reports of heart problems in seven healthcare workers who received the vaccine. CDC officials have added a temporary medical deferral to the national smallpox vaccination program for people with heart disease until more is discovered about the link between the smallpox vaccine and a number of heart-related incidents.
The action came after one of the seven people who reported serious heart problems after getting the smallpox vaccine died this weekend from a heart attack. The other cases involved two who also suffered heart attacks, two who experienced chest pain (angina), and two who suffered inflammation of the muscle surrounding the heart after receiving the smallpox vaccine.
The CDC says 25,645 people have received the smallpox vaccine as a part of the voluntary civilian vaccination program that began earlier this year. The smallpox vaccine is being offered to healthcare workers and emergency personnel who would be among the first to respond to a potential bioterrorist attack. It has not yet been made available to the general public.
"We promised to closely monitor this program and to put safety first, so we are exercising exceptional caution," says CDC director Julie Gerberding, MD, in a news release. "If our investigation shows this precautionary measure should become permanent or the need for other changes or enhancements in the civilian smallpox vaccination program, we will take immediate action."
"We continue to believe that it is important and necessary to vaccinate healthcare workers to prepare our nation in the event we have to respond to a smallpox outbreak," says Gerberding.
The CDC added this temporary precaution to the existing list of deferral criteria based on data from a safety monitoring system that tracks adverse events or side effects associated with the smallpox vaccination program. Officials say it's not yet clear whether this number of heart-related effects is higher than would normally be expected in this group.
Based on previous experience, CDC officials say about 1,000 people out of every 1 million who receive the smallpox vaccine will experience serious, but not life-threatening reactions to the vaccine. Most people experience mild reactions, such as a sore arm, fever, and body aches.
However, rare serious reactions do occur. In the past, between 14 and 52 people per 1 million who received the smallpox vaccine suffered potentially life-threatening reactions. CDC officials say some cases of heart inflammation following vaccination were reported in the 1960s and 1970s. But those reports do not provide any information on who might be a higher risk of these types of heart-related problems after getting the smallpox vaccine.
Officials say the medical history of each of the seven individuals is currently being studied for evidence of risk factors for heart disease. The CDC says it is also initiating research projects designed to identify and describe any potential link between the smallpox vaccine and heart-related problems.
For more information on smallpox and how to protect yourself, see WebMD's special report on Biological and Chemical Weapons.
SOURCE: News release, CDC.