Delaware Health Alert Network #21
April 2, 2003 2:22 pm
Health Advisory CDC ACCEPTS ACIP RECOMMENDATIONS REGARDING SMALLPOX VACCINATION AND CARDIAC EVENTS AND DISTRIBUTES REVISED PRE-VACCINATION EDUCATION MATERIALS
CDC has issued the Health Advisory below concerning smallpox vaccination and cardiac events. Because the Division of Public
Health (DPH) will be administering smallpox vaccinations throughout April, this Advisory provides important information that may help
health care providers advise and evaluate patients who have received or who are considering smallpox vaccination.
DPH has vaccinated 92 people since inception of the program and no cardiac complications have occurred. DPH has contacted all
current vaccinees regarding concerns about cardiac events associated with vaccination and instructed vaccinees to contact their primary care provider upon the earliest symptoms of a cardiac illness. On March 27, DPH revised protocols to include screening for a history of
heart disease and risk factors as a contraindication to smallpox vaccination.
Questions about this advisory for DPH should be directed to 1-888-295-5156.
This is an official CDC Health Advisory
April 1, 2003, 16:21 EST (4:21 PM EST)
CDCHAN-00134-03-04-01-ADV-N
CDC Accepts ACIP Recommendations Regarding Smallpox Vaccination and Cardiac Events and Distributes Revised Pre-Vaccination Education Materials
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, 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 ACIP 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: http://www.bt.cdc.gov/agent/smallpox/index.asp.
Background
There is evidence suggesting that smallpox vaccination may cause cases of heart inflammation (myocarditis), inflammation of the membrane
covering the heart (pericarditis), and a combination of these two problems (myopericarditis). Most reported cases have occurred in
military personnel, who received more than 350,000 doses of smallpox vaccine since December 13, 2002. Overall, military personnel
experienced a rate of myopericarditis of approximately 1 per 20,000 primary vaccinated persons (i.e., people vaccinated for the first
time). This rate is much higher than expected based on historical data and experience. There have been no cases in military people who
had previously received the smallpox vaccine. Cases, aged 21 to 33 years, ranged from mild (no ECG or echocardiogram changes) to severe
(transient heart failure), with onset 7 to 19 days after vaccination. They all survived. The newest case is still in the hospital as of
March 31, 2003. The others have been discharged from hospital, and have either returned to duty or are on short-term convalescent leave
to regain their strength.
In the civilian smallpox vaccination program, as of March 21, 2003, 25,645 persons had been vaccinated. One case of myocarditis and 2
cases of pericarditis have been reported to date. Patients were 45, 45, and 56 years of age, and two were reported to be revaccinees; the
vaccination status of the other patient is unknown. Dates of onset were 2 days, 12 days, and 17 days following vaccination; the patient
with onset at 2 days had some symptoms prior to vaccination.
As of March 30, 2003, six ischemic (e.g., heart attacks or angina) events – 4 heart attacks and 2 cases of angina – have been reported
among civilian vaccinees within 3 weeks of vaccination. Two of the heart attacks presented as out-of-hospital cardiac arrests, and both
patients died. Patients ranged in age from 43 to 69 years; all but one were 54 years of age or older. All but one patient had known
cardiac risk factors; four are known to have three or more risk factors, and thus would have been excluded from vaccination by the
ACIP’s new recommendations for pre-vaccination screening (we are still awaiting clinical information on the most recently reported
case, and it is possible that that case would have been excluded as well). Additionally, a 55 year old military vaccinee died following
vaccination. Autopsy showed a prior myocardial infarction, three-vessel coronary artery disease, and left ventricular hypertrophy.
Histopathology revealed evidence of no myo-pericarditis in this man.
Categories of Health Alert messages:
- Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
- Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
- Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.
Delaware Health Alert Network #21
April 2, 2003 2:22 pm
Health Advisory CDC ACCEPTS ACIP RECOMMENDATIONS REGARDING SMALLPOX VACCINATION AND CARDIAC EVENTS AND DISTRIBUTES REVISED PRE-VACCINATION EDUCATION MATERIALS
CDC has issued the Health Advisory below concerning smallpox vaccination and cardiac events. Because the Division of Public
Health (DPH) will be administering smallpox vaccinations throughout April, this Advisory provides important information that may help
health care providers advise and evaluate patients who have received or who are considering smallpox vaccination.
DPH has vaccinated 92 people since inception of the program and no cardiac complications have occurred. DPH has contacted all
current vaccinees regarding concerns about cardiac events associated with vaccination and instructed vaccinees to contact their primary care provider upon the earliest symptoms of a cardiac illness. On March 27, DPH revised protocols to include screening for a history of
heart disease and risk factors as a contraindication to smallpox vaccination.
Questions about this advisory for DPH should be directed to 1-888-295-5156.
This is an official CDC Health Advisory
April 1, 2003, 16:21 EST (4:21 PM EST)
CDCHAN-00134-03-04-01-ADV-N
CDC Accepts ACIP Recommendations Regarding Smallpox Vaccination and Cardiac Events and Distributes Revised Pre-Vaccination Education Materials
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, 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 ACIP 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: http://www.bt.cdc.gov/agent/smallpox/index.asp.
Background
There is evidence suggesting that smallpox vaccination may cause cases of heart inflammation (myocarditis), inflammation of the membrane
covering the heart (pericarditis), and a combination of these two problems (myopericarditis). Most reported cases have occurred in
military personnel, who received more than 350,000 doses of smallpox vaccine since December 13, 2002. Overall, military personnel
experienced a rate of myopericarditis of approximately 1 per 20,000 primary vaccinated persons (i.e., people vaccinated for the first
time). This rate is much higher than expected based on historical data and experience. There have been no cases in military people who
had previously received the smallpox vaccine. Cases, aged 21 to 33 years, ranged from mild (no ECG or echocardiogram changes) to severe
(transient heart failure), with onset 7 to 19 days after vaccination. They all survived. The newest case is still in the hospital as of
March 31, 2003. The others have been discharged from hospital, and have either returned to duty or are on short-term convalescent leave
to regain their strength.
In the civilian smallpox vaccination program, as of March 21, 2003, 25,645 persons had been vaccinated. One case of myocarditis and 2
cases of pericarditis have been reported to date. Patients were 45, 45, and 56 years of age, and two were reported to be revaccinees; the
vaccination status of the other patient is unknown. Dates of onset were 2 days, 12 days, and 17 days following vaccination; the patient
with onset at 2 days had some symptoms prior to vaccination.
As of March 30, 2003, six ischemic (e.g., heart attacks or angina) events – 4 heart attacks and 2 cases of angina – have been reported
among civilian vaccinees within 3 weeks of vaccination. Two of the heart attacks presented as out-of-hospital cardiac arrests, and both
patients died. Patients ranged in age from 43 to 69 years; all but one were 54 years of age or older. All but one patient had known
cardiac risk factors; four are known to have three or more risk factors, and thus would have been excluded from vaccination by the
ACIP’s new recommendations for pre-vaccination screening (we are still awaiting clinical information on the most recently reported
case, and it is possible that that case would have been excluded as well). Additionally, a 55 year old military vaccinee died following
vaccination. Autopsy showed a prior myocardial infarction, three-vessel coronary artery disease, and left ventricular hypertrophy.
Histopathology revealed evidence of no myo-pericarditis in this man.
Categories of Health Alert messages:
- Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
- Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
- Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.
Delaware Health Alert Network #21
April 2, 2003 2:22 pm
Health
Advisory
CDC ACCEPTS ACIP RECOMMENDATIONS REGARDING SMALLPOX VACCINATION AND CARDIAC EVENTS AND DISTRIBUTES
REVISED PRE-VACCINATION EDUCATION MATERIALS
CDC has issued the Health Advisory below concerning smallpox vaccination and cardiac events. Because the Division of Public
Health (DPH) will be administering smallpox vaccinations throughout April, this Advisory provides important information that may help
health care providers advise and evaluate patients who have received or who are considering smallpox vaccination.
DPH has vaccinated 92 people since inception of the program and no cardiac complications have occurred. DPH has contacted all
current vaccinees regarding concerns about cardiac events associated with vaccination and instructed vaccinees to contact their primary
care provider upon the earliest symptoms of a cardiac illness. On March 27, DPH revised protocols to include screening for a history of
heart disease and risk factors as a contraindication to smallpox vaccination.
Questions about this advisory for DPH should be directed to 1-888-295-5156.
This is an official
CDC Health Advisory
April 1, 2003, 16:21 EST (4:21 PM EST)
CDCHAN-00134-03-04-01-ADV-N
CDC Accepts ACIP Recommendations Regarding Smallpox Vaccination and Cardiac Events
and Distributes Revised Pre-Vaccination Education Materials
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, 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 ACIP 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: http://www.bt.cdc.gov/agent/smallpox/index.asp.
Background
There is evidence suggesting that smallpox vaccination may cause cases of heart inflammation (myocarditis), inflammation of the membrane
covering the heart (pericarditis), and a combination of these two problems (myopericarditis). Most reported cases have occurred in
military personnel, who received more than 350,000 doses of smallpox vaccine since December 13, 2002. Overall, military personnel
experienced a rate of myopericarditis of approximately 1 per 20,000 primary vaccinated persons (i.e., people vaccinated for the first
time). This rate is much higher than expected based on historical data and experience. There have been no cases in military people who
had previously received the smallpox vaccine. Cases, aged 21 to 33 years, ranged from mild (no ECG or echocardiogram changes) to severe
(transient heart failure), with onset 7 to 19 days after vaccination. They all survived. The newest case is still in the hospital as of
March 31, 2003. The others have been discharged from hospital, and have either returned to duty or are on short-term convalescent leave
to regain their strength.
In the civilian smallpox vaccination program, as of March 21, 2003, 25,645 persons had been vaccinated. One case of myocarditis and 2
cases of pericarditis have been reported to date. Patients were 45, 45, and 56 years of age, and two were reported to be revaccinees; the
vaccination status of the other patient is unknown. Dates of onset were 2 days, 12 days, and 17 days following vaccination; the patient
with onset at 2 days had some symptoms prior to vaccination.
As of March 30, 2003, six ischemic (e.g., heart attacks or angina) events – 4 heart attacks and 2 cases of angina – have been reported
among civilian vaccinees within 3 weeks of vaccination. Two of the heart attacks presented as out-of-hospital cardiac arrests, and both
patients died. Patients ranged in age from 43 to 69 years; all but one were 54 years of age or older. All but one patient had known
cardiac risk factors; four are known to have three or more risk factors, and thus would have been excluded from vaccination by the
ACIP’s new recommendations for pre-vaccination screening (we are still awaiting clinical information on the most recently reported
case, and it is possible that that case would have been excluded as well). Additionally, a 55 year old military vaccinee died following
vaccination. Autopsy showed a prior myocardial infarction, three-vessel coronary artery disease, and left ventricular hypertrophy.
Histopathology revealed evidence of no myo-pericarditis in this man.
Categories of Health Alert messages:
- Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
- Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
- Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
