President Bush's Remarks on Smallpox December 2002

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The Above Information About the Smallpox Vaccine Was Provided by The Center for Disease Control in Atlanta, Georgia

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Important Note:Statistical information about smallpox vaccine adverse reactions is based on data from two studies conducted in 1968. Adverse event rates in the United States today may be higher because there may be more people at risk from immune suppression (from cancer, cancer therapy, organ transplants, and illnesses such as HIV/AIDS) and eczema or atopic dermatitis. The outcome associated with adverse events may be less severe than previously reported because of advances in medical care. Rates may be lower for persons previously vaccinated.

After vaccination, it is important to follow care instructions for the site of the vaccine. Because the virus is live, it can spread to other parts of the body, or to other people. The vaccinia virus (the live virus in the smallpox vaccine) may cause rash, fever, and head and body aches. In certain groups of people, complications from the vaccinia virus can be severe. Vaccination within 3 days of exposure will prevent or significantly lessen the severity of smallpox symptoms in the vast majority of people. Vaccination 4 to 7 days after exposure likely offers some protection from disease or may modify the severity of disease. The smallpox vaccine is the best protection you can get if you are exposed to the smallpox virus. Anyone directly exposed to smallpox, regardless of health status, would be offered the smallpox vaccine because the risks associated with smallpox disease are far greater than those posed by the vaccine. There are side effects and risks associated with the smallpox vaccine. Most people experience normal, usually mild reactions that include a sore arm, fever, and body aches. However, other people experience reactions ranging from serious to life-threatening. People most likely to have serious side effects are: people who have had, even once, skin conditions (especially eczema or atopic dermatitis) and people with weakened immune systems, such as those who have received a transplant, are HIV positive, are receiving treatment for cancer, or are currently taking medications (like steroids) that suppress the immune system. In addition, pregnant women should not get the vaccine because of the risk it poses to the fetus. Women who are breastfeeding should not get the vaccine. Children younger than 12 months of age should not get the vaccine. Also, the Advisory Committee on Immunization Practices (ACIP) advises against non-emergency use of smallpox vaccine in children younger than 18 years of age. In addition, those allergic to the vaccine or any of its components should not receive the vaccine. In the past, about 1,000 people for every 1 million people vaccinated for the first time experienced reactions that, while not life-threatening, were serious. These reactions included a toxic or allergic reaction at the site of the vaccination (erythema multiforme), spread of the vaccinia virus to other parts of the body and to other individuals (inadvertent inoculation), and spread of the vaccinia virus to other parts of the body through the blood (generalized vaccinia). These types of reactions may require medical attention. In the past, between 14 and 52 people out of every 1 million people vaccinated for the first time experienced potentially life-threatening reactions to the vaccine. Based on past experience, it is estimated that 1 or 2 people in 1 million who receive the vaccine may die as a result. Careful screening of potential vaccine recipients is essential to ensure that those at increased risk do not receive the vaccine.

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Normal, Typically Mild Reactions The arm receiving the vaccination may be sore and red where the vaccine was given. The glands in the armpits may become large and sore. The vaccinated person may run a low fever. One out of 3 people may feel bad enough to miss work, school, or recreational activity or have trouble sleeping. Serious Reactions In the past, about 1,000 people for every 1 million people vaccinated for the first time experienced reactions that, while not life-threatening, were serious. These reactions may require medical attention: A vaccinia rash or outbreak of sores limited to one area. This is an accidental spreading of the vaccinia virus caused by touching the vaccination site and then touching another part of the body or another person. It usually occurs on the genitals or face, including the eyes, where it can damage sight or lead to blindness. Washing hands with soap and water after touching the vaccine site will help prevent this (inadvertent inoculation). A widespread vaccinia rash. The virus spreads from the vaccination site through the blood. Sores break out on parts of the body away from the vaccination site (generalized vaccinia). A toxic or allergic rash in response to the vaccine that can take various forms (erythema multiforme). Life-Threatening Reactions Rarely, people have had very bad reactions to the vaccine. In the past, between 14 and 52 people per 1 million people vaccinated for the first time experienced potentially life-threatening reactions. These reactions require immediate medical attention: Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis.   Progressive vaccinia (or vaccinia necrosum). Ongoing infection of skin with tissue destruction frequently leading to death.   Postvaccinal encephalitis. Inflammation of the brain. People with certain medical conditions—including people with weakened immune systems or certain skin conditions—are more likely to have these reactions and should not get the smallpox vaccine unless they have been exposed to smallpox. Based on past experience, it is estimated that between 1 and 2 people out of every 1 million people vaccinated may die as a result of life-threatening reactions to the vaccine.

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The Smallpox Vaccine helps the body develop immunity to smallpox. The vaccine is made from a virus called vaccinia which is a “pox”-type virus related to smallpox. The smallpox vaccine contains the “live” vaccinia virus—not dead virus like many other vaccines. For that reason, the vaccination site must be cared for carefully to prevent the virus from spreading. Also, the vaccine can have side effects. The vaccine does not contain the smallpox virus and cannot give you smallpox. According to the Center for Disease Control, the United States currently has a big enough stockpile of smallpox vaccine to vaccinate everyone in the country who might need it in the event of an emergency. Production of new vaccine is underway. Smallpox vaccination provides high level immunity for 3 to 5 years and decreasing immunity thereafter. If a person is vaccinated again later, immunity lasts even longer. Historically, the vaccine has been effective in preventing smallpox infection in 95% of those vaccinated. In addition, the vaccine was proven to prevent or substantially lessen infection when given within a few days of exposure. It is important to note, however, that at the time when the smallpox vaccine was used to eradicate the disease, testing was not as advanced or precise as it is today, so there may still be things to learn about the vaccine and its effectiveness and length of protection. The smallpox vaccine is not given with a hypodermic needle. It is not a shot as most people have experienced. The vaccine is given using a bifurcated (two-pronged) needle that is dipped into the vaccine solution. When removed, the needle retains a droplet of the vaccine. The needle is used to prick the skin a number of times in a few seconds. The pricking is not deep, but it will cause a sore spot and one or two droplets of blood to form. The vaccine usually is given in the upper arm. If the vaccination is successful, a red and itchy bump develops at the vaccine site in three or four days. In the first week, the bump becomes a large blister, fills with pus, and begins to drain. During the second week, the blister begins to dry up and a scab forms. The scab falls off in the third week, leaving a small scar. People who are being vaccinated for the first time have a stronger reaction than those who are being revaccinated. The following pictures show the progression of the site where the vaccine is given.

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