SMALLPOX FACT SHEET

Vaccine Overview

The Smallpox Vaccine

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 (see the section “Smallpox Vaccine Safety” in this fact sheet). The vaccine does not contain the smallpox virus and cannot give you smallpox.

Currently, the United States has a big enough stockpile of smallpox vaccine to vaccinate everyone in the United States in the event of a smallpox emergency.

Length of Protection

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.

Receiving the Vaccine

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.

Smallpox vaccination site
Days 4 through 21

view enlarged image

Post-Vaccination Care

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 (see the section “Smallpox Vaccine Safety” in this fact sheet), complications from the vaccinia virus can be severe.

Benefit of Vaccine Following Exposure

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.

Smallpox Vaccine Safety

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. Also, people who have been diagnosed by a doctor as having a heart condition with or without symptoms, including conditions such as previous myocardial infarction (heart attack), angina (chest pain caused by lack of blood flow to the heart), congestive heart failure, and cardiomyopathy (heart muscle becomes inflamed and doesn’t work as well as it should), stroke or transient ischemic attack (a “mini-stroke” that produces stroke-like symptoms but not lasting damage), chest pain or shortness of breath with activity (such as walking up stairs), or other heart conditions being treated by a doctor should not get the vaccine at this time. (Heart disease may be a temporary exclusion and may change as more information is gathered.) Also, individuals who have 3 or more of the following risk factors should not get the vaccine at this time: high blood pressure diagnosed by a doctor; high blood cholesterol diagnosed by a doctor; diabetes or high blood sugar diagnosed by a doctor; a first degree relative (for example, mother, father, brother or sister) with a heart condition before the age of 50; and/or, currently a cigarette smoker. (These may be temporary exclusions and may change as more information is gathered.)

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.

Smallpox Vaccine Availability

Routine smallpox vaccination among the American public stopped in 1972 after the disease was eradicated in the United States. Until recently, the U.S. government provided the vaccine only to a few hundred scientists and medical professionals working with smallpox and similar viruses in a research setting.

After the events of September and October, 2001, however, the U.S. government took further actions to improve its level of preparedness against terrorism. One of many such measures—designed specifically to prepare for an intentional release of the smallpox virus—included updating and releasing a smallpox response plan. In addition, the U.S. government has enough vaccine to vaccinate every person in the United States in the event of a smallpox emergency.

For more about vaccination, see Smallpox Vaccine.