Smallpox Disease and Vaccine : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Q. Who will be receiving the smallpox vaccine?

A. Under President Bush's smallpox plan, HHS is working with state and local governments to develop volunteer Smallpox Response Teams. The health-care and emergency workers who will serve on these teams — estimated at nearly half a million people — are being offered the vaccine. The Department of Defense will vaccinate some military and civilian personnel who might be deployed in high-risk areas. Dryvax, the currently licensed product, is the vaccine being used to inoculate smallpox response teams and U.S. troops.

The smallpox vaccine is not recommended for the general public at this time because the risks of the vaccine are currently thought to outweigh its benefits. HHS is working on a process to make smallpox vaccine available to adults who want to be vaccinated. Sufficient supplies of a licensed vaccine are not available for the general public yet, and won't be available until approximately 2004. Members of the general public who choose to be vaccinated now would be vaccinated with an investigational vaccine.

Q. How is the smallpox vaccine given?

A. The smallpox vaccine is not given through a shot. A two-pronged (bifurcated) needle with a droplet of the vaccine is used to prick the skin several times in the upper arm. A red, itchy sore spot at the site of the vaccination within 3-4 days is proof that the inoculation was successful; that is, "it took." A blister develops at the vaccination site and then dries up. A scab falls off in the third week, leaving a small scar.

Q. How effective is the smallpox vaccine?

A. The smallpox vaccine has been proven to be highly effective. The first dose protects against the disease for three to five years, possibly longer. For people who haven't been inoculated who are exposed to smallpox, getting vaccinated within four days of exposure may prevent or lessen the severity of the disease in most people. Effective smallpox inoculation led to the global eradication of smallpox in 1980.

Q. What if you have already been inoculated?

A. People who may have received the smallpox vaccine before 1972 are considered susceptible to the disease. Because the vaccine may only be protective for three years to five years, public health officials are assuming that these people are not protected.

Q. What are the risks of the smallpox vaccine?

A. The smallpox vaccine is made from a virus called vaccinia, which is related to the smallpox virus. It provides immunity against smallpox, but it does not cause smallpox. The vaccinia virus is a live virus that has in the past grown on the skin of calves, sheep, and water buffalo. Dryvax was grown on the skin of calves. Because the virus is live, it is possible to get infected with vaccinia at a site other than the site of vaccination. People who get vaccinated must care for the site properly. Failure to care for the site, such as improperly disposing of bandages, could result in passing vaccinia to other parts of the body or to other people.

The most common side effects from the smallpox vaccine are a sore arm, fever, and body aches. People who get the vaccine should understand potential problems that could occur. Reactions to the vaccine have ranged from mild rashes to rare fatal brain inflammation (encephalitis). In the past, it was estimated that out of every million who received the smallpox vaccine, between one and two people died as a result of a reaction to the vaccine.

Relative to the disease, the smallpox vaccine is very safe. However, some people are at increased risk for complications. People at risk include those with eczema or other skin conditions, pregnant women (the fetus is at increased risk), people with immunodeficiency diseases such as HIV infection, and those with suppressed immune systems, which occurs in people with leukemia, lymphoma, generalized malignancy, or following solid organ transplantation. The CDC will report summaries indicating how many people have been vaccinated and the nature of any adverse events.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.