Sarah Bennett
Smallpox is an acute, contagious, and sometimes fatal disease that was eradicated following worldwide vaccination programs. Although smallpox was eliminated in 1980, the threat of a bioterrorist attack using smallpox as a weapon has led to the resumption of smallpox vaccination programs in the U.S. and the stockpiling of vaccines. While there are vaccines to protect against smallpox, they are not recommended or available for the general public. Instead, the CDC has implemented a program to vaccinate key healthcare professionals.
| Characteristics | Values |
|---|---|
| Smallpox vaccine availability in the USA | Smallpox vaccines are not available to the general public. However, there are sufficient vaccines to immunize everyone in the event of an emergency or outbreak. |
| Smallpox vaccine composition | The smallpox vaccine contains live vaccinia virus, not a killed or weakened virus. |
| Smallpox vaccine safety | The smallpox vaccine does not contain the smallpox virus and cannot give you smallpox. Live virus vaccines are generally safe and effective for people with healthy immune systems. |
| Smallpox vaccine side effects | Mild symptoms such as rash, fever, and body aches may occur for some individuals who receive the live virus vaccine. |
| Smallpox vaccine administration | The smallpox vaccine is not given with a hypodermic needle or a traditional shot. It is administered using a bifurcated (two-pronged) needle dipped into the vaccine solution. |
| Smallpox eradication | Smallpox was eradicated by 1980 due to worldwide vaccination programs. Mandatory smallpox vaccination played a significant role in its elimination. |
| Smallpox vaccine stockpiles | There are stockpiles of first, second, and third-generation smallpox vaccines available. Aventis Pasteur donated a stockpile of vaccines from the 1950s to the US government. |
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What You'll Learn
Smallpox vaccines are not available to the general public
Smallpox is a highly contagious and sometimes fatal disease caused by an orthopoxvirus. It is characterised by fever and a progressive skin rash. In 1980, the disease was eradicated following worldwide vaccination programs. However, in the aftermath of the events of September and October 2001, the US government is taking precautions to be ready to deal with a bioterrorist attack using smallpox as a weapon.
While smallpox vaccines do exist, they are not currently available to the general public. The vaccines contain a live vaccinia virus, not a killed or weakened virus like other vaccines. This means that those who are vaccinated must take precautions to prevent the virus from spreading from the site of vaccination. For most people with healthy immune systems, live virus vaccines are safe and effective. However, they can sometimes cause mild symptoms such as rashes, fever, and body aches.
In May 2007, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted that a new live virus vaccine, ACAM2000, is safe and effective for those at high risk of smallpox exposure. However, due to the high rate of adverse effects, the vaccine is only available to the CDC for the Strategic National Stockpile.
There are stockpiles of smallpox vaccines in the US, and plans in place to immunize everyone who might need it in the event of an emergency. Routine vaccination for smallpox has been discontinued in the US, but key healthcare professionals were vaccinated in 2003.
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Smallpox vaccines are safe and effective for those at high risk
Smallpox vaccines have been around since the late 18th century when Dr. Edward Jenner of Gloucestershire, England, discovered that milkmaids exposed to cowpox were immune to smallpox. Since then, three generations of smallpox vaccines have been developed, all of which are available in stockpiles.
First-generation vaccines, grown on the skin of live animals, were widely distributed in the 1950s–1970s to eradicate smallpox. Second-generation vaccines, grown in chorioallantoic membrane or cell cultures, offered greater purity and were used in some areas during the smallpox eradication campaign. Third-generation vaccines, based on attenuated strains of vaccinia, saw limited use before smallpox was eradicated.
While the smallpox vaccine is generally safe and effective, it is associated with a range of side effects, from mild to severe. Mild reactions include fever, muscle aches, fatigue, headache, nausea, rashes, and soreness at the vaccination site. More severe side effects include heart pain (angina), heart inflammation (myocarditis), and inflammation of the membrane covering the heart lining (pericarditis). People with weakened immune systems or certain skin conditions are more likely to experience serious side effects. Pregnant women, breastfeeding women, individuals under 18, and those allergic to the vaccine are advised not to receive the smallpox vaccine.
Despite the potential side effects, the smallpox vaccine is considered safe and effective for those at high risk of exposure to the smallpox virus. In 2007, the US Food and Drug Administration (FDA) approved a new live virus vaccine, ACAM2000, for use in high-risk individuals. However, due to the high rate of adverse effects, this vaccine is only available to the CDC for the Strategic National Stockpile. The United States currently maintains a stockpile of smallpox vaccines sufficient to vaccinate everyone who might need it in an emergency, with production of new vaccines underway.
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Smallpox was eradicated by 1980 due to vaccination
Smallpox was a deadly disease that killed hundreds of millions of people over thousands of years. It did not discriminate, killing at least one in three people infected, often within two weeks. The symptoms were gruesome: a high fever, vomiting, mouth sores, and fluid-filled lesions on the whole body. Survivors were sometimes left with permanent harm, including blindness and infertility.
The first successful vaccine was developed by Edward Jenner in 1796. He observed that milkmaids who had previously caught cowpox did not catch smallpox and showed that a similar inoculation could be used to prevent smallpox in other people. In the 1840s and 1850s, mandatory smallpox vaccination came into effect in Britain and parts of the United States of America, with smallpox vaccination certificates required for travel. While some European regions eliminated the disease by 1900, smallpox continued to ravage other areas, with over 2 million people dying every year.
In 1958, the World Health Assembly called for the global eradication of smallpox – the permanent reduction to zero cases without the risk of reintroduction. The following year, the World Health Organization (WHO) launched the Smallpox Eradication Programme, with enhanced support and cooperation from member states. In 1967, the WHO intensified its efforts with the launch of the Intensified Smallpox Eradication Programme. This campaign saw the use of a two-pronged fork that could hold one dose of reconstituted freeze-dried vaccine, which was easy to use, cheap to produce, and repeatedly reusable after flame sterilization.
In the 1970s, universal childhood immunization programmes, mass vaccination, and targeted surveillance-containment strategies were key components of the worldwide eradication effort. The last naturally occurring case of the deadly Variola major was detected in a three-year-old Bangladeshi girl, Rahima Banu, in October 1975. The final known natural case of smallpox was in Somalia in 1977, in a hospital cook named Ali Maow Maalin.
In 1979, a commission of eminent scientists certified the global eradication of smallpox, and this was endorsed by the World Health Assembly in May 1980. Smallpox is one of only two infectious diseases to have been eradicated, the other being rinderpest in 2011. Since the eradication era, safer vaccines and specific treatments have been developed for smallpox and related diseases such as monkeypox.
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The smallpox vaccine contains a live vaccinia virus
The live vaccinia virus in the smallpox vaccine is not a killed or weakened virus, as is the case with many other vaccines. This means that vaccinated individuals must take precautions to prevent the virus from spreading from the vaccination site to other parts of the body or to other people. For example, the vaccination site on the arm must be carefully maintained. Typically, a successful smallpox vaccination will result in a red, itchy sore spot at the site of vaccination within 3-4 days. A blister will then develop and eventually dry up, forming a scab that falls off in the third week, leaving a small scar.
The vaccinia virus in the smallpox vaccine is similar to the one used in the global eradication of smallpox, Dryvax, which was grown on the skin of calves and freeze-dried for storage. The smallpox vaccine, ACAM2000, is a second-generation vaccine derived from a clone of Dryvax and produced using modern cell culture technology. Second-generation vaccines are grown in a sterile environment, unlike first-generation vaccines, which contain skin bacteria from the animal the vaccine was grown on.
The ACAM2000 smallpox vaccine is manufactured by Emergent Product Development Gaithersburg, Inc. and has been approved by the FDA for active immunization against smallpox for those at high risk of smallpox infection. The United States received 269 million doses of ACAM2000 by 2019, and the vaccine was approved for mpox prevention in the US in August 2024.
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The US government has plans to deal with a bioterrorist attack using smallpox
Smallpox is one of the six pathogens considered a serious threat for bioterrorism. The United States has plans in place to deal with a bioterrorist attack using smallpox, which include rebuilding its vaccine supply, training diagnostic laboratories, enhancing the availability of clinical and epidemiologic information, and completing a detailed plan for handling a smallpox attack.
The US government is stockpiling the smallpox drug Arestvyr, which can be used in combination with the smallpox vaccine to offer double protection. The government is also paying for each course of treatment as part of its efforts to prepare for a possible bioterrorism attack. As of 2013, the US had stockpiled 300 million doses of the smallpox vaccine, up from 15 million in 2001. The US government has also rebuilt its vaccine supply and completed a detailed plan for handling a smallpox attack.
The smallpox vaccine contains the live vaccinia virus, and while it is safe and effective for use in persons at high risk of exposure to the smallpox virus, it is not recommended for the general public. The vaccine does not contain the smallpox virus and cannot give someone smallpox. However, people who have been vaccinated may still experience mild symptoms such as a rash, fever, and head and body aches. The vaccine also does not give lifelong immunity, and previously vaccinated individuals may need to be revaccinated in a smallpox emergency.
If smallpox were used in a bioterrorist attack, public health authorities would likely find out once the first infected person went to a hospital for treatment of an unknown illness. Local public health authorities would then alert state and federal public health officials, who would work to diagnose the disease. If smallpox is confirmed, the CDC, along with state and local public health authorities, would put into place their plans to respond to a bioterrorist attack with smallpox.
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Frequently asked questions
Smallpox vaccines are not available to the general public in the USA. However, there are enough vaccines stockpiled to immunize everyone who might need it in the event of an emergency.
The smallpox vaccine is only recommended for people at high risk of exposure to the smallpox virus. In 2003, a program was started to vaccinate key healthcare professionals.
The smallpox vaccine contains live vaccinia virus. It is not administered with a hypodermic needle but with a bifurcated (two-pronged) needle that is dipped into the vaccine solution.
