Smallpox can be prevented through the use of the smallpox vaccine. The World Health Organization (WHO) used smallpox vaccine to eradicate natural smallpox from the planet. About 95% of people are protected within 10 days of getting a single smallpox vaccination.
Until recently, most service members had not been vaccinated against smallpox. The rest don't have much immunity left from vaccine given years ago. Until the late 1970s, many billions of people around the globe received smallpox vaccine. Smallpox vaccine is still used routinely to protect a small number of people who work with smallpox vaccine virus (vaccinia) or similar viruses. Between December 2002 and January 2008, more than 1.4 million service members received smallpox vaccination.
There is no proven treatment for the smallpox disease, but research to evaluate new antiviral medications is ongoing. Patients infected with smallpox can benefit from supportive therapy (e.g., intravenous fluids, medicine to control fever or pain) and antibiotics for any secondary bacterial infections that occur from all the skin problems smallpox causes.
Research indicates that the first dose of smallpox vaccine offers an increased level of protection from smallpox for 3 years. Immunity decreases thereafter. Substantial, but waning immunity persists for 7-10 years. Subsequent vaccinations increase and extend protection. After 3 doses substantial protection persists for >30 years.
In that European study, about 30% of unvaccinated people infected with smallpox died. About 1.4% of people vaccinated up to 10 years earlier died. Among people vaccinated 11 to 20 years earlier, 7% died. Among people vaccinated 21 or more years earlier, 11% died. These data show that immunity falls off over time and that revaccination is needed to maintain immunity. [Mack TM. Smallpox in Europe, 1950-1971. J Infect Dis 1972; 125:161-169]
In December 2002, the Secretary of Defense decided to vaccinate certain emergency response and medical personnel and other designated personnel that constitute critical mission capabilities to include those essential to the accomplishment of U.S. Central Command's (CENTCOM) missions. In June 2004, DoD expanded the program to include more forces and people in Korea, the US Pacific Command Forward Deployed Naval Forces and CENTCOM Area of Operations (AOR). In September 2007, the ASD (P & R) changed the pre-deployment timeframe for smallpox vaccine administration to 120 days.
For complete information regarding policy, please review the "Policy" section of our website under "Resource Center".
We begin with the assumption that any service member covered by this policy who refuses vaccination may be uninformed about the facts related to the deadly effects of the smallpox virus and the protection afforded by the vaccine. Our first action with those who might refuse the vaccine will be to determine their concern and provide information.
This is a force protection issue. If a service member continues to refuse the vaccine, then a commander will manage the situation as he or she would for any failure to obey a lawful order, including educating the member about the smallpox vaccine as appropriate.
Smallpox is a very serious disease; it is contagious and sometimes fatal. Smallpox is caused by a germ called variola virus.
The symptoms of smallpox begin with high fever, head and body aches, and sometimes vomiting. These symptoms are followed by a rash that spreads from the head and extremities toward the center of the body, then progresses to raised bumps that eventually scab over and fall off after about three weeks, leaving a pitted scar.
Smallpox can cause:
Natural cases of smallpox have been eradicated. The last natural case of smallpox was in Somalia in 1977.
The incubation period for smallpox is about 12 to 14 days (range: 7 to 17 days) after exposure.
The disease usually requires face-to-face contact with a contagious person for several hours. Contact with infected skin could also transmit the virus. Spread by contact with inanimate objects (e.g., clothing, towels, linens) would be less common.
People with smallpox are contagious from when their temperature goes over 101°F (38.3°C). They stay contagious until all their scabs fall off.
Not everybody who talks with a smallpox patient will get the disease. People with smallpox can infect about half of the people who live in their household. On average, each infected person can infect about 5 other people. Those other people show symptoms about 15 days after exposure.
The most common way to transmit smallpox would be from prolonged face-to-face contact. People infected with smallpox exhale little droplets that carry the virus to the nose or mouth of bystanders. The greatest risk comes from prolonged face-to-face contact (6 feet or less, most often after 1 or more hours), with an infected person, especially one who is coughing. Indirect contact through fine-particle aerosolization or contaminated inanimate objects can spread the virus as well, though less efficiently.
Special precautions need to be taken to thoroughly clean all bedding and clothing of smallpox patients with bleach and hot water. Disinfectants such as household bleach or hospital-approved quaternary ammonia disinfectants can be used for cleaning contaminated surfaces.
Animals and insects do not carry or transmit smallpox disease. Smallpox is not spread by food or water.
No. The symptoms of the disease start with body ache and sometimes vomiting with a high fever over 101o. Over the next few days, pus-filled blisters develop over large portions of the body.
The vaccine side effects are usually limited to itching, fever, body ache, swollen lymph nodes, sore arm, mild rash as well as a rash at the injection site. People given a smallpox vaccination need to know the expected response at the vaccination site.
The smallpox virus is fragile. In laboratory experiments, 90% of aerosolized (vaccinia virus [a model for smallpox virus]) dies within 24 hours; in the presence of ultraviolet (UV) light, this percentage would be even greater. If an aerosol release of smallpox occurs, 90% of virus matter will be inactivated or dissipated in about 24 hours.
Standard hospital-grade disinfectants such as quaternary-ammonia compounds are effective in killing the virus. They should be used on surfaces to disinfect hospitalized patients rooms or other contaminated surfaces. Although less desirable because it can damage equipment and furniture, hypochlorite (bleach) is an acceptable alternative. In the hospital setting, patients linens should be autoclaved or washed in hot water with bleach added. Infectious waste should be placed in biohazard bags and autoclaved before incineration.
The most important steps to stop a smallpox epidemic are isolation of smallpox cases, tracing of the contacts of these cases, and vaccination.
Patients showing signs of smallpox infection are capable of spreading the virus. Patients should be placed in medical isolation, so that they will not continue to spread the virus. In addition, people who have come into close contact with smallpox patients should be vaccinated immediately and closely watched for symptoms of smallpox. Vaccination and isolation are the key strategies for stopping a smallpox outbreak from spreading.
Smallpox vaccine contains live vaccinia virus (not smallpox virus) to protect against smallpox. This same vaccine has been given to millions of Americans, including Service members during World War I, World War II, and until the 1980s. Between December 2002 and January 2008, more than 1.4 Million Service members received smallpox vaccination.
The vaccine is made from a virus called vaccinia, which is another "pox"-type virus related to smallpox. The vaccine helps the body develop immunity to smallpox. The vaccine does not contain the smallpox virus and cannot spread smallpox. The vaccine was successfully used to eradicate smallpox from the human population.
The vaccine virus (vaccinia) is similar to the smallpox virus (variola). Edward Jenner reported in 1796 that people given vaccinia (smallpox) vaccine become protected from smallpox. Smallpox vaccine was the very first vaccine and has been used successfully for over 200 years.
Getting smallpox vaccine before exposure will protect about 95 percent of people from getting smallpox. Vaccination within 3 days after 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. Vaccination after this time may not offer any benefit.
Both Dryvax and ACAM2000 are derived from the New York City Board of Health strain using a pox virus called vaccinia, but Dryvax was grown on the skin of calves and essentially freeze-dried for storage. Dryvax was licensed and approved by the FDA, in 1931 and is now in limited supply because it is no longer manufactured.
ACAM2000, Smallpox (Vaccinia) Vaccine, Live, approved by FDA in 2007, is a live vaccinia virus derived from plaque purification cloning from Dryvax®, grown in African Green Monkey kidney (Vero) cells, and tested to be free of adventitious agents.
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ACAM2000, Smallpox (Vaccinia) Vaccine, Live is supplied in multiple-dose 3 mL clear glass vials containing lyophilized powder (freeze-dried vaccine). After reconstitution with 0.3 mL of diluent, the vial contains approximately 100 nominal doses of 0.0025 mL of vaccinia virus (live,) 1.0 - 5.0x108 PFU/mL or 2.5-12.5x105 PFU/dose.
Diluent for ACAM2000 is supplied in 3 mL clear glass vials containing 0.6 mL of diluent.
Bifurcated needles are supplied in boxes (5 x 5 x 1 in) containing 100 needles.
1 mL tuberculin syringes with 25 gauge x 5/8" needles are supplied for vaccine reconstitution.
Prior to reconstitution, ACAM2000 vaccine retains a potency of 1.0x108 PFU or higher per dose for at least 18 months when stored at refrigerated temperatures of 2-8°C (36-46°F).
After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). Do not expose ACAM2000 to room temperature conditions for more than 48 hours. Reconstituted ACAM2000 vaccine may be stored in a refrigerator (2-8°C, 36-46°F) no longer than 30 days, after which it should be discarded.
Diluent for Smallpox Vaccine, (Vero Cells) Lyophilized, ACAM2000 should be stored in a refrigerator (2-8°C, 36-46°F). ACAM2000 contains live vaccinia virus that is transmissible, and should be handled as an infectious agent once vials are opened.
The vaccine contains live vaccinia virus derived from plaque purification cloning from Dryvax (Wyeth Laboratories, Marietta, PA, calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells.
Inactive ingredients: 6-8 mM HEPES (pH 6.5-7.5), 2% human serum albumin USP, 0.5 - 0.7% sodium chloride USP, 5% mannitol USP, and trace amounts of the antibiotics neomycin and polymyxin B.
Diluent for ACAM2000: 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP, 0.3 mLs.
Smallpox vaccination of US military forces dates back to 1812. Smallpox vaccine has been given to millions of Americans, including Service members during World War I, World War II, and into the 1980s.
In the United States, routine vaccination against smallpox ended around 1972 in most places. Military smallpox vaccination programs continued longer. In 1984, routine military vaccinations were limited to recruits entering basic training. Between 1984 and 1989, some service members were immunized but not others. In 1990, the Department of Defense discontinued routine vaccination of recruits.
Between December 2002 and January 2008 more than 1.4 M Service members received smallpox vaccination.
People in many countries are concerned about the potential use of smallpox as a bioterrorism agent. The U.S. government has been preparing for some time for the remote possibility of an outbreak of smallpox as an act of terror. Those preparations quickened after September 11, 2001.
The likelihood that smallpox would be used as a bioweapon is unknown. About 30 percent of people who contract smallpox die; about 70% survive.
Vaccination prevents almost all cases of smallpox. If symptoms of smallpox do appear, they are generally milder than in unvaccinated people.
Mild reactions include swelling and tender lymph nodes that can last two to four weeks after the blister heals. Most people develop itching, headache, fatigue, muscle aches, pain, or chills after smallpox vaccination, usually about eight to 12 days later. Some individuals may have rashes that last two to four days. These side effects are usually temporary and self-limiting, meaning they go away on their own or with minimal medical treatment, for example aspirin and rest.
If the vaccination is successful, a red and itchy bump develops at the vaccine site in three or four days. Then, in the first week, the bump becomes a large blister and fills with pus. During the second week, the blister begins to dry up and a scab forms. The scab falls off in the third or fourth week, leaving a small scar. People who are being vaccinated for the first time have a stronger reaction than those who are being revaccinated.
If someone does not get the expected vaccination site response, they need to be revaccinated. If someone has a question or concern about the smallpox vaccination site they should contact their primary-care manager, medical department representative or their healthcare provider.
Smallpox vaccination is generally a safe and effective means of preventing smallpox. However, in a number of individuals, smallpox vaccination can result in untoward effects and adverse reactions. Most are totally benign, but may be alarming in appearance. Some are serious, but treatable. A few, which rarely occur, are serious, life threatening and can be fatal. Severe adverse reactions are more common in persons receiving primary vaccination compared to those being revaccinated.
In the past, between 14 and 52 people out of 1,000,000 vaccinated for the first time experienced potentially life-threatening reactions. These reactions included serious skin reactions and inflammation of the brain (encephalitis).
From past experience, one or two people per 1 million who received smallpox vaccine died as a result of vaccination side effects. Serious side effects generally are rarer after revaccination, compared to first time vaccinations. Careful screening of potential vaccine recipients is essential to ensure that those at increased risk for serious side effects do not receive the vaccine.
These side effect rates are based on data collected in the United States during the 1960s, when about 300,000 adults got their first smallpox vaccination and over 4,000,000 adults got repeat smallpox vaccinations (revaccinations).
A few heart attacks, some fatal, have been reported after smallpox vaccination. After reviewing these cases, the rate of heart attacks in smallpox vaccinated and unvaccinated people is the same and there is no evidence of a cause-and-effect link between smallpox vaccine and heart attacks. Even so, DoD medically exempts people with heart conditions.
We try to reduce the risk of side effects by exempting people who should not receive this vaccine.
For more information about side effects of the smallpox vaccine please visit http://emergency.cdc.gov/agent/smallpox/vaccination/reactions-vacc-clinic.asp
No. Pregnant women should not receive the smallpox vaccine, unless they have been exposed to smallpox. Most of the time, when pregnant women get smallpox vaccine, the pregnancy goes well. In an outbreak, personal benefit from vaccination may outweigh the risks of vaccination. Women who are pregnant or planning to become pregnant within 4 weeks after vaccination should NOT get the smallpox vaccine. In addition, anyone who has a close contact who is pregnant should not get the vaccine. Close contacts include anyone living in your household and anyone you have close, physical contact with such as a sex partner or someone you share a bed with.
Smallpox vaccine can cause a very rare but serious complication in the fetus called fetal vaccinia. Less than 50 cases of fetal vaccinia have ever occurred. Most babies born to women who got smallpox vaccine will be fine. If a woman is vaccinated, she should avoid pregnancy for a month. She should wait until the vaccination site has completely healed and the scab has fallen off before trying to become pregnant after vaccination. Until that time, effective measures should be taken to prevent pregnancy, such as abstinence, birth control pills, injections, implants, or IUDs. Other methods of birth control, such as condoms, diaphragms, spermicide, and natural family planning are less effective than abstinence.
Women uncertain about whether or not they are pregnant should get a medical evaluation. Clinics should display warning signs about asking women if they are pregnant. Urine or blood tests can help women find out if they are pregnant before immunization.
Women receiving a smallpox vaccination should wait until the scab has fallen off and the vaccination site has completely healed before trying to become pregnant after vaccination. Generally, this means vaccinated women should wait four weeks after their smallpox vaccination. Until that time, effective measures should be taken to prevent pregnancy, such as abstinence, birth control pills, injections, implants, or IUDs. Other methods of birth control, such as condoms, diaphragms, spermicide, and natural family planning are less effective than abstinence.
Vaccinated men may wish to wait a similar amount of time before fathering a child. Until the vaccination site has completely healed, they can be the source of spreading vaccinia to a close contact (such as a sex partner). Covering the vaccination site is very important for both men and women.
Women who are breastfeeding should not get the smallpox vaccine. Breastfeeding places the baby close to the vaccination site on a woman's arm. This advice is true even if women are pumping and then bottle-feeding breast milk. It is unknown whether the vaccine virus or antibodies pass on to the baby through breast milk. A woman who desires to maintain her milk supply may continue to pump breast milk, but the milk should be discarded until the vaccination site has completely healed and not be given to the baby.
Yes, if clothing is not contaminated and proper hand washing is used. Anyone who receives the smallpox vaccine should remember to wash their hands with soap and warm water after direct contact with the vaccination site, or anything that has touched the vaccination site (bandages, clothing, towels, bedding, etc.). This is will help prevent the spread of vaccinia virus to contacts, including young babies.
First, she should check with her healthcare provider to determine if the rash is related to the smallpox vaccine. If she has a vaccine-related rash, breastfeeding should not take place until all scabs from the rash have fallen off and the skin is completely healed. A woman who desires to maintain her milk supply may continue to pump breast milk, but the milk should be discarded until her scabs fully separate and the skin is completely healed.
There have been less than 50 cases of fetal vaccinia ever reported in the world. Because fetal vaccinia is so rare, smallpox vaccination during pregnancy should not be a reason to consider termination of pregnancy.
Smallpox vaccine has not been associated with an increased risk of miscarriage. There is no evidence that smallpox vaccine causes spontaneous abortion (miscarriage).
Except for the rare case of fetal vaccinia, smallpox vaccination of pregnant women has not been linked with premature birth, low birth weight, or other serious birth problems.
Most women who receive smallpox vaccine during pregnancy will deliver normal babies, and standard delivery procedures should be followed. All pregnant women who have received the smallpox vaccine during pregnancy should let their healthcare provider and their baby's healthcare provider know about their vaccination. Their providers should contact the registry by calling 619.553.9255 or e-mailing NHRCfirstname.lastname@example.org.
DoD works with the CDC in operating the National Smallpox Vaccine in Pregnancy Registry. This registry is used to monitor the outcomes of pregnant women who received the smallpox vaccine. This will help us better understand the risks of smallpox vaccine in pregnancy. The registry has already provided important information, which is generally reassuring to women in these circumstances.
Pregnant women who received the smallpox vaccine, or pregnant women whose close contacts received the smallpox vaccine, may contact their healthcare provider or their state health department for help in enrolling in the registry. Health-care providers and staff from state health departments (see www.cdc.gov/other.htm#states) are encouraged to report all exposed pregnant women to the registry by calling 619.553.9255 or e-mailing NHRCemail@example.com. To learn more, click here: www.smallpox.mil/pregnancy
You should follow the same instructions on "How should I care for the vaccination site?" and read the following:
Even patients vaccinated in the past may be at increased risk due to current immunodeficiency. If contact with unvaccinated patients is essential and unavoidable, healthcare workers can continue to have contact with patients, including those with immune deficiencies, as long as the vaccination site is well-covered and thorough hand-hygiene is maintained. In this setting, a more occlusive dressing might be appropriate. Semi-permeable polyurethane dressings (e.g., Opsite®, Tegaderm®) are effective barriers to vaccinia and recombinant vaccinia viruses.
However, exudate may accumulate beneath the dressing, and care must be taken to prevent viral contamination when the dressing is removed. In addition, accumulation of fluid beneath the dressing may increase the maceration of the vaccination site. To prevent accumulation of exudates, cover the vaccination site with dry gauze, and then apply the dressing over the gauze. The dressing should also be changed daily or every few days (according to type of bandaging and amount of exudate), such as at the start or end of a duty shift.
Three Key Points:
Vaccinia virus is present at the vaccination site for 30 days and until the vaccination site is completely healed. This means other people can get infected if they come in contact with virus from your arm.
Most vaccination sites can be left unbandaged, when not in close contact with other persons. Airing the site will speed healing. Wear sleeves covering the site and/or use an absorbent bandage to make a touch-resistant barrier when around others. Dispose of bandages in sealed or double plastic bags. You may carefully add a little bleach, if desired.
Keep the site dry. Do not use creams or ointments; they will delay healing. Long-sleeve clothing worn during the day and at night can protect the site from dirt. Launder clothing and linens that touch the site in hot water with soap or bleach.
Normal bathing can continue. Dry off carefully, so the towel does not rub or spread virus elsewhere. Don't allow others to use that towel until laundered. Don't use public towels, unless laundry workers are aware of special handling precautions. Use a waterproof adhesive bandage if you exercise enough to cause a sweat. Avoid swimming pools and spas until the site is completely healed.
Take good care of your vaccination site.
Some people should not get the smallpox vaccine unless under emergency situations:
In a smallpox outbreak, even people with exemptions to vaccination should be vaccinated if exposed to smallpox, unless extremely immunosuppressed.
You should discuss your concerns and your individual situation with your medical provider to be sure.
Certain medical conditions, such as the absence of a working spleen (asplenia) may increase a person's risk for certain infections. Some vaccines, particularly pneumococcal, meningococcal, and Haemophilus vaccines, are specifically recommended for people without a spleen. People with asplenia are generally not considered immunosuppressed for the purposes of vaccination and should receive routine vaccinations with both live and inactivated vaccines according to the usual schedules.
You should inform your Health Care Provider if you have heart disease, with or without symptoms, or if you have three or more known major cardiac risk factors (i.e., hypertension, diabetes, hypercholesterolemia, heart disease at age 50 years in a first-degree relative, and smoking).
Other contraindications include:
Also if you have had a serious reaction to polymyxin B, neomycin, latex or a previous dose of smallpox vaccine it may be a contraindication for you to receive smallpox vaccine at this time. If you have concerns, please consult with your health care provider before vaccination.
Careful prevaccination screening will help determine any risk issues you may have.
The standardized DoD smallpox screening form can be viewed at the MILVAX-VHCN website at www.smallpox.mil/screeningform
Vaccinia virus can survive in the environment for about 24 hours. It might survive longer if it stays moist and in the dark. If the bandage dries out, the virus is still present, but less able to spread.
No matter the time, it is always best to carefully dispose of used dressings or bandages in sealed or double plastic bags. Always wash your hands after handling dressings or bandages.
In a household, people have much more intimate or close contact than in work sites or other social settings (e.g., church, malls). As usual, the key here is to not move the virus from your vaccination site to another person. So be careful when around others and follow the standard precautions (band-aids, long-sleeves, hand-washing).
Regarding household members with contraindications:
You shouldn't be vaccinated if you have household members with contraindications to the smallpox vaccine, unless you can be separated from them until your scab falls off (about 14 to 28 days).
Regarding children under 1 year of age:
"Minimizing close physical contact with infants less than one year of age is prudent until the scab falls off. If unable to avoid infant contact, wash hands before handling an infant (e.g., feeding, changing diapers) and ensure that the vaccination site is covered with a porous bandage [e.g., Band-Aid, or gauze] and clothing. It is preferable to have someone else handle the infant." This quote comes from the October 2002 recommendations of the Advisory Committee on Immunization Practices.
The Department of Defense reported its first case of inflammation in or around the heart (myopericarditis) after smallpox vaccination in early February 2003. As of January 2008, DoD has identified 161 cases of acute myocarditis and/or pericarditis among 1.4M smallpox vaccinees, with symptoms appearing 7 to 19 days after vaccination. These people had clinical conditions that varied from mild to moderate; the condition was severe in two cases.
Most cases occurred among those receiving smallpox vaccinations for the first time. Most cases occurred among men.
The health of our people is foremost in our priorities. These cases were followed carefully to evaluate their recovery, at 27 hospitals in 21 states and several countries overseas. Detailed follow-up cardiac testing is available in 46 cases: all had normal electrocardiograms (EKGs), echocardiograms ("echos") and normal treadmill test results. Based on our data and European experience, we have reason to believe these people should recover and remain well.
Yes. We will defer people with serious heart or blood vessel-related conditions. From the standpoint of military readiness, people with major heart conditions are unlikely to be in military service. Some examples include a history of angina, an earlier heart attack, artery disease, congestive heart failure, cardiomyopathy, stroke, "mini stroke", or chest pain or shortness of breath with activity (such as walking up stairs). If you have concerns about your health history, speak with your health care provider before vaccination.
Similar to the CDC, and based on input from the American College of Cardiology, we will also defer people with three or more cardiac risk factors. The risk factors include:
(1) current smoker or tobacco user,
(2) high blood pressure,
(3) high cholesterol or triglycerides,
(4) high blood sugar,
(5) a heart condition before age 50 in a parent, brother, or sister.
Vaccination of other people should continue as planned.
If you smoke, we encourage you to stop.
There are no restrictions for recently vaccinated people in regards to contact or handling of animals, other than keeping animals away from the vaccination site and bandages that covered it.
There is no evidence that vaccinia virus infects cats, dogs, or other household pets. The same steps you take to prevent spreading the virus elsewhere on your body or to somebody else (e.g., sleeves, bandages, hand washing) will keep the virus from reaching your pet.
Yes, Department of Defense personnel who are vaccinating others should be vaccinated themselves. This is outlined in the "Clinical Policy for the DoD Smallpox Vaccination Program (SVP)".
Yes. You should know a few of the more serious complications related to vaccination that can occur. Inadvertent inoculation is the most frequent complication of vaccinia vaccination. It accounts for about half of all complications of primary (first) vaccination and revaccination. Inadvertent inoculation usually results from auto-inoculation of vaccinia virus, transferred from the site of vaccination. The most common sites involved are places that itch: the face, eyelids, nose, mouth, genitalia, and rectum.
Most auto-inoculation lesions heal without specific therapy, but vaccinia immunoglobulin (VIG) can help treat severe cases. If vaccinial keratitis develops, VIG is not recommended because of the risk of corneal scarring.
Erythematous or urticarial rashes can occur about 10 days after primary (first) vaccination and can be confused with generalized vaccinia. In these circumstances, the vaccinee is usually afebrile and the rash resolves spontaneously within 2 to 4 days. Rarely, an allergic reaction to to the vaccination called erythema multiforme (i.e., Stevens-Johnson syndrome), may occur.
The most serious complication is postvaccinial encephalitis. Two main forms were noted. The first affected children younger than 1 year old receiving their first (primary) smallpox vaccination, involving convulsions. These children may have residual paralysis after recovery.
The second form affected children 2 years or older, adolescents, and adults receiving their first (primary) smallpox vaccination. These patients developed abrupt onset of fever, vomiting, headache, and malaise, followed by loss of consciousness, amnesia, confusion, convulsions, and coma. About 1 in 3 of these patients died.
No absolute exemptions (contraindications) exist for vaccination of a person with an actual high-risk exposure to smallpox. People at greatest risk for experiencing serious vaccination complications are also at greatest risk for death if exposed to smallpox.
If a relative contraindication to vaccination exists, the risk for experiencing serious vaccination complications must be weighed against the risk for experiencing a potentially fatal smallpox infection. When the level of exposure risk cannot be determined, the decision to vaccinate should be made after discussion between the clinician and the patient of the potential risks versus the benefits of smallpox vaccination.
Vaccination has been successfully and safely administered to people of all ages, from birth onward. As with all vaccinations, the smallpox vaccination process should begin with careful individualized assessment of vaccine indications and contraindications.
The site of vaccination is the upper arm over the insertion of the deltoid muscle. No skin preparation should be performed unless the skin at the intended site of vaccination is obviously dirty, in which case an alcohol swab(s) may be used to clean the area. If alcohol is used, the skin must be allowed to dry thoroughly to prevent inactivation of the live vaccine virus by the alcohol.
The multiple-puncture technique uses a sterilized bifurcated needle inserted vertically into the vaccine vial, causing a droplet of vaccine to adhere between the needle prongs. The droplet contains the recommended dosage of vaccine. Confirm the presence of the droplet between the prongs visually. Holding the bifurcated needle perpendicular to the skin, make 15 punctures rapidly with strokes vigorous enough to allow a trace of blood to appear after 15 to 20 seconds. Wipe off any remaining vaccine with dry sterile gauze, then dispose of the gauze in a biohazard waste container.
Cover the site with a bandage to deter touching the site and perhaps transferring virus to other parts of the body.
Some conditions respond to intravenous vaccinia immunoglobulin (IV-VIG), including eczema vaccinatum, progressive vaccinia, severe ocular vaccinia, severe generalized vaccinia. IV-VIG is not effective in treating post-vaccinial encephalitis.
IV-VIG consists of human IgG antibody from people vaccinated with smallpox vaccine. Current supplies of IV-VIG are limited.
Once a definite or probable diagnosis of a medication-indicating adverse event has been made by a qualified provider (e.g., infectious-disease, dermatology, allergy-immunology physician), that military provider may request use of IV-VIG for a named patient by telephoning the Military Vaccine Agency - Vaccine Healthcare Centers Network at 877-GET-VACC, DSN 761-4245, email DoDVaccines@mail.mil. Procedures for ordering IV-VIG appear at www.smallpox.mil/documents/1101MIP-VIG-ordering-infoNo07.pdf. Healthcare providers from civilian institutions should contact the CDC directly by calling the CDC Director's Emergency Operation Center (DEOC) at (770) 488-7100 and request to speak with the Division of Bioterrorism Preparedness and Response (DBPR) on-call person. The CDC is the release authority for IV-VIG.
The Food and Drug Administration has not approved the use of any antiviral compound for the treatment of the smallpox vaccine virus infections or other Orthopoxvirus infections, including smallpox (variola infection). Certain antiviral compounds are effective against smallpox vaccine virus (vaccinia) or other Orthopoxviruses in vitro and among test animals. However, the safety and effectiveness of these compounds for treating the vaccinia vaccination complications or other Orthopoxvirus infections among humans is unknown. Questions also remain regarding the dosing, timing and length of administration of these antiviral compounds.
Additional information could become available. Health-care providers should consult infectious disease experts for updated information regarding treatment options for the smallpox vaccination complications.
Smallpox vaccination with live vaccinia virus causes the body to produce neutralizing IgG antibodies, as well as vaccinia-specific cell-mediated immunity. In a person with normal immune function, neutralizing antibodies appear about 10 days after primary vaccination and 7 days after revaccination. Clinically, people are considered fully protected after a successful response is demonstrated at the site of vaccination, about 7 days after vaccination.
The vaccination site should be inspected 6 to 8 days after vaccination and the response interpreted at that time. The World Health Organization (WHO) Expert Committee on Smallpox defines two types of responses. The responses include:
A "major reaction" is the internationally accepted term for a successful smallpox vaccination.
Major (i.e., primary) reaction is defined as a vesicular (blister) or pustular lesion or an area of definite palpable induration (hardness) or congestion surrounding a central lesion that might be a crust or an ulcer. The usual progression of the vaccination site after primary vaccination is as follows:
a. The inoculation site becomes reddened and itchy 3 to 4 days after vaccination.
b. A vesicle (blister) surrounded by a red areola then forms, which becomes umbilicated (sunken center) and then pustular (pus-filled) by days 7 to 11 after vaccination.
c. The pustule begins to dry, the redness subsides, and the lesion becomes crusted between the second and third week.
d. By the end of about the third or fourth week, the scab falls off, leaving a permanent scar that at first is pink in color, but eventually becomes flesh-colored.
Skin reactions after revaccination might be less pronounced with more rapid progression and healing than those after primary vaccinations. Revaccination is considered successful if a pustular lesion is present or an area of definite induration or congestion surrounding a central lesion (i.e., scab or ulcer) is visible upon examination 6 to 8 days after revaccination.
An individual (a) born before 1972, or (b) employed as a health care worker before 1977, or (c) who travelled internationally before 1983, or (d) who was on active duty before 1991 or after 2002, or (e) who has a Jennerian scar and who does not have a cutaneous response ('major reaction' or 'take') following Smallpox vaccination is presumed to have been previously vaccinated and therefore, in accordance with the ACAM2000 package insert, does not require a second vaccination attempt to try to elicit a cutaneous response. The patient is considered adequately protected against smallpox (immune) and is fit for all military-related assignments, including deployment. No further diagnostic evaluation is required.
A smallpox vaccinee not meeting the presumptive prior-vaccination criteria (above) who fails to demonstrate a cutaneous response ('major reaction' or 'take') after receiving 15 jabs with ACAM2000 requires a second vaccination attempt in accordance with current policy (reference?). If after a second attempt there is still no evidence of a cutaneous reaction the individual is considered adequately protected against smallpox (immune) for all military-related assignments, including deployment. No further diagnostic evaluation is required.
If an equivocal reaction is observed, check vaccination procedures and repeat the vaccination by using vaccine from another vial, if available. It is often difficult to determine if the reaction was blunted by immunity, insufficiently potent vaccine, or vaccination technique failure. If the repeat vaccination using different vaccine fails to elicit a major reaction, health-care providers should consult an allergist or immunologist before attempting another vaccination.
Wear a warm-up jacket over your short-sleeve scrubs. Have your dressing evaluated every day and changed if exudates appear.
If applicable: When you go to the scrub-replacement machine with dirty scrubs, please have your scrubs rolled or folded so that the arm area is on the inside. Wash your hands and wear clean gloves to feed the scrub machine. Wash your hands after putting the dirty scrubs into the machine. Carry Cal-Stat or other alcohol-based rinse with you.
If laundry workers wear gloves, this is sufficient protection.
Remember: Hand washing, Hand washing, Hand washing.