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  • Hello. I’m ________________ of the MILVAX Agency. This is the DoD Healthcare Providers Briefing for Smallpox.
  • The purpose of this briefing is to provide healthcare providers with an introduction to smallpox disease and vaccination procedures.
  • Please remember these key messages about the DoD Smallpox Immunization Program. First, preserving the health and safety of our people is our top concern. What we care most about is helping our Service members return home safely. Second, smallpox vaccine prevents smallpox, but must be used carefully. Smallpox vaccine leaves vaccinia virus on the surface of the skin. If the site is touched, the virus can be spread to somewhere or someone else. Third, smallpox would disrupt military missions. Fourth, smallpox protection helps our war on terrorism. Smallpox vaccination of military personnel is part of our national strategy to safeguard Americans against a smallpox attack.
  • Smallpox vaccination is mandatory for uniformed personnel and emergency essential or equivalent DoD civilian personnel assigned to CENTCOM AOR, the Korean Peninsula and USPACOM Forward Deployed Naval Forces for 15 or more consecutive days. Vaccination is also required for members of the DoD Smallpox Response Teams. Vaccination can be given up to 120 days before deployment. Current policy requires the distribution of the ACAM2000 Medication Guide and DoD smallpox trifold prior to vaccine administration. All potential vaccinees must be screened using the DoD standard smallpox screening forms located at www.smallpox.mil/screeningform
  • Smallpox has been identified as existing for thousands of years. Egyptian mummies have been uncovered with evidence of pox lesions indicating that they probably died from smallpox. People in India and China, as early as 1,000 AD, attempted to create a “vaccine” to prevent smallpox disease. Scabs from patients were ground into a powder and blown into the nose of people who had not previously contracted the disease to prevent smallpox. In the Ottoman Empire, a form of vaccination called “variolation” was performed to prevent smallpox. This procedure involved taking some infected material from a smallpox patient who had not died from the disease and scratching the material into the skin of a person who had not yet been infected. This created a “localized smallpox infection” that after it healed would prevent subsequent variola infection. This technique was not without risks; in that about 2% of those who received variolation developed full-blown cases of smallpox and died from the attempted vaccination. This procedure was imported to England in the 1700’s and introduced to the American colonies as well. Ben Franklin, John Adams and other Colonial notables were advocates of variolation. General George Washington ordered variolation of his continental army after suffering defeat in the battle of Quebec due to smallpox infecting half his troops. In 1793 Edward Jenner, a scientist living in England, noted that milkmaids did not suffer from the severe facial scarring that routinely occurred secondary to smallpox. He also noted that the milkmaids developed lesions on their fingers and hands but never contracted actual smallpox. He concluded that there might be some substance that existed on the cow’s udders that prevented the milkmaids from getting smallpox infection. His experiments, now famous, involved inoculating a boy with scrapings from a cow’s udder, and then subjecting him to patients with open sores of smallpox. When the boy did not develop smallpox, Jenner repeated this experiment on convicts with minor infractions of the law – with the proviso that they be freed if they survived. These experiments were successful as well. The data was presented to the scientific communities of England and Europe, and the process of vaccination was named in honor of his observations. The Latin word for cow is ‘vaca’ and since the material was obtained from cows the process was called Vaca-cination or vaccination. In 1812 the War Department ordered the Armed Forces to be vaccinated with the Jennerian vaccine. In 1919 citizens were outraged that that Woodrow Wilson permits smallpox vaccination of Armed Forces. This was the beginning of the smallpox vaccination process, which despite its detractors dating back to the 17 and 1800’s was to culminate in the World Health Organization’s global eradication program which successfully rid the world of this dreaded disease in 1978, the World Health Organization officially declared smallpox eradicated in 1980. The last known naturally occurring case of smallpox was in 1977 in Somalia. In 1984 DoD restricted vaccination to recruits at basic training, and in 2002 DoD resumed service-wide Smallpox Vaccination Program. In 2007 FDA approved Acambis’ license to produce ACAM2000. In 2008 DoD began using ACAM2000 in the Smallpox Vaccination Program.
  • Smallpox was once worldwide in scope and was eradicated from the Earth in the 1970’s; however, it was not until 1980 that the World Health Organization declared the earth eradicated of smallpox disease. The most common way smallpox disease is transmitted is through prolonged face-to-face contact; contact with material from pustules, rash, lesions, contaminated clothing or bedding is less common. Small-particle aerosolization is the least common way smallpox disease is transmitted. The incubation period is typically 12 to 14 days, with a range of 7 to 17 days. Transmission rate is highest during the first 7 to 10 days of rash onset, marked by temperature greater than 101 degrees Fahrenheit; however, a person is considered infectious until all scabs have fallen off. The exact date the rash appears may not be noted accurately; therefore, consider cases potentially infectious at fever onset. On average, each person infected with smallpox will infect 3 to 5 other people. In hospital settings, where more serious cases of disease are taken and where workers have closer contact with cases, the average smallpox case will infect 10 to 12 people. Smallpox does not spread quickly; a smallpox outbreak would evolve over the course of months. Given the typical 12 to 14 day incubation period between exposure and symptoms, generations of smallpox cases would arise at intervals of roughly 2 to 3 weeks. During the smallpox era, the seasonal transmission of disease was highest during winter and early spring. Currently, the age distribution of cases would be expected to mimic the age distribution of the population, due to the lack of immunity among many people in the community. There is an expected case-fatality rate of up to 30%. This proportion may be greater due to a lack of natural immunity, a high percentage of non-vaccinated people in the U.S. population, waning immunity against smallpox in previously vaccinated people, and a larger immune-compromised population compared to the smallpox era. The case-fatality rate may be lower due to better intensive care and medical treatment options than 30 years ago and partial immunity among the adult population.     
  • The infectious dose is unknown, but is believed to be only a few virions. Natural infection occurs after the smallpox virus reached the oropharyngeal, respiratory mucosa. The virus then migrates to the regional lymph nodes, where it multiplies. On the third or fourth day primary viremia develops; and by the 8 th day, secondary viremia begins, followed by fever. Primary viremia occurs when the virus enters the bloodstream; and secondary viremia occurs when the virus infects additional tissues. The virus then localizes in the small blood vessels of the skin and infects adjacent cells.
  • Smallpox is characterized by both an enanthem (internal rash) with lesions in the mouth and on the posterior pharynx, as well as an exanthem (external rash) that occurs during secondary veremia. The lesions of this vesiculopustular rash are found more densely on the face and extremities occurring in a centrifugal pattern, including the palms and soles of the feet. All lesions occur at a similar stage of development and are about the same size. Remember, after exposure it takes between 7 and 17 days for symptoms of smallpox to appear. The infected person will feel fine and is not contagious. During this time a person could be vaccinated and still be partially or fully protected depending on the number of days post-exposure; therefore it is critical that healthcare providers isolate cases with symptoms and trace and vaccinate contacts. The smallpox rash progresses from sparse macules, to papules, then vesicles, pustules, and finally scabs approximately three weeks later. A person can infect others once the rash appears and remains contagious until the last smallpox scab falls off.
  • Skin lesion development and progression is shown here, starting with macules in the upper left and moving on to papules on the right; then in the middle vesicles and scabs are shown; leading to scarred skin at he bottom right.
  • It is important to know the key differences in the clinical presentation of smallpox (variola) infection and chickenpox infection (varicella). During smallpox infection, lesions usually appear 1-2 days after a high fever and are all in the same stage of development. Chickenpox lesions also appear a few days after a high fever, but emerge in various stages or crops. Smallpox lesions spread from the extremities towards the center of the body and are more concentrated on the face and extremities. Chickenpox lesions spread from the center of the body outward, and are typically more concentrated on the trunk. A distinguishing feature of chickenpox is that m ost varicella cases occur in children.
  • No cure or treatment for smallpox has ever been developed. This old “Smallpox Isolation” plaque is an indication of how a person with smallpox was typically dealt with. Supportive care for the patient was and still is the only available treatment. To date, there have not been any anti-variola virus medications developed.
  • There is no proven treatment for smallpox, but research to evaluate new antiviral agents is ongoing. Patients with smallpox can benefit from supportive therapy such as intravenous fluids, medicine to control fever or pain and antibiotics for any secondary bacterial infections that may occur. 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. Getting smallpox vaccine before exposure will protect about 95 percent of people from getting smallpox. Preliminary results with the drug cidofovir suggest it may be useful. The use of cidofovir to treat smallpox or smallpox vaccine reactions requires the use of an Investigational New Drug protocol and should be evaluated and monitored by medical experts, for example at the NIH and CDC.
  • Before smallpox was eradicated, it killed many millions of people over hundreds of years. In the past, about 3 out of every 10 people infected with smallpox died. Survivors were often permanently scarred or, rarely, blinded. Terrorists or governments hostile to the U.S. may have or could obtain variola virus to be used as a bioweapon. This presents a serious threat to our troops, and an outbreak would stress medical operations and significantly affect military readiness.
  • Smallpox vaccine was the very first vaccine developed and has been used successfully for over 200 years. The current vaccine in use in the United States, ACAM2000, is a new cell culture vaccine that is a derivative of the Dryvax vaccine that was used during the global smallpox eradication program. Wyeth Laboratories produced Dryvax by using calves’ lymph that was purified, concentrated, freeze-dried and stored in a freezer until it was thawed and prepared for use. The virus used in smallpox vaccine (vaccinia) is similar to the smallpox (variola) virus, and causes a similar immune response. ACAM2000 is manufactured by Acambis, and is licensed by the FDA for pre-exposure smallpox prevention. The vaccinia strain that has been used in the United States is the New York City Board of Health (NYCBOH) strain. However, unlike Dryvax, ACAM2000 is cultured in vero cells rather than from calf lymph, which relieves the vaccine from potential contaminants related to growing the virus in animals. Vaccination is accomplished by percutaneous introduction of the live virus vaccine using a bifurcated needle. This technique is called scarification, and protects a person within 7 to 10 days of vaccination. According to the Centers for Disease Control and Prevention, smallpox vaccine provides protection for around 91% to 97% of those vaccinated. Vaccination does not convey life-long immunity to smallpox. Historical information has shown that re-vaccination needs to be repeated every 5 to 10 years to prevent people from contracting smallpox. During periods of outbreak, when the viral load was heavy, it was known that yearly revaccination might be necessary to prevent people from contracting the disease. A permanent scar, called a Jennerian scar, indicates successful prior vaccination.
  • This chart provides additional information about ACAM2000 smallpox vaccine. ACAM2000 is a live vaccinia virus vaccine, administered percutaneously with a bifurcated needle. ACAM2000 is developed using African Green Monkey vero cells, which reduces the risk of contamination. It is DoD policy to provide ACAM2000 vaccinees with the DoD Smallpox Trifold Brochure as well as the ACAM2000 Medication guide prior to smallpox vaccination administration. ACAM2000 must be diluted with just 0.3 ml of diluent; though the vial provided contains 0.6 ml. Stored ACAM2000 vaccine is not subject to expiration extension, and the shelf life of reconstituted ACAM2000 is 30 days. Primary vaccination using ACAM2000 vaccine requires 15 jabs.
  • It is very important to remember that smallpox vaccine prevents smallpox, but it must be used very carefully. Smallpox vaccine was used by the World Health Organization to eradicate smallpox from the planet. Within 10 days of vaccination, about 95% of people are protected. 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. Solid protection against smallpox lasts for about 3 years. Partial protection lasts longer, but people need to be revaccinated if too much time has passed. In a pre-event setting, revaccination would occur every 10 years; but if an outbreak occurs, the revaccination would move to a three year interval. Laboratory workers who are exposed to smallpox may receive vaccination every 3 years for optimal protection. Smallpox vaccine contains vaccinia virus. This produces an immune response that protects against variola virus, the virus that causes smallpox. The vaccine itself cannot cause smallpox.
  • Servicemembers should carefully read and complete the screening form. This helps accurately document that the vaccine administered is safe. Family members of vaccinees who may have a history of recurrent rashes like eczema should be contacted and informed of the vaccination program and the safety precautions that need to be observed Talk to close contacts and family members about the vaccination program and safety precautions. Vaccinees, close contacts and family members are encouraged to ask questions at any point if they have safety concerns. Screening forms can be located at www.smallpox.mil/screeningform.
  • People whose immune systems are not working fully (due to disease, medication, or treatments) should not receive smallpox vaccination. Some examples of immune compromised conditions include HIV/AIDS, cancer and cancer treatments, transplant medications, and other immune deficiencies. It is important to avoid vaccinating anyone with a history of eczema or atopic dermatitis. If the vaccine recipient is unsure of their dermatologic history, they should consult with a dermatologist to determine if they can receive the smallpox vaccine. Other acute skin conditions such as recent burns, severe acne or active psoriasis, shingles, impetigo and chickenpox should be considered temporary contraindications to vaccination. If there are any close contacts that have any of these problems, the vaccinee should not be placed in contact with those individuals for 30 days and until the site is completely healed. Women who are pregnant should not receive smallpox vaccination, and should avoid getting pregnant for 4 weeks after smallpox vaccination. Other situations that would warrant a medical exemption from smallpox vaccination include a serious heart disease or 3 or more cardiac risk factors (such as smoking, high blood pressure, high cholesterol, diabetes, or a family history of serious heart disease) , and p eople with serious heart or vessel conditions (such as angina, heart attack, artery disease, congestive heart failure, stroke, and other cardiac problems) People taking steroid eye drops or ointments or who are within the first 8 weeks after eye surgery or are within 4 weeks pre-op should not receive smallpox vaccination. Other contraindications to smallpox vaccination include having an infant at home under 1 year of age, or the vaccinee is breast-feeding. Breast-feeding is not a medical contraindication to any immunization, but breastfeeding could put the infant in close contact with the mother’s vaccination site. Anyone who has an allergy to the 2 antibiotics in the vaccine; neomycin and polymyxin B, or any other vaccine component, should not receive the smallpox vaccine. In an actual smallpox outbreak the risk vs. benefit of vaccination would need to be re-evaluated. People directly exposed to smallpox virus should get vaccinated regardless of health status unless extremely immune suppressed.
  • HIV infection is a contraindication to smallpox vaccination because smallpox is a live vaccine and it can overwhelm an individual’s weakened immune system. For this reason, Service members must be current with Service HIV screening policies before smallpox vaccination, and have a documented negative test result prior to immunization. DoD civilian employees and contractors will be offered HIV testing and will have the results before vaccination. HIV testing is recommended for anyone with a history of risk factors for HIV infection. Particularly if the risk has increased since their last HIV test, and if they are not sure of their HIV infection status. Because known risk factors cannot be identified for some people infected with HIV, people concerned they could be infected should be tested.
  • A person may be eligible for smallpox vaccination based on duty assignment and medical history screening results. However, if that person has a household contact, a spouse or a child for example, who has a medical contraindication related to the vaccinia virus within smallpox vaccine, that person may be temporarily exempted from vaccination. It is DoD policy that exempt people should be physically separated and excused from duties that pose the likelihood of contact with potentially infectious materials, such as clothing, towels and linen from recently vaccinated people. This separation includes the use of common sleeping space such as a cot, bunk or berth, with people with contraindications to vaccination. The risk of inadvertent contact, either directly, or by means of clothing, towels, sheets, or other common-access items has been historically quite rare; about 27 cases per 1,000,000 vaccinations. DoD’s goal is to reduce the risk as much as possible. It is unacceptable to permit a vaccinated Service Member to reside in a house, trailer, apartment, or similar close arrangements with a medically barred contact for 30 days and until the vaccination site has healed. Having the vaccinated Service member use alternate lodging on a military installation, vessel, or aircraft, or in contracted space, is acceptable. Having the vaccinated Service member voluntarily arrange for alternate lodging in privately-owned or managed space is acceptable, if the commander has a reasonable expectation that the Service member will comply with the requirement to not share living and toileting space with a medically-barred household contact. Berthing barges, familiar to naval forces whose berthing spaces were refitted during a shipyard period, can be used at naval installations near the water. The vaccinated Service member can continue to have reasonable access to a medically contraindicated close contact so long as the access includes careful hand washing and does not involve extensive physical contact involving clothing, sheets, towels, or other items likely to transfer vaccinia virus.
  • The Advisory Committee on Immunization Practices (ACIP) accepts administration of live and inactivated vaccines simultaneously or at any interval. The only major restriction to giving multiple vaccinations is with multiple live-virus vaccines. In this case they should either be given simultaneously or separated by 28 days or more. To avoid confusion in deciding which vaccine might have caused post-vaccination skin lesions or other side effects, varicella vaccine and smallpox vaccine should be administered >4 weeks apart. Purified Protein Derivative (PPD) can be given simultaneously or 4 weeks after smallpox vaccination. Avoid administering other vaccines near the smallpox vaccination site.
  • Smallpox vaccination requires a special needle. Dr. D. A. Henderson, a professor at Johns Hopkins Medical School who was chosen to run the World Health Organization global smallpox eradication project, invented the bifurcated needle. Dr. Henderson wanted a simplified way to have new vaccinators deliver adequate vaccinations without much training. He requested a sewing needle manufacturer snip off the end of the eye of a needle. This needle was cut to such a length that when dipped into a fluid solution, the eye end would hold the proper amount of vaccine by capillary action. The smallpox vaccine will be ordered through USAMMA shipped directly from the Strategic National Stockpile, at no cost to units. Ancillary supplies are the responsibility of the receiving activity. The vial is a multidose unit of 100 doses. After reconstitution, the vaccine is good for 30 days.
  • To vaccinate safely and effectively, healthcare staff must have documented smallpox training in accordance with service requirements, have a previous history of smallpox vaccination, and must not have any current contraindications to smallpox vaccine. The bifurcated needle incorporates a multipuncture technique known as scarification. When executing this technique, there are a few key points to remember. First, clean the vaccination site with soap and water if visibly dirty, and then dry the vaccination area. Acetone or alcohol may be used only if adequate time is allowed for it to evaporate or if the site is wiped dry with (sterile) gauze to prevent unintentional inactivation of the live virus vaccine. Acetone may be preferred over alcohol, because acetone evaporates more quickly. Use skin over the insertion of the deltoid muscle (preferred) or the posterior aspect of the arm over the triceps muscle for smallpox vaccination. 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. Note that the vaccinator does not place a finger at the upper end of the needle, as to prevent the deep insertion of the needle into the tissues. The vaccine needs to be placed into the dermis and not into the subcutaneous tissues so that the virus will properly replicate to accomplish a successful vaccination. Cover the site with a non-stick bandage to deter touching the site and perhaps transferring virus to other parts of the body.
  • If the vaccination is successful, a red and itchy bump develops at the vaccination site in three or four days. After this, 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 after 2 to 4 weeks, leaving a small scar. People who are being vaccinated for the first time have a stronger reaction than those who are being revaccinated. Healthcare providers should visually inspect the vaccination site for evidence of a pustule or scab beginning on the 6 th to 8 th day. Some revaccinees may not show the typical pustule but may react with a raised and indurated (hardened) area at the vaccination site. This can only be felt by palpation with a gloved finger to determine that this person is exhibiting a proper vaccination response. If someone does not get the expected vaccination site reaction, the original vaccination clinic should be informed, procedures checked and the vaccinee should be evaluated for revaccination with a new lot or vial.
  • Sometimes immunizations fail to produce an immune response to smallpox vaccinations and service members need to be revaccinated. There may be several reasons for this, such as adequate circulating antibodies, poor vaccination technique, a bad lot of vaccine or improper storage and handling of the vaccine. There are two kinds of revaccinations. Those given to individuals that fail to respond to vaccination, and those given as boosters. A person who has previously been vaccinated, determined to have a failed take, and needs a revaccination is required to receive 15 jabs using vaccine from a different vial. Vaccination techniques should be verified prior to revaccination because the majority of failed takes are due to improper technique. If a vaccinee fails to respond to a second attempt at vaccination, they should be referred to an immunologist for evaluation. If more than 10 years have elapsed after a secondary vaccination in a pre event scenario, revaccinate. If more than 3 years have elapsed since the first vaccination and an outbreak occurs, revaccinate.
  • For future screening purposes, contraindications should be recorded in the individual’s medical record. Service members’ vaccination status should also be documented in the service Immunization tracking system (ITS) to reflect their current status. For confirmation of successful vaccinations, i nstruct all vaccinees to come back to the clinic if there is no characteristic lesion. Healthcare workers and response team members traveling into smallpox outbreak areas will have “take” recorded in their health records and service ITS. Other personnel should have vaccination take recorded in health records and Service ITS by the medic or provider trained in vaccination evaluation. In the case of adverse events, document what happened in the individual’s medical records. Use the VAERS system and consult the VHC Network for assistance with preparing and submitting a VAERS report or vaccine adverse event consultation. The Under Secretary of Defense of Personnel and Readiness will ensure that Services will audit immunization tracking systems.
  • Smallpox vaccination leaves vaccinia virus on the skin, so vaccine recipients have to be careful not to spread the virus. Patients should be instructed on the following precautions: Don’t touch any vaccination site and if you do touch it by accident, wash your hands right away. In addition, do not let others touch your vaccination site or materials that cover it. Don’t allow others to use a towel used after vaccination until the towel is laundered. Don’t use public towels unless laundry workers are alerted that you were vaccinated. Sleeves should be worn over the bandaged area as a second layer of protection for others, particularly at night if you sleep in the same bed with someone. Place a band-aid or bandage over the site. Change the bandage every few days, or when the bandage gets wet. The v accination site can be left unbandaged, when not in close contact with other people. Airing will help speed healing of the vaccination site. Dispose of bandages in sealed or double plastic bags. You may carefully add a little bleach, if desired, to kill the virus. Keep the vaccination site dry. Normal bathing can continue. Dry the vaccination site last with a disposable towel. Avoid rubbing the site while drying. Swimming pools, spas or other public bathing facilities should be avoided until the vaccination site is healed. Clothing, towels and sheets should be laundered in hot water with detergent or bleach. When the scab falls off, place it in a sealed plastic bag with a little bleach and throw it in the trash.
  • It is important to review proper hand washing techniques with vaccine recipients. Start with soap and hot water. Rub hands together vigorously for 10 seconds, making sure to cover all surfaces of the hands and fingers. Rinse and dry hands thoroughly with a paper towel. Turn off the faucet with the paper towel, then throw it away. Many alcohol-based cleansers are excellent alternatives when soap and hot water are not available. Apply a few drops of the product to the hand, covering all surfaces of the hands and fingers. Allow hands to dry naturally. Wash hands with soap and water when available. If your patients intend on wearing contact lenses, tell them to be extremely careful. Wearing glasses until the vaccination site has healed is preferred. However, if they do wear their contact lenses, they should wash their hands before they touch their eyes or contact lenses.
  • As with most vaccination guidance, women should defer routine smallpox vaccinations until after pregnancy. Usually, when pregnant women get smallpox vaccine, the pregnancy goes well; however, in rare cases, vaccine virus causes vaccinia infection of the fetus. Women should avoid getting pregnant for 4 weeks after smallpox vaccination. Women who are uncertain about their pregnancy status should be referred for medical evaluation. Screen women of childbearing potential before immunization to avoid unintended vaccination during pregnancy. There have been rare cases of infection of the fetus (unborn baby) with the vaccine virus. Most of these cases occurred in women who received the vaccine for the first time. When fetal vaccinia does occur, it usually results in the death of the fetus. Fewer than 50 such cases around the world were reported over the last 100 years. As far as we know, smallpox vaccine does not cause a fetus to be malformed. It is recognized that some pregnant women may be inadvertently vaccinated, despite extensive efforts to prevent it. DoD, in cooperation with CDC, has developed a Registry to track such cases. Use the VAERS supplement to report cases to the Registry. Send these forms, even if incomplete, with basic contact information. Remember that the vast majority of exposed pregnancies are expected to be unaffected by smallpox vaccine so patients should not be unduly alarmed. POCs can be contacted by phone at 619.553.9255 and by email at NHRC-birthregistry@med.navy.mil. More information can be found online at www.smallpox.mil/pregnancy. People with children should always wash their hands and keep the vaccination site covered when handling an infant, for example, during feeding or changing diapers. Smallpox vaccine is not recommended for nursing mothers, unless an outbreak occurs and personal benefit from vaccination outweighs the risk. Breast-feeding is not a medical contraindication to any immunization, but could put the infant in close contact with the mother’s vaccination site.
  • Recently vaccinated healthcare workers should minimize contact with unvaccinated patients, particularly those with immunodeficiencies until 30 days after vaccination. 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 immunodeficiencies, 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 such as Opsite and 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 a non-adherent gauze, such as telfa, and then apply the semi-permeable bandage over the gauze. The dressing should also be changed daily, according to the type of bandaging and amount of exudate, such as at the start or end of a duty shift. Military treatment facilities have developed plans for site-care stations, to monitor workers’ vaccination sites, promote effective bandaging, and encourage scrupulous hand hygiene. Wearing long sleeve clothing can further reduce the risk for contact transfer. The most critical measure in preventing inadvertent contact spread is thorough hand-hygiene after changing the bandage or after any other contact with the vaccination site.
  • This slide shows the symptoms of 5,951 service members reported at their follow-up visit to assess vaccine reaction. This is only a snapshot of vaccine symptoms forms submitted to the Military Vaccine Agency for the period of Jan-April 2003. For a more comprehensive update, refer to the Safety Summary to Date section of our website that includes the latest information released. Go to www.smallpox.mil/safety.
  • 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. The following 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, to include 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). Another serious reaction may be 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 may require medical attention. This can take various forms, such as erythema multiforme. After the first 550,000 military smallpox vaccinations thru January 2004, few serious reactions occurred. About 70 cases of myocarditis or pericarditis occurred, primarily among first-time vaccinees. These cases ranged from mild to serious. A few heart attacks, some fatal, have been reported. The heart attacks are occurring at the same rate as among unvaccinated people, so a cause-and-effect relationship with vaccination is unlikely. Nonetheless, DoD medically exempts people with heart conditions. One case of lupus-like illness may have been triggered by vaccination. 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, and include people with serious skin rashes, ongoing tissue destruction related to vaccination site infection, swelling of the brain or surrounding tissues or chest pain.
  • Recognition of a serious adverse event after smallpox vaccination will be infrequent, but of high consequence to the patient. Consult as appropriate with allergy-immunology, infectious-disease, dermatology, neurology, cardiology or other specialist(s). Some conditions, like eczema vaccinatum, progressive vaccinia, severe ocular vaccinia, and severe generalized vaccinia, may respond to vaccinia immune globulin (IV-VIG). IV-VIG not effective in treating post-vaccinial encephalitis. VIG consists of human antibodies, called immunoglobulins, from people vaccinated with smallpox vaccine. 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 provider may request use of IV-VIG or cidofovir for a named patient by telephoning the CDC Director’s Emergency Operation Center at (770) 488-7100 from the Division of Bioterrorism Prepareness and Response on call person. Contact should also be made with the VHC to further enhance care and follow-up of the patient.
  • The Vaccine Adverse Event Reporting System, referred to as VAERS, was initiated in 1990 to oversee vaccine safety issues across America. This system is managed jointly by FDA and Centers for Disease Control and Prevention (CDC). It is a ‘passive’ surveillance system. This means that it relies on health care professionals, guardians and patients to submit reports of adverse events following vaccination. Filing a VAERS report does not prove that the reaction was caused by the vaccine but only reflects a possible association. Report to VAERS at www.vaers.hhs.gov and follow the link for online reporting or to print a VAERS form. Call 800-822-7967 or e-mail to info@vaers.org if further assistance is needed. Contact the Vaccine Healthcare Center (VHC) Network for support of serious or prolonged adverse events case management, registry functions & VAERS preparation assistance: AskVHC@amedd.army.mil or via www.VHCInfo.org
  • Adverse events after DoD or USCG directed vaccinations are line-of-duty conditions. Any adverse event which occurs in a Reserve Component member should be managed consistent with the Active Component requirements. If a vaccine-associated adverse event occurs in a non-duty status, the individual should seek medical care as appropriate. The individual must also report the event to the unit commander or designated representative as soon as possible. The commander will initiate a Line of Duty (LOD) and/or Notice of Eligibility (NOE) as appropriate. An individual, healthcare provider, or commander may submit a VAERS report. For payment information on civilian health-care services for members not enrolled to a Military Treatment Facility, members should be provided the Military Medical Support Office phone number 888-647-6676, or website http://mmso.med.navy.mil/.
  • Several information sources are listed here. Policy information can be obtained via the web, through email or telephone inquires to the Military Vaccine Agency at www.smallpox.mil, vaccines@amedd.army.mil, or 877-GET-VACC; that’s 877-438-8222. A DoD Vaccine call center is accessible 24 hours a day by calling 866-210-6469. The nurses can connect you to a physician on call at the Vaccine Health Care Center if needed or you can call the Vaccine Healthcare Center directly during business hours at 202-782-0411 for assistance with adverse event management. Civilian Healthcare Providers should obtain assistance in managing a condition that may be vaccine related by contacting the Military Treatment Facility where the member is enrolled, or the Military Medical support Office for authorization and payment. The Military Medical Support Office (MMSO) can be reached at 888-647-6676, or mmso.med.navy.mil/ If a pregnant woman is accidentally vaccinated, contact the Smallpox Vaccine in Pregnancy Registry at 619.553.9255 or email [email_address] This concludes this block of instruction. We hope this presentation has been helpful in explaining smallpox disease and vaccination procedures.

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  • Introduction SMALLPOX Department of Defense Healthcare Provider’s Briefing 9 Oct 08
  • Purpose To provide healthcare providers with an introduction to smallpox disease and vaccination procedures
  • Key Messages
    • Preserving the health and safety of our people is our top concern
    • Smallpox vaccine prevents smallpox, but requires very careful use
    • Smallpox would disrupt military missions, because it is contagious and deadly
    • Smallpox protection helps our War on Terrorism; new threats require new measures of force protection
  • Policies
    • Smallpox Vaccination:
    • Mandatory for personnel assigned to CENTCOM AOR, the Korean Peninsula and USPACOM Forward Deployed Naval Forces for 15+
    • Required for Smallpox Response Teams
    • Can be given up to 120 days before deployment
    • Policy requires ACAM2000 Medication Guide and DoD smallpox trifold distribution
    • Recipients must be screened
      • Screening form located at www.smallpox.mil/screeningform
  • Smallpox in History
    • 1776: Smallpox – U.S. forces too weak to capture Quebec
      • 5,500 smallpox casualties out of 10,000 forces
      • George Washington orders variolation of Continental Army against smallpox (archaic procedure, 2% fatal)
    • 1796: Europe (w/o Russia)—smallpox kills 400,000 people, causes 1/3 of blindness
    • 1796: Edward Jenner uses cowpox virus from milkmaid to prevent smallpox in young boy
    • 1812: War Department orders Jennerian vaccination of U.S. troops
    • 1890s: National Anti-Vaccination League, political riots in UK
    • 1919: Citizens outraged that Woodrow Wilson permits smallpox vaccination of Armed Forces
    • 1980: WHO declares Earth free of smallpox
    • 1984: DoD restricts vaccination to recruits at basic training
    • 2002: DoD resumes Smallpox Vaccination Program
    • 2007: FDA approves ACAM2000
    • 2008: DoD begins using new vaccine, ACAM2000
    • Smallpox was once worldwide in scope and was declared eradicated from the Earth in 1980
    • Smallpox spreads primarily by prolonged (> 1 h) face-to-face contact (< 6.5 feet)
    • A smallpox patient is most infectious from onset of rash, marked by temperature > 101 ° F (38.8 ° C)
    • A smallpox case, on average infects 3 to 5 other people
    • 15 days between generations of smallpox cases
    • As scabs form, infectivity decreases rapidly
    Epidemiology of Smallpox
    • Infectious dose unknown, but believed to be only a few virions
    • Natural infection occurs after virus implants on oropharyngeal, respiratory mucosa
    • Virus migrates and multiplies in regional lymph nodes
    • Symptomatic viremia develops on day 3 or 4
    • Secondary viremia begins on 8 th day, followed by fever & toxemia
    • Virus localizes in small blood vessels of skin and infects adjacent cells
    Pathogenesis
  • Smallpox Infection Timeline Post-exposure vaccination fully or partially protective through day 3 after exposure. Average smallpox case infects 3 to 5 people. About half of close contacts are infected. First symptoms develop 7 to 17 days after exposure; average depicted here as day 11. After symptoms develop, isolate case. Trace and vaccinate contacts.  
  • Smallpox Development
    • Lesions appear in 1 to 2 day period
    • On any part of body, lesions in same stage of development
    • Lesions most dense on face and extremities
    • New lesions appear in crops every few days
    • Lesions at different stages of maturation
    • More lesions on trunk than face and extremities
    Differential Diagnosis Chickenpox (Varicella) Smallpox (Variola)
  • Historical Quarantine Plaque
    • Supportive therapy helps reduce fever, pain, etc., but no established treatment for smallpox
    • Smallpox vaccination up to 3 days after someone is exposed to smallpox virus will prevent or reduce the severity of smallpox in most people
    • Vaccination 4 to 7 days after exposure likely offers partial protection
    • Pre-exposure vaccination protects 95% of people from getting smallpox.
    • Cidofovir used to treat smallpox under IND protocols, but no human efficacy data
    Care of Smallpox Patient
  • The Threat
    • Before smallpox was eradicated, it killed many millions of people over hundreds of years
    • Terrorists or governments hostile to US may have or could obtain variola virus
    • A smallpox outbreak would significantly affect military readiness
    • An outbreak could restrict movement of troops, aircraft, ships
    • Smallpox would stress medical operations to maximum capacity
    Smallpox would disrupt military missions because it is contagious and deadly
  • Smallpox Vaccine
    • The current vaccine in use in the United States is a new cell culture vaccine that is a derivative of the Dryvax vaccine that was used during the global smallpox eradication program
    • Dryvax was made from a virus called vaccinia , which is another “pox”-type virus related to smallpox
    • ACAM2000, is manufactured by Acambis
    • Live Vaccinia virus (NYCBOH strain) not smallpox (variola) virus
    • Percutaneous inoculation with bifurcated needle (scarification)
      • Pustular lesion/induration surrounding central scab/ulcer 6-8 days post-vaccination
      • Vaccine protects within a few days of vaccination
      • A cutaneous response demonstrates successful vaccination
      • Immunity not life-long
  • Comparison Chart www.smallpox.mil/ACAM2000
  • Smallpox Vaccine Effectiveness
    • World Health Organization (WHO) used Dryvax vaccine to eradicate natural smallpox
      • 95% of people are protected within 10 days (some may take longer)
      • Solid protection lasts for 3 years; partial protection lasts longer
      • ACIP recommends people at high risk for exposure be revaccinated every 10 years (pre-event); during an actual event, consider revaccinating if more than 3 years has elapsed since last vaccination
      • Can protect up to 3 days after exposure
    • Contains live vaccinia virus, cannot cause smallpox
    Smallpox vaccine prevents smallpox but requires very careful use
  • Screening
    • Carefully read & complete screening form; medical professionals available to explain in layman's terms
    • Ask for clarification if unsure how to answer screening questions
    • Contact family members who may know about childhood history of recurrent rashes like eczema
    • Talk to close contacts and family members about the vaccination program and safety precautions
    • Ask for assistance at any point, if you or your Family members have safety concerns
    • Screening form can be located at: www.smallpox.mil/screeningform
    All potential vaccinees must be screened
  • Exemptions to Vaccination
    • Personal or household contraindication
    • Immune system is not working fully (due to disease, medication, or radiation)
    • Has or has ever had eczema or atopic dermatitis
      • Red itchy, scaling rash lasting more than 2 weeks, comes & goes
    • Has active skin diseases, such as:
      • Burns, psoriasis, contact dermatitis, chickenpox, shingles, impetigo, uncontrolled acne, until it clears up or is under control
    • Pregnancy
    • Personal contraindication only
    • Has a serious heart disease (such as angina, heart attack, congestive heart failure, other cardiac problem) or > 3 risk factors
    • Uses steroid eye drops or ointment or is recovering from eye surgery (1 st 8 weeks post-op)
    • Breast-feeding (avoid vaccination in families w/ infant < 1 yr old unless separated)
    • Is allergic to a vaccine component such as polymyxin B, or neomycin
    Some people should not get smallpox vaccine except in emergency situations. Medical Exemptions are given for: Cells of the Immune System
  • Screening for HIV
    • HIV infection is a contraindication to smallpox vaccination
    • S ervice members must be up-to-date with Service HIV screening policies before smallpox vaccination
    • Civilian personnel will be offered an HIV test before vaccination.
    • HIV testing recommended for anyone with a history of risk factors for HIV infection, especially since last HIV test, and not sure of HIV infection status
    • Because known risk factors cannot be identified for some people infected with HIV, people concerned they could be infected should be tested
  • Contact Contraindications
    • Have alternative housing arrangements or be exempted from smallpox vaccination until household contact situation no longer applies (i.e., 30 days after vaccination)
    People who have close contact with a person who has a contraindication to smallpox vaccination shall: Unacceptable: Acceptable:
    • Permitting vaccinated SM to reside in house, trailer, apartment, or similar close arrangements (e.g., “hot-bunking”) with medically-barred contact
    • Vaccinated SM uses alternate lodging (e.g., barracks, dorm room, tents) on military installation, vessel, or aircraft, or in contracted space
    • Berthing barges, familiar to naval forces in shipyards
    • Vaccinated SM voluntarily arranges for alternate lodging in privately-owned or managed space is acceptable, if the commander has reasonable expectation that SM will comply with requirement
    • Schedule vaccinations shortly before or during 2- to 4-week deployments or family separation
  • Timing with Other Vaccines
    • Advisory Committee on Immunization Practices (ACIP) accepts administration of live and inactivated vaccines simultaneously or at any interval.
    • Multiple live-virus vaccines should be given simultaneously or separated by 28 days or more
    • To avoid confusing potential side effects, separate varicella (chickenpox) and vaccinia (smallpox) vaccinations by 28 days
    • Purified Protein Derivative (PPD) can be given simultaneously or 4 weeks after SPV
    • Do not administer other vaccines near smallpox site
  • Bifurcated needle
    • Vaccinators must have documented smallpox training in accordance with service requirements and must have previous smallpox vaccination and no current contraindications to the vaccine. Civilian vaccination is highly recommended prior to handling or administering smallpox vaccine.
    • Site: Skin over deltoid or posterior arm over triceps
      • Do not vaccinate over an old smallpox site, tattoo, scar or open skin.
    • Cleanse site with soap & water, then dry (if dirty)
    • Use acetone or alcohol only if adequate time is allowed for site to dry (or wipe site dry with gauze to prevent inactivation)
    • Multiple-puncture technique uses bifurcated needle inserted vertically into the vaccine vial
    • Primary (first) vaccination: 15 punctures, rapidly in 5 mm area, with strokes vigorous enough to cause a trace of blood after 15-20 seconds
    • Revaccination: 15 punctures
    • Evidence of prior smallpox vaccination (rough descending order of reliability):
      • medical documentation
      • characteristic Jennerian scar
      • entry into U.S. military service before 1984
      • birth in the United States before 1970
    Vaccination Technique
  • Successful Response to Vaccination If someone does not get the expected vaccination site reaction, the original vaccination clinic should be informed
  • Revaccination
    • Revaccination
      • No take: Give one revaccination with 15 punctures (jabs)
      • If a vaccinee does not respond to a second attempt at vaccination, refer for immunologic evaluation
    • Pre-event
      • Revaccinate if > 10 y elapsed since last vaccination
    • Outbreak
      • Revaccinate if > 3 y elapsed since first vaccination
  • Documentation
    • Screening: Record contraindications in medical record and ITS
    • Vaccination: I ndividual medical records and ITS
    • Confirmation of Take
      • Instruct all to come back to clinic if no characteristic lesion
      • Healthcare workers and response team members (traveling into smallpox outbreak area) will have take recorded in their health records and ITS
      • Other personnel should have vaccination take recorded in health records and ITS by medic or provider trained in vaccination evaluation
    • Adverse events
      • Medical records, VAERS, VHC access
    • USD(P&R): Services will audit immunization tracking systems
  • Care of Vaccination Site
    • Wear sleeves to cover the site
    • Wear sleeves at night, if you sleep in bed with someone
    • Use bandages; change them every few days
    • Discard bandages in sealed or double plastic bags; carefully add bleach if desired
    • Keep site dry; bathe normally, but dry the site last, with something disposable (avoid rubbing)
    • Avoid swimming or public bathing facilities
    • Launder clothing, towels and sheets in hot water with detergent or bleach
    • When the scab falls off, throw it away in a sealed plastic bag and wash hands afterwards
    Vaccine virus remains at the site for at least 30 days and until the skin has healed, and can potentially infect others Instruct your patients of the following :
    • Don’t touch any vaccination site
    • If you touch it by accident, wash your hands right away
    • Don’t let others touch your vaccination site or materials that covered it
    • Don’t let others use a towel used after vaccination until laundered
  • Hand Washing & Hand Hygiene
    • Wash hands with soap and warm water
      • Rub hands together vigorously for at least 10 seconds
      • Cover all surfaces of the hands and fingers
      • Rinse hands with warm water
      • Dry hands thoroughly with a paper towel
      • Use paper towel to turn off the faucet
    • Alcohol -based waterless hand rinse, e.g., CalStat ®
      • Excellent alternative if hands are not visibly soiled
      • Apply product to palm and rub hands together, covering all surfaces of hands and fingers, until hands are dry
      • May have sticky feel after repeated use – wash hands with soap and water as needed
    • Be extremely careful with contact lens use!
      • Wearing glasses until the site heals is preferred
      • If contact lenses are used, wash hands thoroughly before touching eyes or contact lenses
  • Pregnancy & Infant Care
    • Smallpox vaccination should be deferred until after pregnancy
    • Avoid pregnancy for 4 weeks after vaccination
    • If a female is pregnant at the time of vaccination, or if a vaccinee becomes pregnant within 4 weeks after vaccination,
      • Contact Smallpox Vaccine in Pregnancy Registry:
        • 619.553.9255
        • NHRC- [email_address]
        • www.smallpox.mil /pregnancy
      • Submit VAERS with Smallpox Pregnancy Supplement
    • In an outbreak, personal benefit from vaccination may outweigh risks
    • Take care to prevent spread of vaccine virus to children. ALWAYS wash hands before handling (e.g., feeding, changing diapers) and keep site covered with a bandage and sleeves
    • Smallpox vaccine not recommended for nursing mothers, as it may put infants in close contact with mother’s vaccination site
  • Extra Precautions for Healthcare Workers
    • Minimize contact with unvaccinated patients until 30 days after vaccination and until scab falls off
    • If contact essential and unavoidable, workers can continue to work with patients, including those with immunodeficiencies:
      • If site well-covered and thorough hand-hygiene maintained
      • Semi-permeable bandage (Opsite, Tegaderm, Cosmopore)
    • To prevent accumulation of exudates, cover site with dry gauze and apply dressing over gauze
    • Change dressing daily (according to type of bandaging and amount of exudate), at the start or end of shift
    • Site-care stations: to monitor worker vaccination sites, promote effective bandaging and encourage scrupulous hand hygiene
    • Long-sleeve clothing further reduces risk for contact transfer
    • Most critical measure: Thorough hand-hygiene after changing bandage or any contact with site
  • Symptoms Reported After Vaccination
    • Day 6-8, symptoms after vaccination, n = 5,951, Jan-Apr 2003
    • Local itching 62% Muscle ache 27%
    • Feeling lousy 26% Lymph nodes swell 23%
    • Headache 23% Bandage reaction 16%
    • Itchy all over 11% Fever (subjective) 6.6%
    • Local rash 11% Body rash 2.3%
    • Restrict activity 2.4% Took medication 5.0%
    • Outpatient visit 1.1% Limited duty 0.3%
    • Missed work 0.4% Hospitalized 0.1%
    www.smallpox.mil /safety
  • Serious Adverse Events
    • Serious reactions that may require medical attention
      • Accidental spread of virus elsewhere on body or to another person
      • Widespread vaccine rash where sores break out away from vaccination site (generalized vaccinia)
      • Allergic rash after vaccination (erythema multiforme)
      • Inflammation of or around heart (myo-pericarditis)
    • Life-threatening reactions that need immediate attention
      • Serious skin rashes in people such as those with eczema or atopic dermatitis (eczema vaccinatum)
      • Ongoing infection of skin with tissue destruction (progressive vaccinia or vaccinia necrosum)
      • Postvaccinal encephalitis, inflammation of the brain
      • Chest pain or shortness of breath
  • Treatment of Adverse Events
    • Be alert for serious, rare adverse events after vaccination
    • Consult the Vaccine Healthcare Centers Network or other specialists as appropriate (allergy-immunology, infectious disease, dermatology, neurology, cardiology, etc.)
    • Some conditions respond to vaccinia immune globulin (IV-VIG)
      • Eczema vaccinatum, progressive vaccinia, severe ocular vaccinia, severe generalized vaccinia
      • IV-VIG not effective in treating post-vaccinial encephalitis
    • IV-VIG consists of human IgG antibody from people vaccinated with smallpox vaccine
    • Contact the CDC Director’s Emergency Operation Center (DEOC) to order IV-VIG at (770) 488-7100
  • Adverse Event Reporting
    • Vaccine Adverse Event Reporting System (VAERS)
      • FDA and CDC review 100% of reports submitted
      • Anyone can submit a VAERS form, online preferred https:// secure.vaers.org
      • Reporting with medical help results in more detail
    • DoD requires a VAERS form for:
      • Loss of duty 24 hours or longer ( > 1 duty day)
      • Hospitalization
      • Suspected vaccine vial contamination
      • Auto-inoculation or contact vaccinia
    • Other submissions encouraged
    • Report to VAERS at www.vaers.hhs.gov or call 800-822-7967
    • For assistance with VAERS submission contact your local clinic or the VHC Network
    [email_address] or www.VHCInfo.org
  • Reserve Adverse-Event Care
    • Adverse events after DoD or USCG directed vaccinations are line-of-duty conditions
    • Someone with an adverse event in a non-duty status possibly associated to any vaccination
      • Seek medical evaluation at a DoD, USCG, or civilian medical treatment facility, if necessary
      • Must report the event to the unit commander or designated representative as soon as possible
      • See local medical department or squadron for guidance
    • Commander will determine Line of Duty and/or Notice of Eligibility status, if required
    • MILVAX Agency
      • www.smallpox.mil ; www.vaccines.mil /smallpox
      • [email_address]
      • 877.GET.VACC
    • DoD Vaccine Clinical Call Center
      • 866.210.6469
    • DoD Vaccine Healthcare Centers
    • for help with complicated adverse-event management
      • www.vhcinfo.org
      • [email_address]
      • 202.782.0411
    • Information for Civilian Healthcare Providers
    • Call the Military Treatment Facility (MTF) where the member is enrolled
    • – OR– contact the Military Medical Support Office (MMSO)
      • 888.647.6676 (if the member is not enrolled to an MTF)
    • Smallpox Vaccine in Pregnancy Registry
      • NHRC- [email_address]
      • 619.553.9255
    Information Sources (877.438.8222)
  • MILVAX
  • www.vaccines.mil www.vaccines.mil