Smallpox
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Variola
stain of variola

Smallpox is a contagious viral illness caused by the variola virus. The virus can spread from an infected person through the air when there is fairly prolonged (1-3 hours) direct contact. It can also spread via body fluids, either by direct contact with fluids from an infected person or by touching objects that have been contaminated by infected body fluids. The last documented case of smallpox disease occurred in 1977. However, smallpox is still considered a possible biological threat.

An infected person usually begins to experience symptoms 12 to 14 days after exposure. Smallpox disease results in a fever and viral-like symptoms, followed by a rash that progresses from papules to pustules. Eventually the pustules form scabs and the scabs fall off. People with smallpox can spread the virus to others beginning when their fever is 101°F until all their scabs fall off.

There is no proven cure for smallpox. Historically, death has occurred in about 30% of cases. Giving smallpox vaccine soon after exposure to the virus can help to reduce the effects of smallpox disease. Vaccine given within 3 days after exposure can help prevent death. Vaccine given within 7 days after exposure can result in a less severe (modified-type) smallpox illness.

About the Vaccine

There is only one smallpox vaccine available in the United States. It is a live, attenuated vaccine made from vaccinia virus. Vaccinia virus is closely related to variola virus, which is the virus that causes smallpox. Immunity against vaccinia virus also provides protection against variola virus. It is administered using a bifurcated needle that is jabbed into the surface of the skin.

Smallpox Vaccines Licensed for Use in the U.S.
Product: ACAM2000® (Vaccinia Virus)
Manufacturer: Acambis Inc.
Year licensed: 2007
Product Insert
Indications Contraindications and precautions

Pre-Event (no smallpox disease outbreak):

  • Laboratory workers who handle cultures or animals contaminated or infected with vaccinia or other related viruses.
  • Emergency response personnel and healthcare workers involved in potential care of smallpox patients.
  • Military personnel with operational or other job-related indications.
  • People administering smallpox vaccine.

Post-Event (smallpox disease outbreak has occurred):

  • People who have been exposed to the smallpox virus.
  • People who are at risk of exposure to smallpox virus.

Pre-Event

  • People who have had a severe allergic reaction to a smallpox vaccine or a smallpox vaccine component.
  • People who are moderately or severely ill should wait until recovery before receiving any vaccine. Minor illnesses, such as a cold, are not a contraindication.
  • Women who are pregnant or breastfeeding.
  • People with current symptoms or a history of atopic dermatitis or eczema.
  • People who are immunosuppressed due to disease, treatment, or medication.
  • People with heart or blood vessel disease.
  • People with three or more risk factors for heart disease, including high blood pressure, high cholesterol, diabetes, cigarette smoker, or history of a heart condition in a parent or sibling prior to 50 years of age.
  • People with a current skin problem causing breaks in the skin.
  • People who have received varicella (chickenpox) vaccine within the past 28 days.
  • People who use steroid eye drops or ointment.
  • People who have had recent eye surgery.
  • People who cannot avoid close contact with others who are at risk for complications if exposed to the vaccine virus, such as children younger than 1 year of age, people with eczema, people who are immune compromised.

Post-Event

  • There are NO absolute contraindications following smallpox exposure. In cases of allergies or immunosuppression, consult an allergist/immunologist.
Vaccine Dose/Route Routine Administration Schedule
ACAM2000 15 punctures into the skin. Single dose.

Note: A booster dose may be needed in 3 to 10 years based on risk of exposure.
Smallpox Vaccination Site Care

To reduce the chance of spreading the vaccine virus to other body parts or other people, please follow these recommendations:

  • Wash your hands regularly, especially before caring for a child younger than 1 year old. Avoid direct contact between child and vaccination site.
  • Remember that virus may be present until site heals and skin returns to normal color, which can take more than 30 days.
  • Do not touch the vaccination site.
  • If you touch the site by accident, wash your hands immediately and then clean clothing or towels/wash cloths.
  • Wash your hands before and after dressing changes.
  • Do not let others (including pets) touch your vaccination site or materials that touched the site.
  • Keep the site dry.
  • Cover with waterproof bandage or plastic wrap when bathing or showering.
  • Do not rub the site.
  • Wash contaminated laundry and items that have touched the site with hot soapy water.
  • Keep contaminated linen, towels, clothes and other items away from family members or household contacts.
Smallpox Vaccine Side Effects
  • Mild pain at the injection site (40% to 47% of people).
  • Severe pain at the injection site (2% to 3% of people).
  • Swelling of lymph nodes in the armpit (about 30% of people).
  • Fever (about 10% of people).
  • Sick enough to miss work (5% to 10% of people).
  • Rash (about 8% of people).
  • Blisters on other parts of the body (about 1 of 10,000 people vaccinated).
  • Eye infection from touching the eye when vaccine virus is on the hand (1 of 45,000 people vaccinated).
  • Rash on the entire body, which usually goes away without problems (1 of 15,000 people vaccinated).
  • Benign or malignant lesions at the vaccination site, which can occur long after vaccination (not common).
  • Inflamed heart muscle or tissue surrounding the heart, which can be life-threatening (1 of 10,000 people vaccinated for the first time).
  • Severe rash on people who have eczema or atopic dermatitis, which can lead to scarring or death (1 of 26,000 people vaccinated).
  • Encephalitis, which can lead to permanent brain damage or death (1 of 83,000 people vaccinated).
  • Skin and tissue destruction starting at the vaccination site and spreading to the rest of the body, which can lead to scarring and death (1 of 667,000 people vaccinated, mainly people with very weak immune systems).
  • Vaccinia virus infection in an unborn child, which can lead to early birth, skin rash with scarring, stillbirth, or death of the child after delivery (very rare).
  • Severe allergic reaction (very rare).
* If there is a history of rash or serious illness <30 days following recent smallpox vaccination, contact with smallpox vaccine/smallpox vaccination site, or exposure to vaccinia virus, AND there are vesicles/pustules -or- patient is hospitalized: CLICK HERE TO OBTAIN AND FOLLOW THE GUIDELINE FOR OBTAINING VACCINIA POLYMERASE CHAIN REACTION (PCR) ASSAY
Product Name Supplied Storage and Handling
ACAM2000
Acambis Inc.
Multidose dose vial with diluent (1 set per package). Prior to shipment ACAM2000 is stored frozen at 15°C to -25°C (+5°F to -13°F). Upon arrival store in refrigerator at 35° to 46°F (2° to 8°C) and do not freeze or expose to freezing temperatures. When reconstituting the vaccine, gently swirl the mixture. Do not shake. After reconstitution, ACAM2000 must be used within 30 days.

ACAM2000 is a clear to slightly hazy, colorless to straw-colored liquid.
Training for individuals about to receive the smallpox vaccine; covering policy, the risks/benefits associated with the smallpox vaccine, situations where you should not receive the vaccine, expected response at the smallpox vaccination site, and post-vaccination site care. Also includes info on possible vaccine side effects.
A PDF containing the full set of frequently asked Questions & Answers about Smallpox
CBS News 08 Jul 14
Forgotten vials of smallpox found in old storage room
A case review of myopericarditis in service members following vaccination with the smallpox vaccine.
Training for individuals about to receive the smallpox vaccine; covering policy, the risks/benefits associated with the smallpox vaccine, situations where you should not receive the vaccine, expected response at the smallpox vaccination site, and post-vaccination site care. Also includes info on possible vaccine side effects.
This is an 8 module online course designed to satisfy the DoD approved smallpox training requirement for medical personnel administering smallpox vaccinations.
GENADMIN PDF 21 Jun 13
III MEF FORCE HEALTH PROTECTION (FHP) REQUIREMENTS 2014
ALCOAST PDF 04 Apr 13
IMMUNIZATIONS UPDATE (Smallpox, Yellow Fever, Tdap)
COMSEVENTHFLT PDF 20 Sep 12
IMMUNIZATION REQUIREMENTS FOR DEPLOYMENT TO SEVENTH FLEET
BUMED PDF 23 Sep 08
UPDATE TO CLINICAL POLICY FOR DOD SMALLPOX VACCINATION
ALNAV PDF 27 Feb 08
TRANSITION FROM CURRENT DRYVAX SMALLPOX VACCINE TO ACAM2000 SMALLPOX VACCINE
ALARACT PDF 14 Feb 08
DOD'S TRANSITION TO ACAM2000 BRAND OF SMALLPOX VACCINE
ALCOAST PDF 30 Jan 08
COAST GUARD SMALLPOX VACCINE PROGRAM UPDATE - TRANSITION FROM DRYVAX TO ACAM2000
08 Jul 14

Sample Q&A: Vaccine Safety

Should women or men defer conceiving a child after receiving the smallpox vaccine?

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.

Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC)
VAERS 19 Mar 14
Vaccine Adverse Event Reporting System
Vaccine Healthcare Center
Vaccine Healthcare Centers Network
Did You Receive the Smallpox Vaccine While Pregnant?
Brochure explaining smallpox vaccine and the Smallpox Vaccination Program
Information on DoD Online Smallpox Vaccination Training
Sanofi Pasteur, v6.0; This medication guide replaces the Smallpox VIS. It is to be used before one receives the vaccination.
Did You Receive the Smallpox Vaccine While Pregnant?
Centers for Disease Control and Prevention
FDA Consumer Update - ACAM2000
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
VAERS 19 Mar 14
Vaccine Adverse Event Reporting System
Supplemental Form for Smallpox Vaccine in Pregnancy Registry
Follow-Up Note for Standard "Take-Check" Visits
Follow-Up Note for Sick Call Evaluation of Patients [pre position this form at ERs and troop medical clinics]
Package Insert - Vaccine
Author: Tedesco
COMMANDANT INSTRUCTION M6230.10
Free program for planning optimal large-scale smallpox vaccination clinics
Vaccination in a Non-Emergency Situation
VAERS 19 Mar 14
Vaccine Adverse Event Reporting System
Department of Health and Human Services
FDA/CBER 16 May 11
Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Smallpox Information
Smallpox Vaccine Information
Smallpox Immunization
Smallpox Information
MMQC-14-1488 30 May 14
U.S. Central Command Smallpox Vaccine Exception to Policy / Information
MMQC-11-1492 22 Jul 11
UPDATED DEPARTMENT OF DEFENSE (DOD) SMALLPOX VACCINE BROCHURES
MMQC-10-1678 15 Nov 10
ACAMBIS, INC / SANOFI-PASTEUR BIOLOGICS CO / CENTERS FOR DISEASE CONTROL & PREVENTION (CDC) / DILUENT LOT # DV01C01 FOR ACAM 2000 SMALLPOX (VACCINIA) VACCINE, LIVE / URGENT PHARMACEUTICAL NOTIFICATION
MMQC-08-1181 09 May 08
SUBMITTING EXECUTIVE SUMMARY AND DESTRUCTION DOCUMENTS FOR EXPIRED OR COMPROMISED ANTHRAX AND SMALLPOX VACCINE / INFORMATION BULLETIN
MMQC-07-1381 27 Dec 07
INTRA-VENOUS VACCINIA IMMUNE GLOBULIN (IV-VIG) / DEFINE PROCEDURES FOR ORDERING IV-VIG
Brochure explaining smallpox vaccine and the Smallpox Vaccination Program
Compiled by the MILVAX Agency
Vaccine Healthcare Centers Network
This is an 8 module online course designed to satisfy the DoD approved smallpox training requirement for medical personnel administering smallpox vaccinations.
Did You Receive the Smallpox Vaccine While Pregnant?
Brochure explaining smallpox vaccine and the Smallpox Vaccination Program
Compiled by the MILVAX Agency
The College of Physicians of Philadelphia
D.A. Henderson discusses the last wild case of variola major
The College of Physicians of Philadelphia
D.A. Henderson discusses the last case of naturally occurring variola minor, a less severe form of smallpox, which occurred in Somalia in 1976
Video: Around The ServicesAround The Services (1:11) 30 Jan 09
Smallpox Study
Sanofi Pasteur, v6.0; This medication guide replaces the Smallpox VIS. It is to be used before one receives the vaccination.
CBS News 08 Jul 14
Forgotten vials of smallpox found in old storage room
ABC News 05 May 14
WHO Debates Fate of Smallpox Vials in US, Russia
Author(s): Beck LA, Boguniewicz M, Hata T, Schneider LC, Hanifin J, Gallo R, Paller AS, Lieff S, Reese J, Zaccaro D, Milgrom H, Barnes KC, Leung DYM
Publication: Journal of Allergy and Clinical Immunology
Subject: Disease
Disease: 
Smallpox
Author(s): Saito T, Fujii T, Kanatani Y
Publication: JAMA. 2009;301(10):1025-1033
Subject: Vaccine-General
Disease: 
Smallpox
Author(s): Centers for Disease Control and Prevention
Publication: MMWR 2009 / 58(Early Release);1-4
Subject: Vaccine-Safety
Disease: 
Smallpox
Author(s): Cummings JF, Polhemus ME, Hawkes C, Klote M, Ludwig GV, Wortmann G
Publication: Clinical Infectious Diseases 2008; 46:000–000
Subject: Vaccine-Safety
Disease: 
Smallpox