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Contraindications for primary smallpox vaccinees are listed below. Most, but not all, also apply to revaccinees.
Nonemergency use of smallpox vaccine
In the absence of a smallpox outbreak, do not give the smallpox vaccine to anyone with the contraindications described below.
All contraindications apply to primary vaccinees. Most, but not all, also apply to revaccinees. Because replication-competent vaccinia virus can spread from the vaccinee's vaccination site to close household contacts, it is important to screen not only vaccinees but also their close household contacts for specific contraindications noted. Household contacts include persons with prolonged contact with the potential vaccinee (e.g., sexual contacts) and others who might have direct contact with the vaccination site or with potentially contaminated materials (e.g., dressings or clothing).
| Contraindication | Primary vaccinees | Revaccinees | Household contacts |
|---|---|---|---|
| History or presence of atopic dermatitis | X | X | X |
Other active exfoliative skin conditions such as:
|
X | X | X |
Conditions associated with immunosuppression such as:
|
X | X | X |
Persons undergoing therapy with:
|
X | X | X |
| Persons who are hematopoietic stem cell transplant recipients <24 months post-transplant OR ≥24 months, but who have graft-versus-host disease or disease relapse | X | X | X |
| Persons with autoimmune disease (e.g., systemic lupus erythematosus) with immunodeficiency as a clinical component | X | X | X |
| Pregnancy | X | X | X |
| Aged <1 year | X | X | X |
| Breastfeeding | X | X | |
| Serious vaccine component allergy | X | X | |
| Known underlying heart disease (e.g., coronary artery disease or cardiomyopathy) | X | X | |
Three or more known cardiac risk factors:
|
X |
In addition to these contraindications, do not vaccinate anyone in a nonemergency situation who:
- has active eye disease that is being treated with topical steroids
- is moderately or severely ill on the day of vaccination
The person may be vaccinated once these issues resolve.
Emergency use of smallpox vaccine
In a smallpox emergency, the risk for adverse events from smallpox vaccination is outweighed more often by the risk for severe smallpox disease. Consequently, contraindications that would apply in a pre-event vaccination program might no longer apply in a post-event vaccination program.
Because of the high case-fatality rate and severity of smallpox, no clear absolute contraindications exist for the use of smallpox vaccines for persons exposed to smallpox virus or at high risk for smallpox infection. In a smallpox emergency, weigh each person's risk for smallpox infection, risk for an adverse event following vaccination, and benefit from vaccination to make the final determination about whether or not to vaccinate.
CDC has published more extensive clinical guidance for using smallpox vaccine in a smallpox emergency.
Resources
- Clinical Guidelines for Smallpox Vaccine Use in a Postevent Vaccination Program Source: MMWR 2015, 64(RR02);1-26.
- Use of Vaccinia Virus Smallpox Vaccine in Laboratory and Health Care Personnel at Risk for Occupational Exposure to Orthopoxviruses – Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2015 Source: MMWR 2016, 65(10);257–262.
- Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program Source: MMWR 2003, 52(RR07);1-16
- Clinical Guidelines for Smallpox Vaccine Use in a Postevent Vaccination Program Source: MMWR 2015, 64(RR02);1-26.
- Use of Vaccinia Virus Smallpox Vaccine in Laboratory and Health Care Personnel at Risk for Occupational Exposure to Orthopoxviruses – Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2015 Source: MMWR 2016, 65(10);257–262.
- Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program Source: MMWR 2003, 52(RR07);1-16