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Who should not get Smallpox/Monkeypox (Mpox) vaccine?
Smallpox (Vaccinia) Vaccine, Live (ACAM 2000)
In non-emergency situations, ACAM 2000 is contraindicated in persons with active exfoliative skin conditions that include eczema, severe acne, psoriasis, varicella zoster virus infection, herpes simplex virus infection, burns, impetigo, severe diaper dermatitis with extensive areas of raw skin, keratosis follicularis and in persons with a history or presence of atopic dermatitis. Persons with immunosuppressive conditions such as HIV infection or acquired immune deficiency syndrome (AIDS), autoimmune disease, lymphoma, leukemia, cancer, solid organ and stem cell transplant recipients, and those receiving cancer treatments or steroids.
Infants under one year of age, women who are pregnant or breastfeeding, and persons who are allergic to any component of smallpox vaccine should not receive ACAM 2000.
Persons with known underlying cardiac disease or who have three or more known significant cardiac risk factors such as diabetes, hypertension, high cholesterol, smoking, or family history of heart disease. Persons receiving smallpox vaccination for the first time are at a higher risk for myopericarditis (inflammation of the heart muscle and surrounding tissues). While specific risk factors for myopericarditis are not known, persons with cardiac risk factors and a history of heart disease are more likely to have severe outcomes when compared to those without cardiac conditions.
Non-emergency use of ACAM 2000 is also contraindicated in individuals with household contacts who have a history of active exfoliative skin conditions that include eczema, severe acne, psoriasis, varicella zoster virus infection, herpes simplex virus infection, burns, impetigo, severe diaper dermatitis with extensive areas of raw skin, keratosis follicularis and in persons with a history or presence of atopic dermatitis. Persons with immunosuppressive conditions such as HIV infection or acquired immune deficiency syndrome (AIDS), autoimmune disease, lymphoma, leukemia, cancer, solid organ and stem cell transplant recipients, and those receiving cancer treatments or steroids. The vaccine is also contraindicated in persons with household contacts who are under one year of age, or pregnant women.
Persons with inflammatory eye disease may be at an increased risk for inadvertent inoculation from rubbing or touching the eye. Persons with inflammatory eye disease who require steroid treatment should not receive ACAM 2000 until therapy is completed and the condition is resolved.
Non-emergency vaccination with ACAM 2000 is not recommended in children and adolescents under the age of 18 years.
ACAM 2000 has not been studied for use in pregnant women and is a Pregnancy Category D product. This means that the live vaccinia vaccine can cause fetal harm when administered to pregnant women. If administered to a pregnant woman, congenital infection, generalized vaccinia, and fetal death can occur.
Smallpox and Monkeypox (Mpox) Vaccine, Live, Non-Replicating (JYNNEOS)
Persons who have previously experienced a severe allergic reaction to JYNNEOS vaccine may be at a higher risk of experiencing an additional serious reaction after receiving a second vaccine dose.
JYNNEOS is approved for use in adults 18 years of age and older considered at a high risk for smallpox or mpox. The FDA has issued an emergency use authorization (EUA) for the JYNNEOS vaccine in persons under 18 years who are considered at high risk for mpox. According to the FDA,
An EUA is an FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency, or the significant potential for a public health emergency, that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s).
While JYNNEOS has been studied in pregnant rabbits and rats, there is no data to support safety of its use in pregnant women. It is also not known whether the vaccine is excreted in human milk or what the effects may be on the breastfed infant.
IMPORTANT NOTE: NVIC encourages you to become fully informed about smallpox/monkeypox (Mpox) and the smallpox/monkeypox (Mpox) vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself. This information is for educational purposes only and is not intended as medical advice.