Estimating the Size of the U.S. Population at Risk of Severe Adverse Events from Replicating Smallpox Vaccine

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Abstract

Objective:

To quantify the population at risk of serious adverse reactions to replicating smallpox vaccine.

Design and Sample:

Conditions known or suspected to carry risk were identified via Centers for Disease Control and Prevention planning documents, other federal publications, and peer-reviewed literature. Conditions identified were categorized as historically recognized risks or more recently recognized immunocompromised states that may pose risk. Major historical risk factors were as follows: eczema/atopic dermatitis, pregnancy, HIV, and primary immunodeficiency. More recently identified states were as follows: rheumatoid arthritis, inflammatory bowel disease, dialysis, bone marrow transplant recipients within 24 months post-transplant, solid-organ transplant recipients within 3 months post-transplant, age under 1 year, and systemic lupus erythematosus.

Measures:

The estimated prevalence or absolute number of affected individuals for each condition was ascertained from peer-reviewed studies, vital statistics, and registry databases.

Results:

An estimated 48,121,280 to 50,028,045 individuals (15.2–15.8% of the U.S. population) are potentially contraindicated to replicating smallpox vaccine. This rises to 119,244,531 to 123,669,327 (37.4–38.8%) if household contacts are included.

Conclusions:

These figures are significant and larger than the only previously published study. Understanding this number allows for improved clinical utilization, equitable attention to the health needs of a vulnerable population, and strategic vaccine stockpiling.

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