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Serious adverse reactions to smallpox vaccine appear to be limited

elf-limited local reactions. One hundred adverse events (12 percent) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis (inflammation of the muscular tissue of the heart) and/or pericarditis (inflammation of a membrane that surrounds the heart) and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized vaccinia (a skin eruption in reaction to vaccination) and 1 case of postvaccinial encephalitis (inflammation of the brain) were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with vaccinia immune globulin were identified. Serious adverse events were more common among older revaccinees than younger first-time vaccinees.

"The absence of preventable serious adverse reactions provides indirect evidence of effective vaccination screening and education, as well as attentive vaccination site care and monitoring," the authors write.

"This comprehensive smallpox vaccine safety monitoring and response system can serve as an effective model for vaccine campaigns that may occur in response to public health emergencies. Unique aspects included rapid detection, investigation, and response to rare and potentially serious adverse events. Our report highlights the success of education, screening, and clinical investigations and reviews in augmenting a robust safety monitoring system to minimize preventable adverse events. Additional reduction of overall vaccinia adverse events might be achievable through study of cardiac and dermatological risk factors, a better understanding of vaccinia host-pathogen interaction, and development of a less reactogenic vaccinia vaccine," the researchers conclude.


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Source:JAMA and Archives Journals


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