(2005; 12 pages)
SMALLPOX VACCINE - Label to highlight reports of myopericarditis
USA. A black box warning has been added to the labelling of Wyeth's smallpox vaccine, Dryvax, to highlight reports of acute myopericarditis in healthy adults. Although Wyeth no longer manufactures Dryvax, as the World Health Assembly certified the world free of naturally occurring smallpox in the 1980s, the US Government asked Wyeth to test stored batches of the vaccine, and the black box warning applies to those vaccines which have been repackaged for immediate use by firefighters, medical personnel and other first responders. The black box warning states that "acute myopericarditis has been observed after administration of Dryvax to healthy adults", and also warns of encephalitis, progressive vaccinia and severe vaccinial skin infections following vaccination with the agent. The warning states that immunocompromised persons should not receive the vaccine in non-emergency situations.
Smallpox vaccine dried, calf lymph type. Prescribing Information, 15 November 2004. Available on the Internet at www.fda.gov