consider whether such information also should be sent to everyone who has already been vaccinated.
As of June 20, 2003, 17 suspected cases of myo/pericarditis and 4 probable cases of myo/pericarditis following smallpox vaccination were reported in the civilian population (CDC, 2003n). Because of the probable association of smallpox vaccination with increased incidence of myo/pericarditis, CDC is now including myo/pericarditis in the tables of “selected adverse events associated with smallpox vaccination among civilians” appearing weekly in the Morbidity and Mortality Weekly Report. The ACIP Smallpox Vaccine Safety Working Group has concluded that “Smallpox vaccination increases risk of myo-pericarditis” (Neff, 2003). The DoD has stated, “the observed rate of myopericarditis among primary vaccinees is 3.6-fold higher than the expected rate among personnel on active duty who were not vaccinated” (Halsell et al., 2003).
Research in non–smallpox vaccine settings suggests that some people who experience myocarditis may develop long-term sequelae such as left ventricular dysfunction (Hiroe et al, 1985) and cardiomyopathy (Hayakawa et al., 1984; Das et al., 1985; Drucker and Newburger, 1997). As of June 20, 2003, two cases of dilated cardiomyopathy were diagnosed in civilian smallpox vaccinees 3 months after vaccination (CDC, 2003n). CDC is now advising, “Because smallpox vaccination appears to be associated causally with myocarditis, which can cause [dilated cardiomyopathy], further evaluation is warranted” (CDC, 2003n). In one study, one-fourth of patients reporting to a major medical center with symptomatic dilated cardiomyopathy died within a year, and half died within 5 years (Dec and Fuster, 1994).
The possibility of long-term sequelae from the smallpox vaccine must be acknowledged. Whereas the acute smallpox vaccine injuries are relatively well understood, less is known about smallpox vaccine injuries that occur on a longer-term basis. SEPPA specifies that an individual who was administered the vaccine who is requesting a benefit under the law must file an initial request for benefits or compensation “not later than one year after the date of administration of the vaccine” (U.S. Congress, 2003). (Individuals who experienced accidental vaccinia inoculation, however, have up to “two years after the date of the first symptom or manifestation of onset of the adverse effect” [U.S. Congress, 2003] to file an initial request.) For individuals who received the smallpox vaccine, it currently is unclear to the committee how, if at all, any injuries that manifest themselves more than 1 year after vaccination will be addressed. It also is unclear how longer-term sequelae that result from an acute smallpox vaccine injury (e.g., cardiomyopathy that results from a “silent” case of myocarditis, with no initial request for benefits filed in the year after vaccination) will be handled. Also, in SEPPA, a “covered injury” is covered if it is “determined … to have been