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TSI-GSD 104 is an inactivated (formalin-inactivated) Eastern Equine Encephalitis Virus (EEEV) vaccine developed primarily for laboratory personnel and others at high risk of exposure to EEEV. The vaccine uses the PE-6 strain of EEEV and is administered as a prophylactic immunization. It has been provided under investigational new drug (IND) protocols since the late 1970s by the U.S. Army Medical Research & Development Command and USAMRIID. The mechanism of action is immunostimulation—inducing neutralizing antibodies against EEEV to prevent infection. Clinical studies have shown it to be safe and immunogenic, with most adverse events being mild and local; no serious related adverse events have been reported. Despite decades of use under IND status, full licensure has not been pursued due to manufacturing constraints[1][5][7].
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