White Papers for Food and Drug Administration (FDA)

Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax Availability

Food and Drug Administration, HHS.

The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) [the Authorization) for
Anthrax Vaccine Adsorbed (AVA) for prevention of inhalation anthrax for
individuals between 18 and 65 years of age who are deemed by the Department
of Defense (DOD] to be at heightened risk of exposure due to attack with
anthrax. FDA is issuing this Authorization under the Federal Food, Drug, and
Cosmetic Act (the act), as requested by DOD. The Authorization contains,
among other things, conditions on the emergency use of AVA. The
Authorization follows the determination by DOD that there is a significant
potential for a military emergency involving a heightened risk to U.S. military
forces of attack with anthrax. On the basis of such determination, Secretary
of Health and Human Services Tommy G. Thompson (the Secretary) declared
an emergency justifying the authorization of the emergency use of AVA. The
Authorization, which includes an explanation of the reasons for its issuance,
is reprinted in this Notice.

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