FDA EXTENDS EMERGENCY-USE AUTHORIZATION FOR ANTHRAX VACCINE
The FDA has extended an emergency-use-authorization (EUA) for military use of the anthrax vaccine by individuals who face a heightened risk of exposure to the toxin.
The extension, requested by the Defense Department, continues indefinitely the EUA that was first issued in January, according to a notice in the Aug. 3 Federal Register. The initial EUA calls for the use of anthrax vaccine adsorbed (AVA) for the prevention of inhalation anthrax for individuals 18 to 65 years old who are deemed by the Defense Department to face a heightened risk of exposure to anthrax.
The EUA will be effective for the duration of the declaration of emergency, which was issued Jan. 14 by former HHS Secretary Tommy Thompson, according to the notice. The FDA gained the authority to issue EUAs after last summer's passage of Project BioShield.
Under the BioShield legislation, the FDA can authorize the use of an unapproved drug or medical product when it is determined the treatment can be used to protect public health during a military, public health or domestic emergency declared by the secretary of defense, the HHS secretary or the secretary of homeland security. The use of AVA for the prevention of inhalation anthrax is considered an unapproved use of the product.