Editorial: Vaccine Policy at Issue (Anthrax)
Just as the Pentagon is set to resume mandatory anthrax shots for the troops, the vaccine's sole manufacturer, Emergent BioSolutions, says it is testing its product as a potential treatment after anthrax exposure.
In fact, the Food and Drug Administration has granted that project "fast track" status, a designation meant to expedite development and review of new drugs, and new uses for existing drugs, that are considered particularly important. The company reportedly is testing a regimen of three shots at two-week intervals, together with antibiotics, as a post-exposure anthrax treatment.
That raises an interesting issue: If the tests are successful and the FDA approves using the vaccine in that way, would the Pentagon be justified in forcing huge numbers of troops who are not infected to take the shots against their will?
Untold numbers of troops have suffered adverse reactions to this vaccine, many of them severe, some incapacitating.
If the drug proves effective as a post-exposure treatment and is approved for that use, it would seem unconscionable for the Pentagon to risk even one service member's health unnecessarily.
The vaccine and accompanying antibiotics could be used as the military uses nerve agent antidote, dispensing it to troops in high-threat regions with instructions to use it in the event of an attack.
By press time, the Pentagon had not responded to a request for comment on an issue that is, admittedly, still hypothetical.
But if the FDA certifies the anthrax vaccine as an effective post-exposure treatment, leaders in Congress should be locked and loaded to ask Defense Secretary Robert Gates and his top health official, William Winkenwerder Jr., pointed questions about the need to continue forcing huge numbers of healthy troops to roll up their sleeves and roll the dice on this vaccine.
In fact, the Food and Drug Administration has granted that project "fast track" status, a designation meant to expedite development and review of new drugs, and new uses for existing drugs, that are considered particularly important. The company reportedly is testing a regimen of three shots at two-week intervals, together with antibiotics, as a post-exposure anthrax treatment.
That raises an interesting issue: If the tests are successful and the FDA approves using the vaccine in that way, would the Pentagon be justified in forcing huge numbers of troops who are not infected to take the shots against their will?
Untold numbers of troops have suffered adverse reactions to this vaccine, many of them severe, some incapacitating.
If the drug proves effective as a post-exposure treatment and is approved for that use, it would seem unconscionable for the Pentagon to risk even one service member's health unnecessarily.
The vaccine and accompanying antibiotics could be used as the military uses nerve agent antidote, dispensing it to troops in high-threat regions with instructions to use it in the event of an attack.
By press time, the Pentagon had not responded to a request for comment on an issue that is, admittedly, still hypothetical.
But if the FDA certifies the anthrax vaccine as an effective post-exposure treatment, leaders in Congress should be locked and loaded to ask Defense Secretary Robert Gates and his top health official, William Winkenwerder Jr., pointed questions about the need to continue forcing huge numbers of healthy troops to roll up their sleeves and roll the dice on this vaccine.
