U.S. District Judge Emmett Sullivan will decide March 21 if he should enforce the blanket injunction he issued last year against the vaccinations. He also will rule whether Secretary of Defense Donald Rumsfeld should be cited for contempt of court for allowing that injunction to be violated.
The possible contempt citation stems from the fact that at least 250 -- and possibly up to 930 service members -- were given the anthrax vaccine after Sullivan ordered the shots stopped.
The anthrax vaccine -- specifically Anthrax Vaccine Absorbed or AVA -- has long been the subject of controversy. Defense officials assert that a series of some 18 studies, including one by the Institute of Medicine -- part of the National Academy of Sciences -- supports the safety of the vaccine.
Opponents said the studies are flawed and the vaccine can trigger severe, even life-threatening, reactions and already has sickened hundreds of individuals.
More than 440 members of the armed services were concerned enough that they chose to face disciplinary action rather than submit to the mandatory series of shots, DoD admitted to Congress. Of those, about 100 have been court-martialed so far, said attorney Mark Zaid, who represents six plaintiffs in the current case.
Judge Sullivan agreed with the vaccine opponents, ruling Oct. 27 to halt the program. He decided the Food and Drug Administration had failed to follow its own procedures in approving the vaccine and had not given opponents the opportunity to be heard.
In December, DoD sought, and shortly thereafter obtained, an Emergency Use Authorization from the Department of Health and Human Services. The new Bioshield law gave HHS the power to allow, in event of an emergency, the use of otherwise-unapproved drugs or, as in this case, the use of an existing drug for an unapproved application.
DoD officials asserted there was a potential emergency risk to military personnel from anthrax and asked HHS to grant an EUA. HHS agreed and FDA concurred -- though FDA insisted service members be allowed to refuse the shots without fear of repercussion.
With the EUA in hand, DoD now has returned to court to seek modification of the injunction to allow use of AVA.
One of the questions raised by Sullivan, who noted the time delay from the original EUA, was whether there still was an emergency. Others have raised the question as well including Rep. Chris Shays, R-Conn., who asked the Central Intelligence Agency for a briefing on the intelligence assessment cited by DoD as justification for the emergency vaccinations.
Even Shays noted, however -- in a second letter on the matter to HHS -- the emergency authorization may be an effective end run around the injunction. More than one expert following the case said DoD appears to be asking Sullivan to modify his ruling, more out of caution than necessity.
There still is one aspect of the injunction DoD may not be able to sidestep -- at least not yet. The Pentagon cannot make the shots mandatory, a point for which they have fought strongly in the past. In fact, the military is supposed to give each service person a brochure making clear the voluntary nature of the shots.
Lawyers for the plaintiffs are seeking to review the brochure. They are worried, Zaid told UPI's BioWar, that the pamphlet will misrepresent the risks -- something Zaid said has happened in the past. Attorneys representing DoD promised Sullivan, during the Monday morning hearing, they would deliver a copy of the language within 24 hours.
"We still haven't gotten it," Zaid said Tuesday evening.
Sullivan will address the question of the brochure and the injunction March 21. It is difficult to anticipate what Sullivan will order, but there is no question he and the Defense Department regard the matter differently.
DoD and the vaccine's manufacturer, Bioport of Lansing, Mich., repeatedly have portrayed the October decision as based strictly on a procedural question. Sullivan, however, cast the matter at the center of his ruling as an opportunity to challenge the usefulness of the vaccine itself.
"It is clear to the court," Sullivan wrote, "that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency ... a new notice and comment period would be the first opportunity that interested parties would have to challenge the vaccine's efficacy against (inhalation anthrax) exposure."
FDA currently is accepting comments on the vaccine under Docket No. 1980N-0208.
Sullivan also will hear arguments on whether Secretary of Defense Donald Rumsfeld should be cited for contempt. Though Rumsfeld immediately issued an order stopping the vaccinations, at least some took place anyway. Initial reports put the number vaccinated at 931, but subsequent investigation indicated about 650 of those involved data-entry errors in the vaccination-tracking system. The problem came to light after it was discovered that six service members had received post-injunction vaccinations in December at Fort Benning, Ga., as late as Dec. 8.
"We do not comment on matters pending in litigation," a DoD spokesman said, who also noted that shipments of the vaccine had been stopped immediately after the injunction was issued.
An order was issued Jan. 28 to remove from military clinics any supply of vaccine already shipped out.