Anthrax shots back on go after 2-year hiatus
By Gayle S. Putrich, Staff writer
After a nearly two-year, court-ordered hiatus, the Defense Department will resume mandatory anthrax vaccinations for troops in the next 30 to 60 days.
Anyone deploying to locations the Pentagon considers “high risk” — those serving in Korea and those assigned to Central Command in the war zones — will be required to take the vaccine. Civilian Defense Department employees and contractors who are considered “mission essential” in specified areas or with specified commands will also be included.
Members of the military who had already started the series of six shots before the program was shut down in 2004 and those in need of the annual booster shot will also be able continue their vaccinations if they so choose, said Dr. William Winkenwerder, assistant secretary of defense for health affairs.
“The threat is very real and it has not gone away,” Winkenwerder said. “The persons we are vaccinating are those at highest risk. It’s an issue of the relative risk for those persons and the optimal way to provide round-the-clock protection for them.”
The U.S. District Court for the District of Columbia shut down the mandatory anthrax vaccine program in late 2004. At that time, Judge Emmet Sullivan ruled that forcing troops to take the vaccine amounted to an illegal order because the Food and Drug Administration failed to follow its own regulatory procedures in declaring the vaccine safe and effective against all forms of anthrax, including the inhalation variety that defense officials say poses a threat to U.S. forces.
The FDA did not specify that the vaccine was safe and effective against the inhalation form of anthrax until December 2005. The license issued in 1970 was aimed mainly at the skin form of anthrax, occasionally contracted by people working with animal hides.
Since that 2005 ruling by the FDA, Winkenwerder said, “the vaccine has been thoroughly reviewed by several independent and outside groups” and the Defense Department’s entire vaccine program has been reviewed.
“The vaccine is safe and effective,” he said.
Those who filed suit to stop the mandatory anthrax vaccine injections years ago say the drug is not as safe as the Pentagon declares it is, and that they will fight the latest iteration of the vaccine program as well.
“We are planning a legal challenge to the fundamentals of the entire program,” said Mark Zaid, one of the attorneys for the six anonymous plaintiffs in the anthrax case in federal civilian court. “The program is no better than it was before. DoD continues to manufacture justification for a program that is likely the worst medical program they have ever implemented. It is not proven to be effective. It is potentially unsafe. And it is not even the same originally licensed vaccine.”
The U.S. Court of Appeals for the Armed Forces recently upheld the conviction of an Army specialist who was punished for refusing orders to take the vaccine in 2000 — before the FDA updated the drugs license for use against inhalation anthrax.
The attorneys in that case intend to petition the U.S. Supreme Court to hear the case before the end of the year.
After a nearly two-year, court-ordered hiatus, the Defense Department will resume mandatory anthrax vaccinations for troops in the next 30 to 60 days.
Anyone deploying to locations the Pentagon considers “high risk” — those serving in Korea and those assigned to Central Command in the war zones — will be required to take the vaccine. Civilian Defense Department employees and contractors who are considered “mission essential” in specified areas or with specified commands will also be included.
Members of the military who had already started the series of six shots before the program was shut down in 2004 and those in need of the annual booster shot will also be able continue their vaccinations if they so choose, said Dr. William Winkenwerder, assistant secretary of defense for health affairs.
“The threat is very real and it has not gone away,” Winkenwerder said. “The persons we are vaccinating are those at highest risk. It’s an issue of the relative risk for those persons and the optimal way to provide round-the-clock protection for them.”
The U.S. District Court for the District of Columbia shut down the mandatory anthrax vaccine program in late 2004. At that time, Judge Emmet Sullivan ruled that forcing troops to take the vaccine amounted to an illegal order because the Food and Drug Administration failed to follow its own regulatory procedures in declaring the vaccine safe and effective against all forms of anthrax, including the inhalation variety that defense officials say poses a threat to U.S. forces.
The FDA did not specify that the vaccine was safe and effective against the inhalation form of anthrax until December 2005. The license issued in 1970 was aimed mainly at the skin form of anthrax, occasionally contracted by people working with animal hides.
Since that 2005 ruling by the FDA, Winkenwerder said, “the vaccine has been thoroughly reviewed by several independent and outside groups” and the Defense Department’s entire vaccine program has been reviewed.
“The vaccine is safe and effective,” he said.
Those who filed suit to stop the mandatory anthrax vaccine injections years ago say the drug is not as safe as the Pentagon declares it is, and that they will fight the latest iteration of the vaccine program as well.
“We are planning a legal challenge to the fundamentals of the entire program,” said Mark Zaid, one of the attorneys for the six anonymous plaintiffs in the anthrax case in federal civilian court. “The program is no better than it was before. DoD continues to manufacture justification for a program that is likely the worst medical program they have ever implemented. It is not proven to be effective. It is potentially unsafe. And it is not even the same originally licensed vaccine.”
The U.S. Court of Appeals for the Armed Forces recently upheld the conviction of an Army specialist who was punished for refusing orders to take the vaccine in 2000 — before the FDA updated the drugs license for use against inhalation anthrax.
The attorneys in that case intend to petition the U.S. Supreme Court to hear the case before the end of the year.
