Anthrax Vaccine Immunization Program

The Anthrax Vaccine Immunization Program (AVIP), is the name of the policy set forth by the United States government to immunize its military and specific civilian personnel with the anthrax vaccine. It began in earnest in 1997 by the Clinton administration. Thereafter it ran into a few FDA and judicial obstacles (mainly concerning the methods and viability of the vaccine manufactured by BioPort, a subsidiary of Emergent BioSolutions Inc.).

History

In 1998, the Clinton administration required the inoculation of all military members[2][3], despite the fact that the Food and Drug Administration (FDA) issued a warning letter to the anthrax vaccine manufacturer threatening to revoke its product licenses unless immediate action was taken to correct deficiencies on March 11, 1997.[4] In June 2001, the DOD halted vaccination due to non-FDA approved changes in BioPort's manufacturing process[5].

On June 28, 2002, in the wake of the 2001 anthrax attacks and leading up to the 2003 invasion of Iraq, all military personnel were required to get anthrax vaccination[6] (in addition to their other vaccinations of smallpox and other diseases and viruses like Japanese encephalitis, Pneumococcal, Tetanus, among others[7]).

While some military personnel had questions about the safety of the vaccine, it was considered a lawful order at that time, and this made refusing the vaccine at peril of the subordinate, including possible discharge (i.e., losing their job and any benefits depending on the type of discharge). This pressure, at least for the National Guard and Reserve pilots and crewmembers, became a deciding retention factor.^[1]

Later that month, the DOD made it policy to include any personnel spending 15 days or more in high anthrax-risk areas, such as the Persian Gulf or the Korean peninsula.^[2]

In Dec. of 2003, Judge Emmet G. Sullivan of the United States District Court in Washington ruled that the Department of Defense could not force military personnel to take the vaccine unless through a special order by the president.^[3]

In October of 2004, for about 8 days in (October 20-28), anthrax vaccinations were resumed^[4], but then an injunction against mandatory vaccination was filed on the basis that the BioPort Anthrax Vaccive Absorbed (AVA) was not proven to work against inhalation anthrax.^[5] The ruling held that the mandatory program was illegal. The DoD was now required to either let the individual member choose under an informed consent policy, or allowed the president to bypass this requirement by executive order.^[6] For military members who had started the vaccination (which usually takes build-up and booster shots), they tended to continue the vaccination program under informed consent. For those who had a choice, they usually decided against it. ^[7]. The government stated that they will resume the vaccination program under informed consent in April 2005.

On December 15, 2005, the FDA re-issued a Final Rule & Order^[8] on the license status of the anthrax vaccine, clearing the way for mandatory vaccination reinstatement. After reviewing extensive scientific evidence and carefully considering comments from the public, the FDA again determined that the vaccine is licensed for the prevention of anthrax, regardless of the route of exposure.

On Oct. 16, 2006 the military announced intentions to resume vaccinations for select personnel again, but the vaccinations remained voluntary until further guidance by the DoD.^[9] The DoD's official resumption status of the program awaited publication of service messages.^[10]

On December 13, 2006, a new class-action lawsuit^[11], filed on behalf of six unnamed plaintiffs, revived the legal battle over the military’s mandatory anthrax immunization program. According to court documents, the basic premise of the lawsuit is the plaintiffs’ claim that the vaccine is “unapproved for its applied/intended use.” The lawsuit says that “plaintiffs will suffer substantial and irreparable injury if they are forced to take the vaccine,” which the suit says has not been properly approved by the government, despite the Food and Drug Administration issuing its “final rule” on the vaccine on December 15, 2005. The suit also says the Defense Department has failed to follow presidential orders and federal laws that require the government to obtain informed consent before giving an unapproved and experimental vaccine to anyone.

References

1. ^ "Anthrax Vaccine, GEO's Survey of Guard and Reserve Pilots and Aircrew" United States General Accounting Office Report to Congressional Requesters. Sept. 2002. GAO-02-445.
2. ^ Pentagon shifts Anthrax vaccine to civilian uses" James Dao with Judith Miller, June 29, 2002.

   Mirrored site: http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C06E7DF1E3EF93AA15755C0A9649C8B63

3. ^ "Judge: U.S. Can't Force Vaccines" CBS News, Dec. 22, 2003.
4. ^ "Pentagon Says 200,000 Who Started Anthrax-Shot Regimen Must Continue" Sandra Jontz, Stars and Stripes European Edition, October 20, 2004
5. ^ [1] DC District Court Permanent Injunction on Summary Judgment, Oct 27, 2004
6. ^ "Anthrax Vaccinations Halted Again" United Press International, October 28, 2004.
7. ^ "Troops divided on getting voluntary vaccine shots." Deborah Funk, July 25, 2005 AF Times
8. ^ Department of Health and Human Services, Food and Drug Administration.
   Docket No. 1980N-0208
   Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order.
   AGENCY: Food and Drug Administration, HHS.
   ACTION: Notice.
9. ^ Pentagon to Resume Anthrax Inoculations." Lolita C. Baldor, Monday, October 16, 2006.
10. ^ DoD's official anthrax vaccine immunization program website
11. ^ "Defense Employees Set For Another Suit to Halt Mandatory Anthrax Shots." Josh White, Wednesday, December 13, 2006; Page A19.

See also

• Anthrax
• Anthrax vaccine
• BioPort is a subsidiary of Emergent BioSolutions

External Links

• Official U.S. Department of Defense web site for AVIP.
• Vaccination Timeline at Stars and Stripes.
• The Military Vaccine Resource Directory maintained by Kathryn D. Hubbell, former Air Force.
• Q&A from the Navy regarding anthrax vaccination from 2002.