Anthrax Vaccine Immunization Program

The Anthrax Vaccine Immunization Program (AVIP), is the name of the policy set forth by the Federal government of the United States 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 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 [http://www.defenselink.mil/releases/1998/b05221998_bt255-98.html] [http://www.anthrax.osd.mil/] , 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. [http://www.fda.gov/cber/infosheets/mich-inf.htm] In June 2001, the DOD halted vaccination due to non-FDA approved changes in BioPort's manufacturing process [http://www.military.com/NewContent/0,13190,SS_102004_Anthrax,00.html] .

On October 15, 2001 military members filed a Food and Drug Administration (FDA) Citizen Petition highlighting the fact that the license for anthrax vaccine adsorbed (AVA) had never formally been finalized by the FDA in accordance with the requirements of 21 CFR § 10.30 as Docket # 01P-0471. [http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm#_Toc527850400] The Petition was later utilized as the foundational basis for a Preliminary Injunction by a Federal Court to temporarily halt the program [Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003)] .

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 [http://www.defenselink.mil/news/Jun2002/n06282002_200206283.html] (in addition to their other vaccinations of smallpox and other diseases and viruses like Japanese encephalitis, Pneumococcal, Tetanus, among others [http://www.vaccines.mil/documents/969r40_562.pdf] ).

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. [ [http://www.gao.gov/new.items/d02445.pdf "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.]

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. [ [http://list.uvm.edu/cgi-bin/wa?A2=ind0206e&L=safety&D=1&P=860 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]

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. [ [http://www.cbsnews.com/stories/2003/12/22/national/main589812.shtml "Judge: U.S. Can't Force Vaccines"] CBS News, Dec. 22, 2003.]

In October 2004, for about 8 days in (October 20-28), anthrax vaccinations were resumed [ [http://www.military.com/NewContent/0,13190,SS_102004_Anthrax,00.html "Pentagon Says 200,000 Who Started Anthrax-Shot Regimen Must Continue"] Sandra Jontz, Stars and Stripes European Edition, October 20, 2004] , 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. [ [http://www.anthrax.mil/documents/library/AnthraxSJtOrder_Op.pdf] DC District Court Permanent Injunction on Summary Judgment, Oct 27, 2004] 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 (Doe v. Rumsfeld, 341 F. Supp. 2d 1, 6 (D.D.C. 2004)). [ [http://www.military.com/NewsContent/0,13319,FL_anthrax_102804,00.html "Anthrax Vaccinations Halted Again"] United Press International, October 28, 2004.] 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. [ [http://www.gulfwarvets.com/voluntary_anthrax1.htm "Troops divided on getting voluntary vaccine shots."] Deborah Funk, July 25, 2005 [http://www.airforcetimes.com/ AF Times] ] . 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 [ [http://www.fda.gov/cber/rules/bvactoxanth.htm 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.] 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. Pertaining to the previous ruling, the DC District Federal Appeals Court declined to vacate or overturn the injunction in 2006, instead mooting the case based on the FDA’s new 2005 licensing of the vaccine. [Doe v. Rumsfeld, 127 Fed. App’x 327 (D.C. Cir. 2006)]

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. [ [http://www.ngms.state.ms.us/publicaffairs/Cmd%20Info%20Articles/pentagon_to_resume_anthrax_inocu.htm Pentagon to Resume Anthrax Inoculations."] Lolita C. Baldor, Monday, October 16, 2006.] The DoD's official resumption status of the program awaited publication of service messages. [ [http://www.anthrax.mil DoD's official anthrax vaccine immunization program website] ]

On December 13, 2006, a new class-action lawsuit [ [http://www.washingtonpost.com/wp-dyn/content/article/2006/12/12/AR2006121201454.html "Defense Employees Set For Another Suit to Halt Mandatory Anthrax Shots."] Josh White, Wednesday, December 13, 2006; Page A19.] , 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.

In February 8, 2007, the military has resumed mandatory vaccinations of certain troops. Specific policies and troop selection varies according to branch of service. [ [http://www.anthrax.osd.mil/resource/policies/policies.asp Current Policies on DoD Anthrax Vaccine Immunization Program] ]

By August 2007, the original court affirmed that the AVIP was not substantially justified prior to the consequent FDA licensure and requisite rule making for the vaccine in December 2005. The Court ultimately granted “prevailing party” status for the plaintiffs against defendants DoD and FDA [Doe v. Rumsfeld, 501 F. Supp. 2d 186, 188 (D.D.C. 2007)] .

By March 2008, a different Federal Judge affirmed the prior ruling in it’s opinion regarding corrections of records writing, “Taken as a whole, Judge Sullivan’s decisions in Doe v. Rumsfeld conclude that, prior to the FDA’s December 2005 rulemaking, it was a violation of federal law for military personnel to be subjected to involuntary AVA inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax.” [https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2005cv2350-31]

By August 6, 2008, an FBI pressing briefing revealed the that the "failing" anthrax vaccine immunization program lied as the primary motivator in the fall 2001 anthrax letter attacks by a US Army scientist, Dr Bruce Ivins. FBI documents reveal the FDA "suspended further production" of anthrax vaccine just prior to the attacks (Dr Ivins' emails and FBI analysis available on pp. 12-16 of affidavit). [http://www.usdoj.gov/amerithrax/docs/07-524-m-01.pdf] Failed potency tests prevented FDA approval. FBI released emails by Dr Ivins showing the vaccine "isn’t passing the potency test" and that "no approved lots" were available just prior to the letter attacks. The FBI explained Dr Ivins' involvement with the failed potency tests. FBI affidavits also documented Dr Ivins receiving the highest Defense Department honors for "getting the anthrax vaccine back into production." The U.S. Department of Justice press statements theorized Dr Ivins’ anthrax letter attack motive: "by launching these attacks, he creates a situation, a scenario, where people all of a sudden realize the need to have this vaccine." [http://www.usdoj.gov/opa/pr/2008/August/08-opa-697.html]

Pamphlet

This is a pamphlet distributed to military members regarding their vaccinations after the Emergency Use Authorization from the FDA after April 4, 2005.

References

ee also

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

External links

* [http://www.anthrax.osd.mil/ Official U.S. Department of Defense web site] for AVIP.
* [http://www.estripes.com/article.asp?section=104&article=39847&archive=true Vaccination Timeline] at Stars and Stripes.
* [http://www.mvrd.org/AVN/timeline.html The Military Vaccine Resource Directory] maintained by [http://www.mvrd.org/showpage.cfm?ID=25 Kathryn D. Hubbell] , former Air Force.
* [http://www-nehc.med.navy.mil/prevmed/epi/AVIP%20Q&A%2027Jun02.doc Q&A from the Navy] regarding anthrax vaccination from 2002.