The Anthrax Vaccine Immunization Program (AVIP), is the name of the policy set forth by the U.S. federal government to immunize its military and certain civilian personnel with BioThrax, an anthrax vaccine manufactured by Emergent BioSolutions Inc. It was set up by the Clinton administration.
In June 2001, the program was halted by the DoD due to changes in the manufacturing process not approved by the Food and Drug Administration (FDA). In the wake of the 2001 anthrax attacks and long after the 2003 invasion of Iraq, all military personnel were required to receive the anthrax vaccine. In Court, it was ruled that vaccination could not be forced on military personnel without a special order by the president. Thereafter it ran into and judicial obstacles (mainly concerning the methods and viability of the vaccine).
Between March 1998 and December 2008, nearly 8 million doses of BioThrax were administered to over 2 million U.S. military personnel as part of the program. In December 2008, the FDA approved a new version of BioThrax which requires five intramuscular doses instead of six subcutaneous doses.Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application. Emergent BioSolutions, 19 Dec 2008 (press release)
Overview The vaccination requirement was instituted in 1998 because of concerns that anthrax could be used as a biological weapon (see anthrax weaponization). Secretary of Defense William Cohen stated that "anthrax poses a clear and present danger to our armed forces. It is the weapon of choice for germ warfare because it is easy to weaponize and is as lethal as the Ebola virus."Letter from William Cohen, Secretary of Defense, to Representative Christopher Shays et al., U.S. House of Representatives (Sept. 30, 1999) Anthrax had previously been used in warfare as early as World War I, against livestock, and was also tested during World War II by Japan, against Chinese civilian populations, and by the US, Canada, and Great Britain on sheep at Gruinard Island. The Japanese attack was part of a larger program of biological warfare and human experimentation that is estimated to have killed 580,000 people.Daniel Barenblatt, A Plague upon Humanity, 2004, p.xii, 173. The Soviet Union weaponized anthrax, and 64 people were killed in an accident at Sverdlovsk in 1979. The Japanese doomsday cult Aum Shinrikyo had carried out a successful attack using sarin and an unsuccessful one in 1993 using anthrax. Iraq was found in 1995 to have a biological weapons program that included anthrax. In 2001, shortly after 9/11, five people were killed in an anthrax attack delivered by mail to the US Senate.
The US armed forces had a longstanding custom of mandating various vaccines for service members, so the leadership expected that the vaccination requirement would be a matter of routine. But according to the director of the program, "Things have changed. They used to stand you in line, give you two or three shots, and off you went. Nobody asked what they were for. [...] There has been a ... shift in the relationship between health care providers and patients. No longer do you just put a patient in a doctor's office or in a shot line."Air Force Magazine, Dec. 1, 2000, "The Anthrax Issue," https://www.airforcemag.com/article/1200anthrax/ The program included the National Guard and Reserve, whose members had less of an expectation of being subject to such a requirement or of being exposed to biological warfare.
Service members began to complain about side effects of the vaccine, and debate ensued about whether these problems were really vaccine-related. The DOD maintained that the vaccine was safe, but surveys showed that many service members did not believe the information that was being given to them about it.Lee Black, "Informed Consent in the Military: The Anthrax Vaccination Case," AMA Journal of Ethics, Oct. 2006, https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10 Treatment of troops who refused or hesitated was up to the discretion of their commanding officers, and therefore varied widely. Some were not punished at all, others acquiesced after further counseling, while still others received serious penalties such as dishonorable discharges. Following the 9/11 attacks, an exemption requested by marine James Muhammad led to his court martial, with his lawyer advising him to plead guilty because he would not be allowed to present his religious reasons and might be subject to the death penalty.Todd South, "Troops who refused anthrax vaccine paid a high price," Military Times, June 17, 2021, https://www.militarytimes.com/news/pentagon-congress/2021/06/17/troops-who-refused-anthrax-vaccine-paid-a-high-price/ The legal situation was complicated by the fact that the vaccine was experimental. Although service members are required to obey orders, it is also illegal under US law to use an experimental drug on patients without their consent.Randall D. Katz, "Friendly Fire: The Mandatory Military Anthrax Vaccination Program," https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1121&context=dlj In the reserves, the requirement led many members to quit, switch to inactive status, or move to another unit. In the Air Force Reserve, a GAO report cited a negative effect on "retention of trained and experienced guard and reserve pilots."
Legal challenges and questions about safety led to the cancellation of the program in 2008.
History 1990s In 1998, the Clinton administration required the inoculation of all military members with the anthrax vaccine known as Anthrax Vaccine Adsorbed (AVA) and by the trade name BioThrax.DoD Press Release
In 1999 at Offutt Air Force Base, the first ever Anthrax refusal court-martial in the United States Air Force was prosecuted. In the case of U.S. v. Bickley, Captain Jeffrey A. Lustick, USAF, prosecuted an airman's refusal to submit to the immunization. The airman was convicted and later administratively separated from the U.S. Air Force.
2000s In June 2001, the DoD halted vaccinations due to non-FDA approved changes in BioPort's manufacturing process.Military.com
On October 15, 2001, military members filed a FDA Citizen Petition highlighting the fact that the license for AVA had never formally been finalized by the FDA in accordance with the requirements of 21 CFR § 10.30 as Docket # 01P-0471.FDA Citizen Petition, Docket 01P-0471 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 receive AVA in addition to their other vaccinations of smallpox.DoD News Article The military does give this vaccination regularly as well as Japanese encephalitis (JEV) when the service member is to be deployed to Southeast Asia, and other vaccines such as pneumococcal, tetanus, among others.DoD Vaccines.mil Website )
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."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.Pentagon shifts Anthrax vaccine to civilian uses" James Dao with Judith Miller, June 29, 2002.
Mirrored site: https://query.nytimes.com/gst/fullpage.html?sec=health&res=9C06E7DF1E3EF93AA15755C0A9649C8B63
In December 2003, Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia ruled that the Department of Defense could not force military personnel to take the vaccine unless through a special order by the president."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,"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 AVA was not proven to work against inhalation anthrax."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)).Anthrax Vaccinations Halted Again. United Press International, October 28, 2004 (archived) 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."Troops divided on getting voluntary vaccine shots" GulfWarVets.com Deborah Funk, July 25, 2005.AF Times AF Times Article 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 & OrderDepartment of Health and Human Services, Food and Drug Administration.Docket No. 1980N-0208Biological 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 AVA, 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 October 16, 2006 the military announced intentions to resume vaccinations for select personnel again, but the vaccinations remained voluntary until further guidance by the DoD.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.
On December 13, 2006, a new class-action lawsuit,"Defense Employees Set For Another Suit to Halt Mandatory Anthrax Shots." Josh White, Washington Post, 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 FDA issuing its "final rule" on the vaccine on December 15, 2005. The suit also says the DOD 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.