Navigation Links
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.).

Senior Chief Petty Officer John Payhurst administers the first in a series of anthrax vaccinations to one of 6,200 sailors aboard the aircraft carrier USS John C. Stennis (CVN 74) on March 17, 1998. Stennis and its embarked Carrier Air Wing 7 are on station in the Persian Gulf in support of Operation Southern Watch, which is the U.S. and coalition enforcement of the no-fly-zone over Southern Iraq. Payhurst, from Virginia Beach, Va., is a Navy hospital corpsmen. The Stennis is homeported in Norfolk, Va. DoD photo by Petty Officer 3rd Class Mike Larson, U.S. Navy.

Contents

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

External Links


'"/>


(Date:7/29/2014)... Gerontological Society of America (GSA) and the National ... MD, PhD, of Columbia University as the 2014 recipient ... and Aging. , This award recognizes and honors the ... the field of creativity and aging shifted the conceptual ... and potential. Cohen inspired individuals to approach longevity asking ...
(Date:7/29/2014)... The Gerontological Society of America (GSA) the ... aging has chosen Corinna E. Lckenhoff, PhD, of ... M. and Paul B. Baltes Foundation Award in Behavioral ... recognizes outstanding early career contributions in behavioral and social ... last ten years are eligible. The award is given ...
(Date:7/29/2014)... 2014 CD-adapco™, the largest privately ... software, today announced its renewed membership with ... public-private partnership focused exclusively on the unique needs ... progress in the first year by bringing together ... Computational Modeling and Simulation (CM&S). This momentum will ...
(Date:7/29/2014)... Colitis Canada has invested $3.4 million this year ... ulcerative colitis, debilitating chronic diseases that affect more ... support 9 promising research projects across Canada. This ... of the diseases, improve our understanding (and potential ... patient care and quality of life. , ...
(Date:7/29/2014)... 29, 2014 The Latin American poultry feed ... with analysis and forecast of revenue. The poultry feed and ... from $25,273.3 million and $647.2 million in 2013 to $34,024.0 ... 6.1% from 2013 to 2018, respectively. , To get an ... the TOC of the Latin American poultry feed and feed ...
Breaking Medicine News(10 mins):Health News:Charon to receive 2014 Gene D. Cohen Award 2Health News:Löckenhoff earns GSA's 2014 Baltes Foundation Award 2Health News:CD-adapco Helps Advance the Use of Simulation in Medical Device Industry 2Health News:Prestigious Crohn's and Colitis Canada grants fund promising Canadian research 2Health News:Latin America Poultry Feed Market is Expected to Reach $870.1 Million in 2018 - New Report by MicroMarket Monitor 2Health News:Latin America Poultry Feed Market is Expected to Reach $870.1 Million in 2018 - New Report by MicroMarket Monitor 3Health News:Latin America Poultry Feed Market is Expected to Reach $870.1 Million in 2018 - New Report by MicroMarket Monitor 4Health News:Latin America Poultry Feed Market is Expected to Reach $870.1 Million in 2018 - New Report by MicroMarket Monitor 5
... , TUESDAY, May 3 (HealthDay News) -- ... the filling station, but research from Mississippi has ... go down -- even ones because of drunken driving ... results suggest that prices have both short-term and intermediate-term ...
... A new study from Rhode Island Hospital has ... infections due to Staph aureus in hospitalized adults are ... points out the substantial medical burden that arises from ... of such catheters used in hospitalized patients. The study ...
... to be a major health issue in the United ... University of Cincinnati (UC) provides evidence that current prevention ... even need expansion to include more of the population, ... The findings are published in the May 3, ...
... and their U.S.-born children gain more than a new ... availability of cheap, convenient, fatty American foods and large ... pounds, approaching U.S. levels of obesity within 15 years ... simply the abundance of high-calorie American junk food that ...
... of international experts are set to develop a pioneering tool ... pulmonary disease (COPD) as part of a new EU project. ... month (May 2011), will create computed and physical models of ... how patients might react to different treatments. The ...
... normal-weight people with belly fat and heart disease have an increased ... a large, new study reports. A "beer belly" or "muffin ... of cigarettes a day or having very high blood cholesterol, the ... That spare tire is even more significant than your overall body ...
Cached Medicine News:Health News:Peripheral venous catheters pose infection risk 2Health News:Screening for hepatitis B may be cost-effective for more of the population, analysis shows 2Health News:Screening for hepatitis B may be cost-effective for more of the population, analysis shows 3Health News:'Fatting in': Immigrant groups eat high-calorie American meals to fit in 2Health News:'Fatting in': Immigrant groups eat high-calorie American meals to fit in 3Health News:Virtual lung models set to personalize asthma and COPD treatment 2Health News:Belly Fat + Heart Disease Can Be Deadly: Study 2
Other medicine definitionOther Tags