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:9/2/2014)... 2 September 2014: Health structures explain nearly 20% ... to the results of a joint ESC-OECD study ... Maggioni. Clinical variables explained more than 80% of ... unique evaluation which combines clinical data and health ... fuller picture of the reasons some patients with ...
(Date:9/2/2014)... Developers and plugin specialist of Final Cut ... from Pixel Film Studios. , “ProIntro has enabled users ... Christina Austin, CEO of Pixel Film Studios. “Blurring the ... game changer.” , Learn how to create a title ... Studios. ProIntro is a package of professionally designed titles ...
(Date:9/2/2014)... NOVAtime Technology, Inc. ( http://www.novatime.com ... announced today that Avon Health Center, a long-time ... NOVAtime 4000 Time and Attendance / Workforce ... latest smart clock, the NT7000 . , Avon ... is an award-winning nursing facility that provides short-term ...
(Date:9/2/2014)... “Harmonicas have been formally used ... to help people with COPD or asthma. At ... systems,” says Dana Keller, PhD, co-inventor of the ... are much the same – improved health with ... harmonica.” , The three approaches to harmonicas in ...
(Date:9/2/2014)... September 02, 2014 September 2014 – The ... gone. But even though men shave daily – and commit ... rough and irritated skin isn’t inevitable, according to Joshua ... , For decades, skin care was something in which ... surge in men of all ages who realize that their ...
Breaking Medicine News(10 mins):Health News:Health structures explain nearly 20 percent of non-adherence to heart failure guidelines 2Health News:Pixel Film Studios Released a New ProIntro Lesson Exclusively for Final Cut Pro X 2Health News:Pixel Film Studios Released a New ProIntro Lesson Exclusively for Final Cut Pro X 3Health News:Avon Healthcare Upgrades to NOVAtime 4000 Time and Attendance / Workforce Management Solution with NT7000 Smart Clocks 2Health News:Avon Healthcare Upgrades to NOVAtime 4000 Time and Attendance / Workforce Management Solution with NT7000 Smart Clocks 3Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 3Health News:Rough Isn’t Rugged in Men’s Skin: Dermatology specialist Dr. Joshua Fox with Advanced Dermatology PC offers tips on easy skin maintenance for men 2Health News:Rough Isn’t Rugged in Men’s Skin: Dermatology specialist Dr. Joshua Fox with Advanced Dermatology PC offers tips on easy skin maintenance for men 3
... dengue fever in early stage was launched in India Monday ... distributor of life science research products and clinical diagnostics. ... to diagnose dengue on the first day of symptoms, the ... - the first in the Indian market - is based ...
... to be safer to use than laser surgery to correct ... being contested by a physician William Mathers, M.D from Health ... comparing data from many recent studies who feels the results ... ,Dr Mathers, Professor of Ophthalmology in the OHSU School ...
... have quit the NHS rather than sign new contracts. Around ... around one million patients without an NHS dentist. ... over the changes. If their issues are still not resolved, ... switch to private practice. ,Since the introduction of ...
... term schizophrenia should be done away with, as it has ... is a harmful concept," said Professor Marius Romme, a visiting ... in Birmingham.,He added, "Symptoms such as delusions, hearing voices and ... be reactions to traumatic and troubling events in life. " ...
... medicine regulators to begin selling its new breast cancer pill ... last month, and comes slightly earlier than some commentators were ... GSK's most promising pipeline drugs as well as a potential ... the drug could cross 2 bln used by 2010. ...
... patients before the surgical removal of the tumour, than ... 1 %. The usual treatment for bowel cancer ... and once reappeared, treatment is difficult and usually incurable. ... to compare the effect of radiotherapy before and after ...
Cached Medicine News:Health News:Laser Surgery Safer Than Contact Lenses? 2Health News:NHS Dentists Shortage worsens over New Contracts 2Health News:‘Schizophrenia’ term ought to be abolish 2
Other medicine definitionOther Tags