106:
about it. 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. 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. 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."
247:
anthrax vaccine just prior to the attacks (Ivins' emails and FBI analysis available on pp. 12–16 of affidavit). Failed potency tests prevented FDA approval. FBI released emails by 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 Ivins' involvement with the failed potency tests. FBI affidavits also documented Ivins receiving the highest
Defense Department honors for "getting the anthrax vaccine back into production". The U.S. Department of Justice press statements theorized 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."
85:). 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." 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. The Soviet Union weaponized anthrax, and 64 people were killed in an
279:. Short of some major breakthrough or intervention, he feared that the vaccine research program was going to be discontinued. Following the anthrax attacks, however, his program was suddenly rejuvenated." The FBI continued on page 39 finding, "within a few months of the anthrax attacks, the FDA fast-tracked the approval process and approved the Anthrax Vaccine Adsorbed ("AVA"), even though it didn't meet the original potency standards. This was a significant development for the anthrax researchers."
228:
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.
102:
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." 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.
296:
301:
212:, 341 F. Supp. 2d 1, 6 (D.D.C. 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. The government stated that they will resume the vaccination program under informed consent in April 2005.
69:, 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).
184:
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
227:
lawsuit, 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
101:
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
152:
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. The Petition was later utilized as the foundational basis for a
246:
By August 6, 2008, an FBI press briefing theorized that the "failing" anthrax vaccine immunization program led as the primary motivator in the fall 2001 anthrax letter attacks allegedly perpetrated by U.S. Army scientist Bruce Ivins. FBI documents reveal the FDA "suspended further production" of
203:
In
October 2004, for about 8 days in (October 20–28), anthrax vaccinations were resumed, but then an injunction against mandatory vaccination was filed on the basis that AVA was not proven to work against inhalation anthrax. The ruling held that the mandatory program was illegal. The DoD was now
105:
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
215:
On
December 15, 2005, the FDA re-issued a Final Rule & Order 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
274:
investigation. The "motive", according to the FBI, was detailed on page 8 of the report: "Motive. According to his e-mails and statements to friends, in the months leading up to the anthrax attacks in the fall of 2001, Dr. Ivins was under intense personal and professional pressure. The anthrax
234:
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 .
72:
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.
261:
In
December 2008, the FDA approved a new version of BioThrax which requires five intramuscular doses instead of six subcutaneous doses. The vaccine is required for US military members who are deployed to the Middle East, although some have objected to the vaccine because of side effects.
216:
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.
242:
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."
219:
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. The DoD's official resumption status of the program awaited publication of service messages.
275:
vaccine program to which he had devoted his entire career of more than 20 years was failing. The anthrax vaccines were receiving criticism in several scientific circles, because of both potency problems and allegations that the anthrax vaccine contributed to
282:
To date, the DOD has not announced a reevaluation of the AVIP, nor consideration of correcting the records of previously punished soldiers, in light of the above-mentioned legislative, legal and criminal findings related to the anthrax vaccine.
93:
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
254:, Secretary of Health and Human Services, declared a need "to provide targeted liability protections for anthrax countermeasures" because "I have determined there is a credible risk that the threat of exposure of
331:
197:
258:
and the resulting disease constitutes a public health emergency" until the year 2015. Emergent BioSolutions immediately prepared to supply 14.5 million doses of anthrax vaccine by 2011.
141:, 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.
238:
By March 2008, a different Federal Judge affirmed the prior ruling in its opinion regarding corrections of records writing, "Taken as a whole, Judge Sullivan's decisions in
188:
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.
481:
231:
On February 8, 2007, the military has resumed mandatory vaccinations of certain troops. Specific policies and troop selection varies according to branch of service.
813:
975:
933:
58:
388:
291:
This is a pamphlet distributed to military members regarding their vaccinations after the Emergency Use Authorization from the FDA after April 4, 2005.
970:
345:
Letter from William Cohen, Secretary of Defense, to Representative Christopher Shays et al., U.S. House of Representatives (Sept. 30, 1999)
630:
862:
31:
949:
586:
615:
200:
ruled that the Department of Defense could not force military personnel to take the vaccine unless through a special order by the president.
376:
746:
692:
842:
575:
784:
679:
Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order.
81:
The vaccination requirement was instituted in 1998 because of concerns that anthrax could be used as a biological weapon (see
810:
536:
35:
729:
122:
In 1998, the Clinton administration required the inoculation of all military members with the anthrax vaccine known as
555:
389:
https://www.militarytimes.com/news/pentagon-congress/2021/06/17/troops-who-refused-anthrax-vaccine-paid-a-high-price/
943:
507:
400:
939:
185:
pressure, at least for the National Guard and Reserve pilots and crewmembers, became a deciding retention factor.
57:
In June 2001, the program was halted by the DoD due to changes in the manufacturing process not approved by the
375:
Lee Black, "Informed Consent in the Military: The Anthrax Vaccination Case," AMA Journal of Ethics, Oct. 2006,
123:
149:
In June 2001, the DoD halted vaccinations due to non-FDA approved changes in BioPort's manufacturing process.
571:
176:(JEV) when the service member is to be deployed to Southeast Asia, and other vaccines such as pneumococcal,
134:
86:
51:
927:
437:
856:
173:
165:
130:
82:
66:
47:
597:
494:
377:
https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10
770:
705:
161:
95:
62:
333:
Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application.
562:
United States General Accounting Office Report to Congressional Requesters. Sept. 2002. GAO-02-445
520:
463:
425:
387:
Todd South, "Troops who refused anthrax vaccine paid a high price," Military Times, June 17, 2021,
828:
612:
832:: Shirleen Dorman, "Emergent BioSolutions Agrees To Supply More Anthrax Vaccine", October 1, 2008
576:
https://query.nytimes.com/gst/fullpage.html?sec=health&res=9C06E7DF1E3EF93AA15755C0A9649C8B63
251:
168:, all military personnel were required to receive AVA in addition to their other vaccinations of
909:
475:
276:
193:
965:
899:
891:
750:
205:
109:
Legal challenges and questions about safety led to the cancellation of the program in 2008.
799:
866:
817:
788:
619:
559:
540:
43:
781:
904:
883:
399:
Randall D. Katz, "Friendly Fire: The Mandatory Military Anthrax Vaccination Program,"
959:
598:"Pentagon Says 200,000 Who Started Anthrax-Shot Regimen Must Continue" Sandra Jontz,
90:
644:
895:
531:
364:
295:
224:
300:
673:
401:
https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1121&context=dlj
208:
policy, or allowed the president to bypass this requirement by executive order (
271:
154:
771:
DC District Court Remand to the USAF Board for Correction of Military Records
913:
613:"DC District Court Permanent Injunction on Summary Judgment," Oct 27, 2004
552:
412:
730:"Defense Employees Set For Another Suit to Halt Mandatory Anthrax Shots."
169:
39:
847:
Center for Infectious Disease Research and Policy (CIDRAP), 22 Dec 2008
674:
Department of Health and Human Services, Food and Drug Administration.
553:"Anthrax Vaccine, GEO's Survey of Guard and Reserve Pilots and Aircrew"
413:"Anthrax Vaccine: GAO's Survey of Guard and Reserve Pilots and Aircrew"
312:
177:
659:
270:
On February 19, 2010, the FBI released its final summary on the
20:
800:
Department of Justice Press Release in Amerithrax Investigation
172:. The military does give this vaccination regularly as well as
747:"Current Policies on DoD Anthrax Vaccine Immunization Program"
441:
706:"DoD's official anthrax vaccine immunization program website"
204:
required to either let the individual member choose under an
574:
James Dao with Judith Miller, June 29, 2002. Mirrored site:
354:
Daniel Barenblatt, A Plague upon Humanity, 2004, p.xii, 173.
19:"AVIP" redirects here. For the Russian male first name, see
587:"Judge: U.S. Can't Force Vaccines," CBS News, Dec. 22, 2003
709:
635:. United Press International, October 28, 2004 (archived)
363:
Air Force Magazine, Dec. 1, 2000, "The Anthrax Issue,"
157:
by a Federal Court to temporarily halt the program .
133:, the first ever Anthrax refusal court-martial in the
645:"Troops divided on getting voluntary vaccine shots"
30:(AVIP), is the name of the policy set forth by the
336:Emergent BioSolutions, 19 Dec 2008 (press release)
89:at Sverdlovsk in 1979. The Japanese doomsday cult
572:Pentagon shifts Anthrax vaccine to civilian uses"
365:https://www.airforcemag.com/article/1200anthrax/
198:U.S. District Court for the District of Columbia
844:FDA approves shortened anthrax-vaccine course.
8:
928:Official U.S. Department of Defense web site
480:: CS1 maint: multiple names: authors list (
695:Lolita C. Baldor, Monday, October 16, 2006.
464:"Airman convicted in anthrax court-martial"
782:FBI Affidavit Documents in Amerithrax Case
681:AGENCY: Food and Drug Administration, HHS.
903:
693:Pentagon to Resume Anthrax Inoculations."
952:regarding anthrax vaccination from 2002.
882:Donegan S, Bellamy R, Gamble CL (2009).
940:The Military Vaccine Resource Directory
811:HHS PREP Act Declaration, Oct. 1, 2008.
324:
126:(AVA) and by the trade name BioThrax.
976:Military medicine in the United States
473:
509:FDA Citizen Petition, Docket 01P-0471
160:On June 28, 2002, in the wake of the
7:
470:. Federation of American Scientists.
98:delivered by mail to the US Senate.
38:and certain civilian personnel with
28:Anthrax Vaccine Immunization Program
602:European Edition, October 20, 2004
14:
884:"Vaccines for preventing anthrax"
632:Anthrax Vaccinations Halted Again
971:Vaccination in the United States
858:AMERITHRAX INVESTIGATIVE SUMMARY
299:
294:
137:was prosecuted. In the case of
896:10.1002/14651858.CD006403.pub2
736:, December 13, 2006; Page A19.
1:
650:Deborah Funk, July 25, 2005.
223:On December 13, 2006, a new
59:Food and Drug Administration
992:
946:, former Air Force parent.
888:Cochrane Database Syst Rev
61:(FDA). In the wake of the
50:Inc. It was set up by the
18:
816:October 17, 2009, at the
787:December 6, 2008, at the
618:August 25, 2009, at the
533:DoD Vaccines.mil Website
192:In December 2003, Judge
124:Anthrax Vaccine Adsorbed
135:United States Air Force
32:U.S. federal government
462:Richmond, Mike, Capt.
190:
164:and leading up to the
52:Clinton administration
950:Q&A from the Navy
936:at Stars and Stripes.
865:May 28, 2010, at the
677:Docket No. 1980N-0208
182:
174:Japanese encephalitis
166:2003 invasion of Iraq
131:Offutt Air Force Base
83:anthrax weaponization
67:2003 invasion of Iraq
48:Emergent BioSolutions
16:US government program
934:Vaccination Timeline
250:On October 1, 2008,
162:2001 anthrax attacks
63:2001 anthrax attacks
830:Wall Street Journal
65:and long after the
944:Kathryn D. Hubbell
558:2018-04-25 at the
539:2008-09-16 at the
438:"DoD AVIP Website"
252:Michael O. Leavitt
600:Stars and Stripes
426:DoD Press Release
277:Gulf War syndrome
194:Emmet G. Sullivan
983:
917:
907:
869:
860:, Feb. 19, 2010.
854:
848:
840:
834:
826:
820:
808:
802:
797:
791:
779:
773:
768:
762:
761:
759:
758:
749:. Archived from
743:
737:
727:
721:
720:
718:
717:
708:. Archived from
702:
696:
690:
684:
671:
665:
662:AF Times Article
657:
651:
642:
636:
628:
622:
610:
604:
595:
589:
584:
578:
569:
563:
550:
544:
529:
523:
521:DoD News Article
518:
512:
505:
499:
492:
486:
485:
479:
471:
459:
453:
452:
450:
449:
440:. Archived from
434:
428:
423:
417:
416:
409:
403:
397:
391:
385:
379:
373:
367:
361:
355:
352:
346:
343:
337:
329:
303:
298:
206:informed consent
180:, among others.
46:manufactured by
34:to immunize its
991:
990:
986:
985:
984:
982:
981:
980:
956:
955:
924:
890:(2): CD006403.
881:
878:
876:Further reading
873:
872:
867:Wayback Machine
855:
851:
841:
837:
827:
823:
818:Wayback Machine
809:
805:
798:
794:
789:Wayback Machine
780:
776:
769:
765:
756:
754:
745:
744:
740:
734:Washington Post
728:
724:
715:
713:
704:
703:
699:
691:
687:
683:ACTION: Notice.
682:
680:
678:
676:
672:
668:
658:
654:
647:GulfWarVets.com
643:
639:
629:
625:
620:Wayback Machine
611:
607:
596:
592:
585:
581:
570:
566:
560:Wayback Machine
551:
547:
541:Wayback Machine
530:
526:
519:
515:
506:
502:
493:
489:
472:
461:
460:
456:
447:
445:
436:
435:
431:
424:
420:
411:
410:
406:
398:
394:
386:
382:
374:
370:
362:
358:
353:
349:
344:
340:
330:
326:
321:
309:
289:
268:
240:Doe v. Rumsfeld
210:Doe v. Rumsfeld
147:
139:U.S. v. Bickley
120:
115:
79:
44:anthrax vaccine
24:
17:
12:
11:
5:
989:
987:
979:
978:
973:
968:
958:
957:
954:
953:
947:
942:maintained by
937:
931:
923:
922:External links
920:
919:
918:
877:
874:
871:
870:
849:
835:
821:
803:
792:
774:
763:
738:
722:
697:
685:
666:
652:
637:
623:
605:
590:
579:
564:
545:
524:
513:
500:
487:
468:Air Force News
454:
429:
418:
404:
392:
380:
368:
356:
347:
338:
323:
322:
320:
317:
316:
315:
308:
305:
288:
285:
267:
264:
146:
143:
119:
116:
114:
111:
96:anthrax attack
78:
75:
15:
13:
10:
9:
6:
4:
3:
2:
988:
977:
974:
972:
969:
967:
964:
963:
961:
951:
948:
945:
941:
938:
935:
932:
929:
926:
925:
921:
915:
911:
906:
901:
897:
893:
889:
885:
880:
879:
875:
868:
864:
861:
859:
853:
850:
846:
845:
839:
836:
833:
831:
825:
822:
819:
815:
812:
807:
804:
801:
796:
793:
790:
786:
783:
778:
775:
772:
767:
764:
753:on 2007-08-10
752:
748:
742:
739:
735:
731:
726:
723:
712:on 2007-07-08
711:
707:
701:
698:
694:
689:
686:
675:
670:
667:
664:
663:
656:
653:
649:
648:
641:
638:
634:
633:
627:
624:
621:
617:
614:
609:
606:
603:
601:
594:
591:
588:
583:
580:
577:
573:
568:
565:
561:
557:
554:
549:
546:
542:
538:
535:
534:
528:
525:
522:
517:
514:
511:
510:
504:
501:
498:
497:
491:
488:
483:
477:
469:
465:
458:
455:
444:on 2006-11-09
443:
439:
433:
430:
427:
422:
419:
414:
408:
405:
402:
396:
393:
390:
384:
381:
378:
372:
369:
366:
360:
357:
351:
348:
342:
339:
335:
334:
328:
325:
318:
314:
311:
310:
306:
304:
302:
297:
292:
286:
284:
280:
278:
273:
265:
263:
259:
257:
253:
248:
244:
241:
236:
232:
229:
226:
221:
217:
213:
211:
207:
201:
199:
195:
189:
186:
181:
179:
175:
171:
167:
163:
158:
156:
150:
144:
142:
140:
136:
132:
127:
125:
117:
112:
110:
107:
103:
99:
97:
92:
91:Aum Shinrikyo
88:
84:
76:
74:
70:
68:
64:
60:
55:
53:
49:
45:
41:
37:
33:
29:
22:
887:
857:
852:
843:
838:
829:
824:
806:
795:
777:
766:
755:. Retrieved
751:the original
741:
733:
732:Josh White,
725:
714:. Retrieved
710:the original
700:
688:
669:
661:
655:
646:
640:
631:
626:
608:
599:
593:
582:
567:
548:
532:
527:
516:
508:
503:
496:Military.com
495:
490:
467:
457:
446:. Retrieved
442:the original
432:
421:
407:
395:
383:
371:
359:
350:
341:
332:
327:
293:
290:
281:
269:
260:
256:B. anthracis
255:
249:
245:
239:
237:
233:
230:
225:class-action
222:
218:
214:
209:
202:
191:
187:
183:
159:
153:Preliminary
151:
148:
138:
128:
121:
108:
104:
100:
80:
71:
56:
27:
25:
129:In 1999 at
960:Categories
757:2007-08-16
716:2007-03-26
448:2006-11-10
319:References
272:Amerithrax
155:Injunction
930:for AVIP.
660:AF Times
914:19370633
863:Archived
814:Archived
785:Archived
616:Archived
556:Archived
537:Archived
476:cite web
307:See also
287:Pamphlet
170:smallpox
87:accident
77:Overview
40:BioThrax
36:military
966:Anthrax
905:6532564
313:Anthrax
196:of the
178:tetanus
113:History
912:
902:
266:2010s
145:2000s
118:1990s
42:, an
910:PMID
482:link
26:The
21:Avip
900:PMC
892:doi
54:.
962::
908:.
898:.
886:.
478:}}
474:{{
466:.
916:.
894::
760:.
719:.
543:)
484:)
451:.
415:.
23:.
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.