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Smallpox Vaccine Injury Law Project

The Chronology - Was: Breaking News

6 July 2004

(Posted 6 July 2004)

SEIU - Nation’s Largest Health Care Union Warns That, Without Better Safeguards, Plan Itself Poses Public Health Risks

AFL-CIO - Workers' Compensation and the federal smallpox vaccination program

Texas Nurses Association Urges Caution For Texas Nurses Volunteering For Smallpox Vaccine

Statement by Dr. Kenneth Alibek Program Manager Battelle Memorial Institute, 1998 - Chilling discussion of the Soviet bioweapons program.

WHO Advisory Committee on Variola Virus Research, Report of the Fifth Meeting Geneva, Switzerland 4 - 5 November 2003

World Health Organization, Executive Board, EB111/5, 111th Session, 23 December 2002, Provisional agenda item 5.3, Smallpox eradication: destruction of Variola virus stocks, Report by the Secretariat

World Health Organization Executive Board, EB109/17, 109th Session, 20 December 2001, Provisional agenda item 3.14, Smallpox eradication: destruction of variola virus stocks, Report by the Secretariat

World Health Organization, Executive Board, EB106/3, 106th Session 10 April 2000, Provisional agenda item 5, Smallpox eradication: destruction of variola virus stocks: Report by the Secretariat.

World Health Organization Fifty-Second World Health Assembly, A52/5, Provisional agenda item 13, 15 April 1999, Smallpox eradication: destruction of variola virus stocks, Report by the Secretariat

Smallpox eradication: Destruction of variola virus stocksWeekly Epidemiological Record, 1999, 74, 185-192

8 March 2004

Draft Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination - 3/8/2004 - (PDF),

17 Feb 2004

42 CFR Part 102 RIN 0906–AA61 Smallpox Vaccine Injury Compensation Program: Administrative Implementation; Correction (corrects the typos in the numbering)

13 Feb 2004

Secondary and Tertiary Transfer of Vaccinia Virus Among U.S. Military Personnel — United States and Worldwide, 2002–2004

Update: Adverse Events Following Civilian Smallpox Vaccination — United States, 2003 During January 24–December 31, 2003, smallpox vaccine

27 Jan 2004

Amendment To Extend the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures - Declaration is revised to comply with statutory changes and is extended to Jan 2005.

16 Dec 2003

42 CFR Part 102 Smallpox Vaccine Injury Compensation Program: Administrative Implementation;
Interim Final Rule, 16 Dec 2003 (PDF)

15 Dec 2003

HHS announces the regulations for the smallpox compensation program.

4 Sept 2003

Maryland Attorney General's Opinion on compensation for public workers who are injured by the smallpox vaccine. This is good analysis of the federal vaccination compensation law and how it fits with one state's worker's compensation laws.

18 Aug 2003

Smallpox immunity may last a lifetime - 13:49 18 August 03 NewScientist.com news service. Scientist find reasonable levels of circulating antibodies in persons vaccinated against smallpox more than 30 years ago. They speculate that many persons may be immune and that others would have milder disease and be less contagious. This may not be the whole story. things First, there is reason to be believe that cellular immunity is critical. Second, milder disease should be more contagious because people are not bed-ridden but can get around. Smallpox always had a spectrum of severity, with most cases being much milder than the worst case scenario we talk about. It may be that the milder cases were the key vectors.

14 Aug 2003

National Academices of Science releases a report advising states to start a registery of persons vaccianted for smallpox and trained to do vaccinations. Says general public should only be given the vaccine as part of clinical trials. Read the report here.

3 July 2003

CDC Update on monkeypox.

27 June 2003

Monkeypox update from the CDC. 26 persons received smallpox vaccine to protect them from monkeypox.

19 June 2003

More info from the CDC on monkeypox. This MMWR report casts doubt on the suspected cases of human to human spread, but testing is continuing. The report includes the updated diagnostic criteria.

Interim Questions and Answers on Embargo and Prohibition of Certain Rodents and Prairie Dogs
June 19, 2003, 5:00 PM ET.

Embargo Order on small mammals that are potential carriers of monkeypox.

16 June 2003

Monkeypox appears to more easily transmitted from person to person than originally thought. This increases the risk that health care providers caring for patients infected with monkeypox are at risk of infection. Health care institutions should be careful to record the names of everyone who is in contact with a monkeypox patient to assure that they are watched for signs of infection. If smallpox vaccine is used, it should be administered by a health department employee because there is no immunity for the use of smallpox vaccine for monkeypox. Institutions must consider removing employees from the workplace as there is also no immunity if patients get infected. Employees must understand that there is no compensation available if they are injured by the vaccine, but that monkeypox may be a fatal disease and is more risky than smallpox vaccine. The CDC says that smallpox vaccine is not approved for monkeypox and can only be administered as if it were an investigation new drug because it is an off label use. I do not believe that this is the case, since once a drug is approved for one purpose it is legal to use for all other purposes, it just cannot be advertised for off-label use. This may not make any practical difference since the CDC physically controls the vaccine and decides who administers it.

News from the CDC Public Health Law Conference in Atlanta:

There has been a great turn-out for the conference, probably fueled by the availability of bioterrorism money for travel by health department personnel. There have been some very interesting presentations. I will provide a link when these are posted on the CDC WWW site.

The CDC's official position is that all smallpox vaccinations will be voluntary and require informed consent, even if there is a smallpox outbreak. This is difficult to reconcile with best disease control practices for smallpox, unless the unstated caveat is that persons refusing vaccination will be locked up in secure isolation for 2 weeks. (Which would be impossible for more than a small number of contacts.)

14 June 2003

More information from the CDC about state and federal legal actions regarding monkeypox.

12 June 2003

Monkeypox News

The monkeypox outbreak in the United States is raising the issue of the use of smallpox vaccine to prevent monkeypox infection in exposed persons. (Information on monkeypox infection control. MMWR info. CDC Monkeypox Site.) Monkeypox is related to the smallpox virus, but produces milder disease and generally does not spread from person to person. People catch monkeypox from infected animals, and the disease spreads readily form animal to animal and across many species. This outbreak has been traced to pet dealer who imported an infected giant African pouched rat, which subsequently infected prairie dogs being sold as pets. People exposed to the prairie dogs then became ill with monkeypox. So far, all have recovered without permanent injury, but it is an unpleasant disease and could pose a more severe threat to immunosuppressed persons.

Smallpox vaccine provides cross-immunity to monkeypox and is now being recommended for persons exposed to monkeypox. Assuming that the exposed person does not have a contra-indication for smallpox vaccination, it may make sense to risk the complications of smallpox vaccine to prevent a high risk of contracting monkeypox. Legally, this is not a use of smallpox vaccine that is contemplated under the Secretary's declaration. In my reading of the law, this means that there is no immunity under the Homeland Security Act for those administering the vaccine, and that the smallpox vaccine compensation fund does not cover injuries caused by the administration of smallpox vaccine to prevent monkeypox. If any one has a different reading of the law, please email me. Please do not send me general questions about monkeypox - direct those to the CDC.

As a general matter, I believe that we should completely ban the importation of animals for pets from regions with known endemic zoonoses, i.e., diseases that are know to spread from animals to people. This includes wild chipmunks and other rodents from the US where plague is endemic, as well as pets from Africa and other places (such as South China) which are known to harbor dangerous zoonoses. Health care providers should include questions about exposure to unusual pets on their patient history forms. In no cases should such animals be allowed in health care institutions. (See CDC guidelines on hospital environmental health, including animals in health care institutions.)

19 May 2003

Smallpox Vaccine Injury and Law Guide updated to reflect the passing of the Smallpox Emergency Personnel Protection Act of 2003.

9 May 2003

GAO Report - SARS OUTBREAK Improvements to Public Health Capacity Are Needed for Responding to Bioterrorism and Emerging Infectious Diseases, Wednesday, May 7, 2003

1 May 2003

GAO issues a report critical of the smallpox vaccionation program: Smallpox Vaccination: Implementation of National Program Faces Challenges

17 April 2003

HR 1170 - Text of Smallpox Compensation Act (pdf), as passed and signed by the president, 30 April 2003(HTML)

Disaster Preparedness and Response in Texas Hospitals: Part I, Bioterrorism - an excellent starting point for developing a bioterrorism plan. Original Link

11 April 2003

CDC releases HIPAA guidence for releasing information for public health purposes. This will affect information related to smallpox vaccinations.

NY Times reports that the Congress and the President have cut a deal on the smallpox vaccine injury compensation program. The major difference between the new plan and one proposed by the administration is that the estates of persons with dependents can elect a $50,000 a year payment until the youngest is 18, rather than a $262,100 lump sum payment.

8 April 2003

Bioterrorism: Adequacy of Preparedness Varies Across State and Local Jurisdictions. GAO-03-373, April 7.

3 April 2003

CDC releases: Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program, Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC)

Curiously, these 4 April 2003 recommendations do not appear to mention cardiac problems as a contra-indication, nor is there any mention of the latex allergy problems noted on the Dryvax label.

1 April 2003

NY Times reports that Democrats have killed the smallpox vaccine injury compensation fund because it is too little compensation.

Institute of Medicine Releases Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation: Letter Report 2, by the Committee on Smallpox Vaccination Program Implementation.

28 March 2003

The Model State Emergency Health Powers Act rears its ugly head again. As fears of bioterrorism spread, the misguided attempt by the CDC to force states to pass Draconian bioterrorism legislation is picking up steam again. This law was written by a group funded by the CDC and while public health groups were consulted in theory, in practice few of them are willing to speak out against anything the CDC proposes because they are dependent on the CDC for funding. The law is completely unnecessary because every state passed an emergency preparedness law in the 1990s to qualify for federal funding. These laws can be used to manage bioterrorism as well as other national disasters, and the Model State Emergency Health Powers Act only confuses the lines of authority. For more information, see Review of The Model State Emergency Health Powers Act. Tell your legislator friends that this is a bad law and should be resisted.

CDC establishes the National Smallpox Vaccine in Pregnancy Registry to identify and track women who are exposed to smallpox vaccine while pregnant. While fetal vaccinia is very rare, it is a recognized problem.

CDC releases more information on Cardiac Adverse Events Following Smallpox Vaccination.

27 March 2003

New York Times reports that 10 soldiers (out of 350,00) developed transient heart inflamation from the smallpox vaccine.

Research Letter to JAMA published 26 March 2003 argues that up to 50% of hospital inpatients have one or more conditions predisposing them to secondary infection with vaccinia. This was based on a review of 2001 hospital discharge date for New York hospitals. (The high percentage is a result of insurance payment policies that keep all but the sickest patients out of the hospital.) The authors question whether the CDC recommendations on meticulous care of the vaccination site and hand washing by vaccinated health care providers is an adequate protection.

26 March 2003

Smallpox Vaccine Injury and Legal Guide now includes a review of Senate Bill 15's compensation plan. Review of Senate Bill 15 alone. Senate Bill 15 also rewrites the National Childhood Vaccine Injury Act, but is structured so that it is impossible to tell the impact of this rewrite without a line by line comparison with the original law. It does not add smallpox vaccine to the NCVIA.

CDC issues a press release noting a potential association between smallpox vaccination and heart problems, including one death, advises that heart problems are now a contra-indication for vaccination. While this is a reasonable precaution, 6 cases of heart problems in 25,000 vaccinations could also be due to chance.

24 March 2003

Text of Senate Bill 15 - Biodefense Improvement and Treatment for America Act - is now available. This bill sets up a smallpox compensation fund and modifies other portions of the federal laws governing smallpox vaccinations. It is a long bill and an analysis will be posted.

13 March 2003

Slides from Prof. Richards presentation at William Mitchell College of Law on the Bioterrorism Band-aid: Why We Cannot Manage Bioterrorism with a Broken Public Health System. This was given as a public lecture on March 12th, 2003, and includes a discussion why the smallpox vaccination plan for hospitals was an initial failure

6 March 2003

HHS proposes smallpox vaccination compensation plan. This plan would apply the existing standards from the federal benefits for police and fire to persons vaccinated with the smallpox vaccine. The proposal would include persons who get vaccinia through secondary transmission. It cover death and disability benefits and health care costs, although it is not clear whether it will reimburse costs paid by health insurers or just out of pocket costs paid by the injured person.

26 Feb 2003

CDC releases: Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC)

Nothing really new, but a good reorganization. Makes clear that HIV testing is recommended: "HIV testing is recommended for persons who have any history of a risk factor for HIV infection or for anyone who is concerned that he or she might have HIV infection." but does not require it.

The consent for vaccination should include a check off on HIV testing. Patients checking REFUSED should be asked to sign a form explaining that they understand the risks of disseminated vaccinia and still refuse HIV testing.

Interestingly, although the vaccine label warns against giving the vaccine to anyone with latex allergy, the CDC materials continue to be silent on latex allergies.

24 Feb 2003

Rep. Waxman Introduces Smallpox Vaccination and Compensation Act of 2003
Feb. 13, 2003 - Rep. Waxman introduced legislation to provide compensation for health care workers and others injured by the smallpox vaccine. The legislation also includes provisions to assist state efforts against smallpox and to protect health care workers and their employers during the vaccination campaign.
- Rep. Waxman's Statement
- Legislation Summary
- Bill Text: H.R. 865

15 Feb 2003

Risk management suggestions for non-participating hospitals with workers who are vaccinated at reserve duty or on their own. Click here to email me how your hospital is handling this problem.

14 Feb 2003

NPR Morning Edition report on smallpox vaccination program. No real news, but says Rep. Waxman has introduced a bill to pay medical expenses.

Info on Waxman Bill (the text is not available yet)

Sponsor: Rep Waxman, Henry A. [CA-30] (introduced 2/13/2003)
Latest Major Action: 2/13/2003 Referred to House committee. Status: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and the Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Title: To protect the health and safety of individuals receiving smallpox vaccinations and to provide compensation and assured access to care for individuals injured by the vaccine, and for other purposes.

13 Feb 2003

CDC sets up a site tracking smallpox vaccinations and adverse events. Telebriefing on this reporing program.

12 Feb 2003

CDC releases: Draft Recommendations for Use of Smallpox Vaccine in a Pre-Event Smallpox Vaccination Program. This is an update of the previous recommendations, with some new information. Says there is enough VIG to treat 4,000 severe reactions, but does not provide information on actual units available. Estimates severe complication rate at 100/1,000,000.

10 Feb 2003

Review article reiterates the risks of smallpox vaccination to persons with HIV: John G. Bartlett, Smallpox Vaccination and Patients with Human Immunodeficiency Virus Infection or Acquired Immunodeficiency Syndrome, Clinical Infectious Diseases 2003;36:468-471 (This link may only work if you have a subscription to the journal.)

7 Feb 2003

Senate Testimony - The Smallpox Vaccination Plan: Challenges and Next Steps

6 Feb 2003

Texas Attorney General says smallpox vaccine injuries are probably covered by workers comp.

CDC releases: Smallpox Vaccine Adverse Events Monitoring and Response System for the First Stage of the Smallpox Vaccination Program - original link

4 Feb 2003

Texas Nurses Association Recommends that it's members not participate.

CDC Updates their the QA on 304 and issues Guidance for the Healthcare Community Concerning Section 304 of the Homeland Security Act.

3 Feb 2003

Proposed Amendment of the Homeland Security Act, Section 304, to protect against claims for vaccine-related injuries - will this protect hospitals and health care workers?

31 Jan 2003

Secretary's Declaration is formally published in the Federal Register.

PDF version of the CDC's Smallpox Vaccination and Adverse Reactions Guidance for Clinicians becomes available. (Warning - large file) This should be required reading for every person considering volunteering for the smallpox vaccination.

IOM Report - Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation -- Letter Report #1 - raises many questions about the advisability of the program, the management of screening and informed consent, and lack of a comprehensive cost accounting which will leave health departments bearing significant, but unknown costs beyond those covered by federal funding. These concerns are echoed in the statement of American Public Health Association (APHA) - more APHA news.

Massachusetts Nurses Association Issues Position Statement On the Mass. DPH Smallpox Pre-Event Vaccination Plan - this statement is very critical of the plan. It stresses that the needles used for the vaccinations do not meet the federal standards for safety, being essentially the same as those used in the 1960s before needle safety was an issue. It also raises an issue identified in the FDA label for the vaccine, but not addressed by the CDC - some or all of this vaccine is stoppered with latex, which poses a real risk to latex allergic health care providers. Interestingly this problem has been ignored in the CDC materials, including the new comprehensive guide to smallpox vaccinations and adverse events.

AHA - Update National Smallpox Vaccination Program for Hospital Workers.

24 Jan 2004

HHS releases unofficial (unpublished) declaration establishing the parameters of immunity under the Homeland Security Act.

CDC releases Smallpox Vaccination and Adverse Reactions - Guidance for Clinicians. A detailed guide to vaccine practices and adverse reactions, complete with pictures. Must reading for any health care worker considering vaccination.

Immunizations begin in Connecticut hospitals. Liability issues are still unresolved. Hospitals are strongly advised to take risk management actions before vaccinating workers. See the new Risk Management section in the Smallpox Vaccine Injury and Law Guide, 24 Jan 03.

14 Jan 2004

Secretary of HHS's letter on the meaning of the Homeland Security Act's immunity provisions added to the guide. Click here for more info.

13 Jan 2003

Democrat senators have introduced a bill, The Comprehensive Homeland Security Act of 2003, containing a sense of the Congress provision that purports to establish that Congress did not give immunity to vaccinated persons who spread vaccinia and that the general immunity only covers hospitals which give the vaccine themselves:

(7) The Homeland Security Act of 2002 failed to protect from liability a vaccinated person who transmits vaccinia accidentally. This section should be amended to protect these people from liability. The section also failed to protect hospitals that did not administer the vaccine, but employ vaccinated health workers. The section should be amended to clarify which hospitals are covered.

While the Act can be read differently, this Bill will now be the closest thing to legislative history available and will certainly be persuasive to some judges. This section also casts into doubt the meaning of the rebuttable presumption about secondary spread, i.e., that everyone who contacts vaccinia is a person to whom a countermeasure was applied. Since the Act is claimed not to cover secondary transmission by the vaccinated person, might a judge find that a vicarious liability claim would not be covered as well? At this point, the immunity provisions of the Act are very confused and hospitals should be carefully review their implications before relying on them. Click here for more info.

10 January 2003

The first report is in from a Chicago hospital that employees are showing up having been vaccinated in their role as military reservists. They are faced with the conflict between the label recommendations on the vaccine which say remove vaccinated workers from the workplace, and the CDC recommendations which say it is OK to leave them in the workplace, as long as they wash their hands.

09 January 2003

FDA releases: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients

Recommends that blood be deferred if it may be contaminated with vaccinia.

18 Dec 2002

Many hospital workers are in the National Guard and may be immunized as part of their guard duties before the Homeland Security Act immunity is in place. Should they be removed from the workplace as per the vaccine label recommendations, or left in the workplace, as per the CDC recommendations? If they transmit virus to a patient, there will be significant legal liability. If they are excluded, who pays? Can they be forced to take sick leave?


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