Health Hippo
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Natural forces within us are the true healers of disease.
A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. The agent stimulates the body’s immune system to recognize the agent as foreign, destroy it, and “remember” it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.
The National Vaccine Injury Compensation Program created a no-fault compensation program for those injured by childhood vaccines. By providing a standardized method to compensate injured persons, the Act attempts to balance vaccine safety and availability. It is funded by an excise tax on vaccines. It was followed by the Smallpox and Countermeasures injury compensation programs, the latter of which provides for people injured as a result of government countermeasures to pandemics or biological attacks.
U.S. Code
- Affordable Care Act: Immunizations
- Sec. 4204 Authority To Purchase Recommended Vaccines for Adults.
- Balanced Budget Act: Vaccines
- Sec. 4107 Vaccines outreach expansion.
- 21 USC CHAPTER 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS
- 42 USC Part B – Federal-State Cooperation
- Sec.247d Public health emergencies
- Sec.247d-1 Vaccine tracking and distribution
- Sec.247d-3a Improving State and local public health security
- Sec.247d-3b Partnerships for State and regional hospital preparedness to improve surge capacity
- Sec.247d-4 Revitalizing the Centers for Disease Control and Prevention
- Sec.247d-5 Combating antimicrobial resistance
- Sec.247d-5a Identification of clinically susceptible concentrations of antimicrobials
- Sec.247d-6 Public health countermeasures to a bioterrorist attack
- Sec.247d-6a Authority for use of certain procedures regarding qualified countermeasure research and development activities
- Sec.247d-6b Strategic National Stockpile and security countermeasure procurements
- Sec.247d-6d Targeted liability protections for pandemic and epidemic products and security countermeasures
- Sec.247d-6e Covered countermeasure process
- Sec.247d-7 Demonstration program to enhance bioterrorism training, coordination, and readiness
- Sec.247d-7a Grants regarding training and education of certain health professionals
- Sec.247d-7b Emergency system for advance registration of health professions volunteers
- Sec.247d-7c Supplies and services in lieu of award funds
- Sec.247d-7d Security for countermeasure development and production
- Sec.247d-7e Biomedical Advanced Research and Development Authority
- Sec.247d-7f National Biodefense Science Board and working groups
- 42 USC Sec. 256c Bulk purchases of vaccines for certain programs.
- 42 USC Sec. 283d Children’s Vaccine Initiative.
- 42 USC Sec. 300aa-1 National Vaccine Injury Compensation Program: Establishment
- Sec.300aa-2 Program responsibilities
- Sec.300aa-3 Plan
- Sec.300aa-4 Report
- Sec.300aa-5 National Vaccine Advisory Committee
- Sec.300aa-6 Authorization of appropriations
- Sec.300aa-10 Establishment of program
- Sec.300aa-11 Petitions for compensation
- Sec.300aa-12 Court jurisdiction
- Sec.300aa-13 Determination of eligibility and compensation
- Sec.300aa-14 Vaccine Injury Table
- Sec.300aa-15 Compensation
- Sec.300aa-16 Limitations of actions
- Sec.300aa-17 Subrogation
- Sec.300aa-18 Repealed
- Sec.300aa-19 Advisory Commission on Childhood Vaccines
- Sec.300aa-21 Authority to bring actions
- Sec.300aa-22 Standards of responsibility
- Sec.300aa-23 Trial
- Sec.300aa-25 Recording and reporting of information
- Sec.300aa-26 Vaccine information
- Sec.300aa-27 Mandate for safer childhood vaccines
Code of Federal Regulations
- 42 CFR PART 100 VACCINE INJURY COMPENSATION (100.1 – 100.3)
- Sec. 100.1 Applicability.
- Sec. 100.2 Average cost of a health insurance policy.
- Sec. 100.3 Vaccine injury table.
- 42 CFR PART 102 SMALLPOX COMPENSATION PROGRAM (102.1 – 102.92)
- SUBPART A General Provisions (102.1 – 102.3)
- SUBPART B Persons Eligible To Receive Benefits (102.10 – 102.11)
- SUBPART C Covered Injuries (102.20 – 102.22-102.29)
- SUBPART D Available Benefits (102.30 – 102.33)
- SUBPART E Procedures for Filing Request Packages (102.40 – 102.46)
- Sec. 102.40 How to obtain forms and instructions.
- Sec. 102.41 How to file a Request Package.
- Sec. 102.42 Deadlines for filing request forms.
- Sec. 102.43 Deadlines for submitting documentation.
- Sec. 102.44 Representatives of requesters.
- Sec. 102.45 Multiple survivors.
- Sec. 102.46 Amending a request package.
- SUBPART F Required Documentation To Be Deemed Eligible (102.50 – 102.54)
- SUBPART G Required Documentation for Eligible Requesters To Receive Benefits (102.60 – 102.63)
- SUBPART H Secretarial Determinations (102.70 – 102.74)
- SUBPART I Calculation and Payment of Benefits (102.80 – 102.84)
- SUBPART J Reconsideration of the Secretary’s Determinations (102.90 – 102.92)
- SUBPART A General Provisions (110.1 – 110.3)
- SUBPART B Persons Eligible To Receive Benefits (110.10 – 110.11)
- SUBPART C Covered Injuries (110.20 – 110.20)
- SUBPART D Available Benefits (110.30 – 110.33)
- SUBPART E Procedures for Filing Request Packages (110.40 – 110.46)
- Sec. 110.40 How to obtain forms and instructions.
- Sec. 110.41 How to file a Request Package.
- Sec. 110.42 Deadlines for filing Request Forms.
- Sec. 110.43 Deadlines for submitting documentation.
- Sec. 110.44 Legal or personal representatives of requesters.
- Sec. 110.45 Multiple survivors.
- Sec. 110.46 Amending a Request Package.
Cases
- Vaccine Claims: Special Masters Vaccine rules, guidance for practitioners, sample filings, fast track procedures.
- Opinions/Orders Reported and unreported opinions.
- Omnibus Autism Proceeding Test case decision and background information.
- Salmins v. HHS (2014)(petitioner provided preponderant evidence that her human papillomavirus vaccine (HPV/Gardasil) caused her Guillain-Barré syndrome)
- Althen v. Secretary of Health and Human Servs. (Fed. Cir., July 29, 2005) (clarifies the standard for proving causation when an injury is not listed in the Vaccine Injury Table)
- Salceda v. Secretary of Health and Human Servs. (Fed. Cir., November 28, 1995) (claimant who suffered vaccine-related injury before November 15, 1988, and filed civil action deemed ineligible to file a petition under the Vaccine Act)
- Shalala v. Whitecotton (U.S., April 18, 1995) (claimant who experienced symptoms of injury after receiving vaccination does not make out prima facie case for compensation under Vaccine Injury Act when evidence fails to indicate no symptoms of injury prior to vaccination)
- Gottsdanker v. Cutter Laboratories (Cal. 1960)(the essence of plaintiffs’ claim is not that the vaccine failed to prevent polio, but that it actually and directly caused it)
- Jacobson v. Massachusetts 197 U.S. 11 (1905)(very old opinion ordering compulsory smallpox vaccination)
Reports
- Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled through Negotiation (GAO 2014) Most of more than 9,800 claims filed with the National Vaccine Injury Compensation Program since 1999 have taken multiple years to adjudicate. Since 2006, about 80 percent of compensated claims have been resolved through a negotiated settlement.
- CDC: Vaccines and Immunizations Immunization schedules, common questions, surveillance, side effects, safety, laws. Vaccines are responsible for the control of many infectious diseases that were once common in this country and around the world, including polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), mumps, tetanus, and Haemophilus influenzae type b (Hib). Vaccine eradicated smallpox, one of the most devastating diseases in history.
- vaccines.gov The federal gateway to information on vaccines and immunization for infants, children, teenagers, adults, and seniors. Vaccines.gov provides resources from federal agencies for the general public and their communities about vaccines across the lifespan.
- Potentially Improper Frequency of Pneumococcal Vaccinations for Medicare Beneficiaries (OIG 2013) This memorandum report determines the number of Medicare beneficiaries aged 65 years or older who received multiple pneumococcal vaccinations during a 5-year period (between 2007- 2011) and the Medicare payments associated with those vaccinations.
- HHS Is Monitoring the Progress of Its Medical Countermeasure Efforts but Has Not Provided Previously Recommended Spending Estimates (GAO 2013) The Department of Health and Human Services (HHS) has established timelines and milestones for the 72 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) priorities–33 activities, 25 threat-based approaches, and 14 capabilities–that HHS selected as key to fulfilling PHEMCE strategic goals.
- Vaccines for Children Program: Vulnerabilities in Vaccine Management (OIG 2012) In 2010, approximately 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion. VFC providers must meet certain requirements for vaccine management, such as storing vaccines within required temperature ranges and monitoring expiration dates, to ensure that these vaccines provide children with maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse.
- Many Factors, Including Administrative Challenges, Affect Access to Part D Vaccinations (GAO 2011) Many of the almost 22 million Medicare beneficiaries age 65 and older who were enrolled in Medicare Part D in 2009 did not receive the routinely recommended vaccinations covered by Part D.
- Improvements Needed for Acquiring Medical Countermeasures to Threats from Terrorism and Other Sources (GAO 2011) HHS invested about $1.9 billion in development and $2.4 billion for acquisition of countermeasures to fulfill these priorities from fiscal year 2007 to fiscal year 2010.
- Project Bioshield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats (GAO 2009) HHS determines priorities for medical countermeasure procurement based on those chemical, biological, radiological, and nuclear agents that have been identified by the Department of Homeland Security as posing a material threat to the U.S. population that could affect national security.
- 2009 H1N1 School-Located Vaccination Program Implementation (OIG 2010) This memorandum report provides information about selected 2009 HINI SScchhoool~l-Located Vaccination (SLV) programs. The Centers for Disease Control and Prevention (CDC) considers SLY to be a viable, large-scale vaccination method for children.
- Military Health: DOD’s Vaccine Healthcare Centers Network (GAO 2007) Members of the military have long been required to receive immunizations. The Department of Defense (DOD) estimates that over 2.2 million servicemembers receive at least one mandatory immunization annually.
- Childhood Vaccines: Challenges in Preventing Future Shortages (GAO 2002) Vaccine shortages began to appear in November 2000, when supplies of the tetanus and diptheria booster fell short. By October 2001, the Centers for Disease Control and Prevention (CDC) reported shortages of five vaccines that protect against eight childhood diseases.
- Anthrax Vaccine: Changes to the Manufacturing Process (GAO 2001) The original anthrax vaccine was developed in the 1950s and was first produced on a large scale by Merck. The BioPort Corporation in Michigan is now the sole facility in the United States capable of producing the vaccine.
- Nursing Home Vaccination: Reaching Healthy People Goals (OIG 2000) To identify ways to accelerate fulfillment of the Healthy People 2010 objective of vaccinating 90 percent of nursing home residents against influenza and pneumococcal disease.
- Anthrax Vaccine: Safety and Efficacy Issues (GAO 1999) Discussed the results of its ongoing examination of the safety and efficacy of the anthrax vaccine, focusing on the: (1) need for a six-shot regimen and annual booster shots; (2) long- and short-term safety of the vaccine; (3) efficacy of the vaccine; (4) extent to which problems the Food and Drug Administration (FDA) found in the vaccine production facility in Michigan could compromise the safety, efficacy, and quality of the vaccine; and (5) effects of the anthrax vaccine on children, pregnant women or lactating women.
- CDC’s National Immunization Survey: Methodological Problems Limit Survey’s Utility (GAO 1996) GAO assessed the Centers for Disease Control and Prevention’s (CDC) National Immunization Survey (NIS), focusing on: (1) survey costs; (2) survey methods; and (3) use in identifying groups of children in need of more timely immunization.
- CDC’s National Immunization Survey: Methodological Problems Limit Survey’s Utility. (GAO 1996) GAO assessed the Centers for Disease Control and Prevention’s (CDC) National Immunization Survey (NIS), focusing on: (1) survey costs; (2) survey methods; and (3) use in identifying groups of children in need of more timely immunization.
- Physician Participation in the Vaccines for Children Program (OIG 1995) Participating physicians can use the free vaccines to immunize children enrolled in Medicaid, Native American children, Alaskan Native children, and children without insurance.
- Vaccines for Children: Refocusing the Program’s Goal and Implementation (GAO 1995) More than 95 percent of the nation’s children receive recommended vaccinations by the time they enter school.
- Vaccines for Children: Barriers to Immunization (GAO 1995) Available studies did not contain enough evidence for GAO to conclude that vaccine cost–a major focus of the Vaccines for Children Program–has been a significant barrier to immunization.
- Immunization: HHS Could Do More to Increase Vaccination Among Older Adults (GAO 1995) Pneumonia and influenza are the leading causes of vaccine- preventable death. The elderly suffer the most from these diseases and the costs to the federal government are substantial.
- Vaccines for Children: Critical Issues in Design and Implementation (GAO 1994) The Vaccines for Children program was authorized by Congress in 1993 in order to increase immunization rates through free vaccinations.
- Vaccines for Children: Major Implementation Hurdles Remain (GAO 1994) The Vaccines for Children program was authorized by Congress in 1993 in order to increase immunization rates through free vaccinations.
- The Role of the Federal Maternal and Child Health Bureau in Preschool Immunizations (OIG 1993) Low preschool immunization rates reflect fragmented efforts to deliver immunizations, the high cost of vaccines, and poor public awareness. Reaction to this situation has prompted government agencies to expand and further coordinate efforts to improve immunization rates.
- The National Vaccine Injury Compensation Program: A Program Review (OIG 1992) After a claim is submitted to the Claims Court, physicians at PHS review each case based on the Vaccine Injury Table and send their recommendations for or against compensation to the Claims Court, where a hearing takes place. With DOJ attorneys representing the government and private attorneys representing petitioners.
- AID’s Malaria Vaccine Research Activities (GAO 1989) Reviewed the Agency for International Development’s (AID) Malaria Immunology and Vaccine Research (MIVR) project, focusing on whether: (1) the procedures and processes AID used to select research and support subprojects ensured funding for high-quality, relevant, cost-conscious subprojects; (2) AID instituted an effective, impartial system to monitor performance; (3) AID periodically evaluated the malaria project’s relevance, impact, and management; and (4) AID adequately subjected project expenditures to financial oversight and audit.
- Problems in Regulating Selected Vaccines (GAO 1973) This report concerns (1) the safety and potency of adenovirus and adenovrrus-influenza vaccines and (2) the safety of pertussis vaccines.
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