Summary of Current Issues in the National Vaccine Injury Compensation Program

Overview of the National Vaccine Injury Compensation Program (VICP)

The National Childhood Vaccine Injury Act of 1986 (P.L. 99-660) established the VICP. The VICP, which went into effect in October 1988, is a no-fault alternative to the tort system designed to compensate individuals injured by childhood vaccines, whether administered in the private or public sector. Vaccines currently covered under the Program include diphtheria, tetanus, pertussis DTP, DTaP, DT, TT or Td, measles, mumps, rubella (MMR or any components). and polio (OPV or IPV). Effective August 6, 1997, hepatitis B, Haemophilus influenza type b, and varicella vaccines have been added for coverage under the Program. Eight years' retroactive coverage from the effective date will be provided for vaccine-related adverse events associated with these three new vaccines.

The VICP is a critical component to the national immunization strategy. In its 9 years of existence, the VICP has met its policy goals of ensuring vaccine supply, stabilizing vaccine costs, and establishing an accessible forum for individuals injured by childhood vaccines.

Program Statistics

As of July 31, a total of 5,169 claims have been filed with the VICP. Of note, 84% of the backlog of Pre-1988 claims have been fully adjudicated, and all remaining Pre-1988 claims are in the adjudication process. 73% of all claims filed are for DTP, 14% for MMR or components, 10% for OPV/IPV, 1% for DT, TT or Td, and 2% for vaccines not covered under the VICP or unspecified vaccines. Awards have ranged from $120.00 to $7.5 million. The average injury award since the inception of the VICP for both Pre-1988 and Post-1988 claims is $690,037. Awards for death cases are capped at $250,000 plus attorneys' fees/costs.

Changes to the Vaccine Injury Table

Under the Act, the Secretary of Health and Human Services (HHS) was mandated to review scientific information on the adverse effects of vaccines covered under the VICP and propose changes to the Vaccine Injury Table (the Table) to bring it in line with current scientific evidence.

Section 312

Under Section 312 of the Act, the Institute of Medicine (IOM) conducted a review of the adverse effects of pertussis and rubella vaccines and published its findings in 1991. These findings underwent extensive review by the Public Health Service Task Force on the VICP, the National Vaccine Advisory Committee (NVAC), the Advisory Commission on Childhood Vaccines (ACCV), and interested parties from the general public. The Final Rule to accomplish the Table revision was published in the Federal Register (60 FR 7678-7696) on February 8, 1995 and became effective March 10, 1995.

The Final Rule revised the Table in several respects. First, a new condition of chronic arthritis was added to the Table for vaccines containing rubella. Second, the time of onset forcertain conditions on the Table was altered. In addition, the conditions of shock-collapse and residual seizure disorder following DTP vaccine were deleted from the Table. Finally, clarifications in the definitions of conditions such as residual seizure disorder and encephalopathy were made in the Qualifications and Aids to Interpretation which accompany the Table.

Section 313

Under Section 313 of the Act, the IOM reviewed the adverse events following vaccination with the remaining vaccines covered under the VICP, as well as hepatitis B and Haemophilus influenzae type b (Hib) vaccines. These findings were published in September 1993 and were reviewed by an Ad Hoc Committee of the NVAC. On February 20, 1997, the Final Rule entitled "National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table--II" was published in the Federal Register (62 FR 7685-7690). Modifications to the Table include addition of brachial neuritis and removal of encephalopathy for tetanus-containing vaccines, addition of thrombocytopenia and vaccine-strain measles virus infection, removal of residual seizure disorder for measles-containing vaccines, and addition of vaccine-strain poliovirus infection for live polio virus vaccine.

These revisions to the Table apply to all claims filed on or after the effective date of March 24, 1997. Modifications to the Table also include the addition of hepatitis B, Hib, and varicella (chicken pox) vaccines to the VICP, as well as any future vaccine recommended by CDC for routine administration to children. However, the effective date of coverage of these new vaccines is delayed until Congress enacts an excise tax for them. Under the current statutory language, 8 years' retroactive coverage will be provided for those claiming injury or death resulting from a vaccine newly added to the VICP.

Vaccine Excise Tax Revision

The Vaccine Injury Compensation Trust Fund (the Fund) provides funding for vaccine-related injuries or deaths from vaccines administered on or after October 1, 1988. The Trust Fund is currently funded by an excise tax imposed on each dose of covered vaccine. Originally, these taxes were imposed on each vaccine using a risk-based formula in which DTP, DTaP, or any pertussis containing combination was taxed at $4.56 per dose; DT, Td, or TT was taxed at $0.06; MMR, MR, M, or R was taxed at $4.44; and polio (both OPV & IPV) was taxed at $0.29. Over time, changes in the recommended schedule of vaccinations, the increasing use of combination vaccines, and the addition of new vaccines for coverage made the risk assessment for covered vaccines increasingly difficult to determine.

Recognizing these limitations, the Secretary of Health and Human Services proposed legislation which eventually passed by Congress called the Taxpayer Relief Act of 1997 (P.L. 105-34). Signed into law by the President on August 5, 1997, the legislation repealed the existing risk-based excise tax structure, replacing it with a flat-tax rate of 75 cents per dose for all covered vaccines. Three-dose vaccines such as DTP, DtaP and MMR are now taxed at $2.25; two-dose vaccines (e.g., Td, MR or DT) are now $1.50; and single-dose vaccines (e.g., OPV, TT, R) are now 75 cents. These revisions went into effect on August 6, 1997.