HRSA Awards Contract to Study Adverse Events in Childhood Vaccines

The Health Resources and Services Administration (HRSA), has awarded a contract to the Institute of Medicine (IOM) to study adverse events associated with certain childhood vaccines.

HRSA manages the national Vaccine Injury Compensation Program (VICP), which provides compensation to individuals found to have been injured by those vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children. The VICP also ensures liability protection to vaccine companies and health care providers who administer vaccines, and stabilizes the vaccine marketplace. Claims may be filed on behalf of anyone receiving a covered vaccine, regardless of age.

Under the $1.7 million contract, the IOM will:

• Form a committee to develop a framework and process for identifying and evaluating the relevant evidence. The committee will review the biological, clinical and epidemiological literature for four vaccines: varicella, influenza, hepatitis B and human papillomavirus.
  
  
• Issue a consensus report with conclusions about the causal nature of the relationship between specific vaccines and adverse events. The report will examine the strength and relevance of biological evidence that might underlie specific theories for how a specific vaccine is related to a specific adverse event.

The report is expected to be completed in two years. Once the report is published and upon consideration of its findings, HRSA, in consultation with the Advisory Commission on Childhood Vaccines, may choose to develop proposals for modifying the Vaccine Injury Table.

“The Vaccine Injury Compensation Program provides compassionate and generous compensation to children and families found to have been seriously injured by covered vaccines,” said HRSA Administrator Elizabeth M. Duke. “But the number of covered vaccines has more than doubled since the last major review of the Vaccine Injury Table. The study will help strengthen the VICP's role in compensating those children or adults who may be injured by a vaccine.”

This month marks the 20th anniversary of the VICP, established under the National Childhood Vaccine Injury Act of 1986. Key VICP accomplishments include:

• Awarding more than $1.8 billion to more than 2,200 families and individuals. Awards often include a lump sum payment and an annuity that provides a lifetime stream of benefits for the family of an injured child, or an injured individual.
  
  
• Serving as an effective alternative to the tort system. The program processes claims using current vaccine safety research to determine injuries thought to be caused by vaccines. In resolving claims, the Department of Justice represents the Secretary of Health and Human Services before the U.S. Court of Federal Claims. The Court decides which claims will be compensated and the amount of the award. Lawsuits filed against vaccine companies, which peaked at 255 in 1986 (all for the diphtheria, tetanus and pertussis, or DTP, vaccine), have dropped to less than two dozen non-autism lawsuits filed annually for all 16 vaccines currently covered by the VICP.

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The Health Resources and Services Administration (HRSA), part of the U. S. Department of Health and Human Services, is the primary Federal agency for improving access to health care services for people who are uninsured, isolated, or medically vulnerable. For more information about HRSA and its programs, visit www.hrsa.gov.

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