*This is an archive page. The links are no longer being updated. 1992.08.21 : Regulation -- Vaccine Compensation Contact: Patricia Campbell (301) 443-3376 August 21, 1992 The Health Resources and Services Administration today announced the publication of a proposed rule to revise parts of the table used by the federal government to determine whether persons injured by childhood vaccines are entitled to financial compensation. Some conditions would be redefined, removed or added. "Vaccines in the United States are overwhelmingly safe," said HRSA Administrator Robert G. Harmon, M.D., M.P.H. "In 1991, more than 35 million doses of covered vaccines were distributed, with adverse reactions being extremely rare. For example, the frequency of vaccine-associated poliomyelitis from oral polio vaccine was estimated to be one case per 2.6 million doses." The National Vaccine Injury Compensation Program, created by the U.S. Congress in 1986 to address those rare instances of vaccine-related injuries, provides a no-fault system to compensate those who have been injured by diphtheria, tetanus, pertussis, polio, measles, mumps or rubella vaccines. Petitions for compensation under the program are filed with the United States Claims Court, and HRSA reviews injury claims and makes recommendations to the court as to whether claims meet the requirements for compensation. To do this, a Vaccine Injury Table, which lists illnesses and conditions presumed to be caused by the vaccines, is used. So called "Table" injuries entitle the petitioner to a presumption of eligibility for compensation under the Vaccine Injury Compensation Program. The Congress recognized that the Table as devised in 1986 might compensate some individuals whose injuries were not actually caused by the vaccines, and so mandated that a review be undertaken by the Institute of Medicine, a component of the National Academy of Sciences, to examine the medical and scientific information on adverse reactions to vaccines. The changes proposed are based on the findings of the August 1991 IOM report "Adverse Effects of Pertussis and Rubella Vaccines," as well as recommendations made by two advisory bodies-- the National Vaccine Advisory Committee and the Advisory Commission on Childhood Vaccines. The removal of a condition from the Table will not necessarily result in compensation being denied where it would have previously been awarded. Instead, the automatic presumption that the vaccine caused the injury will no longer apply. Petitioners may still prevail by providing proof that injuries were vaccine- related. "Since 1986, approximately $250 million has been awarded to children and their families through the Vaccine Injury Compensation Program," said Fitzhugh Mullan, M.D., director of the Bureau of Health Professions, which administers the VICP. "We want to ensure that every child eligible for compensation receives it." There will be a 180-day public comment period following publication on August 14 of the proposed regulation in the Federal Register, as well as a public hearing. Only claims filed on or after the effective date of the regulation would be adjudicated using the revised Table. (A complete list of proposed changes is attached.) Written comments should be addressed to HRSA, Rm. 8-05, Parklawn Bldg., 5600 Fishers Lane, Rockville, Md. 20857. HRSA is a U.S. Public Health Service agency within HHS. ### SUMMARY OF PROPOSED CHANGES TO THE VACCINE INJURY TABLE AND QUALIFICATIONS AND AIDS TO INTERPRETATION PROPOSED CHANGES TO THE VACCINE INJURY TABLE For Diphtheria, Tetanus and Pertussis (DTP) vaccines and various combinations, such as DT, Td or Tetanus Toxoid: o The time for the onset of anaphylaxis/anaphylactic shock (a condition of hypersensitivity to proteins or other substances, caused by previous exposure, resulting in shock or other physical reactions) is narrowed. To be eligible as a Table injury, the onset would have to occur within four hours of vaccination, instead of the earlier 24 hours. o Shock-collapse or hypotonic-hyporesponsive collapse is removed from the Table. This is a "shock-like" condition that occurs infrequently with pertussis immunization, but is considered transient with no proven permanent complications. o Residual seizure disorder is removed from the Table. This is a seizure occurring within 72 hours of vaccination, followed by two more seizures within the next year, each with a documented fever less than 102 degrees Fahrenheit. For Measles, Mumps, Rubella (MMR) vaccines alone or in any combination: o Narrows the time for the onset of anaphylaxis or anaphylactic shock (see above for definition) from 24 hours to four hours. o For residual seizure disorder, narrows the time for the initial post-vaccination seizure from zero-15 days to five-15 days. For Measles, Mumps, Rubella (MMR), Measles, Rubella (MR) or Rubella vaccines only: o Adds chronic arthritis to the Table, with the onset of signs within 42 days of vaccination with a vaccine containing rubella. For Inactivated Polio Vaccine (IPV): o Narrows the time for onset of anaphylaxis/anaphylactic shock from 24 hours to four hours. - More - - 2 - PROPOSED CHANGES TO THE QUALIFICATION AND AIDS TO INTERPRETATION o The definition for anaphylaxis and anaphylactic shock is added. o Definitions for infantile spasms and sudden infant death syndrome (SIDS) are added with language specifying them as conditions not covered under the Table. o Clarifies the definition of encephalopathy by: -Defining acute encephalopathy by age group--less than 24 months old versus 24 months old or older. -Defining chronic encephalopathy, which must follow the acute encephalopathy and continue for more than six months. -Specifying the clinical signs that are not consistent with acute encephalopathy. o Clarifies the definition of residual seizure disorder by: -Specifying that the two additional post-vaccination afebrile seizures required over the next 12 months be separated in time by at least 24 hours. -Changing the temperature standard for defining "afebrile" from 102 degrees Fahrenheit to 101 degrees Fahrenheit rectally and 100 degrees Fahrenheit orally. o Adds criteria for the diagnosis of chronic arthritis, including guidelines for the onset and continued signs of both acute and chronic arthritis following vaccination with a vaccine containing rubella. The Aids to Interpretation will contain a list of non-vaccine related musculoskeletal disorders that would be considered conditions not related to vaccine injury. ###