Anyone may petition the HHS secretary to propose regulations to amend the Vaccine Injury Table.

HHS Awaiting IOM Report on Vaccines' Effects

Expected to arrive in early summer, it will review the evidence for adverse health events associated with vaccines covered by the National Vaccine Injury Compensation Program.

The secretary of Health and Human Services will not begin a rulemaking to possibly add Guillain-Barré Syndrome (GBS) as an injury following certain vaccines to the National Vaccine Injury Compensation Program. HHS will wait until the Institute of Medicine delivers a report about vaccines covered by the program, according to a Federal Register notice published by HHS' Health Resources and Services Administration.

HHS contracted for the report in 2008 and expects it to be delivered in early summer, according to the notice, which says IOM was asked to review the epidemiological, clinical, and biological evidence regarding adverse health events associated with these vaccines:

  • Varicella vaccines
  • influenza vaccines
  • hepatitis B vaccine
  • human papillomavirus vaccines
  • hepatitis A vaccines
  • meningococcal vaccines
  • measles-mumps rubella vaccines
  • diphtheria, tetanus, pertussis vaccines

Anyone (including the Advisory Commission on Childhood Vaccines) may petition the HHS secretary to propose regulations to amend the Vaccine Injury Table, and this happened Sept. 9, 2010, when someone the notice does not name submitted a petition asking to add GBS. The statute authorizing the program provides for adding additional vaccines when they are recommended by the Centers for Disease Control and Prevention for routine administration to children.

The commission discussed the petition at a March 3, 2011, meeting and unanimously agreed to await the IOM report before acting.

According to the notice, the petition claimed "[e]very drug company admits that GBS is linked to many different vaccines including influenza, meningitis, and cervical cancer [human papillomavirus]" and stated that the petitioner's mother received the seasonal influenza vaccine and was subsequently diagnosed with GBS.

GBS is a rare disorder in which the body's immune system attacks part of the peripheral nervous system. The cause is unknown, but GBS often follows an infectious illness such as a respiratory infection or stomach flu. While GBS can be life-threatening, most patients recover from even the most severe cases.

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