108th Congress

“Childhood Influenza Vaccine Program” – Hearing before the House Appropriations Subcommittee on Labor, HHS, Education, Representative Ralph Regula [R-OH], Chairman

October 5, 2004

Witnesses:

• Dr. Anthony S. Fauci, Director of NIAID
• Dr. Julie Gerberding, Director of CDC
• Dr. William Egan, Deputy Director, Center for Biologics Evaluation and Research, FDA.
• Dr. Mary McCormick, Chair, Committee on Immunization Safety Review for IOM and Professor, Harvard School of Public Health
• Dr. Thomas Burbacher, Associate Professor of Environmental Health, University of Washington
• Dr. Mady Hornig, Associate Professor of Epidemiology, Mailman School of Public Health, Columbia University
• Dr. Richard Deth, Professor of Pharmacology, Northeastern University.

During the mark up of the FY2005 Labor, HHS, and Education Appropriations bill, Representative Dave Weldon (R-FL) offered an amendment that would have withheld funds to purchase influenza vaccines for children ages 6 to 23 months of age, unless the vaccines purchased by the CDC were thimerosal-free. As a compromise, Representative Regula offered to hold a hearing to examine the issues in lieu of accepting the amendment.

At the outset of the hearing, Representative Regula posed the questions: What is thimerosal and why is it used in vaccines? Does it pose a health risk for children? What would be the effects of the Weldon amendment on the CDC childhood immunization program? Other Members including Representatives Weldon; John Peterson (R-PA); Don Sherwood (R-PA); David Obey [D-WI], Ranking Member; Nita Lowey (D-NY), Patrick Kennedy (D-RI), and Rosa DeLauro (D-CT) expressed concern about thimerosal remaining in the influenza vaccines and potential risks for development of autism and autism spectrum disorders, such as ADHD. Considerable time was devoted to discussion that, although thimerosal has been removed from all other childhood vaccines administered in this country, just half of the available flu vaccine for these children this year is thimerosal free. Members questioned why the companies involved could not retool more quickly to address this. There were also questions about why, if there is no accepted scientific evidence to prove a causal relationship between the use of thimerosal and the development of autism, was the Government requiring the removal of this preservative in vaccines. Drs. Gerberding and Fauci explained that while there is not evidence to prove the linkage, “we do not know everything.”

The witnesses on Panel 2 expressed diverse viewpoints about the safety of thimerosal. Dr. McCormick referenced the recent report of the IOM Committee which “concluded that the hypothesis that thimerosal acts on biological mechanisms that are known to be related to the cause of autism is only theoretical.” On the other hand, Dr. Deth testified that there is “scientific evidence indicating that thimerosal is a neurotoxin and an important contributor to causing neurodevelopmental disorders...and the severity of thimerosal’s neurotoxicity can vary from relatively modest impairments, such as ADHD, to profound conditions such as severe autism.”

In addition, just prior to the beginning of the hearing, it was announced that the supply of influenza vaccine for the coming winter will be cut in half because Chiron, one of only two companies making flu shots for use in the United States, said it would not be able to sell 48 million doses here because of contamination.