Getting Vaccine Changed Frustrates Congress: Report on Latest Hearing

By John A. MacDonald for the CT Courant

Senior U.S. government health officials said Tuesday they are committed to removing a mercury-based preservative from all doses of flu vaccine given to children. But the officials’ inability to provide a timetable left members of Congress frustrated and complaining about delays.

At best, the preservative may be eliminated from the vaccine by 2009, said Dr. Julie L. Gerberding, director of the Centers for Disease Control.

She said only one manufacturer currently produces doses of the vaccine
that do not contain the preservative and the process of expanding its
facilities or getting other manufacturers in the business is complex and
time-consuming.

“Your frustration is obvious and I share it,” Gerberding told the House Appropriations subcommittee, which is studying a proposal to require removal of the preservative by the 2005-06 flu season.

A government recommendation earlier this year that parents have children ages 6 months to 23 months vaccinated against the flu set off a new round of concern about exposing children to the mercury-based preservative, known as thimerosal, which many parents suspect can have adverse health consequences. The preservative has been virtually eliminated from other childhood vaccines.

Responding to the concerns, the Institute of Medicine has conducted two major studies into side effects that vaccines may cause. The latest
study, released in May, found no conclusive evidence to link the
preservative to autism, a developmental disorder – as some parents’
groups believed. Earlier, the institute found no connection between autism and the measles-mumps-rubella vaccine.

Neither study satisfied many parents or Rep. Dave Weldon, R-Fla.,
who has taken up the parents’ cause. “There is continued concern in the
general population about mercury-containing flu vaccines,” he said, “and there is new research in the scientific community indicating that mercury in
these vaccines may not be as benign as many have assumed.”

Weldon said he supports childhood immunizations, but has introduced legislation to prohibit the government from purchasing or administering any vaccine containing thimerosal starting next year.

Gerberding indicated the government could not meet that timetable.
She estimated that 4.6 million doses of thimerosal-free flu vaccine will be
produced this year but that it would take 11.9 million doses to vaccinate all U.S. children ages 6 months to 23 months. By 2008, she estimated, the sole manufacturer of thimerosal-free vaccine will be able to produce 8 million doses.

Asked how long it would take to complete the job, she responded, “A few years.”

William Egan, acting director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said only three manufacturers have been licensed to produce the flu vaccine for the U.S. market and only Aventis Pasteur makes thimerosal-free doses. The preservative is necessary in multi-dose vials of the vaccine to prevent contamination, but not in single-dose vials, Egan said.

Aventis Pasteur must reconfigure its production lines to make additional single-dose vials of vaccine, a change that is expensive and time-consuming, Egan said, adding, “This is a difficult process.”

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said it is virtually impossible to prove that a vaccine containing thimerosal is risk-free to children. But, he added:

“The benefits of vaccines far outweigh the possible risks, and vaccines
remain the most effective tool we have to prevent serious and life-threatening infections.”

Committee members appeared uncertain about their next move.

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