You asked why the Illinois Department of Public Health acted to keep mercury as an ingredient in vaccines for children and pregnant women, and whether the Illinois legislature was taking action to counteract this decision.

SUMMARY

In 2005, the Illinois legislature passed PA 94-614 (410 ILCS 51 et seq. ) to phase out the use of mercury-containing vaccines by January 1, 2008. But the act contains a provision that allows the Illinois Department of Public Health (IDPH) to evaluate and assess the needs of Illinois citizens to have access to vaccines. Under this provision, IDPH has filed for a statewide exemption from the law for four vaccines that contain more than trace amounts of mercury. Despite IDPH's action, there are no current proposals to change the law.

MERCURY-FREE VACCINE ACT (PA 94-614)

This act was designed to gradually phase out the use of mercury-containing vaccines. Although a mercury-containing preservative called thimerosal has been used in some vaccines since the 1930s, the legislature was concerned that mercury in vaccines could cause autism. Beginning January 1, 2006, the law prohibits the administration of a

vaccine with more than a trace amount of mercury (1. 25 micrograms) per dose, and prohibits any use of mercury in vaccines beginning January 1, 2008.

However, PA 94-614 allows the IDPH to exempt the use of a vaccine from the law's requirements if the department determines that “an actual or potential bio-terrorist incident or an epidemic or shortage of supply of a vaccine at a reasonable cost that would prevent a person from receiving the needed vaccine” make it necessary to administer a vaccine containing more than the maximum level of mercury under the statute. Within 48 hours of issuing the exemption, IDPH must notify the legislature and provide reasons for its decision. This exemption expires after 12 months, but may be renewed if “the same incident or public health emergency” remains.

EXEMPTION NOTIFICATION

On January 3, 2006, IDPH issued an exemption notification [enclosed] to the legislature for four vaccines: influenza, japanese encephalitis, combined tetanus-diphteria, and meningococcal.

Shortage of Mercury-Free Vaccine

IDPH reasoned that eliminating thimerosal from vaccines could result in a public health emergency because drug manufacturers do not currently produce enough preservative-free vaccines to meet demand in Illinois.

For example, IDPH was concerned that compliance with PA 94-614 would result in a shortage of flu shots. According to IDPH, the primary flu vaccine supplier, Sanofi Pasteur, has distributed more than 58 million doses of its vaccine in the United States; of this supply, only eight million doses are preservative-free. Six million of these doses are for children, and two million for adults. Sanofi plans to produce the same amount of preservative-free shots next year. Because Sanofi does not reserve a supply of preservative-free doses for any one state, IDPH determined that sufficient amounts of the vaccine could not be guaranteed if the state depended on mercury-free vaccines.

Cost of Mercury-Free Vaccine

IDPH was also concerned that the higher cost of preservative-free vaccines could limit public access to them. For example, IDPH acknowledged that the tetanus-diphteria vaccine was available in a preservative-free, single-dose, pre-filled syringe containing only trace amounts of thimerosal. Yet to pay for its projected supply needs for 2006, including the immunization requirements for booster doses in secondary and post-secondary education, IDPH would need to exceed its budget.

LEGISLATIVE RESPONSE

According to Marilyn Thomas, chief counsel for IDPH, there are no proposed legislative changes to PA 94-614. Thomas said that PA 94-614 was written to send a message to the vaccine industry, but not intended to immediately solve the problem of mercury-containing vaccines. The legislature included the exemption language as a “compromise measure” to ensure that adequate vaccine supplies would be available. In the long run, IDPH anticipates that manufacturers will produce preservative-free vaccines in sufficient quantities to meet public health needs.

A spokesperson for Illinois state representative Kurt Granberg, who sponsored PA 94-614, said that the representative was unlikely to propose any changes to the law this year.

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