Chiron agrees with the Government Accountability Office that some influenza vaccine distribution inadequacies may need to be addressed.

"It is possible that there may have to be special considerations as to how we satisfy the needs in areas that are not served well by the distributors," Chiron CEO Howard Pien said before a hearing of the Senate Special Committee on Aging Sept. 28.

"I'm distraught to hear that we're not getting it to important pockets in different parts of the country."

Pien's testimony accompanied critiques of the current vaccine distribution system.

"We also have heard that because of the distribution through the intermediaries, that the vaccine doesn't always go to the health care providers first....I just want to reemphasize that distribution is currently a concern," GAO Health Care and Public Health Issues Director Janet Heinrich said.

Local public health officials urged a stronger federal presence to improve the distribution system.

"Public health urges stronger federal leadership to bring all of the parties together to find ways to rationalize the current chaotic distribution system and to collaborate to assure optimal distribution of all the flu vaccine," Idaho North Central District Health Department Director Carol Moehrle said.

The committee considered pandemic preparedness and how to increase overall immunization rates.

"Vitally important is a recommendation for universal immunization. Expanding today's recommendations to cover more than the 60% of the population currently covered will enhance our pandemic readiness as a nation," Pien said.

Since roughly 60% of the population is currently covered by the recommendations, "moving to a universal recommendation is not that great a leap," ¹ Chiron's statement notes.

The company said that before the pandemic arrives several issues must be addressed. "One of them is indemnification, or coverage from the insurance standpoint," Pien said.

An agreed-upon compensation mechanism should be in place prior to a pandemic to protect Chiron from risk. The company said that such a mechanism will ensure a rapid shift to pandemic vaccine production.

"Chiron believes that discussions and planning should occur now between manufacturers and the FDA in order to determine the regulatory pathway for approval of a vaccine, including any amendments to official release requirements in the event of a pandemic."

National Vaccine Advisory Committee members also expressed concern in June that FDA regulations could create a barrier to fast approval of pandemic influenza vaccines (² Also see "Flu Pandemic Plan Needs To Coordinate Public And Private Vaccine Supplies" - Pink Sheet, 7 June, 2004., p. 31).

Chiron cited increases in the Centers for Medicare & Medicaid Services reimbursement rates in 2003 as another means to increasing immunization rates.

"The best health economic policy is for the CMS to continue to encourage physicians to actively immunize against flu by setting adequate administration fees and reimbursement rates," Pien said.

The reimbursement increases by CMS of "roughly 90% to between $6 and $8 from less than $4 has served to encourage physicians to actively seek out immunization in their population," Chiron said.

During the hearing, Sen. Evan Bayh (D-Ind.) asked the Centers for Disease Control & Prevention why CDC chose to prepare for the flu season by purchasing a strategic reserve as opposed to granting a governmental guarantee for unused vaccines as was proposed in a bill he sponsored last year entitled (³ S 2038) (⁴ Also see "Flu Vaccine Program Review Will Consider “Major Changes In Strategy”" - Pink Sheet, 9 February, 2004., p. 41).

CDC National Center for Infectious Disease Deputy Director Stephen Ostroff, MD, responded that the fixed number was selected because it could be funded through the Vaccines for Children program.

⁵ CDC's statement attributed improved flu and pneumococcal vaccination levels to the CDC's collaboration with CMS to encourage and promote "standing orders," which allows facilities to provide vaccinations without a prescription.

Chiron Acknowledges Potential Gaps In Influenza Vaccine Distribution

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