Washington Editor

Looking to avoid future flu shot scarcities such as this year's shortfall, the Government Reform Committee held its third hearing this year on the nation's flu vaccine program.

The committee, chaired by Rep. Tom Davis (R-Va.), took testimony from federal health officials, outside authorities and industry representatives, including Chiron Corp.'s Howard Pien. He serves as president and CEO of the Emeryville, Calif.-based company, which this year was unable to deliver about half the nation's flu vaccine supply because of contamination at a manufacturing site in the UK.

Davis blamed Chiron's misstep on "systematic problems based on a lack of manufacturing oversight." He added that all parties involved in the vaccination process should learn from this year's problem to "ensure that a similar situation does not occur in the future."

In advance of the hearing, Davis and four committee staff members spent last week in London meeting with British health authorities, as well as with representatives of Chiron and MedImmune Inc. The British health authorities suspended Chiron from manufacturing Fluvirin for three months at a site in Liverpool, a suspension that precluded the company from sending its expected shipment of 46 million to 48 million flu shots to the U.S. this year. (See BioWorld Today, Oct. 6, 2004.)

"This has been a painful experience," Pien said, "from which we are learning a great deal."

He detailed steps Chiron is taking to remedy its Liverpool facility in order to receive permission to produce and export its vaccine in time for the next flu season. Chiefly, the company has made a number of personnel changes, including a shift of employees from Chiron's overall operations into specific vaccine positions and the addition of outside consultants. Notably, Pien essentially has removed himself from the company's day-to-day operations by hiring a chief operating officer. In the meantime, Pien will focus on the UK facility.

"This plan addresses quality systems in a holistic manner," he said. "It covers personnel, procedures, equipment and infrastructure."

Looking beyond Chiron's plans, Pien pointed to longer-term fixes needed to stabilize the U.S. supply of flu vaccines. He said a stable supply is dependent upon domestic production from a variety of manufacturers, as opposed to the current setup in which 95 percent of the nation's supply is dependent on Chiron and Aventis, now part of Sanofi-Aventis Group, of Paris.

He said government policy should foster company innovation by ensuring demand, fair pricing and reimbursement, an efficient regulatory pathway and protection from liability. Pien ended his testimony on an ominous note.

"The pandemic clock is already ticking," he said. "Thus, we cannot afford any delay."

Other speakers addressed measures for avoiding flu vaccine shortages, including the use of technological advances to move away from chicken egg-based vaccine production. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., described the ability of cell culture- and recombinant DNA-based technology to supplant chicken egg-based vaccine production.

Julie Gerberding, the director of the Centers for Disease Control and Prevention in Atlanta, said the Department of Health and Human Services has applied for $100 million of budget financing to further develop those new vaccine production methods.

A day earlier, a Senate committee suggested to Lester Crawford, the acting commissioner of the FDA, that the budget would allow for the requested funding to be directed toward research to develop vaccines in cells instead of eggs. Crawford said he was "encouraged by Congress's positive response to the $100 million request."

For his part, Crawford was grilled by a number of committee members who questioned the FDA's handling of prior manufacturing contamination problems at the Chiron facility. Of note, issues arose in June 2003, a month before Chiron acquired the plant in its purchase of PowderJect Pharmaceuticals plc.

"The FDA failed to provide effective oversight," charged Rep. Henry Waxman (D-Calif.). He later added that "there is no better example of what's wrong at the FDA than its failures at the Chiron Liverpool facility."

Crawford defended the agency by noting that Fluvirin passed muster for the 2003-2004 flu season, concluding that the problem last year was resolved before this year's problem occurred.

Gerberding, Fauci and Crawford all agreed that in addition to using new production technologies, shortages could be avoided if more companies produced flu vaccines and antivirals for the U.S. market. Of note, MedImmune Inc. indicated that next year it could produce between 8 million and 10 million doses of FluMist, its intranasal flu vaccine. Crawford said the company, which is applying to expand the product's label from 5- to 49-year olds to include people up to 64, could produce up to 40 million doses by 2007.

Kathleen Coelingh, the senior director of regulatory and scientific affairs at Gaithersburg, Md.-based MedImmune, explained her support to the committee for tax incentives in order to encourage companies to research new technologies and also develop production facilities in the U.S.

While no single solution exists, one point can be agreed upon.

"We need to be sure that what happened this year never happens again," Davis said.