The National Vaccine Advisory Committee is forming an influenza strategy working group to "take a critical look" at the national influenza program.

At the NVAC meeting Feb. 3, HHS Acting Assistant Secretary for Health Cristina Beato, MD, charged NVAC and the Advisory Committee on Immunization Practices to "thoroughly step back, assess and review our national influenza program, and to report back to me at the June meeting."

The working group will prepare a preliminary report and map out the review by June. Then, after receiving further guidance from the Secretary's office, the group will complete a "thorough review," NVAC Executive Secretary Bruce Gellin, MD, said.

The review should ask "is this program still the best program that this country should have?" Beato said. "I don't want to see...what can be done to tweak it," but, rather, a more substantial review.

NVAC Chair Georges Peter, MD, Brown Medical School, said the working group will consider "how do we routinely enhance influenza coverage? How do we enhance influenza strain selection so that we can be prepared? What technology aspects should be addressed? Do we have adequate surge capacity?"

"The more important question - is our current immunization policy the appropriate one?" Peter said.

Beato suggested the working group consider "what pieces should we keep, if any? Do we keep it all? Does it need to be restructured? How will we set that up? What will be the critical pathways? How would we do this in a free market economy?"

"We want to make sure that the market enterprise is what will sustain the system for the long term," so discussion should include economists, Beato said.

"We've been not having any discussions about the cost/benefit of the influenza vaccine and what the benefit of major changes in strategy would be," Peter concurred. "I know those discussions take place, but that is an important element that we need to add to the deliberations."

The flu vaccine system has received substantial attention this year because of shortages of the vaccine and an early season that involved a strain not included in this year's formulation.

Sen. Larry Craig (R-Idaho) has introduced legislation under which the Centers for Disease Control & Prevention would establish the amount of vaccine needed each year and guarantee its purchase. CDC would contract with manufacturers by March 15 each year for production of necessary doses, and then purchase unused doses. The Flu Protection Act (¹ S 2038) was introduced Jan. 28.

The President's FY 2005 budget request released Feb. 2 includes $40 mil. "to stockpile influenza vaccine to meet exceptional demands," Beato told NVAC.

Both government purchasing plans were met with mixed reactions from manufacturers.

"Demand created by guaranteed purchases would be artificial if not accompanied by an increase in vaccinations," Chiron VP-Strategic Planning Clement Lewin, PhD, said.

Lewin and Aventis VP-Public Policy & Governmental Affairs Christine Grant said manufacturers would participate in government purchasing programs but warned against neglecting efforts to increase demand.

"Large-scale government purchasing of the vaccine has the potential - just the potential - of disrupting the current private sector distribution system," Lewin said.

"We have concerns about the long-term viability of any drug purchase program where doses are destroyed. Essentially, the program would achieve its goals in the short term, but Chiron believes - as does Aventis - that real demand for influenza vaccine must be increased if supply is to grow in the long term," Lewin explained.

In efforts to reach more patients, both manufacturers are considering extending the immunization season.

Strain selection for the 2004-2005 flu season has begun. The World Health Organization is meeting Feb. 11-13 to make recommendations, and the Vaccines & Related Biological Products Advisory Committee will make recommendations Feb. 18-19. [To watch a ² webcast or video of the meeting, go to FDAAdvisoryCommittee.com.]

Flu Vaccine Program Review Will Consider “Major Changes In Strategy”

More from Archive

More from Pink Sheet