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October 2007 NVAC Meeting Minutes - page 33 / 40





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October 2007 NVAC Meeting Minutes

Dr. Baylor raised the question of whether the purpose of the plan had yet been addressed. Dr. Gordon responded that he understood it was to guide vaccine research and development (R and D) over the next 5 years. Dr. Baylor responded that R and D was only part of the equation and that the plan needed to address access—both to immunizations and to healthcare—more broadly.

Dr. Schwartz said that NIH did not want to be so presumptuous as to tell other agencies what research they should conduct. He said that R and D represents less than 25 percent of preparedness overall and that research by its nature does not lend itself to prioritization.

Dr. Schuchat stated that the plan’s focus should be more on establishing a strong research infrastructure than addressing a “laundry list” of diseases. Dr. Gordon raised the point that the title of the Subcommittee includes both “development” and “supply,” which include much more than research. With this in mind, suggestions regarding research might best be general while those addressing development might well be specific.

Discussion of possible focus areas ensued.

Action Item: Those in attendance wishing to provide input to the National Vaccine Plan should submit comments on the existing draft to Dr. Strikas by November 2. There will be a conference call on November 8. Comments should address priorities and criteria for prioritization. Comments can address specific diseases as well as broader methodologies and enabling technologies.

Ms. Baciu, representing the IOM, reported that IOM efforts are currently in their early stages but would include a broad spectrum of stakeholders. Dr. Strikas will collect and process input from the general public and provide resultant data to IOM for inclusion. IOM’s final report is targeted for March 2009 in support of the goal of realizing a final plan by the latter part of 2009.

Subcommittee Role With Regard to Staphylococcus Vaccines—Dr. Cornelia L. Dekker, Subcommittee Chair

Dr. Dekker opened the discussion by asking what the Subcommittee’s role should be, given the recent widespread national media coverage of Methicillin-resistant Staphylococcus aureus (MRSA).

Dr. Schwartz said that MRSA had been a concern for a number of those attending and that ACIP Chair Jon Abramson had, at one point, proposed applying Unmet Needs funds to the problem.

Dr. Fridkin said the current focus to combat MRSA needs to be on the hospital. This includes identifying the burden of disease across the hospital population and characterizing trends to address appropriate strategies for vaccination. Dr. Curlin said the NIH needs specific information on community disease rates.

In the discussion that followed, Dr. Fridkin stated that CDC does have samples of the strains in question. Dr. Gordon said that establishing the burden of disease was key to any development efforts by industry. Dr. York confirmed that identifying the subpopulations at highest risk would be necessary for any proof-of-concept trials.

Dr. Curlin said that any efforts to combat MRSA had to be aimed at management of infection and of clinical treatment at the provider level. A number of efforts at developing vaccines are now being supported through the NIH Clinical Trial Planning Grant Program (R34).

Dr. Schuchat suggested that Staphylococcus efforts would be a prime example for informing the National Vaccine Plan. It might even suggest a future path to financing such efforts.

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